MedTrace Logo

Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease

NCT01466374 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2015-10-12

No results posted yet for this study

Summary

The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.

Conditions

Interventions

DRUG

Placebo

Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks

DRUG

Placebo

Normal Saline, Intravenous, 0 mg, Every other week, Up to 337days

DRUG

BMS-936557 (Anti-IP-10 Antibody)

Solution for IV administration, Intravenous, 10 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks

DRUG

BMS-936557 (Anti-IP-10 Antibody)

Solution for IV administration, Intravenous, 20 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks

DRUG

BMS-936557 (Anti-IP-10 Antibody)

Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days

DRUG

BMS-936557 (Anti-IP-10 Antibody)

Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days

DRUG

BMS-936557 (Anti-IP-10 Antibody)

Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-06-30
Completion
2014-12-31

Countries

  • United States
  • Belgium
  • France
  • Hungary
  • Israel
  • Poland
  • Puerto Rico
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01466374 on ClinicalTrials.gov