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

Phase 2

Recruiting

• Conditions: Alopecia Areata
• Interventions: Drug: Rezpegaldesleukin; Drug: Placebo

• Registration Number: NCT06340360
• Lead Sponsor: Nektar Therapeutics

Brief 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, and a 24-week follow-up period. The maximum study duration is approximately 65 weeks for all participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-04-01
• Study Start: 2024-04-02
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-08-31
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Adults who are at least 18 years ≤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 contraceptive method(s). For male patient with partner that is WOCBP in which conception is possible, male patient must agree to use approved 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

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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.

• Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening.

• Other skin conditions that would interfere with study assessments of AA

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose	Rezpegaldesleukin	Rezpegaldesleukin Low Dose Every 2 weeks
High Dose	Rezpegaldesleukin	Rezpegaldesleukin High Dose Every 2 weeks
Placebo	Placebo	Placebo Every 2 weeks

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36	Baseline and Week 36	The SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline in SALT score	Baseline and Weeks 12, 16, 20, 24, 28, and 32	SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).
Proportion of patients achieving improvement in Severity of Alopecia Tool (SALT) ≥ 50%/75%/90%	Baseline and Weeks 12, 16, 20, 24, 28, 32, and 36	Proportion of patients achieving improvement of ≥ 50%/75%/90% in Severity of Alopecia Tool (SALT) relative to their baseline score (SALT50/75/90). SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).
Proportion of patients achieving an absolute SALT score ≤ 10/20/30/50	Baseline and Weeks 12, 16, 20, 24, 28, 32, and 36	Proportion of patients achieving an absolute SALT score of ≤ 10/20/30/50. SALT score is the sum of percentage of hair loss in all areas (higher score indicates greater hair loss). Total percentage of patients with absolute SALT score of ≤ 10/20/30/50 will be calculated.

Trial Locations

Locations (1)

Nektar Investigative Site; 🇵🇱 Sosnowiec, Śląskie, Poland