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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/NCT03607422
Registration number
NCT03607422
Ethics application status
Date submitted
25/07/2018
Date registered
31/07/2018
Date last updated
5/03/2024
Titles & IDs
Public title
A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)
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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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2022-502936-38-00
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Secondary ID [2]
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M18-891
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Universal Trial Number (UTN)
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Trial acronym
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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, no oozing or crusting;
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). Worst 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). Worst 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). Worst 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 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). Worst 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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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, no oozing or crusting;;
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
Query!
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). Worst 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
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
Week 16
Query!
Eligibility
Key inclusion criteria
- Body weight of = 40 kg at Baseline Visit for participants = 12 and < 18 years of age
- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to
Baseline and subject meets Hanifin and Rajka criteria
- Active moderate to severe AD defined by Eczema Area and Severity Index (EASI) = 16,
validated Investigator's Global Assessment (vIGA) = 3, body surface area (BSA)
affected by AD = 10%, and weekly average of daily Worst Pruritus numerical rating
scale (NRS) score = 4.
- Candidate for systemic therapy or have recently required systemic therapy for AD
- Documented history (within 6 months prior to Baseline) of inadequate response to
topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented
systemic treatment for AD or for whom topical treatments are otherwise medically
inadvisable due to side effects or safety risks
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 AD 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
27/07/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
3/12/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
912
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
The Skin Hospital /ID# 217846 - Westmead
Query!
Recruitment hospital [2]
0
0
The Skin Centre /ID# 205922 - Benowa
Query!
Recruitment hospital [3]
0
0
Box Hill Hospital /ID# 206023 - Box Hill
Query!
Recruitment hospital [4]
0
0
Monash Children's Hospital /ID# 217917 - Clayton
Query!
Recruitment hospital [5]
0
0
Sinclair Dermatology /ID# 217791 - East Melbourne
Query!
Recruitment hospital [6]
0
0
The Royal Melbourne Hospital /ID# 205919 - Parkville
Query!
Recruitment hospital [7]
0
0
Murdoch Children's Research Institute /ID# 205667 - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [2]
0
0
4217 - Benowa
Query!
Recruitment postcode(s) [3]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [4]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [5]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [6]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [7]
0
0
3052 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Connecticut
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Idaho
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Illinois
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Indiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kansas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maryland
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Massachusetts
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Michigan
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nebraska
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Jersey
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Mexico
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New York
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
North Carolina
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Ohio
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Oklahoma
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oregon
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Tennessee
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Texas
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Utah
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Vermont
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Virginia
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Washington
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Wisconsin
Query!
Country [31]
0
0
Austria
Query!
State/province [31]
0
0
Niederoesterreich
Query!
Country [32]
0
0
Austria
Query!
State/province [32]
0
0
Oberoesterreich
Query!
Country [33]
0
0
Austria
Query!
State/province [33]
0
0
Wien
Query!
Country [34]
0
0
Austria
Query!
State/province [34]
0
0
Salzburg
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Bruxelles-Capitale
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Oost-Vlaanderen
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Liege
Query!
Country [38]
0
0
Bulgaria
Query!
State/province [38]
0
0
Sofia
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Alberta
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
British Columbia
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Newfoundland and Labrador
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Ontario
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Saskatchewan
Query!
Country [44]
0
0
Croatia
Query!
State/province [44]
0
0
Grad Zagreb
Query!
Country [45]
0
0
Croatia
Query!
State/province [45]
0
0
Zagrebacka Zupanija
Query!
Country [46]
0
0
Czechia
Query!
State/province [46]
0
0
Plzen
Query!
Country [47]
0
0
Czechia
Query!
State/province [47]
0
0
Praha
Query!
Country [48]
0
0
Czechia
Query!
State/province [48]
0
0
Usti nad Labem
Query!
Country [49]
0
0
Denmark
Query!
State/province [49]
0
0
Midtjylland
Query!
Country [50]
0
0
Denmark
Query!
State/province [50]
0
0
Sjælland
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Ile-de-France
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Bordeaux
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Brest
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Lorient
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Paris
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Schleswig-Holstein
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Darmstadt
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Dresden
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Hamburg
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Mahlow
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Simmern
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Witten
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Wuppertal
Query!
Country [64]
0
0
Greece
Query!
State/province [64]
0
0
Attiki
Query!
Country [65]
0
0
Greece
Query!
State/province [65]
0
0
Thessaloniki
Query!
Country [66]
0
0
Hungary
Query!
State/province [66]
0
0
Borsod-Abauj-Zemplen
Query!
Country [67]
0
0
Hungary
Query!
State/province [67]
0
0
Heves
Query!
Country [68]
0
0
Hungary
Query!
State/province [68]
0
0
Somogy
Query!
Country [69]
0
0
Hungary
Query!
State/province [69]
0
0
Veszprem
Query!
Country [70]
0
0
Hungary
Query!
State/province [70]
0
0
Budapest
Query!
Country [71]
0
0
Hungary
Query!
State/province [71]
0
0
Pecs
Query!
Country [72]
0
0
Ireland
Query!
State/province [72]
0
0
Dublin
Query!
Country [73]
0
0
Ireland
Query!
State/province [73]
0
0
Cork
Query!
Country [74]
0
0
Ireland
Query!
State/province [74]
0
0
Galway
Query!
Country [75]
0
0
Ireland
Query!
State/province [75]
0
0
Waterford
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Lazio
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Brescia
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Cagliari
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Italy
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Plymouth
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Commercial sector/Industry
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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/NCT03607422
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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/NCT03607422
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