A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.

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.

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).

Study Overview

• Status: Recruiting
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: FB102; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Support Officer; Phone Number: +61 3 7050 1941; Email: recruitment@clinibase.com

Study Locations

• Australia
  • New South Wales (nsw)
    • Saint Leonards, New South Wales (nsw), Australia, 2065
      • Not yet recruiting
      • St Leonards
  • Queensland
    • Coorparoo, Queensland, Australia, 4151
      • Recruiting
      • Coorparoo
  • Victoria
    • South Yarra, Victoria, Australia, 3141
      • Not yet recruiting
      • South Yarra
• New Zealand
  • Auckland
    • Auckland, Auckland, New Zealand, 0632
      • Not yet recruiting
      • Auckland
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8013
      • Not yet recruiting
      • Christchurch
  • Palmerston North Central
    • Palmerston North, Palmerston North Central, New Zealand, 4414
      • Not yet recruiting
      • Palmerston North

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo	Drug: Placebo; Route of administration- Intravenous (IV)
Active Comparator: FB102; Participants will receive FB102.	Drug: FB102; Route of administration- Intravenous (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)		Upto 36 Weeks post first dose administration
Change from Baseline of Severity of Alopecia Tool (SALT) score at Week 16.	The Severity of Alopecia Tool (SALT) score ranges from 0 (no scalp hair loss) to 100 (complete scalp hair loss), with higher scores indicating greater severity. Change from baseline in SALT score at Week 16 will assess treatment effect. The AA-IGA categorizes SALT scores as follows: 0 = None (0%), 1 = Limited (1-20%), 2 = Moderate (21-49%), 3 = Severe (50-94%), 4 = Very Severe (95-100%).	From Screening through Week 16.

Collaborators and Investigators

• Sponsor: Forte Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2025
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): March 10, 2027

Study Registration Dates

• First Submitted: September 25, 2025
• First Submitted That Met QC Criteria: September 25, 2025
• First Posted (Estimated): October 3, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Alopecia; Hypotrichosis; Hair Diseases; Skin and Connective Tissue Diseases; Alopecia Areata
• Other Study ID Numbers: FB102-701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No