HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata

NCT07049328 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HCWALO101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 1, open-label, multi-center, competitive enrollment, and dose-escalation study of HCW9302 in subjects with Alopecia Areata (AA)

Conditions

Alopecia Areata(AA)

Keywords

Alopecia; Interleukin-2 (IL-2); T-Reg

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (TEAEs) in Subjects Receiving HCW9302 Monotherapy

  Evaluate the safety profile of HCW9302 monotherapy in subjects with Alopecia Areata (AA), based on the incidence, type, and severity of adverse events (AEs) classified according to MedDRA.

  9 Weeks

• Designate the recommended Phase 2 dose level (RP2D) for Phase 2 study of HCW9302 in subjects with AA

  9 Weeks

Secondary Outcomes (2)

• Determine the percent change from baseline of Severity of Alopecia Tool (SALT) score (0-100) at Day 29 and Week 9 in AA subjects receiving HCW9302

  9 Weeks

• Determine the change from baseline of Alopecia Areata-Investigator Global Assessment (AA-IGA) score at Day 29 and Week 9 in AA subjects receiving HCW9302

  9 Weeks

Study Arms (1)

Study of HCW9302, an IL-2 fusion protein, for alopecia areata

EXPERIMENTAL

Single dose subcutaneous injection of HCW9302.

Drug: HCW9302, an IL-2 fusion protein

Interventions

HCW9302, an IL-2 fusion protein DRUG

Injection

Study of HCW9302, an IL-2 fusion protein, for alopecia areata

Eligibility Criteria

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

You may qualify if:

• Adult women who are 18 to 70 years of age, or adult males who are 18 to 60 years of age at the time of informed consent.
• Clinical diagnosis of Alopecia Areata (AA) (including ophiasis, totalis or universalis forms) at Screening.
• Negative serum pregnancy test within 14 days of treatment start if female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
• Female subjects of childbearing potential must adhere to using a highly effective medically accepted method of birth control (defined as those with failure less than 1%; see Appendix 2) prior to screening and agree to continue its use for at least 28 days after the last dose of HCW9302 or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use a barrier method of birth control and agree to continue its use for at least 28 days after the last dose of HCW9302.
• Laboratory tests performed within 28 days of treatment start:
• Absolute neutrophil count (AGC/ANC) ≥ 1,500/μL (≥1.5 × 109/L)
• Platelets ≥ 100,000/μL (≥ 100 × 109/L)
• Hemoglobin ≥ 10 g/dL (\>100g/L)
• Calculated glomerular filtration rate (GFR)\* \>40 mL/min OR serum creatinine ≤ 1.5 × ULN
• Total bilirubin ≤ 2.0 × ULN or ≤ 3.0 × ULN for subjects with Gilbert's syndrome
• AST, ALT, ALP ≤ 2.0 × ULN
• Able and willing to comply with requested study visits and procedures.
• Able and willing to provide written informed consent and HIPAA authorization

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: a. Aldesleukin b. Investigational IL-2 analog
• Concurrent use of oral or topical treatments targeting hair growth or hair restoration (including but not limited to finasteride, dutasteride, topical minoxidil or oral minoxidil) if discontinuation or dosage change is planned during the study period.
• Prior use of phototherapy and any systemic immunosuppressant (systemic steroids, cyclosporin, methotrexate or any other immunosuppressive therapy) or immunomodulating biologic therapy (including but not limited to dupilumab, tralokinumab, lebrikizumab, nemolizumab, rocatinlimab, or daxdilimab, whether marketed or investigational) within 3 months prior to Screening.
• Prior use of any B-cell depleting agents, whether marketed or investigational, including but not limited to rituximab, ocrelizumab, ofatumumab, or belimumab, within 6 months prior to Screening.
• Known hypersensitivity or history of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study.
• History of diabetes mellitus, regardless of whether it is controlled or not.
• History of myocardial infarction, congestive heart failure, uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months prior to Screening.
• Significant organ dysfunction that is unstable or inadequately treated within 6 months prior to Screening.
• History of cancer or lymphoproliferative disease, except for the following: adequately treated basal cell or squamous cell skin cancer without current evidence of disease.
• Currently receiving any chronic systemic (oral or intravenous) anti-infective therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria).
• Active tuberculosis (TB) (based on TB blood test or a TB skin test) or a history of inadequately treated TB.
• Herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months prior to Screening. Subjects with a history of frequent outbreaks of Herpes Simplex Virus (defined as 4 or more outbreaks a year).

Sponsors & Collaborators

• HCW Biologics: lead

Study Sites (2)

James A. Haley Veterans' Hospital

Tampa, Florida, 33612, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Alopecia Areata; Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pallavi Chaturvedi, PhD.

CONTACT

19548422024; clinical@hcwbiologics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: July 3, 2025
• Study Start: August 16, 2025
• Primary Completion (Estimated): July 16, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)