A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)

Summary

This is an interventional, randomized, double blind, parallel group, placebo-controlled, Phase 2b, 3-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with severe to very severe alopecia areata. The estimated duration includes a screening period of up to 35 days, a 36-week treatment period, an optional 16-week treatment extension period, and a 24-week follow-up period. The maximum study duration is approximately 81 weeks for all participants.

Timeline

Start

2024-04-02

Primary completion

2025-11-26

Completion

2026-08-20

Outcome

Met primary endpoint

release “Mean percent reduction in SALT scores at 36 weeks was 30% for both treatment arms versus 6% in the placebo arm, achieving statistical significance (p<0.05)” nektar.com ↗

Drugs

Indications