HCW9302 for Alopecia Areata

(IL-2 Trial)

Recruiting at 2 trial locations

Overseen By Pallavi Chaturvedi, PhD.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: HCW Biologics

Must not be taking: Immunosuppressants, Immunomodulators, B-cell depleting

Disqualifiers: Diabetes, Heart disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HCW9302 for individuals with Alopecia Areata, a condition causing patchy hair loss that can affect the entire scalp or body. Researchers aim to assess the treatment's safety and its impact on hair growth. The trial administers a single dose of HCW9302 via subcutaneous injection (an injection under the skin). This trial may suit adults diagnosed with Alopecia Areata who are not currently using treatments targeting hair growth. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop using any oral or topical treatments targeting hair growth if you plan to change or discontinue them during the study. Additionally, you must not have used certain treatments like systemic immunosuppressants or B-cell depleting agents within specific timeframes before the study.

Is there any evidence suggesting that HCW9302 is likely to be safe for humans?

Research shows that HCW9302, a new treatment, is undergoing tests to determine its safety and tolerability in people with alopecia areata, a condition causing hair loss. The study aims to identify the optimal dose and understand any potential side effects. As this is the first administration of HCW9302 to humans, detailed safety information is still being collected. The FDA's approval for testing in humans suggests confidence in its potential safety. Gathering more data from this study is crucial to confirm how well people can handle this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for alopecia areata, which often include corticosteroids and immunosuppressants, HCW9302 is unique because it uses an IL-2 fusion protein. This innovative approach targets specific immune pathways, potentially offering a more precise treatment with fewer side effects. Researchers are excited about HCW9302 because its targeted action could lead to improved hair regrowth and a better quality of life for patients with alopecia areata.

What evidence suggests that HCW9302 might be an effective treatment for alopecia areata?

Research suggests that HCW9302, a special protein studied in this trial, might help with Alopecia Areata (AA) by improving the immune system's self-regulation. This protein enhances the function of certain immune cells to reduce inflammation, a major cause of AA. Early results from similar treatments have shown promise in reducing hair loss and encouraging hair regrowth. Although specific data on HCW9302 remains limited, its mechanism provides a strong basis for its potential effectiveness. Scientists remain hopeful it could offer a new solution for people with AA.

Are You a Good Fit for This Trial?

This trial is for individuals with Alopecia Areata, a condition where hair falls out in patches. Details about who can join are not fully provided, but typically participants must meet certain health standards and may need to have a specific severity of the condition.

Inclusion Criteria

I am a woman aged 18-70 or a man aged 18-60.

Negative serum pregnancy test within 14 days of treatment start if female and of childbearing potential

Laboratory tests performed within 28 days of treatment start

Exclusion Criteria

Positive based on serological screening for specific infections at screening

Psychiatric illness/social situations that would limit compliance with study requirements

I don't have lasting side effects from past treatments that would affect new treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Dose Treatment

Single dose subcutaneous injection of HCW9302 to evaluate safety and determine dose levels

1 week

1 visit (in-person)

Multidose Treatment

HCW9302 administered subcutaneously every 28 days for 4 consecutive treatments

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HCW9302

Trial Overview The study is testing HCW9302, an IL-2 fusion protein designed to treat Alopecia Areata. It's an early-stage (Phase 1) trial that involves gradually increasing doses to find safe levels. The trial is open-label and conducted at multiple centers.

How Is the Trial Designed?

Group I: Study of HCW9302, an IL-2 fusion protein, for alopecia areata Experimental Treatment 1 Intervention

Single dose subcutaneous injection of HCW9302.

Who Is Running the Clinical Trial?

HCW Biologics

Lead Sponsor

Trials

2

Recruited

60+

Citations

1. withpower.com withpower.com/trial/phase-1-alopecia-areata-7-2025-834a0

HCW9302 for Alopecia Areata (IL-2 Trial) The IL-2 medical study, being run by HCW Biologics, is evaluating whether HCW9302 will have tolerable side effects & efficacy for patients with Alopecia ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07049328

HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata The study involves dose escalation to determine the toxicity profile of HCW9302 and to designate a dose level for the Phase 2 expansion phase (RP2D).

3. investors.hcwbiologics.com investors.hcwbiologics.com/news-releases/news-release-details/hcw-biologics-granted-fda-clearance-evaluate-one-companys-lead

HCW Biologics Granted FDA Clearance to Evaluate One of ... HCW Biologics granted FDA clearance to evaluate one of the Company's lead product candidates in a first-in-human Phase 1 clinical trial.

4. bioworld.com bioworld.com/articles/716854-hcw-9302-gains-ind-clearance-for-first-in-human-study-in-alopecia-areata

HCW-9302 gains IND clearance for first-in-human study in ... HCW Biologics Inc. has received clearance of its IND application from the FDA to initiate a first-in-human phase I trial to evaluate ...

5. synapse.patsnap.com synapse.patsnap.com/drug/049ec85eef804620b5ca172fef8f49fe

HCW-9302 - Drug Targets, Indications, Patents We found that HCW9302 exhibited a longer serum half-life with an approximately 1000-fold higher affinity for the IL-2Rα than IL-2. HCW9302 could be administered ...