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

ACTIVE_NOT_RECRUITINGPHASE2

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)

NCT06340360•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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults who are at least 18 years and ≤60 years for males (≤70 years of age for females) old at the time of informed consent
•Diagnosis of Alopecia Areata (AA) severity at screening and baseline:
•1. severe to very severe AA (≥ 50% scalp involvement) as measured using the SALT score
•2. Documented history over 6 months with no spontaneous improvement prior to baseline
•3. Current episode of severe to very severe AA of less than 8 years
•Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and baseline.
•While on investigational product and for at least 30 days after taking the last dose of investigational product (IP), WOCBP who engage in activity in which conception is possible must use approved highly effective contraceptive method(s). For male patient with partner that is WOCBP in which conception is possible, male patient must agree to use approved highly effective contraceptive method(s).
•Able to complete patient questionnaires
•Able and willing to comply with requested study visits and procedures
•Able and willing to provide written informed consent
+1 more criteria

Exclusion Criteria

•Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding.
•Patient has primarily "diffuse" type AA (characterized by diffuse hair shedding).
•Presence of another form of alopecia.
•Prior use of any of the following treatments:
•1. aldesleukin
•2. investigational IL-2 analog
•3. oral Janus kinase (JAK) inhibitor for any indication, including, but not limited to, baricitinib, upadacitinib, abrocitinib, tofacitinib, and ruxolitinib, whether marketed or investigational
•4. systemic immune-modulating biologic therapy (including, but not limited to, dupilumab, tralokinumab, lebrikizumab, nemolizumab, rocatinlimab, rituximab, ocrelizumab, ofatumumab, belimumab, daxdilimab, etc.) whether marketed or investigational
•History of cancer or lymphoproliferative disease within 5 years prior to Day 1. Note: Patients with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma with no evidence of metastatic disease for 3 years and/or localized carcinoma in situ of the cervix with no evidence of recurrence within the 3 years prior to Day 1 are not to be excluded.
•Current infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening.
+1 more criteria

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

Key Dates

Start Date

April 2, 2024

Primary Completion Date

November 26, 2025

Completion Date

August 1, 2026

Last Updated

December 29, 2025

Enrollment

ACTUAL participants

Conditions

Alopecia Areata

Interventions

Rezpegaldesleukin

DRUG

Placebo

DRUG

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata

NCT06826196

Alopecia Areata (AA)

View study

RECRUITING

CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry

NCT06562270

Alopecia Areata

View study

RECRUITINGPHASE3

Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata

CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry

Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata

Combined Microneedling With Either 1% Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants in Japan With Alopecia Areata

A Study to Learn About Litfulo Capsule in People With Severe Alopecia Areata in Routine Clinical Practice.