Recent Updates
Recently added Catalysts

BMS-936557

Phase 2

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

BMS-936557 target and mechanism

ModalitySmall molecule

Also known as BMS-936557 (Anti-IP-10 Antibody)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment121

FDA Designations

No designations recorded

BMS-936557 clinical trials

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about BMS-936557

What is BMS-936557 used for?

BMS-936557 is an investigational therapy that was studied for the treatment of moderate to severely active Crohn's disease, a chronic inflammatory condition of the gastrointestinal tract. It was evaluated in a Phase 2 clinical trial in adults with this condition. It is not approved for any indication.

Who is developing BMS-936557?

BMS-936557 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company sponsored the clinical research program for this asset in Crohn's disease.

What phase is BMS-936557 in?

BMS-936557 is in Phase 2 development. It has completed one Phase 2 clinical trial in patients with moderate to severely active Crohn's disease. The trial has been completed and there are no active trials of this drug currently listed.

What clinical trials is BMS-936557 in?

BMS-936557 was evaluated in a single Phase 2 trial, NCT01466374, titled Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease. The trial enrolled 121 patients across the United States, Belgium, France, Hungary, Israel, Poland, Puerto Rico, and South Africa, and it is now completed.

Is BMS-936557 the same as BMS-936557 (Anti-IP-10 Antibody)?

Yes, BMS-936557 is also known as BMS-936557 (Anti-IP-10 Antibody). The parenthetical name reflects its classification as an antibody directed against IP-10. Both names refer to the same investigational compound studied in Crohn's disease.