Alopecia AreataPhase 2NCT06340360
A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)
A Phase 2 study testing Rezpegaldesleukin in people with Alopecia Areata, run by Nektar Therapeutics at 26 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Rezpegaldesleukin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 26 sitesin 3 countries
- Study dates
- 2 Apr 2024to 20 Aug 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
Poland11 sites
Nektar Investigative Site
Gdansk, Pomeranian Voivodeship, 80-546
Nektar Investigative Site
Katowice, Silesian Voivodeship, 40-611
Nektar Investigative Site
Nowa Sól, Lubusz Voivodeship, 67-100
Nektar Investigative Site
Olsztyn, Warmian-Masurian Voivodeship, 10-229
Nektar Investigative Site
Sosnowiec, Silesian Voivodeship, 41-200
Nektar Investigative Site
Szczecin, West Pomeranian Voivodeship, 71-500
Nektar Investigative Site
Warsaw, Masovian Voivodeship, 02-482
Nektar Investigative Site
Warsaw, Masovian Voivodeship, 02-953
Nektar Investigative Site
Wroclaw, Lower Silesian Voivodeship, 50-450
Nektar Investigative Site
Wroclaw, Lower Silesian Voivodeship, 50-566
Nektar Investigative Site
Wroclaw, Lower Silesian Voivodeship, 51-685
United States10 sites
Nektar Investigative Site
Atlanta, Georgia, 30331
Nektar Investigative Site
Camp Hill, Pennsylvania, 17011
Nektar Investigative Site
Clinton Township, Michigan, 48038
Nektar Investigative Site
Frisco, Texas, 75034
Nektar Investigative Site
Gurnee, Illinois, 60031
Nektar Investigative Site
Indianapolis, Indiana, 46202
Nektar Investigative Site
New York, New York, 10075
Nektar Investigative Site
Northridge, California, 91324
Nektar Investigative Site
Pflugerville, Texas, 78660
Nektar Investigative Site
Portsmouth, New Hampshire, 03801
Canada5 sites
Nektar Investigative Site
Markham, Ontario, L3P 1X3
Nektar Investigative Site
Oakville, Ontario, L6J 7W5
Nektar Investigative Site
Richmond Hill, Ontario, L4B 1A5
Nektar Investigative Site
Sherbrooke, Quebec, J1G 1X9
Nektar Investigative Site
Surrey, British Columbia, V3V 0C6
About this study
Official title: A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)
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
- Being tested
- Rezpegaldesleukin, Placebo
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RezpegaldesleukinDrug
Also called REZPEG, NKTR-358, LY3471851 (formerly)
Pharmaceutical form: Injection solution Route of administration: subcutaneous
PlaceboDrug
Pharmaceutical form: Injection solution Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | Rezpegaldesleukin Low Dose Every 2 weeks Receives: Drug: Rezpegaldesleukin |
| High Dose | Experimental | Rezpegaldesleukin High Dose Every 2 weeks Receives: Drug: Rezpegaldesleukin |
| Placebo | Placebo comparator | Placebo Every 2 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and Week 36
Secondary outcomes (3)
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).
Measured: Baseline and Weeks 12, 16, 20, 24, 28, and 32
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).
Measured: Baseline and Weeks 12, 16, 20, 24, 28, 32, and 36
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.
Measured: Baseline and Weeks 12, 16, 20, 24, 28, 32, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start2 Apr 2024
- Primary completion26 Nov 2025
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to 1 of 3 groups (low dose, high dose, or placebo).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nektar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Nektar Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340360
- Sponsor's protocol ID
- 23-358-06
- Other IDs
- 2023-509981-39, 2023
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No