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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03569293
Registration number
NCT03569293
Ethics application status
Date submitted
14/06/2018
Date registered
26/06/2018
Date last updated
5/03/2024
Titles & IDs
Public title
Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)
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Scientific title
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
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Secondary ID [1]
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2022-502938-30-00
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Secondary ID [2]
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M16-045
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Universal Trial Number (UTN)
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Trial acronym
Measure Up 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo for Upadacitinib
Treatment: Drugs - Upadacitinib
Placebo Comparator: Placebo / Upadacitinib - Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260.
Experimental: Upadacitinib 15 mg QD - Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks.
Experimental: Upadacitinib 30 mg QD - Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks.
Treatment: Drugs: Placebo for Upadacitinib
Tablets taken orally once a day
Treatment: Drugs: Upadacitinib
Tablets taken orally once a day
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16
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Assessment method [1]
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EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
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Timepoint [1]
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Baseline and Week 16
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Primary outcome [2]
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Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of = 2 Points at Week 16
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Assessment method [2]
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The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:
0 - Clear: No inflammatory signs of AD;
1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;
3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present;
4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.
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Timepoint [2]
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Baseline and Week 16
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Secondary outcome [1]
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Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16
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Assessment method [1]
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Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
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Timepoint [1]
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Baseline (last available rolling average before the first dose of study drug) and Week 16
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Secondary outcome [2]
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Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16
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Assessment method [2]
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EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
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Timepoint [2]
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Baseline and Week 16
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Secondary outcome [3]
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Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 4
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Assessment method [3]
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Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
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Timepoint [3]
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Baseline (last available rolling average before the first dose of study drug) and Week 4
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Secondary outcome [4]
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Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2
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Assessment method [4]
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EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.
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Timepoint [4]
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Baseline and Week 2
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Secondary outcome [5]
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Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 1
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Assessment method [5]
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Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
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Timepoint [5]
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Baseline (last available rolling average before the first dose of study drug) and Week 1
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Secondary outcome [6]
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Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Day 2
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Assessment method [6]
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Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
The percentage of participants who had a 4-point or greater improvement from Baseline in Worst Pruritus NRS score at Day 2 was pre-specified as a ranked secondary endpoint for participants in the upadacitinib 30 mg group versus placebo group only.
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Timepoint [6]
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Baseline and Day 2
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Secondary outcome [7]
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Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Day 3
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Assessment method [7]
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Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
The percentage of participants who had a 4-point or greater improvement in Worst Pruritus NRS score from Baseline at Day 3 was pre-specified as a ranked secondary endpoint for participants in the upadacitinib 15 mg group versus placebo group only.
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Timepoint [7]
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Baseline and Day 3
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Secondary outcome [8]
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Main Study: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period
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Assessment method [8]
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A flare, characterized as a clinically meaningful worsening in EASI, is defined as an increase in EASI score of = 6.6 points from Baseline during the double-blind treatment period and prior to use of any rescue medication. Flare was assessed in participants with an EASI score of 65.4 or less at Baseline.
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Timepoint [8]
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From first dose of study drug to Week 16
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Secondary outcome [9]
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Main Study: Percentage of Participants Achieving a Reduction of = 12 Points From Baseline in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score at Week 16
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Assessment method [9]
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The ADerm-IS is a 10-item patient reported outcome (PRO) questionnaire designed to assess a variety of impacts that participants experience from their AD.
The ADerm-IS sleep domain consists of 3 questions designed to assess the impact of AD on sleep on a daily basis over a 24-hour recall period. The items include difficulty falling asleep, impact on sleep, and waking at night. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The ADerm-IS sleep domain score is the sum of the 3 item scores and ranges from 0 (no impact) to 30 (worst impact). The ADerm-IS sleep domain was analyzed based on weekly rolling averages of daily scores.
The minimal clinically important difference for ADerm-IS sleep domain score is 12.
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Timepoint [9]
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Baseline (last available rolling average before the first dose of study drug) and Week 16
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Secondary outcome [10]
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Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score at Week 16
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Assessment method [10]
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The ADerm-SS is an 11-item PRO questionnaire designed to assess signs and symptoms that patients may experience due to AD using a 24-hour recall period. For the skin pain item participants were asked on a daily basis to indicate how bad their worst skin pain due to AD was in the past 24 hours on an NRS from 0 (no pain) to 10 (worst imaginable pain). The ADerm-SS skin pain score was analyzed using weekly rolling averages of daily scores. The minimal clinically important difference for ADerm-SS skin pain score is 4.
