A Phase 2, randomized, double-blind, placebo-controlled, parallel group, 3-arm, multinational, multicenter, proof-of-concept study to evaluate the efficacy and safety of amlitelimab monotherapy by subcutaneous injection in adult participants with severe alopecia areata

Alopecia areata

Change from baseline in SALT score at Week 36

Change from the baseline in SALT score at Week 24 (key secondary), Proportion of participants achieving a SALT score ≤20 at Weeks 24 and 36, Time to SALT score ≤20, Proportion of participants achieving a SALT score ≤10 at Weeks 24 and 36, Time to SALT score ≤10, Proportion of participants achieving a SALT50 at Weeks 24 and 36, Proportion of participants achieving a SALT75 at Weeks 24 and 36, Proportion of participants achieving a SALT90 at Weeks 24 and 36, Proportion of participants achieving ClinRO Measure for eyebrow (EB) Hair Loss 0 or 1 with ≥2-point improvement from baseline at Weeks 24 and 36 (among participants with ClinRO Measure for EB Hair Loss ≥2 at Baseline), Proportion of participants achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 with ≥2-point improvement from baseline (among participants with ClinRO Measure for EL Hair Loss ≥2 at Baseline), Proportion of participants achieving a PGI-C response defined as a score of “moderately improved” or “greatly improved” at Weeks 24 and 36, Proportion of participants achieving a PGI-S response defined as a score of “mild“ or “none” at Weeks 24 and 36, Mean changes from baseline in SKINDEX-16AA at Weeks 24 and 36, Proportion of participants with PRO Scalp Hair Assessment score of 0 to 1 with ≥2-point improvement from baseline (among participants with PRO Scalp Hair Assessment score ≥3 at Baseline), Proportion of participants achieving grade 0 or 1 with ≥2­point improvement from baseline PRO Measure for EB Hair Loss (among participants with PRO Measure for EB Hair Loss ≥2 at Baseline), Proportion of participants achieving grade 0 or 1 with ≥2­point improvement from baseline PRO Measure for EL Hair Loss at Weeks 24 and 36 (among participants with PRO Measure for EL Hair Loss ≥2 at Baseline), Proportion of participants who experienced treatment-emergent adverse events (TEAEs), experienced treatment-emergent serious adverse event (TESAEs) and/or Treatment-Emergent adverse event of special interest (AESIs), Serum amlitelimab concentrations measured at prespecified timepoints, Incidence of ADAs) of amlitelimab at prespecified timepoints

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