A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Running, not enrolling · 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 combined with topical corticosteroids (TCS) 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

NCT03568318

Run by

AbbVie

People needed

1533

Starts

2018-08-09

Expected to finish

2030-10-23

Last updated by the study team

2025-12-23

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 ≥ 12 and < 18 years of age
• Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit and subject meets Hanifin and Rajka criteria.
• Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) ≥ 4.
• 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 or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline Visit

You may not qualify if…

• Prior exposure to any Janus kinase (JAK) inhibitor
• Unable or unwilling to discontinue current atopic dermatitis (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

Where it is running

• Clinical Research Center AL /ID# 201865 — Birmingham, Alabama, United States
• ACCEL Research Sites /ID# 213364 — Birmingham, Alabama, United States
• Advanced Dermatology and Skin Care Centre /ID# 213550 — Mobile, Alabama, United States
• Alliance Dermatology and MOHs Center, PC /ID#200540 — Phoenix, Arizona, United States
• Arizona Research Center, Inc. /ID# 200546 — Phoenix, Arizona, United States
• Clear Dermatology & Aesthetics Center /ID# 201257 — Scottsdale, Arizona, United States
• University of Arizona /ID# 201059 — Tucson, Arizona, United States
• Bakersfield Derma & Skin Cance /ID# 200892 — Bakersfield, California, United States
• Mosaic Dermatology /ID# 200553 — Beverly Hills, California, United States
• University of California Irvine /ID# 200902 — Irvine, California, United States
• Therapeutics Clinical Research /ID# 200593 — San Diego, California, United States
• Stanford University /ID# 200597 — Stanford, California, United States
• Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822 — Aurora, Colorado, United States
• Colorado Center for Dermatology, PLLC /ID# 203626 — Centennial, Colorado, United States
• Duplicate_Western States Clinical Research, Inc. /ID# 201702 — Wheat Ridge, Colorado, United States
• Dermatology Physicians of Connecticut /ID# 201004 — Shelton, Connecticut, United States
• Clearlyderm Dermatology /ID# 207709 — Boca Raton, Florida, United States
• Skin Care Research, LLC /ID# 200812 — Boca Raton, Florida, United States
• Clinical Research of West Florida, Inc /ID# 203643 — Clearwater, Florida, United States
• Florida Academic Centers Research and Education /ID# 200544 — Coral Gables, Florida, United States
• Tory P Sullivan, MD PA /ID# 201174 — North Miami Beach, Florida, United States
• Park Avenue Dermatology, PA /ID# 201012 — Orange Park, Florida, United States
• Precision Clinical Research /ID# 208734 — Sunrise, Florida, United States
• Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628 — Boise, Idaho, United States
• Total Skin and Beauty Derm Ctr /ID# 200548 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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