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Timepoint [10]
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Baseline (last available rolling average before the first dose of study drug) and Week 16
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Secondary outcome [11]
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Main Study: Percentage of Participants Achieving a Reduction of = 28 Points From Baseline in ADerm-SS 7-Item Total Symptom Score (TSS-7) at Week 16
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Assessment method [11]
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The ADerm-SS is an 11-item questionnaire designed to assess signs and symptoms that participants may experience due to AD using a 24-hour recall period. The 7-item total symptom score includes 7 symptoms (items 1-7 of the ADerm-SS), each assessed on a NRS from 0 (no symptom) to 10 (worst imaginable). The 7 symptoms included in the score are itch while asleep, itch while awake, skin pain (each assessed daily), skin cracking, skin cracking pain, dry skin, and skin flaking (assessed weekly). The TSS-7 score ranges from 0 to 70, with higher scores indicating worsening symptoms. The minimal clinically important difference for ADerm-SS TSS-7 is 28.
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Timepoint [11]
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Baseline and Week 16
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Secondary outcome [12]
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Main Study: Percentage of Participants Achieving a Reduction of = 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16
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Assessment method [12]
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The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.
ADerm-IS emotional state sums three items [Items 8-10] measuring self-consciousness, embarrassment, and sadness with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The emotional state domain score ranges from 0 to 30, where higher scores represent worst impact.
The minimal clinically important difference for ADerm-IS emotional state domain score is 11.
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Timepoint [12]
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Baseline and Week 16
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Secondary outcome [13]
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Main Study: Percentage of Participants Achieving a Reduction of = 14 Points From Baseline in in ADerm-IS Daily Activities Domain Score at Week 16
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Assessment method [13]
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The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.
ADerm-IS daily activities sums four items measuring limitations of household, physical, and social activities, and difficulty concentrating with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The daily activities domain score ranges from 0 to 40, where higher scores represent worst impact.
The minimal clinically important difference for the ADerm-IS daily activities domain score is 14.
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Timepoint [13]
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Baseline and Week 16
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Secondary outcome [14]
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Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16
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Assessment method [14]
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EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
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Timepoint [14]
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Baseline and Week 16
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Secondary outcome [15]
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Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16
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Assessment method [15]
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Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.
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Timepoint [15]
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Baseline (last available rolling average before the first dose of study drug) and Week 16
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Secondary outcome [16]
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Main Study: Percent Change From Baseline in EASI Score at Week 16
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Assessment method [16]
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EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1)] moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.
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Timepoint [16]
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Baseline and Week 16
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Secondary outcome [17]
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Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 16
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Assessment method [17]
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The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.
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Timepoint [17]
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Baseline and Week 16
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Secondary outcome [18]
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Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
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Assessment method [18]
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The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.
the DLQI was administered to participants who were = 16 (16 to 75) years old at the time of the Screening visit.
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Timepoint [18]
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Baseline and Week 16
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Secondary outcome [19]
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Main Study: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16
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Assessment method [19]
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SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.
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Timepoint [19]
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Baseline and Week 16
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Secondary outcome [20]
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Main Study: Percentage of Participants Achieving a Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score and Hospital Anxiety and Depression Scale-Depression (HADS-D) Score of < 8 at Week 16
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Assessment method [20]
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The HADS is a 14-item questionnaire, with seven items related to anxiety (HADS-A) and seven items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each domain, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression.
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Timepoint [20]
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Baseline and Week 16
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Secondary outcome [21]
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Main Study: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16
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Assessment method [21]
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The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.
the DLQI was administered to participants who were = 16 (16 to 75) years old at the time of the Screening visit.
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Timepoint [21]
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Week 16
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Secondary outcome [22]
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Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16
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Assessment method [22]
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EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.
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Timepoint [22]
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Baseline and Week 16
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Secondary outcome [23]
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Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of = 2 Points at Week 16
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Assessment method [23]
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The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:
0 - Clear: No signs of AD;
1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;
3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting;
4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.
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Timepoint [23]
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Baseline and Week 16
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Secondary outcome [24]
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Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 16
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Assessment method [24]
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Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.
