Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- AbbVie
- Study ID
- NCT03569293
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Placebo for Upadacitinib — DRUGTablets taken orally once a day
- Upadacitinib — DRUGTablets taken orally once a day
Study Details
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.
Key Dates
- Start date
- Aug 13, 2018
- Status verified
- Oct 2025
- Primary completion
- Jan 6, 2021
- Completion
- Oct 10, 2025
Study Design
- Enrollment
- 912 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Placebo / UpadacitinibParticipants 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 QDParticipants will receive upadacitinib 15 mg orally once a day for up to 260 weeks.
- Experimental: Upadacitinib 30 mg QDParticipants will receive upadacitinib 30 mg orally once a day for up to 260 weeks.
Primary Outcome Measure
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 [ Time Frame: Baseline and Week 16 ]
Locations (58)
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Alliance Dermatology and MOHs· Phoenix, AZClear Dermatology & Aesthetics Center· Scottsdale, AZBakersfield Derma & Skin Cance· Bakersfield, CAFirst OC Dermatology· Fountain Valley, CACalifornia Allergy and Asthma Medical Group· Los Angeles, CAAllergy & Asthma Associates of Southern California· Mission Viejo, CA
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