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BMS-936557

Phase 2

Crohn's Disease | Small molecule | Gastrointestinal |Bristol-Myers Squibb Company|Last Updated: Oct 12, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment121

FDA Designations

No designations recorded

Clinical trial landscape

BMS-936557 · 1 trial · 1 indication

Phase 2 1
NCT01466374Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's DiseaseCrohn's Disease
COMPLETED121 Analytics
PHASE2COMPLETED
Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease
Crohn's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical remission (CDAI score of <150)
Week 11

CDAI: Crohn's Disease Activity Index

Secondary Endpoints

Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150)
Week 7 and Week 11
Proportion of subjects in clinical response (defined as CDAI score reduction from Baseline of ≥ 100 points or an absolute CDAI score of < 150)
Week 7 and Week 11
Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Week 11
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1: InductionEXPERIMENTALPlacebo
Cohort 2: InductionEXPERIMENTALAnti-IP-10 Antibody
Cohort 3: InductionEXPERIMENTALAnti-IP-10 Antibody
Cohort 1: MaintenanceEXPERIMENTALPlacebo
Cohort 2: MaintenanceEXPERIMENTALAnti-IP-10 Antibody
Cohort 3: MaintenanceEXPERIMENTALAnti-IP-10 Antibody
Cohort 1: Open LabelEXPERIMENTALAnti-IP-10 Antibody

Interventions

NameTypeDescription
PlaceboDRUGNormal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks
BMS-936557 (Anti-IP-10 Antibody)DRUGSolution for IV administration, Intravenous, 10 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Adults subjects with confirmed Crohn's Disease (CD) for at least 3 months * Moderate to severely active CD as defined by Crohn's Disease Activity Index (CDAI) 220 to 450 * In the past have had insufficient response and or intolerance to ≥ 1 of the conventional therapy (immunos...

Countries:United StatesBelgiumFranceHungaryIsraelPolandPuerto RicoSouth Africa
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Frequently asked questions about BMS-936557

What is BMS-936557 used for?

BMS-936557 is an investigational small molecule being studied for the treatment of moderate to severely active Crohn's Disease, a type of inflammatory bowel disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes BMS-936557?

BMS-936557 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Crohn's Disease.

What phase is BMS-936557 in?

BMS-936557 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied for the treatment of moderate to severely active Crohn's Disease.

What clinical trials is BMS-936557 in?

BMS-936557 has one completed Phase 2 clinical trial registered under NCT01466374, titled 'Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease.' The trial enrolled 121 participants across multiple countries including the United States, Belgium, France, Hungary, Israel, Poland, Puerto Rico, and South Africa.

Is BMS-936557 FDA approved?

BMS-936557 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Crohn's Disease. The drug has completed one clinical trial, but it has not yet received regulatory approval for any use.