Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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Anti-IP10: Anti Interferon-inducible ligand 10

Official Title
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A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Placebo
* Drug: Placebo
* Drug: BMS-936557 (Anti-IP-10 Antibody)
* Drug: BMS-936557 (Anti-IP-10 Antibody)
* Drug: BMS-936557 (Anti-IP-10 Antibody)
* Drug: BMS-936557 (Anti-IP-10 Antibody)
* Drug: BMS-936557 (Anti-IP-10 Antibody)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults subjects with confirmed Crohn's Disease (CD) for at least 3 months Moderate to severely active CD as defined by Crohn's Disease Activity Index (CDAI) 220 to 450 In the past have had insufficient response and or intolerance to ≥ 1 of the conventional therapy (immunosuppressants, corticosteroids and/or approved biologic therapy) Exclusion Criteria: Ulcerative colitis (UC) or indeterminate colitis Short bowel syndrome Known stricture or noninflammatory stenosis leading to symptoms of obstruction Current stoma or current need for colostomy or ileostomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Induction<br>Placebo | Drug: Placebo<br>* Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks<br>|
| Experimental: Cohort 2: Induction<br>Anti-IP-10 Antibody | Drug: BMS-936557 (Anti-IP-10 Antibody)<br>* Solution for IV administration, Intravenous, 10 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks<br>* Other names: Anti-IP-10 Antibody;|
| Experimental: Cohort 3: Induction<br>Anti-IP-10 Antibody | Drug: BMS-936557 (Anti-IP-10 Antibody)<br>* Solution for IV administration, Intravenous, 20 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks<br>* Other names: Anti-IP-10 Antibody;|
| Experimental: Cohort 1: Maintenance<br>Placebo | Drug: Placebo<br>* Normal Saline, Intravenous, 0 mg, Every other week, Up to 337days<br>|
| Experimental: Cohort 2: Maintenance<br>Anti-IP-10 Antibody | Drug: BMS-936557 (Anti-IP-10 Antibody)<br>* Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days<br>|
| Experimental: Cohort 3: Maintenance<br>Anti-IP-10 Antibody | Drug: BMS-936557 (Anti-IP-10 Antibody)<br>* Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days<br>|
| Experimental: Cohort 1: Open Label<br>Anti-IP-10 Antibody | Drug: BMS-936557 (Anti-IP-10 Antibody)<br>* Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission (CDAI score of <150) | CDAI: Crohn's Disease Activity Index | Week 11 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 |