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Timepoint [24]
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Baseline (last available rolling average before the first dose of study drug) and Week 16
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Secondary outcome [25]
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Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16
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Assessment method [25]
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EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.
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Timepoint [25]
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Baseline and Week 16
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Secondary outcome [26]
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Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 4
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Assessment method [26]
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Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.
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Timepoint [26]
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Baseline (last available rolling average before the first dose of study drug) and Week 4
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Secondary outcome [27]
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Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2
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Assessment method [27]
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EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.
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Timepoint [27]
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Baseline and Week 2
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Secondary outcome [28]
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Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 1
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Assessment method [28]
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Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.
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Timepoint [28]
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Baseline (last available rolling average before the first dose of study drug) and Week 1
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Secondary outcome [29]
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Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Day 2
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Assessment method [29]
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Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
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Timepoint [29]
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Baseline and Day 2
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Secondary outcome [30]
0
0
Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Day 3
Query!
Assessment method [30]
0
0
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Query!
Timepoint [30]
0
0
Baseline and Day 3
Query!
Secondary outcome [31]
0
0
Adolescents: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period
Query!
Assessment method [31]
0
0
A flare, characterized as a clinically meaningful worsening in EASI, is defined as an increase in EASI score of = 6.6 points from Baseline during the double-blind treatment period and prior to use of any rescue medication. Flares were assessed in participants with an EASI score of 65.4 or less at Baseline.
Query!
Timepoint [31]
0
0
From first dose of study drug to Week 16
Query!
Secondary outcome [32]
0
0
Adolescents: Percentage of Participants Achieving a Reduction of = 12 Points From Baseline in ADerm-IS Sleep Domain Score at Week 16
Query!
Assessment method [32]
0
0
The ADerm-IS is a 10-item patient reported outcome questionnaire designed to assess a variety of impacts that participants experience from their AD.
The ADerm-IS sleep domain consists of 3 questions designed to assess the impact of AD on sleep on a daily basis over a 24-hour recall period. The items include difficulty falling asleep, impact on sleep, and waking at night. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The ADerm-IS sleep domain score is the sum of the 3 item scores and ranges from 0 (no impact) to 30 (worst impact). The ADerm-IS sleep domain was analyzed based on weekly rolling averages of daily scores.
The minimal clinically important difference for ADerm-IS sleep domain score is 12.
Query!
Timepoint [32]
0
0
Baseline (last available rolling average before the first dose of study drug) and Week 16
Query!
Secondary outcome [33]
0
0
Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in ADerm-SS Skin Pain Score at Week 16
Query!
Assessment method [33]
0
0
The ADerm-SS is an 11-item PRO questionnaire designed to assess signs and symptoms that patients may experience due to AD using a 24-hour recall period. For the skin pain item participants were asked to indicate on a daily basis how bad their worst skin pain due to AD was in the past 24 hours on an NRS from 0 (no pain) to 10 (worst imaginable pain). The minimal clinically important difference for ADerm-SS skin pain score is 4.
The ADerm-SS skin pain score was analyzed based on weekly rolling averages of daily scores.
Query!
Timepoint [33]
0
0
Baseline (last available rolling average before the first dose of study drug) and Week 16
Query!
Secondary outcome [34]
0
0
Adolescents: Percentage of Participants Achieving a Reduction of = 28 Points From Baseline in ADerm-SS TSS-7 at Week 16
Query!
Assessment method [34]
0
0
The ADerm-SS is an 11-item questionnaire designed to assess signs and symptoms that participants may experience due to AD using a 24-hour recall period. The 7-item total symptom score includes 7 symptoms (items 1-7 of the ADerm-SS), each assessed on a NRS from 0 (no symptom) to 10 (worst imaginable). The 7 symptoms included in the score are itch while asleep, itch while awake, skin pain (each assessed daily), skin cracking, skin cracking pain, dry skin, and skin flaking (assessed weekly). The TSS-7 score ranges from 0 to 70, with higher scores indicating worsening symptoms. The minimal clinically important difference for ADerm-SS TSS-7 is 28.
Query!
Timepoint [34]
0
0
Baseline and Week 16
Query!
Secondary outcome [35]
0
0
Adolescents: Percentage of Participants Achieving a Reduction of = 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16
Query!
Assessment method [35]
0
0
The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.
ADerm-IS emotional state sums three items [Items 8-10] measuring self-consciousness, embarrassment, and sadness with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The emotional state domain score ranges from 0 to 30, where higher scores represent worst impact.
