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FB-401

Phase 2

Atopic Dermatitis | Monoclonal antibody | Dermatology |Forte Biosciences, Inc.|Last Updated: Sep 16, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment154

FDA Designations

No designations recorded

Clinical trial landscape

FB-401 · 1 trial · 1 indication

Phase 2 1
NCT04504279Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic DermatitisAtopic Dermatitis
COMPLETED154 Analytics
PHASE2COMPLETED
Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

EASI 50
16 weeks

The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16

Secondary Endpoints

Includes percent change in EASI
16 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FB-401EXPERIMENTALFB-401 applied topically for 16 weeks.
PlaceboPLACEBO_COMPARATORPlacebo applied topically for 16 weeks.

Interventions

NameTypeDescription
FB-401BIOLOGICALTopical application
PlaceboBIOLOGICALVehicle
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Eligibility Criteria

Age Range2 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

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...

Countries:United States
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Frequently asked questions about FB-401

What is FB-401 used for?

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.

Who makes FB-401?

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.

What phase is FB-401 in?

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.

What clinical trials is FB-401 in?

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.

How does FB-401 work?

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.