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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 |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
FB102 is an investigational small molecule being developed for alopecia areata, vitiligo, and celiac disease. It is also being studied in healthy volunteers to assess safety and effects. The drug is in Phase 1 clinical development for these conditions.
FB102 targets CD122, a protein that is part of the interleukin-2 receptor. By binding to CD122, the drug is designed to modulate immune responses involved in autoimmune and inflammatory conditions such as alopecia areata, vitiligo, and celiac disease.
FB102 is being developed by Forte Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol FBRX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple indications.
FB102 is in Phase 1 clinical development. It is being studied in early-stage trials for alopecia areata, vitiligo, and celiac disease, as well as in healthy volunteers. The drug has received Fast Track designation from the FDA, but it is not yet approved.
FB102 is being evaluated in several recruiting trials: NCT06905873 for non-segmental vitiligo, NCT06982963 for celiac disease, NCT07205159 for alopecia areata, and NCT07623057 in healthy volunteers. These trials are enrolling adults aged 18 and older in Australia and New Zealand.
Yes, FB102 is also known as FB102 Single dose. This alternative name refers to the same investigational drug being developed by Forte Biosciences for the treatment of autoimmune and inflammatory conditions.