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

This study is currently recruiting participants.
Verified August 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01294410
First received: February 10, 2011
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Colitis, Ulcerative
Drug: Placebo
Drug: Anti-IP-10 Antibody
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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)] ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of the subjects with clinical response of BMS-936557 with that of the placebo [ Time Frame: IP-78 (Week 11) ] [ Designated as safety issue: No ]
    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

  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 289
Study Start Date: March 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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
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: 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
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: 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
Experimental: Maintenance
Placebo or Anti-IP-10 Antibody
Drug: Placebo
Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days
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
Open Label Drug: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294410

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Hide Study Locations
Locations
United States, California
University Of California, San Diego Recruiting
La Jolla, California, United States, 92009-3
Contact: William J. Sandborn, Site 079    858-534-3320      
Santa Monica Research Institute Not yet recruiting
Santa Monica, California, United States, 90404
Contact: Richard Corlin, Site 110    310-752-0603      
United States, Colorado
Western States Clinical Research Inc. Recruiting
Wheatridge, Colorado, United States, 80033
Contact: William Elzi, Site 052    303-940-9773      
United States, Florida
University Of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: John F. Valentine, Site 021    352-265-8971      
Shafran Gasteroenterology Center Recruiting
Winter Park, Florida, United States, 32789
Contact: Ira Shafran, Site 018    407-629-8121      
United States, Georgia
Atlanta Gastroenterology Associates Recruiting
Atlanta, Georgia, United States, 30342
Contact: Douglas C. Wolf, Site 053    770-656-7298      
United States, Kansas
Health Science Research Center Recruiting
Pratt, Kansas, United States, 67124
Contact: Daniel J. Suiter, Site 019    620-672-7411 ext 47      
United States, Kentucky
University Of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0084
Contact: Willem J.S. De Villiers, Site 007    859-323-6423      
Medical-Dental Complex Recruiting
Louisville, Kentucky, United States, 40202
Contact: Gerald W. Dryden, Jr., Site 050    502-852-1919      
United States, Louisiana
Gastroenterology Research Of New Orleans Recruiting
Hammond, Louisiana, United States, 70403
Contact: Russell Wardlaw, Site 111    985-277-5144      
United States, Maryland
Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Robert Hardi, Site 010    301-652-5520      
United States, Minnesota
Minnesota Gastroenterology, Pa Recruiting
Plymouth, Minnesota, United States, 55446
Contact: Robert P. Mccabe, Site 089    612-871-1145      
United States, Missouri
Midwest Center For Clinical Research Recruiting
Lee'S Summit, Missouri, United States, 64064
Contact: Marc Taormina, Site 020    816-251-1258      
United States, New York
Long Island Clinical Research Assoc., Llp Recruiting
Great Neck, New York, United States, 11021
Contact: Blanche Fung Liu, Site 013    516-466-1051      
Mount Sinai School Of Medicine Recruiting
New York, New York, United States, 10029
Contact: Thomas Ullman, Site 054    212-241-3430      
United States, North Carolina
University Of North Carolina At Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7032
Contact: Hans Herfarth, Site 011    919-966-6806      
Charlotte Gastroenterology & Hepatology, Pllc Recruiting
Charlotte, North Carolina, United States, 28207
Contact: John S. Hanson, Site 009    704-375-9485      
United States, Ohio
Consultants For Clinical Research Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Alan V. Safdi, Site 049    513-872-4549      
Gastroenterology Research Of Lima Not yet recruiting
Lima, Ohio, United States, 45806
Contact: Scott Rinesmith, Site 117         
United States, Rhode Island
Pharma Resource Recruiting
East Providence, Rhode Island, United States, 02915
Contact: Vincent Armenio, Site 006    401-431-0043      
United States, Tennessee
Nashville Medical Research Institute Recruiting
Nashville, Tennessee, United States, 37205
Contact: Ronald Edward Pruitt, Site 017         
United States, Texas
Gastroenterology Research Of San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Charles W. Randall, Site 001    210-615-3848      
Australia, Australian Capital Territory
Local Institution Recruiting
Garran, Australian Capital Territory, Australia, 2605
Contact: , Site 038         
Australia, New South Wales
Local Institution Recruiting
Concord, New South Wales, Australia, 2139
Contact: , Site 042         
Australia, Queensland
Local Institution Recruiting
Herston, Queensland, Australia, 4029
Contact: , Site 039         
Australia, Victoria
Local Institution Recruiting
Parkville, Victoria, Australia, 3050
Contact: , Site 043         
Local Institution Recruiting
South Brisbane, Victoria, Australia, 4101
Contact: , Site 041         
Australia, Western Australia
Local Institution Recruiting
