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HCW9302, an IL-2 fusion protein

Phase 1

Alopecia Areata(AA) | Small molecule | Immunology |HCW Biologics Inc.|Last Updated: Oct 20, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07049328HCW9302 (Interleukin-2 Fusion Protein) for Alopecia AreataPHASE1 RECRUITING 30 — — Aug 16, 2025Dec 15, 2026Oct 20, 20252 United States
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Study Endpoints
Primary Endpoints
Incidence of Treatment-Emergent Adverse Events (TEAEs) in Subjects Receiving HCW9302 Monotherapy
9 Weeks

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.

Designate the recommended Phase 2 dose level (RP2D) for Phase 2 study of HCW9302 in subjects with AA
9 Weeks
Secondary Endpoints
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
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Study of HCW9302, an IL-2 fusion protein, for alopecia areataEXPERIMENTALSingle dose subcutaneous injection of HCW9302.
Interventions
NameTypeDescription
HCW9302, an IL-2 fusion proteinDRUGInjection
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. 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. 2. Clinical diagnosis of Alopecia Areata (AA) (including ophiasis, totalis or universalis forms) at Screening. 3. Negative serum pregnancy test within 14 d...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07049328primaryCompletionDate: changed
LOWMay 24, 2026NCT07049328studyFirstPostDate: changed