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:
Bristol-Myers Squibb
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
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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:
Genetics Home Reference related topics:
ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
U.S. FDA Resources
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
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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 LocationsLocations
| 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 May 16, 2013