Fremantle, Western Australia, Australia, 6959
Contact: , Site 036         
Austria
Local Institution Recruiting
Graz, Austria, 8036
Contact: , Site 029         
Local Institution Recruiting
Vienna, Austria, 1090
Contact: , Site 027         
Belgium
Local Institution Recruiting
Bonheiden, Belgium, 2820
Contact: , Site 062         
Local Institution Recruiting
Edegem, Belgium, 2650
Contact: , Site 099         
Local Institution Recruiting
Leuven, Belgium, B-3000
Contact: , Site 066         
Brazil
Local Institution Recruiting
Goiania, Goias, Brazil, 74535-170
Contact: , Site 069         
Local Institution Recruiting
Botucatu, Sao Paulo, Brazil, 18618-000
Contact: , Site 072         
Local Institution Recruiting
Rio De Janeiro, Brazil, 21941-913
Contact: , Site 070         
Canada, Alberta
Local Institution Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: , Site 085         
Local Institution Not yet recruiting
Edmonton, Alberta, Canada, T5H 4B9
Contact: , Site 086         
Canada, British Columbia
Local Institution Recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Contact: , Site 057         
Canada, Ontario
Local Institution Recruiting
Kingston, Ontario, Canada, K7L 5G2
Contact: , Site 084         
Local Institution Not yet recruiting
London, Ontario, Canada, N6A 5A5
Contact: , Site 115         
Local Institution Recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Contact: , Site 083         
France
Local Institution Recruiting
Clichy, France, 92110
Contact: , Site 088         
Local Institution Recruiting
Lille Cedex, France, 59037
Contact: , Site 102         
Local Institution Recruiting
Nice, France, 6200
Contact: , Site 090         
Local Institution Recruiting
Pessac, France, 33600
Contact: , Site 091         
Local Institution Recruiting
Vandoeuvre Les Nancy, France, 54511
Contact: , Site 100         
Germany
Local Institution Recruiting
Hamburg, Germany, 20148
Contact: , Site 004         
Local Institution Recruiting
Kiel, Germany, 24105
Contact: , Site 005         
Local Institution Recruiting
Muenster, Germany, 48149
Contact: , Site 002         
Local Institution Recruiting
Muenster, Germany, 48155
Contact: , Site 003         
Hungary
Local Institution Not yet recruiting
Budapest, Hungary, 1083
Contact: , Site 094         
Local Institution Recruiting
Budapest, Hungary, 1088
Contact: , Site 064         
Local Institution Not yet recruiting
Budapest, Hungary, H-1115
Contact: , Site 113         
Local Institution Recruiting
Debrecen, Hungary, 4012
Contact: , Site 116         
Local Institution Recruiting
Szeged, Hungary, 6720
Contact: , Site 114         
Italy
Local Institution Not yet recruiting
Padova, Italy, 35128
Contact: , Site 074         
Local Institution Not yet recruiting
Roma, Italy, 00152
Contact: , Site 075         
Local Institution Recruiting
San Donato Milanese (Mi), Italy, 20097
Contact: , Site 076         
Local Institution Not yet recruiting
San Giovanni Rotondo (Fg), Italy, 71013
Contact: , Site 073         
Mexico
Local Institution Recruiting
Mexico, Distrito Federal, Mexico, 14080
Contact: , Site 093         
Local Institution Not yet recruiting
Mexico, D. F., Distrito Federal, Mexico, 6726
Contact: , Site 096         
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 45040
Contact: , Site 105         
Local Institution Not yet recruiting
Guadalajara, Jalisco, Mexico, 44340
Contact: , Site 098         
Local Institution Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: , Site 097         
Local Institution Recruiting
Veracruz, Mexico, 91900
Contact: , Site 095         
Netherlands
Local Institution Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: , Site 061         
Local Institution Recruiting
Amsterdam, Netherlands, 1081 HV
Contact: , Site 082         
Local Institution Not yet recruiting
Rotterdam, Netherlands, 3015 CE
Contact: , Site 032         
Poland
Local Institution Recruiting
Rzeszow, Poland, 35-068
Contact: , Site 118         
Local Institution Recruiting
Sosnowiec, Poland, 41-200
Contact: , Site 025         
Local Institution Recruiting
Warszawa, Poland, 02-507
Contact: , Site 077         
Local Institution Recruiting
Warszawa, Poland, 03-580
Contact: , Site 045         
South Africa
Local Institution Not yet recruiting
Bloemfontein, Free State, South Africa, 9301
Contact: , Site 080         
Local Institution Recruiting
Overport, Kwa Zulu Natal, South Africa, 4091
Contact: , Site 059         
Local Institution Recruiting
Claremont, Western Cape, South Africa, 7708
Contact: , Site 067         
Local Institution Recruiting
Paarl, Western Cape, South Africa, 7620
Contact: , Site 068         
Local Institution Not yet recruiting
Panorama, Western Cape, South Africa, 7506
Contact: , Site 058         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01294410     History of Changes
Other Study ID Numbers: IM129-005, 2010-022506-41
Study First Received: February 10, 2011
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: National Health and Medical Research Council
Mexico: Federal Commission for Sanitary Risks Protection
Brazil: National Health Surveillance Agency
Brazil: National Committee of Ethics in Research
South Africa: Medicines Control Council
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Austria: Federal Office for Safety in Health Care
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Poland: National Institute of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Italy: Ministry of Health
Italy: Ethics Committee
Italy: National Institute of Health
Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014