A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FB102, Placebo.
- Who it may be relevant to
- Registry conditions: Alopecia Areata. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, New Zealand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.
Overview
This is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of FB102 in patients with severe to very severe alopecia areata (AA).
Detailed description
Up to approximately 32 participants who meet all the Screening eligibility criteria will be randomized in a 3:1 ratio to receive FB102, or placebo dosing to match.
Interventions
- Drug FB102
Route of administration- Intravenous (IV) - Drug Placebo
Route of administration- Intravenous (IV)
Primary outcome measures
- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [Time frame: Upto 36 Weeks post first dose administration]
- Change from Baseline of Severity of Alopecia Tool (SALT) score at Week 16. [Time frame: From Screening through Week 16.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Australia · 3 centers
- St Leonards — Saint Leonards
- Coorparoo — Coorparoo
- South Yarra — South Yarra
New Zealand · 3 centers
- Auckland — Auckland
- Christchurch — Christchurch
- Palmerston North — Palmerston North
Identifiers
NCT: NCT07205159 · FB102-701