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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/NCT05507580
Registration number
NCT05507580
Ethics application status
Date submitted
18/08/2022
Date registered
19/08/2022
Date last updated
26/01/2024
Titles & IDs
Public title
A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis
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Scientific title
A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects With Moderate to Severe Atopic Dermatitis
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Secondary ID [1]
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2022-000434-42
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Secondary ID [2]
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M22-000
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Universal Trial Number (UTN)
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Trial acronym
Flex-Up
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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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0
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Dermatological conditions
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Skin
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0
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Other skin conditions
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib
Experimental: Double-Blind Treatment Period Dose A - Participants will be administered updadacitinib Dose A once daily (QD) for 12 weeks.
Experimental: Double-Blind Treatment Period Dose B - Participants will be administered updadacitinib Dose B once daily (QD) for 12 weeks.
Experimental: Single-Blinded Treatment Period Arm A - Participants will be administered updadacitinib once daily (QD) for 12 weeks.
Experimental: Single-Blinded Treatment Period Arm B - Participants will be administered updadacitinib once daily (QD) for 12 weeks.
Experimental: Single-Blinded Treatment Period Arm C - Participants will be administered updadacitinib once daily (QD) for 12 weeks.
Experimental: Single-Blinded Treatment Period Arm D - Participants will be administered updadacitinib once daily (QD) for 12 weeks.
Treatment: Drugs: Upadacitinib
Oral tablet
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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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Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 90
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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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Week 24
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Secondary outcome [1]
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Percentage of Participants Achieving EASI 75
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Assessment method [1]
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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.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Percentage of Participants Achieving EASI 100
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Assessment method [2]
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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.
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Timepoint [2]
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Up to Week 24
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Secondary outcome [3]
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Percentage of Participants Achieving EASI 75
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Assessment method [3]
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.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Percentage of Participants Achieving EASI 90
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Assessment method [4]
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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.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Percentage of Participants Achieving EASI 100
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Assessment method [5]
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.
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Percentage of Participants Achieving EASI 90 and Worst Pruritus Numerical Rating Scale (NRS) of 0 or 1
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Assessment method [6]
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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 final EASI score ranges from 0 to 72 where higher scores represent worse disease.
Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours.
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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Percentage of Participants Achieving EASI 90 and Worst Pruritus NRS of 0 or 1
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Assessment method [7]
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 final EASI score ranges from 0 to 72 where higher scores represent worse disease.
Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours.
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Timepoint [7]
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Week 24
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Secondary outcome [8]
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Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1
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Assessment method [8]
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vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.
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Timepoint [8]
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Up to Week 24
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Secondary outcome [9]
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Percentage of Participants Achieving Improvement (reduction) in Worst Pruritus NRS of >= 4
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Assessment method [9]
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Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours. Higher score denoting worse itch.
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Timepoint [9]
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0
Up to Week 24
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Secondary outcome [10]
0
0
Percentage of Participants Achieving Worst Pruritus NRS of 0 or 1
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Assessment method [10]
0
0
Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours. Higher score denoting worse itch.
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Timepoint [10]
0
0
Up to Week 24
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Secondary outcome [11]
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Percentage of Participants Achieving Improvement (reduction) in Dermatology Life Quality Index (DLQI) of >= 4
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Assessment method [11]
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DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. 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 (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
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Timepoint [11]
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Up to Week 24
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Secondary outcome [12]
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Percentage of Participants Achieving DLQI of 0 or 1
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Assessment method [12]
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0
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. 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 (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
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Timepoint [12]
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Up to Week 24
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Eligibility
Key inclusion criteria
- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to
Baseline and participant meets Hanifin and Rajka criteria.
- Eczema Area and Severity Index (EASI) score >= 16, vIGA-AD score >= 3 and >= 10% Body
Surface Area (BSA) of AD involvement at the Baseline Visit.
- Baseline weekly average of daily Worst Pruritus NRS >= 4.
- Candidate for systemic treatment defined as prior use of systemic treatment for AD, OR
previous inadequate response to TCS, TCI or PDE-4 inhibitors, OR for whom topical
treatments are otherwise medically inadvisable.
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Minimum age
18
Years
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Maximum age
64
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants with current or past history of infection including:
- Two or more episodes of herpes zoster, or one or more episodes of disseminated
herpes zoster;
- One or more episodes of disseminated herpes simplex (including eczema
herpeticum);
- Human immunodeficiency virus (HIV) infection defined as confirmed positive
anti-HIV antibody (HIV Ab) test;
- Active tuberculosis (TB) or meet TB exclusionary parameters (protocol specified
requirements for TB testing);
- Japan only: Positive result of beta-D-glucan (screening for Pneumocystis
jirovecii infection) or two consecutive indeterminate results of beta-D-glucan
during the Screening Period;
- Active infection(s) requiring treatment with intravenous anti-infectives within
30 days, or oral/intramuscular anti-infectives within 14 days prior to the
Baseline Visit;
- Chronic recurring infection and/or active viral infection that, based on the
investigator's clinical assessment, makes the participant an unsuitable candidate
for the study;
- COVID-19 infection: In participants who tested positive for COVID, at least 5
days must have passed since a COVID-19 positive test result for study entry of
asymptomatic participants. Participants with mild/moderate COVID-19 infection can
be enrolled if fever is resolved without use of antipyretics for 24 hours and
other symptoms improved, or if 5 days have passed since the COVID-19 positive
test result (whichever comes last). Participants may be rescreened if judged to
be in good general health, as determined by the investigator based upon the
medical history and physical examination.
- Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
- Any of the following medical diseases or disorders:
- Recent (within past 6 months) cerebrovascular accident, myocardial infarction,
coronary stenting, and aorto-coronary bypass surgery;
- History of an organ transplant which requires continued immunosuppression;
- History of an allergic reaction or significant sensitivity to constituents of the
study drug (and its excipients) and/or other products in the same class;
- History of gastrointestinal perforation (other than due to appendicitis or
mechanical injury), diverticulitis, or significantly increased risk for
gastrointestinal perforation per investigator judgment;
- Conditions that could interfere with drug absorption including but not limited to
short bowel syndrome or gastric bypass surgery; participants with a history of
gastric banding/segmentation are not excluded;
- History of malignancy except for successfully treated non-melanoma skin cancer
(NMSC) or localized carcinoma in situ of the cervix.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Other
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/05/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
9/08/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
461
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Holdsworth House Medical Practice /ID# 254028 - Darlinghurst
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Recruitment hospital [2]
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Premier Specialist /ID# 246150 - Kogarah
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Recruitment hospital [3]
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Veracity Clinical Research /ID# 246154 - Woolloongabba
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Recruitment hospital [4]
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North Eastern Health Specialists /ID# 246153 - Campbelltown
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Recruitment hospital [5]
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Skin Health Institute Inc /ID# 246146 - Carlton
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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5074 - Campbelltown
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Recruitment postcode(s) [5]
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3053 - Carlton
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Bruxelles-Capitale
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Belgium
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Hainaut
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Belgium
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Oost-Vlaanderen
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0
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Belgium
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Gent
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0
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Belgium
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Liege
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Bulgaria
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Sofia
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Bulgaria
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Pleven
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Bulgaria
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Sofiya
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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China
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Beijing
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China
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Guangdong
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China
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Liaoning
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China
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Shanghai
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Germany
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Hessen
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Germany
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Nordrhein-Westfalen
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Bad Bentheim
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Bramsche
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Buxtehude
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Darmstadt
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Germany
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Friedrichshafen
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Germany
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Halle (Saale)
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Germany
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Hamburg
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Germany
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Mahlow
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Germany
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Mainz
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Hungary
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Heves
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Milano
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Italy
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Italy
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Italy
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Chieti
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Italy
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Milan
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Chiba
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Fukuoka
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Hokkaido
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Tokyo
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Gyeonggido
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Seoul Teugbyeolsi
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Seoul
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Amsterdam
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Breda
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New Zealand
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Auckland
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New Zealand
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Hamilton
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Kujawsko-pomorskie
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Lodzkie
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Slaskie
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Wielkopolskie
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Bydgoszcz
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Porto
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Martin
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Madrid
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Alicante
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Spain
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Pontevedra
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Edinburgh
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United Kingdom
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Funding & Sponsors
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Commercial sector/Industry
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AbbVie
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Summary
Brief summary
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to
inflammation of the skin. Therapies spread over the skin may not be enough to control the AD
in trial participants who require systemic anti-inflammatory treatment. This study evaluates
the dosing flexibility of upadacitinib in adult participants with moderate to severe AD.
Adverse events and change in the disease activity will be assessed.
Upadacitinib is an approved drug for the treatment of moderate to severe/active
immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis,
ankylosing spondylitis, ulcerative colitis (UC), Crohn's Disease (CD), and AD. The study is
comprised of a 35-day Screening Period, a 12-week double-blind period and a 12-week
single-blind period. During the double-blind period, participants are placed in 1 of 2
groups, called treatment arms and will be randomized in a 1:1 ratio to receive upadacitinib.
At 12 weeks during the single blind period, participants will be blinded to the upadacitinib
dose based on their EASI response and reassigned to in 1 of 4 arms. After the last study
visit, there is a 30-day follow-up visit. Approximately 454 adult participants ages 18 to 64
with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to
160 sites worldwide.
The study is comprised of a 12-week double-blind period, followed by a 12-week single-blind
period. Participants will receive upadacitinib oral tablets once daily for up to 24 weeks.
There may be higher treatment burden for participants in this trial compared to their
standard of care (due to study procedures). Participants will attend regular visits during
the study at a hospital or clinic. The effect of the treatment will be checked by medical
assessments, blood tests, checking for side effects and completing questionnaires.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05507580
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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/NCT05507580
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