Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response After Treatment With Dupilumab

Completed · Phase 4

Conditions studied: Atopic Dermatitis

In brief

This is a single-arm, open-label study that will examine the effect of abrocitinib in subjects with atopic dermatitis.

Key facts

Study ID

NCT05602207

Run by

Innovaderm Research Inc.

People needed

24

Starts

2022-11-25

Expected to finish

2025-01-09

Last updated by the study team

2025-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subject 18 years of age or older, at the time of consent.
• Subject has clinically confirmed diagnosis of active atopic dermatitis (AD), according to Hanifin and Rajka criteria.
• Subject has at least a 1-year history of AD and had no significant flares in AD for at least 4 weeks before screening.
• Subjects who had moderate to severe AD before initiating dupilumab treatment.
• Subject currently has an unsatisfactory response or facial erythema after at least 12 weeks of treatment with dupilumab, defined as follows:
• A global vIGA-AD ≥ 2, at least 1% BSA with facial erythema, and a modified vIGA-AD for the face ≥2 at screening and Day 1 OR
• A global vIGA-AD ≥ 2, at least 3% BSA affected by AD on the trunk and/or limbs, and a modified vIGA-AD for the trunk/limbs ≥ 2 at screening and Day 1.

You may not qualify if…

• Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
• Subject has clinically infected AD.
• Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments.
• Subject has a history of cancer within 5 years prior to Day 1.
• Subject has a history of lymphoproliferative disorder, lymphoma, or leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
• Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
• Subject is known to have immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
• Subject has a current or recent clinically serious infection.
• Subject has used abrocitinib prior to Day 1.
• Subject has a known hypersensitivity to abrocitinib or its excipients.
• Subject has a known history of clinically significant drug or alcohol abuse within 6 months prior to Day 1 that in the opinion of the investigator will preclude participation in the study.

Where it is running

• Inno-6050 Site 22 — Birmingham, Alabama, United States
• Inno-6050 Site 13 — Fountain Valley, California, United States
• Inno-6050 Site 21 — Miami Lakes, Florida, United States
• Inno-6050 Site 19 — St. Petersburg, Florida, United States
• Inno-6050 Site 16 — Quincy, Massachusetts, United States
• Inno-6050 Site 17 — Auburn Hills, Michigan, United States
• Inno-6050 Site 15 — Winnipeg, Manitoba, Canada
• Inno-6050 Site 18 — Newmarket, Ontario, Canada
• Inno-6050 Site 11 — Toronto, Ontario, Canada
• Inno-6050 Site 10 — Montreal, Quebec, Canada
• Inno-6050 Site 14 — Québec, Quebec, Canada
• Inno-6050 Site 20 — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.