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Also known as FB102 Single dose
FB102 · 3 trials · 3 indications
Vh:Cd and IEL Composite Scale (VCIEL)
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%).
The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study
The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | FB102 |
| B | EXPERIMENTAL | FB102 |
| C | PLACEBO_COMPARATOR | Placebo |
| FB102 | ACTIVE_COMPARATOR | Participants will receive FB102. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| Name | Type | Description |
|---|---|---|
| FB102 | BIOLOGICAL | FB102 (10 mg/kg induction doses and 3 mg/kg or 5 mg/kg maintenance doses) or placebo arms in a 2:2:1 ratio. |
| Placebo | OTHER | Placebo |
Inclusion Criteria: 1. Men and women aged 18 to 70 years at Screening. 2. Has documented diagnosis of CeD confirmed by intestinal biopsy and positive celiac serology at least 12 months prior to Screening (intestinal biopsy and serology do not have to be performed concurrently). 3. Body mass index (...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | Amlitelimab |
| Forte Biosciences Inc. | FBRX | 1 | PHASE2 | FB102 |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 1 | PHASE2 | TEV-53408 |
| Barinthus Biotherapeutics plc Sponsored ADR | BRNS | 1 | EARLY_PHASE1 | VTP-1000 |
FB102 is an investigational small molecule developed by Forte Biosciences, Inc. (ticker FBRX). It is being studied for autoimmune and inflammatory skin and gastrointestinal conditions, specifically alopecia areata, celiac disease, and vitiligo. FB102 has received FDA Fast Track designation and remains in clinical development.
FB102 targets CD122, a protein that forms part of the receptor complex for interleukin-2. By binding CD122, FB102 is designed to modulate IL-2 signaling, which plays a central role in regulating immune cell activity relevant to autoimmune conditions such as alopecia areata, celiac disease, and vitiligo.
FB102 is being evaluated as a treatment for severe to very severe alopecia areata. A Phase 1 study, NCT07205159, is recruiting adults aged 18 and older in Australia and New Zealand to assess the safety and efficacy of FB102 in this patient population. FB102 is investigational and has not been approved.
FB102 is developed by Forte Biosciences, Inc., a biopharmaceutical company that trades under the ticker symbol FBRX. Forte Biosciences is advancing FB102 across multiple immune-mediated indications, including alopecia areata, celiac disease, and vitiligo.
FB102 is in Phase 1 and Phase 2 clinical development. Phase 1 studies are recruiting for alopecia areata and vitiligo, while a randomized, double-blind, placebo-controlled Phase 2 study is recruiting adults with celiac disease. FB102 is investigational and has not been approved by the FDA.
FB102 is being studied in three recruiting trials. NCT07205159 is a Phase 1 study in severe to very severe alopecia areata in Australia and New Zealand. NCT06982963 is a Phase 2 randomized, double-blind, placebo-controlled study in celiac disease in Australia. NCT06905873 is a Phase 1 study in non-segmental vitiligo in Australia and New Zealand.
Yes, FB102 Single dose is an alternative name used for FB102, the investigational small molecule developed by Forte Biosciences, Inc. (ticker FBRX). Both names refer to the same CD122-targeting compound being studied in alopecia areata, celiac disease, and vitiligo.