Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response After Treatment With Dupilumab
Atopic Dermatitis
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring eczema, dupilumab, abrocitinib
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Inno-6050 Site 13Recruiting
- Inno-6050 Site 19Recruiting
- Inno-6050 Site 16Recruiting
- Inno-6050 Site 17Recruiting
- Inno-6050 Site 15Recruiting
- Inno-6050 Site 18Recruiting
- Inno-6050 Site 11Recruiting
- Inno-6050 Site 10Recruiting
- Inno-6050 Site 14Recruiting
- Inno-6050 Site 20Recruiting
Arms of the Study
Arm 1
Experimental
Abrocitinib 100 mg tablet (marketed drug)