A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)
NCT ID: NCT06340360
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
94 participants
INTERVENTIONAL
2024-04-02
2026-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low Dose
Rezpegaldesleukin Low Dose Every 2 weeks
Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
High Dose
Rezpegaldesleukin High Dose Every 2 weeks
Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Placebo
Placebo Every 2 weeks
Placebo
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Interventions
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Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Placebo
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Able to communicate, read and/or understand the local language
Exclusion Criteria
* 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.
* Other skin conditions that would interfere with study assessments of AA
18 Years
70 Years
ALL
No
Sponsors
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Nektar Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Nektar Therapeutics
Locations
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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
Countries
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Other Identifiers
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2023-509981-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
23-358-06
Identifier Type: -
Identifier Source: org_study_id