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

Korábbi kezelés

• Subject has used abrocitinib prior to Day 1.
• 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.

Más betegség

• 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 a known hypersensitivity to abrocitinib or its excipients.

Egyéb

• Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.

• 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.