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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)

Purpose

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.

Condition

Alopecia Areata

Eligibility

Eligible Ages: Between 18 Years and 70 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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 - Able to communicate, read and/or understand the local language

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. - Other skin conditions that would interfere with study assessments of AA

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to 1 of 3 groups (low dose, high dose, or placebo).
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Low Dose	Rezpegaldesleukin Low Dose Every 2 weeks	Drug: Rezpegaldesleukin Pharmaceutical form: Injection solution Route of administration: subcutaneous Other names: REZPEG NKTR-358 LY3471851 (formerly)
Experimental High Dose	Rezpegaldesleukin High Dose Every 2 weeks	Drug: Rezpegaldesleukin Pharmaceutical form: Injection solution Route of administration: subcutaneous Other names: REZPEG NKTR-358 LY3471851 (formerly)
Placebo Comparator Placebo	Placebo Every 2 weeks	Drug: Placebo Pharmaceutical form: Injection solution Route of administration: subcutaneous

Recruiting Locations

More Details

NCT ID: NCT06340360
Status: Active, not recruiting
Sponsor: Nektar Therapeutics

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.