The minimal clinically important difference for ADerm-IS emotional state domain score is 11.
Query!
Timepoint [35]
0
0
Baseline and Week 16
Query!
Secondary outcome [36]
0
0
Adolescents: Percentage of Participants Achieving a Reduction of = 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16
Query!
Assessment method [36]
0
0
The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.
ADerm-IS daily activities sums four items measuring limitations of household, physical, and social activities, and difficulty concentrating with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The daily activities domain score ranges from 0 to 40, where higher scores represent worst impact.
The minimal clinically important difference for the ADerm-IS daily activities domain score is 14.
Query!
Timepoint [36]
0
0
Baseline and Week 16
Query!
Secondary outcome [37]
0
0
Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16
Query!
Assessment method [37]
0
0
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
An EASI 100 response is defined as a 100% reduction (improvement) from Baseline in EASI score.
Query!
Timepoint [37]
0
0
Baseline and Week 16
Query!
Secondary outcome [38]
0
0
Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16
Query!
Assessment method [38]
0
0
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.
Query!
Timepoint [38]
0
0
Baseline (last available rolling average before the first dose of study drug) and Week 16
Query!
Secondary outcome [39]
0
0
Adolescents: Percent Change From Baseline in EASI Score at Week 16
Query!
Assessment method [39]
0
0
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1)] moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.
Query!
Timepoint [39]
0
0
Baseline and Week 16
Query!
Secondary outcome [40]
0
0
Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in POEM Total Score at Week 16
Query!
Assessment method [40]
0
0
The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.
Query!
Timepoint [40]
0
0
Baseline and Week 16
Query!
Secondary outcome [41]
0
0
Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in DLQI Score at Week 16
Query!
Assessment method [41]
0
0
The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.
the DLQI was administered to participants who were = 16 (16 to 75) years old at the time of the Screening visit.
Query!
Timepoint [41]
0
0
Baseline and Week 16
Query!
Secondary outcome [42]
0
0
Adolescents: Percent Change From Baseline in SCORAD Score at Week 16
Query!
Assessment method [42]
0
0
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.
Query!
Timepoint [42]
0
0
Baseline and Week 16
Query!
Secondary outcome [43]
0
0
Adolescents: Percentage of Participants Achieving HADS-A Score and HADS-D Score of < 8 at Week 16
Query!
Assessment method [43]
0
0
The HADS is a 14-item questionnaire, with seven items related to anxiety (HADS-A) and seven items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each domain, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression.
Query!
Timepoint [43]
0
0
Baseline and Week 16
Query!
Secondary outcome [44]
0
0
Adolescents: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16
Query!
Assessment method [44]
0
0
The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.
the DLQI was administered to participants who were = 16 (16 to 75) years old at the time of the Screening visit.
Query!
Timepoint [44]
0
0
Baseline and Week 16
Query!
Eligibility
Key inclusion criteria
- Body weight of = 40 kg at Baseline Visit for participants between = 12 and < 18 years
of age
- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline
Visit and subject meets Hanifin and Rajka criteria.
- Active moderate to severe AD defined by:
- Eczema Area and Severity Index (EASI) score = 16 at the Screening and Baseline
Visits;
- Validated Investigator's Global Assessment (vIGA) score = 3 at the Screening and
Baseline Visits;
- = 10% Body surface area (BSA) of AD involvement at the Screening and Baseline
Visits;
- Baseline weekly average of daily Worst Pruritus NRS = 4.
- Candidate for systemic therapy or have recently required systemic therapy for AD
- Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days
before the Baseline Visit.
- Documented history of inadequate response to topical corticosteroids (TCS) or topical
calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months
before Baseline Visit
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Prior exposure to any Janus kinase (JAK) inhibitor
- Unable or unwilling to discontinue current atopic dermatitis treatments prior to the
study
- Requirement of prohibited medications during the study
- Other active skin diseases or skin infections requiring systemic treatment or would
interfere with appropriate assessment of atopic dermatitis lesions
- Female subject who is pregnant, breastfeeding, or considering pregnancy during the
study
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
13/08/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
9/10/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
912
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Woden Dermatology /ID# 205799 - Phillip
Query!
Recruitment hospital [2]
0
0
Holdsworth House Medical Practice /ID# 211236 - Darlinghurst
Query!
