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

Alopecia Areata Clinical Trial

Official title:

A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo-Controlled 60-Week Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06340360
• Other study ID #: 23-358-06
• Secondary ID: 2023-509981-39
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2, 2024
• Est. completion date: February 2026

Study information

• Verified date: June 2024
• Source: Nektar Therapeutics
• Contact: Nektar Recruitment
• Phone: 8554828676
• Email: StudyInquiry[@]nektar.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: February 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
• Placebo
Pharmaceutical form: Injection solution Route of administration: subcutaneous

Locations

Country	Name	City	State
Canada	Lynderm Research Inc	Markham	Ontario
Canada	The Centre for Clinical Trials	Oakville	Ontario
Canada	The Centre for Dermatology	Richmond Hill	Ontario
Canada	Centre de Recherche Saint-Louis SHERBROOKE	Sherbrooke	Quebec
Canada	Enverus Medical Research	Surrey	British Columbia
United States	Atlanta Biomedical Clinical Research	Atlanta	Georgia
United States	DermDox Centers for Dermatology	Camp Hill	Pennsylvania
United States	Michigan Center for Skin Care Research	Clinton Township	Michigan
United States	North Texas Center for Clinical Research	Frisco	Texas
United States	Clinical Investigation Specialists, Inc.	Gurnee	Illinois
United States	Sadick Research Group LLC	New York	New York
United States	Quest Dermatology Research	Northridge	California
United States	Austin Institute for Clinical Research	Pflugerville	Texas
United States	ALLCUTIS Research, LLC.	Portsmouth	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Nektar Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent change from baseline in SALT score	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 Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 52 and 60.
Secondary	Proportion of patients achieving improvement in Severity of Alopecia Tool (SALT) = 50%/75%/90%	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).	Baseline and Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 52 and 60.
Secondary	Proportion of patients achieving an absolute SALT score = 10/20/30/50	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.	Baseline and Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 52 and 60.