A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Moderate to Severe Atopic Dermatitis (SIERRA1)

Condition studied

Atopic dermatitis (AD)

Investigational medicinal product(s)

Eligibility

Primary endpoint

1. Percent change from Baseline in EASI score at Week 12

Endpoint detail

1. Response of achieving 75% reduction in EASI (EASI75) score at Wk 12, 2. Response of achieving vIGA score of 0 or 1 with reduction from Baseline of ≥2 points at Wk 12, 3. Response of achieving ≥4-point decrease in PP-NRS score at Wk 12, 4. Change from baseline and percent change in: EASI score, affected BSA and PP-NRS score at each post-baseline visit, 5. Change from baseline and percent change in DLQI score and in POEM score at Wk 12, 6. Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib compared with placebo