A Phase 1, Randomized, Blinded, Placebo-controlled, Dose Escalation Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of ITK Inhibitor Soquelitinib in Participants With Moderate to Severe Atopic Dermatitis
Safety, tolerability, and preliminary efficacy of soquelitinib in participants with moderate to severe AD
• Adult male or female, ≥18 years of age at Screening.
• Atopic dermatitis, according to Hanifin and Rajka criteria and confirmed by a dermatologist.
• Moderate to severe disease defined by EASI ≥16; body surface area ≥10; and vIGA ≥3.
• Documented history of inadequate response or intolerance to one or more topical therapies (including but not limited to corticosteroids, immune modulators, PDE-4 inhibitors) and/or systemic therapies (including but not limited to, dupilumab, cyclosporine, mycophenolate, azathioprine, oral corticosteroids or a JAK inhibitor, e.g., tofacitinib, baricitinib, and ruxolitinib).
• A male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study intervention and refrain from donating sperm during this period.
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
‣ Not a woman of childbearing potential (WOCBP) OR
⁃ A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after last dose of study treatment