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ACTIVE NOT RECRUITING
NCT06340360
PHASE2

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

Sponsor: Nektar Therapeutics

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2024-04-02

Completion Date

2026-08

Last Updated

2026-03-31

Healthy Volunteers

No

Conditions

Interventions

DRUG

Rezpegaldesleukin

Pharmaceutical form: Injection solution Route of administration: subcutaneous

DRUG

Placebo

Pharmaceutical form: Injection solution Route of administration: subcutaneous

Locations (26)

Nektar Investigative Site

Northridge, California, United States

Nektar Investigative Site

Atlanta, Georgia, United States

Nektar Investigative Site

Gurnee, Illinois, United States

Nektar Investigative Site

Indianapolis, Indiana, United States

Nektar Investigative Site

Clinton Township, Michigan, United States

Nektar Investigative Site

Portsmouth, New Hampshire, United States

Nektar Investigative Site

New York, New York, United States

Nektar Investigative Site

Camp Hill, Pennsylvania, United States

Nektar Investigative Site

Frisco, Texas, United States

Nektar Investigative Site

Pflugerville, Texas, United States

Nektar Investigative Site

Surrey, British Columbia, Canada

Nektar Investigative Site

Markham, Ontario, Canada

Nektar Investigative Site

Oakville, Ontario, Canada

Nektar Investigative Site

Richmond Hill, Ontario, Canada

Nektar Investigative Site

Sherbrooke, Quebec, Canada

Nektar Investigative Site

Wroclaw, Lower Silesian Voivodeship, Poland

Nektar Investigative Site

Wroclaw, Lower Silesian Voivodeship, Poland

Nektar Investigative Site

Wroclaw, Lower Silesian Voivodeship, Poland

Nektar Investigative Site

Nowa Sól, Lubusz Voivodeship, Poland

Nektar Investigative Site

Warsaw, Masovian Voivodeship, Poland

Nektar Investigative Site

Warsaw, Masovian Voivodeship, Poland

Nektar Investigative Site

Gdansk, Pomeranian Voivodeship, Poland

Nektar Investigative Site

Katowice, Silesian Voivodeship, Poland

Nektar Investigative Site

Sosnowiec, Silesian Voivodeship, Poland

Nektar Investigative Site

Olsztyn, Warmian-Masurian Voivodeship, Poland

Nektar Investigative Site

Szczecin, West Pomeranian Voivodeship, Poland