Actively Recruiting
A Phase 1 Study of HCW9302, an IL-2 Fusion Protein, for Alopecia Areata
Led by HCW Biologics · Updated on 2025-10-20
30
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1, open-label, multi-center study to evaluate HCW9302, an interleukin-2 fusion protein, in adults with Alopecia Areata (AA). The study aims to determine the safety and toxicity profile of HCW9302 and to identify a suitable dose level for future Phase 2 studies. Participants include adults diagnosed with various forms of AA, such as ophiasis, totalis, or universalis. The study involves escalating doses of HCW9302 to assess tolerability. Up to five dose levels will be tested, with a lower dose option available if higher doses cause unacceptable side effects. Initially, participants will receive a single subcutaneous injection of HCW9302. Based on these results, a follow-up phase may involve multiple doses given every 28 days for four treatments. Participants will undergo laboratory tests and clinical assessments during the 9-week study period to monitor safety and effects on AA severity. Key measures include tracking treatment-related adverse events and changes in Alopecia Areata severity scores. Participants must comply with scheduled visits and procedures, provide informed consent, and will be closely monitored throughout the trial until its completion.
CONDITIONS
Brief Title
HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult women aged 18 to 70 years or adult men aged 18 to 60 years at consent
- Clinical diagnosis of Alopecia Areata including ophiasis, totalis, or universalis forms
- Negative serum pregnancy test within 14 days before treatment for females of childbearing potential
- Females of childbearing potential must use effective birth control before and for 28 days after last dose; males must use barrier contraception for 28 days after last dose
- Laboratory tests within 28 days before treatment meeting specified blood counts and organ function values
- 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...
- Unwillingness to use birth control or pregnancy/breastfeeding in women of reproductive potential
- Primarily diffuse type Alopecia Areata
- Presence of other alopecia forms
- Prior use of Aldesleukin or investigational IL-2 analogs
- Concurrent or planned changes in oral or topical hair growth treatments during study
- Use of phototherapy or systemic immunosuppressants or immunomodulating biologics within 3 months before screening
- Use of B-cell depleting agents within 6 months before screening
- Known allergy to study-related compounds
- History of diabetes mellitus
- Recent serious cardiac conditions or uncontrolled diabetes/hypertension within 6 months
- Unstable or inadequately treated significant organ dysfunction within 6 months
- History of cancer except certain treated skin cancers
- Use of chronic systemic anti-infective therapy for chronic infections
- Active or inadequately treated tuberculosis
- Recent Herpes zoster or cytomegalovirus infections; frequent herpes simplex outbreaks
- Major surgery within 3 months before screening or planned during study
- Active systemic infection requiring parenteral therapy
- Prior organ transplant
- Positive for HIV, hepatitis B or C
- Ongoing toxicity from prior therapies affecting study treatment
- Psychiatric or social conditions limiting compliance
- Other skin conditions affecting AA assessments
- Other medical conditions excluding participation as judged by investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks depending on dose escalation and study phase
Participants receive subcutaneous injections of HCW9302 to evaluate safety and determine the recommended dose for further study.
1 single dose injection initially; if proceeding to multidose, injections every 28 days for 4 consecutive treatments
Duration - Up to 9 weeks after last dose
Participants are monitored for safety and treatment effects after dosing is completed.
Multiple follow-up visits over 9 weeks
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.
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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