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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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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 Dermatitis
NCT04504279154
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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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Competitive Landscape -Atopic Dermatitis 80 trials

Top 20 of 26 competitors

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY6PHASE3Baricitinib, corticosteroid
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Pfizer Inc.PFE12PHASE3Abrocitinib
Sanofi SA Sponsored ADRSNY13PHASE3Amlitelimab
Regeneron Pharmaceuticals, Inc.REGN4PHASE3Dupilumab
Incyte CorporationINCY3PHASE3Ruxolitinib, Vehicle
Organon & Co.OGN1PHASE3Tapinarof , 1%, Vehicle
Apogee Therapeutics, Inc.APGE3PHASE2APG777
Novartis AG Sponsored ADRNVS2PHASE2GIA632
Kymera Therapeutics, Inc.KYMR1PHASE2KT-621
Corvus Pharmaceuticals, Inc.CRVS1PHASE2Soquelitinib
Johnson & JohnsonJNJ1PHASE2JNJ-95597528
Nektar TherapeuticsNKTR1PHASE2Rezpegaldesleukin
Celldex Therapeutics, Inc.CLDX1PHASE2Barzolvolimab
Evommune, Inc.EVMN1PHASE2EVO756
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
Q32 Bio IncQTTB1PHASE2ADX-914
Turn Therapeutics Inc.TTRX1PHASE2GX-03
Sunshine Biopharma IncorporatedSBFM2PHASE3611, corticosteroid
Co-Diagnostics, Inc.CODX1PHASE3611
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