Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022506-41 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Induction | Experimental | Placebo or Anti-IP-10 Antibody |
|
| Cohort 2: Induction | Experimental | Placebo or Anti-IP-10 Antibody |
|
| Cohort 3: Induction | Experimental | Placebo or Anti-IP-10 Antibody |
|
| Maintenance | Experimental | Placebo or Anti-IP-10 Antibody |
|
| Open Label | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks |
|
| Measure | Description | 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)] |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of California, San Diego | La Jolla | California | 92093 | United States | ||
| Santa Monica Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26721935 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days |
|
| Anti-IP-10 Antibody | Drug | Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks |
|
| Anti-IP-10 Antibody | Drug | Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks |
|
| Anti-IP-10 Antibody | Drug | Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days |
|
| Anti-IP-10 Antibody | Drug | Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days |
|
| Anti-IP-10 Antibody | Drug | Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days |
|
| Anti-IP-10 Antibody | Drug | Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open |
|
| 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) |
| Santa Monica |
| California |
| 90404 |
| United States |
| Western States Clinical Research Inc. | Wheat Ridge | Colorado | 80033 | United States |
| University Of Florida | Gainesville | Florida | 32610 | United States |
| Shafran Gasteroenterology Center | Winter Park | Florida | 32789 | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | United States |
| Health Science Research Center | Pratt | Kansas | 67124 | United States |
| University Of Kentucky | Lexington | Kentucky | 40536 | United States |
| University Of Louisville | Louisville | Kentucky | 40202 | United States |
| Gastroenterology Research Of New Orleans | Hammond | Louisiana | 70403 | United States |
| Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr | Chevy Chase | Maryland | 20815 | United States |
| Minnesota Gastroenterology, Pa | Plymouth | Minnesota | 55446 | United States |
| Westglen Gastrointestinal Consultants | Lee's Summit | Missouri | 64064 | United States |
| Long Island Clinical Research Assoc., Llp | Great Neck | New York | 11021 | United States |
| Mount Sinai School Of Medicine | New York | New York | 10029 | United States |
| University Of North Carolina At Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Charlotte Gastroenterology & Hepatology, Pllc | Charlotte | North Carolina | 28207 | United States |
| Consultants For Clinical Research | Cincinnati | Ohio | 45219 | United States |
| Gastroenterology Research Of Lima | Lima | Ohio | 45806 | United States |
| Pharma Resource | East Providence | Rhode Island | 02915 | United States |
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | United States |
| Gastroenterology Research Of San Antonio | San Antonio | Texas | 78229 | United States |
| Gastroenterology Research Of Tyler (Gerty) | Tyler | Texas | 75701 | United States |
| Local Institution | Garran | Australian Capital Territory | 2605 | Australia |
| Local Institution | Concord | New South Wales | 2139 | Australia |
| Local Institution | Herston | Queensland | 4029 | Australia |
| Local Institution | Parkville | Victoria | 3050 | Australia |
| Local Institution | South Brisbane | Victoria | 4101 | Australia |
| Local Institution | Fremantle | Western Australia | 6959 | Australia |
| Local Institution | Graz | 8036 | Austria |
| Local Institution | Vienna | 1090 | Austria |
| Local Institution | Bonheiden | 2820 | Belgium |
| Local Institution | Edegem | 2650 | Belgium |
| Local Institution | Leuven | B-3000 | Belgium |
| Local Institution | Goiânia | Goiás | 74535 | Brazil |
| Local Institution | Rio de Janeiro | Rio de Janeiro | 21941 | Brazil |
| Local Institution | Botucatu | São Paulo | 18618 | Brazil |
| Local Institution | Calgary | Alberta | T2N 4Z6 | Canada |
| Local Institution | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Local Institution | Kingston | Ontario | K7L 5G2 | Canada |
| Local Institution | Vaughan | Ontario | L4L 4Y7 | Canada |
| Local Institution | Clichy | 92110 | France |
| Local Institution | Lille | 59037 | France |
| Local Institution | Nice | 06200 | France |
| Local Institution | Pessac | 33600 | France |
| Local Institution | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution | Hamburg | 20148 | Germany |
| Local Institution | Kiel | 24105 | Germany |
| Local Institution | Münster | 48149 | Germany |
| Local Institution | Münster | 48155 | Germany |
| Local Institution | Budapest | 1088 | Hungary |
| Local Institution | Budapest | 1115 | Hungary |
| Local Institution | Debrecen | 4012 | Hungary |
| Local Institution | Szeged | 6720 | Hungary |
| Local Institution | Padova | 35128 | Italy |
| Local Institution | Roma | 00152 | Italy |
| Local Institution | San Donato Milanese (mi) | 20097 | Italy |
| Local Institution | San Giovanni Rotondo (fg) | 71013 | Italy |
| Local Institution | Guadalajara | Jalisco | 44340 | Mexico |
| Local Institution | Guadalajara | Jalisco | 45040 | Mexico |
| Local Institution | Mexico City | Mexico City | 14080 | Mexico |
| Local Institution | Mexico, D. F. | Mexico City | 06726 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64460 | Mexico |
| Local Institution | Veracruz | Veracruz | 91900 | Mexico |
| Local Institution | Amsterdam | 1081 HV | Netherlands |
| Local Institution | Amsterdam | 1105 AZ | Netherlands |
| Local Institution | Rotterdam | 3015 CE | Netherlands |
| Local Institution | Rzeszów | 35-068 | Poland |
| Local Institution | Sosnowiec | 41-200 | Poland |
| Local Institution | Warsaw | 02-507 | Poland |
| Local Institution | Warsaw | 03-580 | Poland |
| Local Institution | Overport | KwaZulu-Natal | 4091 | South Africa |
| Local Institution | Claremont | Western Cape | 7708 | South Africa |
| Local Institution | Panorama | Western Cape | 7506 | South Africa |
| Local Institution | Paarl | 7646 | South Africa |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided