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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01294410
First received: February 10, 2011
Last updated: September 15, 2014
Last verified: May 2014
  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: January 2015
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, California
University Of California, San Diego
La Jolla, California, United States, 92093
Santa Monica Research Institute
Santa Monica, California, United States, 90404
United States, Colorado
Western States Clinical Research Inc.
Wheatridge, Colorado, United States, 80033
United States, Florida
University Of Florida
Gainesville, Florida, United States, 32610
Shafran Gasteroenterology Center
Winter Park, Florida, United States, 32789
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
United States, Kansas
Health Science Research Center
Pratt, Kansas, United States, 67124
United States, Kentucky
University Of Kentucky
Lexington, Kentucky, United States, 40536
University Of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Gastroenterology Research Of New Orleans
Hammond, Louisiana, United States, 70403
United States, Maryland
Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr
Chevy Chase, Maryland, United States, 20815
United States, Minnesota
Minnesota Gastroenterology, Pa
Plymouth, Minnesota, United States, 55446
United States, Missouri
Westglen Gastrointestinal Consultants
Lee's Summit, Missouri, United States, 64064
United States, New York
Long Island Clinical Research Assoc., Llp
Great Neck, New York, United States, 11021
Mount Sinai School Of Medicine
New York, New York, United States, 10029
United States, North Carolina
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Charlotte Gastroenterology & Hepatology, Pllc
Charlotte, North Carolina, United States, 28207
United States, Ohio
Consultants For Clinical Research
Cincinnati, Ohio, United States, 45219
Gastroenterology Research Of Lima
Lima, Ohio, United States, 45806
United States, Rhode Island
Pharma Resource
East Providence, Rhode Island, United States, 02915
United States, Tennessee
Nashville Medical Research Institute
Nashville, Tennessee, United States, 37205
United States, Texas
Gastroenterology Research Of San Antonio
San Antonio, Texas, United States, 78229
Gastroenterology Research Of Tyler (Gerty)
Tyler, Texas, United States, 75701
Australia, Australian Capital Territory
Local Institution
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Local Institution
Concord, New South Wales, Australia, 2139
Australia, Queensland
Local Institution
Herston, Queensland, Australia, 4029
Australia, Victoria
Local Institution
Parkville, Victoria, Australia, 3050
Local Institution
South Brisbane, Victoria, Australia, 4101
Australia, Western Australia
Local Institution
Fremantle, Western Australia, Australia, 6959
Austria
Local Institution
Graz, Austria, 8036
Local Institution
Vienna, Austria, 1090
Belgium
Local Institution
Bonheiden, Belgium, 2820
Local Institution
Edegem, Belgium, 2650
Local Institution
Leuven, Belgium, B-3000
Brazil
Local Institution
Goiania, Goias, Brazil, 74535
Local Institution
Botucatu, Sao Paulo, Brazil, 18618
Local Institution
Rio De Janeiro, Brazil, 21941
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Ontario
Local Institution
Kingston, Ontario, Canada, K7L 5G2
Local Institution
Vaughan, Ontario, Canada, L4L 4Y7
France
Local Institution
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
Germany
Local Institution
Hamburg, Germany, 20148
Local Institution
Kiel, Germany, 24105
Local Institution
Muenster, Germany, 48149
Local Institution
Muenster, Germany, 48155
Hungary
Local Institution
Budapest, Hungary, 1088
Local Institution
Budapest, Hungary, 1115
Local Institution
Debrecen, Hungary, 4012
Local Institution
Szeged, Hungary, 6720
Italy
Local Institution
Padova, Italy, 35128
Local Institution
Roma, Italy, 00152
Local Institution
San Donato Milanese (mi), Italy, 20097
Local Institution
San Giovanni Rotondo (fg), Italy, 71013
Mexico
Local Institution
Mexico, Distrito Federal, Mexico, 14080
Local Institution
Mexico, D. F., Distrito Federal, Mexico, 06726
Local Institution
Guadalajara, Jalisco, Mexico, 44340
Local Institution
Guadalajara, Jalisco, Mexico, 45040
Local Institution
Monterrey, Nuevo Leon, Mexico, 64460
Local Institution
Veracruz, Mexico, 91900
Netherlands
Local Institution
Amsterdam, Netherlands, 1081 HV
Local Institution
Amsterdam, Netherlands, 1105 AZ
Local Institution
Rotterdam, Netherlands, 3015 CE
Poland
Local Institution
Rzeszow, Poland, 35-068
Local Institution
Sosnowiec, Poland, 41-200
Local Institution
Warszawa, Poland, 02-507
Local Institution
Warszawa, Poland, 03-580
South Africa
Local Institution
Overport, Kwa Zulu Natal, South Africa, 4091
Local Institution
Claremont, Western Cape, South Africa, 7708
Local Institution
Panorama, Western Cape, South Africa, 7506
Local Institution
Paarl, South Africa, 7646
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: September 15, 2014
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:
Ulcer
Colitis, Ulcerative
Colitis
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Inflammatory Bowel Diseases
Colonic Diseases
Intestinal Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014