Actively Recruiting
HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata
Led by HCW Biologics · Updated on 2025-10-20
30
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1, open-label, multi-center, competitive enrollment, and dose-escalation study of HCW9302 in subjects with Alopecia Areata (AA)
CONDITIONS
Official Title
HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years for females, or 18 to 60 years for males at time of consent
- Clinical diagnosis of Alopecia Areata including ophiasis, totalis, or universalis forms at screening
- Negative pregnancy test within 14 days before treatment start for females of childbearing potential
- Female participants of childbearing potential must use highly effective birth control before screening and for at least 28 days after last dose; males must use barrier contraception for same period
- Laboratory values within 28 days before treatment start: ANC ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 10 g/dL, GFR > 40 mL/min or creatinine ≤ 1.5 × ULN, bilirubin ≤ 2.0 × ULN or ≤ 3.0 × ULN with Gilbert's syndrome, AST/ALT/ALP ≤ 2.0 × ULN
- Able and willing to comply with study visits and procedures
- Able and willing to provide written informed consent and HIPAA authorization
You will not qualify if you...
- Men and women unwilling to use birth control or women who are pregnant or breastfeeding
- Primarily diffuse type Alopecia Areata with diffuse hair shedding
- Presence of another form of alopecia
- Prior use of Aldesleukin or investigational IL-2 analog
- Concurrent use of oral or topical hair growth or restoration treatments if dosage or discontinuation changes planned during study
- Use of phototherapy, systemic immunosuppressants, or immunomodulating biologics within 3 months prior to screening
- Use of B-cell depleting agents within 6 months prior to screening
- Known hypersensitivity to similar compounds
- History of diabetes mellitus
- History of recent serious cardiovascular events or uncontrolled diseases within 6 months
- Significant unstable or untreated organ dysfunction within 6 months
- History of cancer except certain treated skin cancers without current disease
- Chronic systemic anti-infective therapy for chronic infection
- Active or inadequately treated tuberculosis
- Recent herpes zoster or cytomegalovirus infection; frequent herpes simplex outbreaks
- Major surgery within 3 months prior to screening or planned during study
- Active systemic infection requiring parenteral therapy
- Prior organ allograft or allogeneic transplantation
- Positive HIV, hepatitis B, or hepatitis C serology at screening
- Ongoing toxicity from prior therapies that may interfere with study treatment
- Psychiatric illness or social situations limiting compliance
- Other skin conditions interfering with Alopecia Areata assessment
- Other illness or medical issues deemed exclusionary by Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
James A. Haley Veterans' Hospital
Tampa, Florida, United States, 33612
Actively Recruiting
2
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
P
Pallavi Chaturvedi, PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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