Phase 2 Alopecia Areata Trial, Recruiting NCT07327359 Sponsor: Olix Pharmaceuticals, Inc. Condition: Alopecia Areata
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Phase 2 Alopecia Areata Trial, Recruiting

NCT07327359
Recruiting Phase 2 🇦🇺 Australian site

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:

  • You are an adult male.
  • You are between 18 and 59 years old.
  • You have been diagnosed with male-pattern baldness at a moderate to significant level (known as Hamilton-Norwood scale stages III to V — confirm with trial site if unsure of your stage).
  • Your body weight is at least 50 kg (about 110 lbs) and your body mass index (a measure of weight relative to height) is 18.0 or above.
  • You are a non-smoker.
  • You are in generally good health with no significant medical conditions.
  • You are willing and able to receive multiple injections and attend all required appointments throughout the study.
  • You are comfortable having blood drawn.

Who may not be able to join:

  • You have a significant medical history or current condition affecting your lungs, liver, kidneys, blood, digestive system, hormones, immune system, or nervous system, or you have had a major illness or surgery in the past 3 months.
  • You have diabetes that is not well controlled.
  • You have a condition that affects your immune system's ability to function properly.
  • You have a history of significant heart disease.
  • You have a history of certain heart rhythm risk factors (confirm with trial site).
  • You have any skin conditions affecting your scalp.
  • You have a history of or signs of raised, thick scarring on your skin (keloids or hypertrophic scars).
  • Your hair loss is caused by something other than male-pattern baldness, such as alopecia areata, scarring, or other conditions.
  • You have previously had a surgical hair restoration procedure or hair transplant.
  • Your scalp has ever been treated with radiation.
  • You use semi-permanent hair products.
  • You plan to wear an occlusive wig, hair extensions, or hair weaves during the study.
  • You have used over-the-counter hair regrowth products or cosmetic hair treatments within 2 weeks before your first dose.
  • You have used topical or local treatments on the scalp (confirm specific products with trial site).
  • You have used certain non-topical medications within 24 weeks before your first dose (confirm with trial site).
  • You have used anti-cancer or chemotherapy drugs that could affect hair loss within the past 12 months.
  • Your scalp hair loss in the treatment area is caused by an injury, disease, or medical treatment.
  • You currently have an infection that requires antibiotic, antifungal, antiparasitic, or antiviral medication.
  • You have had any cancer in the last 5 years (except for certain skin cancers that were fully removed by surgery).
  • You have tested positive for HIV, hepatitis B, or hepatitis C.
  • You test positive for recreational drugs, alcohol, or nicotine at your screening visit or before your first dose.
  • You have received any vaccines within 14 days before your first dose.
  • You have donated blood or plasma, lost more than 500 mL of blood, or received a blood transfusion within the timeframes specified by the trial (confirm exact timeframes with trial site).
  • You have taken part in another clinical trial involving an experimental drug within the past 60 days (or longer, depending on the drug — confirm with trial site).
  • You drink more than 10 standard alcoholic drinks per week, or more than 2 in a single day on a regular basis.
  • You have had surgery or been hospitalised in the 3 months before screening, or have surgery planned during the study.
  • You have a known allergy or sensitivity to the study drug or any of its ingredients.
  • You are unwilling or unable to follow the study requirements, or you refuse to give your informed consent.
  • Any other condition that the study doctor feels would make participation unsuitable for you.

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 26 July 2026
Phase 2: approximately ~30% 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: +613 9509 6166

Australian sites

Emeritus Research Camberwell, Camberwell, Victoria
+613 9509 6166

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

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Olix Pharmaceuticals, Inc.
Registry
ClinicalTrials.gov
Start date
4 December 2025
Est. completion
1 April 2026

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

To investigate the incidence, type, severity, and relationship of adverse events (AEs)/serious AEs (SAEs), assessed using the CTCAE Version 5.0 (Phase 1b); To assess local tolerability at intradermal (ID) injection site (Phase 1b); To evaluate the change from baseline in non-vellus Target Area Hair Count (TAHC) at 24 weeks (Day 169) (Phase 2a)

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: 26 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