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

September 23, 2015 updated by: Bristol-Myers Squibb

A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Anti-IP10: Anti Interferon-inducible ligand 10

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1090
        • Local Institution
      • Leuven, Belgium, 3000
        • Local Institution
  • France
      • Amiens Cedex 1, France, 80054
        • Local Institution
      • Clichy, France, 92110
        • Local Institution
      • Nice, France, 06200
        • Local Institution
      • Pessac, France, 33064
        • Local Institution
      • Rouen, France, 76031
        • Local Institution
      • Vandoeuvre Les Nancy, France, 54511
        • Local Institution
  • Hungary
      • Budapest, Hungary, 1083
        • Local Institution
      • Budapest, Hungary, 1088
        • Local Institution
      • Budapest, Hungary, H-1115
        • Local Institution
      • Debrecen, Hungary, 4012
        • Local Institution
  • Israel
      • Haifa, Israel, 31048
        • Local Institution
      • Kfar Saba, Israel, 44281
        • Local Institution
      • Nazareth, Israel, 16100
        • Local Institution
  • Poland
      • Krakow, Poland, 31-501
        • Local Institution
      • Rzeszow, Poland, 35-068
        • Local Institution
      • Warszawa, Poland, 02-507
        • Local Institution
      • Warszawa, Poland, 03-580
        • Local Institution
  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • University of Puerto Rico School of Medicine
  • South Africa
    • Kwa Zulu Natal
      • Overport, Kwa Zulu Natal, South Africa, 4091
        • Local Institution
    • Western Cape
      • Claremont, Western Cape, South Africa, 7708
        • Local Institution
      • Panorama, Western Cape, South Africa, 7506
        • Local Institution
  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Southern California Medical Gastroenterology Group
    • Florida
      • Winter Park, Florida, United States, 32789
        • Shafran Gasteroenterology Center
    • Louisiana
      • Hammond, Louisiana, United States, 70403
        • Gastroenterology Research Of New Orleans
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr
    • Missouri
      • Lees Summit, Missouri, United States, 64064
        • Midwest Center For Clinical Research
    • New York
      • Great Neck, New York, United States, 11021
        • NYU Langone Long Island Clinical Research Associates
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
    • Texas
      • San Antonio, Texas, United States, 78229
        • Gastroenterology Research of San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 (immunosuppressants, corticosteroids and/or approved biologic therapy)

Exclusion Criteria:

  • Ulcerative colitis (UC) or indeterminate colitis
  • Short bowel syndrome
  • Known stricture or noninflammatory stenosis leading to symptoms of obstruction
  • Current stoma or current need for colostomy or ileostomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1: Induction
Placebo
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
Experimental: Cohort 2: Induction
Anti-IP-10 Antibody
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
Other Names:
  • Anti-IP-10 Antibody
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
Other Names:
  • Anti-IP-10 Antibody
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
Experimental: Cohort 3: Induction
Anti-IP-10 Antibody
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
Other Names:
  • Anti-IP-10 Antibody
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
Other Names:
  • Anti-IP-10 Antibody
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
Experimental: Cohort 1: Maintenance
Placebo
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
Experimental: Cohort 2: Maintenance
Anti-IP-10 Antibody
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
Other Names:
  • Anti-IP-10 Antibody
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
Other Names:
  • Anti-IP-10 Antibody
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
Experimental: Cohort 3: Maintenance
Anti-IP-10 Antibody
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
Other Names:
  • Anti-IP-10 Antibody
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
Other Names:
  • Anti-IP-10 Antibody
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
Experimental: Cohort 1: Open Label
Anti-IP-10 Antibody
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
Other Names:
  • Anti-IP-10 Antibody
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
Other Names:
  • Anti-IP-10 Antibody
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical remission (CDAI score of <150)
Time Frame: Week 11
CDAI: Crohn's Disease Activity Index
Week 11

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150)
Time Frame: Week 7 and Week 11
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)
Time Frame: Week 7 and Week 11
Week 7 and Week 11
Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame: Week 11
Week 11
Safety of BMS-936557 in the induction period defined by proportion of subjects reporting AE, SAEs, AEs leading to discontinuation, and markedly abnormal laboratory values
Time Frame: Week 11
AE - Adverse Event SAE - Serious Adverse Event
Week 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM129-008
  • 2011-002981-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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