Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)

Completed · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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 facts

Study ID

NCT03569293

Run by

AbbVie

People needed

912

Starts

2018-08-13

Expected to finish

2025-10-10

Last updated by the study team

2026-06-17

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body weight of ≥ 40 kg at Baseline Visit for participants between ≥ 12 and < 18 years of age
• Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline Visit and subject meets Hanifin and Rajka criteria.
• Active moderate to severe AD defined by:
• Eczema Area and Severity Index (EASI) score ≥ 16 at the Screening and Baseline Visits;
• Validated Investigator's Global Assessment (vIGA) score ≥ 3 at the Screening and Baseline Visits;
• ≥ 10% Body surface area (BSA) of AD involvement at the Screening and Baseline Visits;
• Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
• Candidate for systemic therapy or have recently required systemic therapy for AD
• Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.
• Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit

You may not qualify if…

• Prior exposure to any Janus kinase (JAK) inhibitor
• Unable or unwilling to discontinue current atopic dermatitis treatments prior to the study
• Requirement of prohibited medications during the study
• Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
• Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Where it is running

• Clear Dermatology & Aesthetics Center /ID# 201256 — Scottsdale, Arizona, United States
• Bakersfield Derma & Skin Cance /ID# 200433 — Bakersfield, California, United States
• First OC Dermatology /ID# 201910 — Fountain Valley, California, United States
• California Allergy and Asthma Medical Group /ID# 200727 — Los Angeles, California, United States
• Allergy & Asthma Associates of Southern California /ID# 200733 — Mission Viejo, California, United States
• Dermatology Clinical Trials /ID# 205876 — Newport Beach, California, United States
• UC Davis /ID# 203622 — Sacramento, California, United States
• Synergy Dermatology /ID# 200842 — San Francisco, California, United States
• San Luis Derm and Laser Clinic /ID# 200372 — San Luis Obispo, California, United States
• Stanford University /ID# 200440 — Stanford, California, United States
• Care Access Research - Walnut Creek /ID# 200940 — Walnut Creek, California, United States
• Dermatology Physicians of Connecticut /ID# 200928 — Shelton, Connecticut, United States
• Foxhall Research Center /ID# 213682 — Washington D.C., District of Columbia, United States
• Duplicate_George Washington Univ Med /ID# 200364 — Washington D.C., District of Columbia, United States
• Clearlyderm Dermatology /ID# 208371 — Boca Raton, Florida, United States
• Skin Care Research, LLC /ID# 200811 — Boca Raton, Florida, United States
• Olympian Clinical Research /ID# 202914 — Clearwater, Florida, United States
• Multi-Speciality Research Associates /ID# 213254 — Lake City, Florida, United States
• GSI Clinical Research, LLC /ID# 200849 — Margate, Florida, United States
• Florida International Rsrch cr /ID# 218507 — Miami, Florida, United States
• Tory P Sullivan, MD PA /ID# 200671 — North Miami Beach, Florida, United States
• Leavitt Medical Associates of Florida /ID# 200880 — Ormond Beach, Florida, United States
• Precision Clinical Research /ID# 209002 — Sunrise, Florida, United States
• Integrated Clinical Research LLC /ID# 200900 — West Palm Beach, Florida, United States
• Alliance Dermatology and MOHs /ID# 200375 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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