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

NCT06340360 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 23-358-062023-509981-39
• Study Type: interventional
• Target: 94
• Locations: 3 countries
• Sites: 26

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, 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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in Severity of Alopecia Tool (SALT) score at 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).

  Baseline and Week 36

Secondary Outcomes (3)

• Percent change from baseline in SALT score

  Baseline and Weeks 12, 16, 20, 24, 28, and 32

• 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 an absolute SALT score ≤ 10/20/30/50

  Baseline and Weeks 12, 16, 20, 24, 28, 32, and 36

Study Arms (3)

Low Dose

EXPERIMENTAL

Rezpegaldesleukin Low Dose Every 2 weeks

Drug: Rezpegaldesleukin

High Dose

EXPERIMENTAL

Rezpegaldesleukin High Dose Every 2 weeks

Drug: Rezpegaldesleukin

Placebo

PLACEBO COMPARATOR

Placebo Every 2 weeks

Drug: Placebo

Interventions

Rezpegaldesleukin DRUG

Pharmaceutical form: Injection solution Route of administration: subcutaneous

Also known as: REZPEG, NKTR-358, LY3471851 (formerly)

High Dose; Low Dose

Placebo DRUG

Pharmaceutical form: Injection solution Route of administration: subcutaneous

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• severe to very severe AA (≥ 50% scalp involvement) as measured using the SALT score
• Documented history over 6 months with no spontaneous improvement prior to baseline
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nektar Therapeutics: lead

Study Sites (26)

Nektar Investigative Site

Northridge, California, 91324, United States

Location

Nektar Investigative Site

Atlanta, Georgia, 30331, United States

Location

Nektar Investigative Site

Gurnee, Illinois, 60031, United States

Location

Nektar Investigative Site

Indianapolis, Indiana, 46202, United States

Location

Nektar Investigative Site

Clinton Township, Michigan, 48038, United States

Location

Nektar Investigative Site

Portsmouth, New Hampshire, 03801, United States

Location

Nektar Investigative Site

New York, New York, 10075, United States

Location

Nektar Investigative Site

Camp Hill, Pennsylvania, 17011, United States

Location

Nektar Investigative Site

Frisco, Texas, 75034, United States

Location

Nektar Investigative Site

Pflugerville, Texas, 78660, United States

Location

Nektar Investigative Site

Surrey, British Columbia, V3V 0C6, Canada

Location

Nektar Investigative Site

Markham, Ontario, L3P 1X3, Canada

Location

Nektar Investigative Site

Oakville, Ontario, L6J 7W5, Canada

Location

Nektar Investigative Site

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Nektar Investigative Site

Sherbrooke, Quebec, J1G 1X9, Canada

Location

Nektar Investigative Site

Wroclaw, Lower Silesian Voivodeship, 50-450, Poland

Location

Nektar Investigative Site

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

Location

Nektar Investigative Site

Wroclaw, Lower Silesian Voivodeship, 51-685, Poland

Location

Nektar Investigative Site

Nowa Sól, Lubusz Voivodeship, 67-100, Poland

Location

Nektar Investigative Site

Warsaw, Masovian Voivodeship, 02-482, Poland

Location

Nektar Investigative Site

Warsaw, Masovian Voivodeship, 02-953, Poland

Location

Nektar Investigative Site

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Nektar Investigative Site

Katowice, Silesian Voivodeship, 40-611, Poland

Location

Nektar Investigative Site

Sosnowiec, Silesian Voivodeship, 41-200, Poland

Location

Nektar Investigative Site

Olsztyn, Warmian-Masurian Voivodeship, 10-229, Poland

Location

Nektar Investigative Site

Szczecin, West Pomeranian Voivodeship, 71-500, Poland

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

rhoA GTP-Binding Protein

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

rho GTP-Binding Proteins; Monomeric GTP-Binding Proteins; GTP-Binding Proteins; GTP Phosphohydrolases; Acid Anhydride Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Intracellular Signaling Peptides and Proteins

Study Officials

• Study Director

  Nektar Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to 1 of 3 groups (low dose, high dose, or placebo).

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: April 2, 2024
• Primary Completion: November 26, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (11); US (10); CA (5)