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BMS-986166

Phase 2

Dermatitis, Atopic | Small molecule | Dermatology |Bristol-Myers Squibb Company|Last Updated: Oct 18, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05014438A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic DermatitisPHASE2 COMPLETED 17 — — Aug 17, 2021Aug 22, 2022Oct 18, 202342 United States, Australia +5
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Study Endpoints
Primary Endpoints
Mean Percentage Change From Baseline in EASI Score at Week 16
From baseline and 16 weeks

The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better.

Secondary Endpoints
Percentage of Participants Exhibiting a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 (Cleared) or 1 (Almost Cleared) AND a ≥ 2 Point Reduction From Baseline at Week 16
From baseline and 16 weeks
Percentage of Participants Exhibiting a ≥ 50% (EASI-50) Reduction From Baseline in EASI Score at Week 16
From baseline and 16 weeks
Percentage of Participants Exhibiting a ≥ 4-point Improvement From Baseline in Pruritus NRS at Week 16
From baseline and 16 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
Treatment BMS-986166 Dose 1EXPERIMENTAL -
Treatment BMS-986166 Dose 2EXPERIMENTAL -
Treatment BMS-986166 Dose 3EXPERIMENTAL -
Treatment BranebrutinibEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986166DRUGSpecified dose on specified days
BranebrutinibDRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * Chronic atopic dermatitis (AD) diagnosed according to the Eichenfield modification of Hanifin's and Rajka's (E-HR) criteria at Screening * Disease duration of at least 24 months since diagnosis by any criteria * Documented history of inadequate control of AD by a stable regime...

Countries:United StatesAustraliaAustriaCanadaGermanyPolandSpain
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