Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FB-401 · 1 trial · 1 indication
The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16
| Arm | Type | Description |
|---|---|---|
| FB-401 | EXPERIMENTAL | FB-401 applied topically for 16 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo applied topically for 16 weeks. |
| Name | Type | Description |
|---|---|---|
| FB-401 | BIOLOGICAL | Topical application |
| Placebo | BIOLOGICAL | Vehicle |
Inclusion Criteria: * Male or female, ≥ 2 years of age * Clinical diagnosis of atopic dermatitis as defined by Hanifin and Rajka criteria that has been present for ≥ 3 months before the screening visit * Investigator Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at Screening and Baselin...
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FB-401 is an investigational monoclonal antibody being developed for the treatment of atopic dermatitis, a form of eczema. It is intended for use in children, adolescents, and adults aged 2 years and older with mild to moderate atopic dermatitis.
FB-401 is being developed by Forte Biosciences, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol FBRX on the NASDAQ.
FB-401 is in Phase 2 clinical development. It has completed a Phase 2 trial, but it is not yet approved by the FDA and remains an investigational drug.
FB-401 has been evaluated in a Phase 2 clinical trial with the identifier NCT04504279. This trial was a randomized, double-blind, placebo-controlled study that enrolled 154 participants with atopic dermatitis in the United States.
FB-401 is a monoclonal antibody, a type of biologic drug designed to target specific proteins involved in disease processes. However, the specific molecular target of FB-401 has not been disclosed in available information.