FB102 treatment for adults with severe to very severe alopecia areata

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 1 trial enrolling up to approximately 32 participants with severe to very severe alopecia areata (≥50% scalp hair loss, including alopecia totalis or universalis). Participants will be randomized 3:1 to receive FB102 or placebo with matching dosing and undergo central photo review and SALT scoring to confirm eligibility and measure outcomes. The study focuses on safety and tolerability while collecting preliminary efficacy data on hair regrowth. Adult men and women meeting age and other inclusion/exclusion criteria attend scheduled visits at Australian trial sites for treatment and monitoring.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males aged 18-60 years and females aged 18-75 years at Screening.
* Clinical diagnosis of severe to very severe AA with ≥50% scalp hair loss (including AT or AU) confirmed by SALT score and central photo review; no other cause of hair loss.

  * AT = complete scalp hair loss; AU = complete scalp, facial, and body hair loss. Note: There are additional inclusion criteria. The study center will determine if participant meets all of the criteria

Exclusion Criteria:

* Other types of alopecia (e.g., diffuse AA, traction, scarring alopecia, telogen effluvium, trichotillomania, chemotherapy-induced hair loss, androgenetic alopecia).
* Other scalp diseases impacting AA assessment (e.g., psoriasis, dermatitis, tinea capitis).
* Active systemic diseases causing hair loss (e.g., lupus, thyroiditis, systemic sclerosis, lichen planus, syphilis).

Note: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria

Where it's running

• Coorparoo
  Coorparoo, Queensland, Australia Recruiting
• St Leonards
  Saint Leonards, New South Wales (nsw), Australia Not yet recruiting
• South Yarra
  South Yarra, Victoria, Australia Not yet recruiting
• Auckland
  Auckland, Auckland, New Zealand Not yet recruiting
• Christchurch
  Christchurch, Canterbury, New Zealand Not yet recruiting
• Palmerston North
  Palmerston North, Palmerston North Central, New Zealand Not yet recruiting

Study contacts

• Study coordinator: Support Officer
• Email: recruitment@clinibase.com
• Phone: +61 3 7050 1941

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.