Recruitment hospital [3]
0
0
North Eastern Health Specialists /ID# 205802 - Hectorville
Query!
Recruitment hospital [4]
0
0
Skin Health Institute Inc /ID# 204791 - Carlton
Query!
Recruitment hospital [5]
0
0
Fremantle Dermatology /ID# 205305 - Fremantle
Query!
Recruitment postcode(s) [1]
0
0
2606 - Phillip
Query!
Recruitment postcode(s) [2]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [3]
0
0
5073 - Hectorville
Query!
Recruitment postcode(s) [4]
0
0
3053 - Carlton
Query!
Recruitment postcode(s) [5]
0
0
6160 - Fremantle
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Michigan
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Nebraska
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nevada
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Hampshire
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New York
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Ohio
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Oklahoma
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Oregon
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Pennsylvania
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Rhode Island
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
South Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Texas
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Washington
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Buenos Aires
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Ciuadad Autonoma De Buenos Aires
Query!
Country [26]
0
0
Bosnia and Herzegovina
Query!
State/province [26]
0
0
Republika Srpska
Query!
Country [27]
0
0
Bosnia and Herzegovina
Query!
State/province [27]
0
0
Sarajevo
Query!
Country [28]
0
0
Bulgaria
Query!
State/province [28]
0
0
Sofia
Query!
Country [29]
0
0
Bulgaria
Query!
State/province [29]
0
0
Pleven
Query!
Country [30]
0
0
Bulgaria
Query!
State/province [30]
0
0
Stara Zagora
Query!
Country [31]
0
0
Canada
Query!
State/province [31]
0
0
Alberta
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
British Columbia
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Manitoba
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
New Brunswick
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Newfoundland and Labrador
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
Ontario
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Quebec
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Beijing
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Guangdong
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Liaoning
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Shanghai
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Zhejiang
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Wuhan
Query!
Country [44]
0
0
Colombia
Query!
State/province [44]
0
0
Antioquia
Query!
Country [45]
0
0
Colombia
Query!
State/province [45]
0
0
Atlantico
Query!
Country [46]
0
0
Colombia
Query!
State/province [46]
0
0
Cordoba
Query!
Country [47]
0
0
Croatia
Query!
State/province [47]
0
0
Grad Zagreb
Query!
Country [48]
0
0
Croatia
Query!
State/province [48]
0
0
Osjecko-baranjska Zupanija
Query!
Country [49]
0
0
Croatia
Query!
State/province [49]
0
0
Primorsko-goranska Zupanija
Query!
Country [50]
0
0
Croatia
Query!
State/province [50]
0
0
Splitsko-dalmatinska Zupanija
Query!
Country [51]
0
0
Denmark
Query!
State/province [51]
0
0
Hovedstaden
Query!
Country [52]
0
0
Denmark
Query!
State/province [52]
0
0
Midtjylland
Query!
Country [53]
0
0
Estonia
Query!
State/province [53]
0
0
Harjumaa
Query!
Country [54]
0
0
Estonia
Query!
State/province [54]
0
0
Tartumaa
Query!
Country [55]
0
0
Finland
Query!
State/province [55]
0
0
Varsinais-Suomi
Query!
Country [56]
0
0
Finland
Query!
State/province [56]
0
0
Kuopio
Query!
Country [57]
0
0
Finland
Query!
State/province [57]
0
0
Tampere
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Auvergne-Rhone-Alpes
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Pays-de-la-Loire
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Sarthe
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Lille Cedex
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Martigues
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Paris
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Rouen
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Toulouse
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Bayern
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Hessen
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Nordrhein-Westfalen
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Rheinland-Pfalz
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Schleswig-Holstein
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Bonn
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Hamburg
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Hannover
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Mainz
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Roma
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Ancona
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Bologna
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Catania
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Napoli
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Perak
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Ponce
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San Juan
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Cluj Napoca
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Russian Federation
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Russian Federation
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Geneve
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London, City Of
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United Kingdom
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United Kingdom
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Salford
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Funding & Sponsors
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Commercial sector/Industry
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Name
AbbVie
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Summary
Brief summary
The objective of this study is to assess the efficacy and safety of upadacitinib for the
treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD)
who are candidates for systemic therapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03569293
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Principal investigator
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ABBVIE INC.
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AbbVie
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03569293
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