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

Research summary

This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm study to investigate the efficacy and safety of SC injections of amlitelimab as monotherapy in participants aged 12 years and older with severe AA. At the end of the treatment period, all participants will have the option to enter a separate study, the open label extension study. The study duration will be up to 44 weeks for participants not entering the open extension study including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up (20 weeks from the last IMP administration). Two dosing intervals of amlitelimab, 500 mg (2x250mg injections) LD followed by 250 mg at Q4W, and 500 mg LD followed by 250 mg at Q12W, are being studied (see Section 4.3 for justification of the doses). Because different dosing intervals are being studied, a fixed dose, parallel design is needed to provide comparative data across the dose regimens compared to placebo. To better assess and interpret safety and efficacy data, a placebo control arm is appropriate and necessary. The placebo arm provides as a baseline comparison, holding to the ethical principal of equipoise. Also allowing scientific rigor when evaluating placebo effect and managing confounding variables. Objectives, endpoints, estimands, and appropriateness of measurements are described in Section 3 of the Protocol. For additional details regarding study design and its rationale please refer to Section 4 of the Protocol. A primary database lock (DBL) will be performed when all randomized participants have completed or had the opportunity to complete their 24-week treatment phase. The database will be updated at the end of the study for all participants who did not enter the open label extension study to include the post-treatment follow-up information and updates for the events previously ongoing at the time of the primary lock.

Principal Investigator

Dr Gorav Wali

Contact us

Email: melanie.westmoreland@ouh.nhs.uk

IRAS number

1009854