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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Nektar Therapeutics

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20]

Trial duration

20 Nov 2024 → ongoing

Decision date (initial)

2024-11-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Nektar Therapeutics

External identifiers

EU CT number

2023-509981-39-00

ClinicalTrials.gov

NCT06340360

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy

To compare the efficacy of rezpegaldesleukin versus placebo on reducing hair loss at Week 36 in patients with severe to very severe AA.

Secondary objectives 1

1. To compare the efficacy of rezpegaldesleukin versus placebo on reducing hair loss in patients with severe to very severe AA

Conditions and MedDRA coding

Alopecia Areata

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 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
2. 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
3. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and baseline.
4. 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).
5. Able to complete patient questionnaires
6. Able and willing to comply with requested study visits and procedures
7. Able and willing to provide written informed consent
8. Able to communicate, read and/or understand the local language

Exclusion criteria 7

1. Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding.
2. Patient has primarily “diffuse” type AA (characterized by diffuse hair shedding).
3. Presence of another form of alopecia.
4. 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
5. 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.
6. Current infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus at screening.
7. Other skin conditions that would interfere with study assessments of AA

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36

Secondary endpoints 3

1. Percent change from baseline in SALT score at Weeks 12, 16, 20, 24, 28 and 32
2. 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
3. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Nektar Therapeutics

Sponsor organisation

Nektar Therapeutics

Address

455 Mission Bay Boulevard South

City

San Francisco

Postcode

94158-2158

Country

United States

Scientific contact point

Organisation

Nektar Therapeutics

Contact name

Sohail Chaudry

Public contact point

Organisation

Nektar Therapeutics

Contact name

Study Director

Third parties 17

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 24 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications