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

Last updated: March 31, 2025
Sponsor: Nektar Therapeutics
Overall Status: Active - Not Recruiting

Phase

2

Condition

Alopecia

Hair Loss

Treatment

Rezpegaldesleukin

Placebo

Clinical Study ID

NCT06340360
23-358-06
2023-509981-39
  • Ages 18-70
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Adults who are at least 18 years and ≤60 years for males (≤70 years of age forfemales) 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 SALTscore

  2. Documented history over 6 months with no spontaneous improvement prior tobaseline

  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 atscreening and baseline.

  • While on investigational product and for at least 30 days after taking the last doseof investigational product (IP), WOCBP who engage in activity in which conception ispossible must use approved highly effective contraceptive method(s). For malepatient with partner that is WOCBP in which conception is possible, male patientmust 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

Exclusion Criteria:

  • Men and women (of reproductive potential) unwilling to use birth control and womenwho 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 notlimited to, baricitinib, upadacitinib, abrocitinib, tofacitinib, andruxolitinib, 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 orinvestigational

  • History of cancer or lymphoproliferative disease within 5 years prior to Day 1.Note: Patients with successfully treated nonmetastatic cutaneous squamous cell orbasal cell carcinoma with no evidence of metastatic disease for 3 years and/orlocalized 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

Study Design

Total Participants: 94
Treatment Group(s): 2
Primary Treatment: Rezpegaldesleukin
Phase: 2
Study Start date:
April 02, 2024
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Enverus Medical Research

    Surrey, British Columbia V3V 0C6
    Canada

    Active - Recruiting

  • Nektar Investigative Site

    Surrey, British Columbia V3V 0C6
    Canada

    Site Not Available

  • Lynderm Research Inc

    Markham, Ontario L3P 1X3
    Canada

    Active - Recruiting

  • Nektar Investigative Site

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • Nektar Investigative Site

    Oakville, Ontario L6J 7W5
    Canada

    Site Not Available

  • The Centre for Clinical Trials

    Oakville, Ontario L6J 7W5
    Canada

    Active - Recruiting

  • Nektar Investigative Site

    Richmond Hill, Ontario L4B 1A5
    Canada

    Site Not Available

  • The Centre for Dermatology

    Richmond Hill, Ontario L4B 1A5
    Canada

    Active - Recruiting

  • Centre de Recherche Saint-Louis SHERBROOKE

    Sherbrooke, Quebec J1G 1X9
    Canada

    Active - Recruiting

  • Nektar Investigative Site

    Sherbrooke, Quebec J1G 1X9
    Canada

    Site Not Available

  • Nektar Investigative Site

    Wrocław, Dolnośląskie 51-685
    Poland

    Site Not Available

  • Nektar Investigative Site

    Nowa Sól, Lubuskie 67-100
    Poland

    Site Not Available

  • Nektar Investigative Site

    Warszawa, Mazowieckie 02-482
    Poland

    Site Not Available

  • Nektar Investigative Site

    Rzeszów, Podkarpackie 35-055
    Poland

    Site Not Available

  • Nektar Investigative Site

    Gdańsk, Pomorskie 80-546
    Poland

    Site Not Available

  • Nektar Investigative Site

    Olsztyn, Warmińsko-mazurskie 10-229
    Poland

    Site Not Available

  • Nektar Investigative Site

    Skórzewo, Wielkopolskie 60-185
    Poland

    Site Not Available

  • Nektar Investigative Site

    Szczecin, Zachodniopomorskie 71-500
    Poland

    Site Not Available

  • Nektar Investigative Site

    Katowice, Śląskie 40-611
    Poland

    Site Not Available

  • Nektar Investigative Site

    Sosnowiec, Śląskie 41-200
    Poland

    Site Not Available

  • Nektar Investigative Site

    Northridge, California 91324
    United States

    Site Not Available

  • Quest Dermatology Research

    Northridge, California 91324
    United States

    Active - Recruiting

  • Atlanta Biomedical Clinical Research

    Atlanta, Georgia 30331
    United States

    Active - Recruiting

  • Nektar Investigative Site

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Clinical Investigation Specialists, Inc.

    Gurnee, Illinois 60031
    United States

    Active - Recruiting

  • Nektar Investigative Site

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Indiana Clinical and Translational Sciences Institute (CTSI) Clinical Research Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Nektar Investigative Site

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Michigan Center for Skin Care Research

    Clinton Township, Michigan 48038
    United States

    Active - Recruiting

  • Nektar Investigative Site

    Clinton Township, Michigan 48038
    United States

    Site Not Available

  • ALLCUTIS Research, LLC.

    Portsmouth, New Hampshire 03801
    United States

    Active - Recruiting

  • Nektar Investigative Site

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Nektar Investigative Site

    New York, New York 10075
    United States

    Site Not Available

  • Sadick Research Group LLC

    New York, New York 10075
    United States

    Active - Recruiting

  • DermDox Centers for Dermatology

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • Nektar Investigative Site

    Camp Hill, Pennsylvania 17011
    United States

    Site Not Available

  • Nektar Investigative Site

    Frisco, Texas 75034
    United States

    Site Not Available

  • North Texas Center for Clinical Research

    Frisco, Texas 75034
    United States

    Active - Recruiting

  • Austin Institute for Clinical Research

    Pflugerville, Texas 786660
    United States

    Active - Recruiting

  • Nektar Investigative Site

    Pflugerville, Texas 78660
    United States

    Site Not Available

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