A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Completed · Phase 3

Conditions studied: Atopic Dermatitis

In brief

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 compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed. Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment Period 1 and a 16-week treatment Period 2. Participants are randomly assigned to 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab in Period 1. There is a 30-day or 12-week follow-up visit for those on upadacitinib or dupilumab respectively, who will not enter Period 2. In Period 2, participants will receive upadacitinib Dose A or Dose B for 16 weeks, followed by a 30-day follow-up visit. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care . 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.

Key facts

Study ID

NCT05601882

Run by

AbbVie

People needed

920

Starts

2022-11-28

Expected to finish

2024-08-08

Last updated by the study team

2025-02-14

Who can join

Age: 12 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;validated Investigator´s Global Assessment for AD (vIGA-AD) score ≥ 3 and ≥ 10% Body Surface Area Involvement of Atopic Dermatitis (BSA of AD) involvement at the Baseline Visit.
• Baseline weekly average of daily Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4.
• Documented history of inadequate response to previous systemic treatment defined as documented history of previous inadequate response to at least one prior systemic treatment for AD OR for whom other systemic treatments are otherwise medically inadvisable.

You may not qualify if…

• History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
• History of an organ transplant which requires continued immunosuppression.

Where it is running

• Alliance Dermatology and Mohs Center /ID# 249671 — Phoenix, Arizona, United States
• Clinical Trials Institute - Northwest Arkansas /ID# 249838 — Fayetteville, Arkansas, United States
• Arkansas Research Trials /ID# 250722 — North Little Rock, Arkansas, United States
• Joseph Raoof Md,Inc /Id# 250211 — Encino, California, United States
• First OC Dermatology /ID# 250686 — Fountain Valley, California, United States
• Antelope Valley Clinical Trials /ID# 249946 — Lancaster, California, United States
• Dermatology Research Associates /ID# 249829 — Los Angeles, California, United States
• University of California Davis Health /ID# 250044 — Sacramento, California, United States
• Clinical Trials Research Institute /ID# 250213 — Thousand Oaks, California, United States
• Western States Clinical Res /ID# 250274 — Wheat Ridge, Colorado, United States
• UConn Health /ID# 253807 — Farmington, Connecticut, United States
• Yale Center for Clinical Investigation /ID# 254791 — New Haven, Connecticut, United States
• Clearlyderm Dermatology /ID# 250457 — Boca Raton, Florida, United States
• Skin Care Research Boca Raton /ID# 250458 — Boca Raton, Florida, United States
• Olympian Clinical Research /ID# 250453 — Clearwater, Florida, United States
• Skin Care Research - Hollywood /ID# 250459 — Hollywood, Florida, United States
• Solutions Through Adv Rch /ID# 250455 — Jacksonville, Florida, United States
• GSI Clinical Research, LLC /ID# 250768 — Margate, Florida, United States
• D&H National Research Centers /ID# 250734 — Miami, Florida, United States
• Florida International Rsrch cr /ID# 249667 — Miami, Florida, United States
• Wellness Clinical Research - Miami Lakes /ID# 250236 — Miami Lakes, Florida, United States
• Tory P Sullivan, MD PA /ID# 251136 — North Miami Beach, Florida, United States
• Precision Clinical Research /ID# 250990 — Sunrise, Florida, United States
• Advanced Clinical Research Institute /ID# 250460 — Tampa, Florida, United States
• Medical Dermatology Specialists /ID# 250212 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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