Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis

June 24, 2015 updated by: Bristol-Myers Squibb

A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)

The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis

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.

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.
305

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

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Local Institution
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Local Institution
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Local Institution
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Local Institution
      • South Brisbane, Victoria, Australia, 4101
        • Local Institution
    • Western Australia
      • Fremantle, Western Australia, Australia, 6959
        • Local Institution
  • Austria
      • Graz, Austria, 8036
        • Local Institution
      • Vienna, Austria, 1090
        • Local Institution
  • Belgium
      • Bonheiden, Belgium, 2820
        • Local Institution
      • Edegem, Belgium, 2650
        • Local Institution
      • Leuven, Belgium, B-3000
        • Local Institution
  • Brazil
      • Rio De Janeiro, Brazil, 21941
        • Local Institution
    • Goias
      • Goiania, Goias, Brazil, 74535
        • Local Institution
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618
        • Local Institution
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Local Institution
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Local Institution
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Local Institution
  • France
      • Clichy, France, 92110
        • Local Institution
      • Lille Cedex, France, 59037
        • Local Institution
      • Nice, France, 06200
        • Local Institution
      • Pessac, France, 33600
        • Local Institution
      • Vandoeuvre Les Nancy, France, 54511
        • Local Institution
  • Germany
      • Hamburg, Germany, 20148
        • Local Institution
      • Kiel, Germany, 24105
        • Local Institution
      • Muenster, Germany, 48149
        • Local Institution
      • Muenster, Germany, 48155
        • Local Institution
  • Hungary
      • Budapest, Hungary, 1088
        • Local Institution
      • Budapest, Hungary, 1115
        • Local Institution
      • Debrecen, Hungary, 4012
        • Local Institution
      • Szeged, Hungary, 6720
        • Local Institution
  • Italy
      • Padova, Italy, 35128
        • Local Institution
      • Roma, Italy, 00152
        • Local Institution
      • San Donato Milanese (mi), Italy, 20097
        • Local Institution
      • San Giovanni Rotondo (fg), Italy, 71013
        • Local Institution
  • Mexico
      • Veracruz, Mexico, 91900
        • Local Institution
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 14080
        • Local Institution
      • Mexico, D. F., Distrito Federal, Mexico, 06726
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Local Institution
      • Guadalajara, Jalisco, Mexico, 45040
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Local Institution
      • Amsterdam, Netherlands, 1081 HV
        • Local Institution
      • Rotterdam, Netherlands, 3015 CE
        • Local Institution
  • Poland
      • Rzeszow, Poland, 35-068
        • Local Institution
      • Sosnowiec, Poland, 41-200
        • Local Institution
      • Warszawa, Poland, 02-507
        • Local Institution
      • Warszawa, Poland, 03-580
        • Local Institution
  • South Africa
      • Paarl, South Africa, 7646
        • Local Institution
    • 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
      • La Jolla, California, United States, 92093
        • University of California, San Diego
      • Santa Monica, California, United States, 90404
        • Santa Monica Research Institute
    • Colorado
      • Wheatridge, Colorado, United States, 80033
        • Western States Clinical Research Inc.
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Winter Park, Florida, United States, 32789
        • Shafran Gasteroenterology Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Associates
    • Kansas
      • Pratt, Kansas, United States, 67124
        • Health Science Research Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • 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
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Minnesota Gastroenterology, PA
    • Missouri
      • Lee's Summit, Missouri, United States, 64064
        • Westglen Gastrointestinal Consultants
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Assoc., Llp
      • 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
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology & Hepatology, PLLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
      • Lima, Ohio, United States, 45806
        • Gastroenterology Research Of Lima
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • Pharma Resource
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research Institute
    • Texas
      • San Antonio, Texas, United States, 78229
        • Gastroenterology Research of San Antonio
      • Tyler, Texas, United States, 75701
        • Gastroenterology Research Of Tyler (Gerty)

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:

  • Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence
  • Mayo score ≥6 with an endoscopic subscore of ≥2
  • Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)

Exclusion Criteria:

  • Diagnosis of Crohn's Disease or Indeterminate Colitis
  • Diagnosis of UC that is limited to the rectum
  • Evidence of fulminant colitis, toxic megacolon, or bowel perforation
  • Current need for a colostomy or ileostomy
  • Previous total or subtotal colectomy

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 or Anti-IP-10 Antibody
Drug: Placebo
Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
Drug: Placebo
Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Drug: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Drug: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open
Experimental: Cohort 2: Induction
Placebo or Anti-IP-10 Antibody
Drug: Placebo
Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
Drug: Placebo
Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Drug: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Drug: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open
Experimental: Cohort 3: Induction
Placebo or Anti-IP-10 Antibody
Drug: Placebo
Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
Drug: Placebo
Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Drug: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Drug: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open
Experimental: Maintenance
Placebo or Anti-IP-10 Antibody
Drug: Placebo
Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
Drug: Placebo
Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Drug: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Drug: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open
Other: Open Label
Drug: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Drug: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Drug: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days
Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 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
Time Frame
Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo
Time Frame: End of Induction [Week 11, Induction Period-78 (IP-78)]
End of Induction [Week 11, Induction Period-78 (IP-78)]

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 the subjects with clinical response of BMS-936557 with that of the placebo
Time Frame: IP-78 (Week 11)
Defined as a reduction from baseline in Mayo score ≥3 points and ≥30% and decrease from baseline in rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1 point
IP-78 (Week 11)
Proportion of subjects with mucosal healing (defined as endoscopy subscore of ≤1 point) of BMS-936557 with that of the placebo
Time Frame: IP-78 (Week 11)
IP-78 (Week 11)
Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values
Time Frame: IP-78 (Week 11)
IP-78 (Week 11)
Mean change from baseline at Inflammatory Bowel Disease Questionnaire (IBDQ) of subjects treated with BMS-936557 and placebo
Time Frame: Baseline (IP-1, Week 1) and IP-78 (Week 11)
Baseline (IP-1, Week 1) and IP-78 (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.
March 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.
December 1, 2012

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).
February 10, 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.
February 10, 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.
February 11, 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.
June 25, 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.
June 24, 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.
June 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.
  • IM129-005
  • 2010-022506-41 (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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