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BMS-986256

Phase 1

Lupus Erythematosus, Cutaneous | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: May 9, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04493541A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus ErythematosusPHASE1 COMPLETED 13 — — Aug 26, 2020Apr 21, 2023May 9, 20231 Germany
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Study Endpoints
Primary Endpoints
Incidence of Serious Adverse Events (SAEs)
Up to 24 weeks
Incidence of Adverse Events (AEs)
Up to 20 weeks
Number of laboratory test abnormalities: Hematology
Up to 20 weeks
Number of laboratory test abnormalities: Urinalysis
Up to 20 weeks
Number of laboratory test abnormalities: Clinical Chemistry
Up to 20 weeks
Incidence of clinically significant changes in physical examination findings
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Body temperature
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Respiratory rate
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Blood pressure
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Heart rate
Up to 20 weeks
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters
Up to 20 weeks
Secondary Endpoints
Maximum observed plasma concentration (Cmax) of BMS-986256
Up to 20 weeks
Time to maximum concentration (Tmax) of BMS-986256
Up to 20 weeks
Trough observed plasma concentration (Ctrough) of BMS-986256
Up to 20 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-986256EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BMS-986256DRUGSpecified Dose on Specified Days
BMS-986256 PlaceboOTHERSpecified Dose on Specified Days
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: a) Must have one of following diagnoses: i) Meet European League Against Rheumatoid (EULAR)/American College of Rheumatology 2019 Classification Criteria for systemic lupus erythematosus (SLE) OR ii) Biopsy-proven acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lu...

Countries:Germany
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