Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002981-19 | 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
The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.
Anti-IP10: Anti Interferon-inducible ligand 10
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Induction | Experimental | Placebo |
|
| Cohort 2: Induction | Experimental | Anti-IP-10 Antibody |
|
| Cohort 3: Induction | Experimental | Anti-IP-10 Antibody |
|
| Cohort 1: Maintenance | Experimental | Placebo |
|
| Cohort 2: Maintenance | Experimental | Anti-IP-10 Antibody |
|
| Cohort 3: Maintenance | Experimental | Anti-IP-10 Antibody |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission (CDAI score of <150) | CDAI: Crohn's Disease Activity Index | Week 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150) | Week 7 and Week 11 | |
| Proportion of subjects in clinical response (defined as CDAI score reduction from Baseline of ≥ 100 points or an absolute CDAI score of < 150) |
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 |
|---|---|---|---|---|---|---|
| Southern California Medical Gastroenterology Group | Santa Monica | California | 90404 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28333187 | Derived | Sandborn WJ, Rutgeerts P, Colombel JF, Ghosh S, Petryka R, Sands BE, Mitra P, Luo A. Eldelumab [anti-interferon-gamma-inducible protein-10 antibody] Induction Therapy for Active Crohn's Disease: a Randomised, Double-blind, Placebo-controlled Phase IIa Study. J Crohns Colitis. 2017 Jul 1;11(7):811-819. doi: 10.1093/ecco-jcc/jjx005. | |
| 25935574 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cohort 1: Open Label |
| Experimental |
Anti-IP-10 Antibody |
|
| Placebo | Drug | Normal Saline, Intravenous, 0 mg, Every other week, Up to 337days |
|
| BMS-936557 (Anti-IP-10 Antibody) | Drug | Solution for IV administration, Intravenous, 10 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks |
|
|
| BMS-936557 (Anti-IP-10 Antibody) | Drug | Solution for IV administration, Intravenous, 20 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks |
|
|
| BMS-936557 (Anti-IP-10 Antibody) | Drug | Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days |
|
| BMS-936557 (Anti-IP-10 Antibody) | Drug | Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days |
|
| BMS-936557 (Anti-IP-10 Antibody) | Drug | Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open |
|
| Week 7 and Week 11 |
| Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) | Week 11 |
| Safety of BMS-936557 in the induction period defined by proportion of subjects reporting AE, SAEs, AEs leading to discontinuation, and markedly abnormal laboratory values | AE - Adverse Event SAE - Serious Adverse Event | Week 11 |
| Shafran Gasteroenterology Center |
| Winter Park |
| Florida |
| 32789 |
| 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 |
| Midwest Center For Clinical Research | Lees Summit | Missouri | 64064 | United States |
| Nyu Langone Long Island Clinical Research Associates | 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 |
| Consultants For Clinical Research | Cincinnati | Ohio | 45219 | United States |
| Gastroenterology Research Of San Antonio | San Antonio | Texas | 78229 | United States |
| Local Institution | Brussels | 1090 | Belgium |
| Local Institution | Leuven | 3000 | Belgium |
| Local Institution | Amiens | 80054 | France |
| Local Institution | Clichy | 92110 | France |
| Local Institution | Nice | 06200 | France |
| Local Institution | Pessac | 33064 | France |
| Local Institution | Rouen | 76031 | France |
| Local Institution | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution | Budapest | 1083 | Hungary |
| Local Institution | Budapest | 1088 | Hungary |
| Local Institution | Budapest | H-1115 | Hungary |
| Local Institution | Debrecen | 4012 | Hungary |
| Local Institution | Haifa | 31048 | Israel |
| Local Institution | Kfar Saba | 44281 | Israel |
| Local Institution | Nazareth | 16100 | Israel |
| Local Institution | Krakow | 31-501 | Poland |
| Local Institution | Rzeszów | 35-068 | Poland |
| Local Institution | Warsaw | 02-507 | Poland |
| Local Institution | Warsaw | 03-580 | Poland |
| University Of Puerto Rico School Of Medicine | San Juan | 00936 | Puerto Rico |
| Local Institution | Overport | KwaZulu-Natal | 4091 | South Africa |
| Local Institution | Claremont | Western Cape | 7708 | South Africa |
| Local Institution | Panorama | Western Cape | 7506 | South Africa |
| Khanna R, Zou G, D'Haens G, Rutgeerts P, McDonald JW, Daperno M, Feagan BG, Sandborn WJ, Dubcenco E, Stitt L, Vandervoort MK, Donner A, Luo A, Levesque BG. Reliability among central readers in the evaluation of endoscopic findings from patients with Crohn's disease. Gut. 2016 Jul;65(7):1119-25. doi: 10.1136/gutjnl-2014-308973. Epub 2015 May 2. |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C587732 | BMS-936557 |
Not provided
Not provided
Not provided