A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA) (NCT06340360)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (12 items).
Location: Nektar Investigative Site — Northridge, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (26 Sites)
- Nektar Investigative Site — Northridge, California
- Nektar Investigative Site — Atlanta, Georgia
- Nektar Investigative Site — Gurnee, Illinois
- Nektar Investigative Site — Indianapolis, Indiana
- Nektar Investigative Site — Clinton Township, Michigan
- Nektar Investigative Site — Portsmouth, New Hampshire
- Nektar Investigative Site — New York, New York
- Nektar Investigative Site — Camp Hill, Pennsylvania
- Nektar Investigative Site — Frisco, Texas
- Nektar Investigative Site — Pflugerville, Texas
- Nektar Investigative Site — Surrey, British Columbia
- Nektar Investigative Site — Markham, Ontario
- Nektar Investigative Site — Oakville, Ontario
- Nektar Investigative Site — Richmond Hill, Ontario
- Nektar Investigative Site — Sherbrooke, Quebec
- Nektar Investigative Site — Wroclaw, Lower Silesian Voivodeship
- Nektar Investigative Site — Wroclaw, Lower Silesian Voivodeship
- Nektar Investigative Site — Wroclaw, Lower Silesian Voivodeship
- Nektar Investigative Site — Nowa Sól, Lubusz Voivodeship
- Nektar Investigative Site — Warsaw, Masovian Voivodeship
- Nektar Investigative Site — Warsaw, Masovian Voivodeship
- Nektar Investigative Site — Gdansk, Pomeranian Voivodeship
- Nektar Investigative Site — Katowice, Silesian Voivodeship
- Nektar Investigative Site — Sosnowiec, Silesian Voivodeship
- Nektar Investigative Site — Olsztyn, Warmian-Masurian Voivodeship
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.