A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata Patients (Rezolve AA)
- Conditions
- Alopecia Areata
- Registration Number
- 2023-509981-39-00
- Lead Sponsor
- Nektar Therapeutics
- Brief Summary
To compare the efficacy of rezpegaldesleukin versus placebo on reducing hair loss at Week 36 in patients with severe to very severe AA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- Target Recruitment
- 38
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
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, or hepatitis C virus at screening.
Other skin conditions that would interfere with study assessments of AA
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36 Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36
- Secondary Outcome Measures
Name Time Method Percent change from baseline in SALT score at Weeks 12, 16, 20, 24, 28 and 32 Percent change from baseline in SALT score at Weeks 12, 16, 20, 24, 28 and 32
Proportion of patients achieving improvement in SALT (≥50%, ≥75%, and ≥90%) relative to their baseline score (SALT50, SALT75 and SALT90) at Weeks 12, 16, 20, 24, 28, 32, and 36 Proportion of patients achieving improvement in SALT (≥50%, ≥75%, and ≥90%) relative to their baseline score (SALT50, SALT75 and SALT90) at Weeks 12, 16, 20, 24, 28, 32, and 36
Proportion of patients achieving an absolute SALT score ≤10, ≤20, ≤30, ≤50 relative to their baseline score at Weeks 12, 16, 20, 24, 28, 32, and 36 Proportion of patients achieving an absolute SALT score ≤10, ≤20, ≤30, ≤50 relative to their baseline score at Weeks 12, 16, 20, 24, 28, 32, and 36
Trial Locations
- Locations (14)
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
🇵🇱Rzeszow, Poland
Prywatna Praktyka Lekarska Ewa Ring
🇵🇱Warszawa, Poland
Klinika Ambroziak Sp. z o.o.
🇵🇱Warsaw, Poland
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
🇵🇱Szczecin, Poland
Dermatologiczna Praktyka Lekarska Michal Torz, DERMACEUM Centrum Badan Klinicznych
🇵🇱Wroclaw, Poland
Pratia S.A.
🇵🇱Skorzewo, Poland
Dermedic Jacek Zdybski
🇵🇱Ostrowiec Swietokrzyski, Poland
Centrum Badan Klinicznych Pi-House Sp. z o.o.
🇵🇱Gdansk, Poland
Provita Sp. z o.o.
🇵🇱Katowice, Poland
Wromedica I Bielicka A Strzalkowska s.c.
🇵🇱Wroclaw, Poland
Scroll for more (4 remaining)Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie🇵🇱Rzeszow, PolandAdam ReichSite contact+48605076722adi_medicalis@go2.pl