Phase 1 Alopecia Areata Trial, Recruiting NCT07049328 Sponsor: HCW Biologics Condition: Alopecia Areata
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Phase 1 Alopecia Areata Trial, Recruiting

NCT07049328
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Women between 18 and 70 years old, or men between 18 and 60 years old at the time of signing up for the trial
  • People who have been diagnosed with Alopecia Areata (AA), including specific types called ophiasis, totalis, or universalis
  • Women who could become pregnant must have a negative pregnancy test within 14 days before starting treatment
  • Women who could become pregnant must agree to use a highly effective form of birth control before and for at least 28 days after the last dose of the study drug, and men must agree to use a barrier method (such as a condom) for the same period
  • People whose recent blood test results (taken within 28 days of starting treatment) show that their blood cell counts, kidney function, and liver function are all within acceptable ranges (confirm with trial site)
  • People who are able and willing to attend all required study visits and follow study procedures
  • People who are able and willing to sign a consent form agreeing to take part in the study

Who may not be able to join:

  • Women who are pregnant or breastfeeding, or anyone of reproductive age who is unwilling to use birth control
  • People whose Alopecia Areata is mainly the "diffuse" type, which causes widespread general hair shedding across the scalp
  • People who have another type of hair loss condition in addition to AA
  • People who have previously used a medication called Aldesleukin or any experimental IL-2 (a type of immune system drug) similar to the study drug
  • People currently using oral or topical treatments for hair growth or restoration (such as finasteride, dutasteride, or minoxidil) if they plan to stop or change the dose during the study
  • People who have used light therapy, systemic immune-suppressing medications (such as steroids, cyclosporin, or methotrexate), or certain biologic medications (such as dupilumab) within the 3 months before screening
  • People who have used certain B-cell depleting medications (such as rituximab) within the 6 months before screening
  • People who have a known allergy or sensitivity to medications similar to the study drug
  • People with a history of diabetes, whether controlled or not
  • People who have had a heart attack, heart failure, uncontrolled irregular heartbeat, stroke, uncontrolled high blood pressure, or uncontrolled diabetes within the 6 months before screening
  • People with serious, unstable, or poorly treated organ problems within the 6 months before screening
  • People with a history of cancer or lymphoma, except for certain treated skin cancers with no current signs of disease
  • People currently taking long-term antibiotic or antiviral medicines by mouth or through a drip for a chronic (ongoing) infection
  • People with active tuberculosis (TB), or a history of TB that was not fully treated
  • People who had a shingles (herpes zoster) or CMV infection that cleared up less than 2 months before screening, or people who get cold sores or herpes simplex outbreaks 4 or more times a year
  • People who had major surgery within 3 months before screening, or who have major surgery planned during the study
  • People with an active infection currently requiring antibiotic or antiviral treatment given through a drip
  • People who have previously had an organ transplant
  • People who test positive for HIV, hepatitis B, or hepatitis C at screening
  • People still experiencing side effects from previous treatments that have not sufficiently cleared up
  • People with mental health or personal circumstances that would make it difficult to follow the study's requirements
  • People with other skin conditions that could interfere with how the study measures the effects of AA
  • People with any other illness or medical issue that the study doctor believes would make participation unsafe or unsuitable (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 19548422024

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
HCW Biologics
Registry
ClinicalTrials.gov
Start date
16 August 2025
Est. completion
16 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of Treatment-Emergent Adverse Events (TEAEs) in Subjects Receiving HCW9302 Monotherapy; Designate the recommended Phase 2 dose level (RP2D) for Phase 2 study of HCW9302 in subjects with AA

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov