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

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: Completed
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Drug: Placebo; Drug: Placebo; Drug: Anti-IP-10 Antibody; Drug: Anti-IP-10 Antibody; Drug: Anti-IP-10 Antibody; Drug: Anti-IP-10 Antibody; Drug: Anti-IP-10 Antibody; Drug: Anti-IP-10 Antibody

• Study Type: Interventional
• Enrollment (Actual): 305
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	End of Induction [Week 11, Induction Period-78 (IP-78)]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of the subjects with clinical response of BMS-936557 with that of the placebo	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		IP-78 (Week 11)
Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values		IP-78 (Week 11)
Mean change from baseline at Inflammatory Bowel Disease Questionnaire (IBDQ) of subjects treated with BMS-936557 and placebo		Baseline (IP-1, Week 1) and IP-78 (Week 11)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• Sandborn WJ, Colombel JF, Ghosh S, Sands BE, Dryden G, Hebuterne X, Leong RW, Bressler B, Ullman T, Lakatos PL, Reinisch W, Xu LA, Luo A. Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study. J Crohns Colitis. 2016 Apr;10(4):418-28. doi: 10.1093/ecco-jcc/jjv224. Epub 2015 Dec 30.

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 10, 2011
• First Posted (Estimate): February 11, 2011

Study Record Updates

• Last Update Posted (Estimate): June 25, 2015
• Last Update Submitted That Met QC Criteria: June 24, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins
• Other Study ID Numbers: IM129-005; 2010-022506-41 (EudraCT Number)