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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Alopecia Areata

In brief

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.

Key facts

Study ID

NCT06340360

Run by

Nektar Therapeutics

People needed

94

Starts

2024-04-02

Expected to finish

2026-08-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• severe to very severe AA (≥ 50% scalp involvement) as measured using the SALT score
• Documented history over 6 months with no spontaneous improvement prior to baseline
• 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
• Able to communicate, read and/or understand the local language

You may not qualify if…

• 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:
• aldesleukin
• investigational IL-2 analog
• oral Janus kinase (JAK) inhibitor for any indication, including, but not limited to, baricitinib, upadacitinib, abrocitinib, tofacitinib, and ruxolitinib, whether marketed or investigational
• 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.
• Other skin conditions that would interfere with study assessments of AA

Where it is running

• 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

Full record on ClinicalTrials.gov

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