NCT06340360

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

A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	Rezpegaldesleukin	Pharmaceutical form: Injection solution Route of administration: subcutaneous
DRUG	Placebo	Pharmaceutical form: Injection solution Route of administration: subcutaneous

Timeline

• Start date: 2024-04-02
• Primary completion: 2025-11-26
• Completion: 2026-08-01
• First posted: 2024-04-01
• Last updated: 2026-03-31

Locations

26 sites across 3 countries: United States, Canada, Poland

Regulatory

• FDA-regulated drug study