Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease

Study Description

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Brief Summary:

The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor (anti-TNF) therapy.

Condition or disease	Intervention/treatment	Phase
Crohn's Disease	Biological: Placebo matching with BMS-945429; Biological: BMS-945429	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	72 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
Study Start Date :	June 2012
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	December 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Induction Cohort: Placebo matching with BMS-945429	Biological: Placebo matching with BMS-945429; Injection, Intravenous (IV), 0 mg, Day One Only, One Day Biological: Placebo matching with BMS-945429; Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, 8 weeks
Experimental: Induction Cohort: BMS-945429 (600 IV/200 SC mg)	Biological: Placebo matching with BMS-945429; Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day Biological: BMS-945429; Injection, Intravenous (IV), 600 mg, Day One Only, One Day Biological: BMS-945429; Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day
Experimental: Induction Cohort: BMS-945429 (300 IV/100 SC mg)	Biological: Placebo matching with BMS-945429; Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day Biological: BMS-945429; Injection, Intravenous (IV), 300 mg, Day One Only, One Day Biological: BMS-945429; Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day
Experimental: Induction Cohort: BMS-945429 (150 IV/100 SC mg)	Biological: Placebo matching with BMS-945429; Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day Biological: BMS-945429; Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day Biological: BMS-945429; Injection, Intravenous (IV), 150 mg, Day One Only, One Day
Experimental: Induction Cohort: BMS-945429 (400 SC/200 SC mg)	Biological: Placebo matching with BMS-945429; Injection, Intravenous (IV), 0 mg, Day One Only, One Day Biological: BMS-945429; Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day Biological: BMS-945429; Injection, Subcutaneous (SC), 400 mg, Day One and Week 4, 4 weeks
Experimental: Maintenance Cohort: Placebo matching with BMS-945429	Biological: Placebo matching with BMS-945429; Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, Up to 48 weeks
Experimental: Maintenance Cohort: BMS-945429 (100 SC mg)	Biological: BMS-945429; Injection, Subcutaneous (SC), 100 mg, Every 4 weeks, Up to 48 weeks
Experimental: Maintenance Cohort: BMS-945429 (200 SC mg)	Biological: BMS-945429; Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 48 weeks
Experimental: Open Label Cohort: BMS-945429 (200 SC mg)	Biological: BMS-945429; Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period

Outcome Measures

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Primary Outcome Measures :

1. Proportion of subjects with clinical remission as measured by the Crohn's Disease Activity Index [ Time Frame: At 8 weeks during the Induction Period ]

Secondary Outcome Measures :

1. Proportion of subjects with clinical response during Induction Period [ Time Frame: Week 8 ]
2. Change from baseline of Inflammatory Bowel Disease Questionnaire (IBDQ) and Short Form-36 (SF-36) [ Time Frame: Baseline (Week 0), Week 8 and Week 12 ]
3. Safety during the Induction Period as measured by adverse events, vital signs, physical examinations and safety lab values [ Time Frame: Up to Week 12 ]
4. Immunogenicity during the Induction Period will be assessed based on levels of anti-BMS-945429 antibodies [ Time Frame: Up to Week 12 ]
5. Steady-state trough concentration (Cmin) of BMS-945429 during the Induction Period [ Time Frame: Week 4, Week 8, Week 12 ]
6. Observed maximum concentration (Cmax) of BMS-945429 during the Induction Period [ Time Frame: Week 0 and Week 4 ]
7. Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-945429 during the Induction Period [ Time Frame: Week 0, Week 4, Week 8 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Confirmed Crohn's Disease diagnosis via radiology, endoscopy or histology within prior 12 months. Diagnosed for at least 3 months
• Active Disease with Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450
• Failed conventional therapy or steroid dependent

Exclusion Criteria:

• Diagnosed/clinical findings of Ulcerative Colitis (UC), indeterminate colitis, non colonic/ileal disease
• Stricture/stenosis, Stoma, proctocolectomy, subtotal colectomy, ileorectal anastomosis
• History of diverticulitis, or evidence of Gastrointestinal (GI) perforations

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 56 Study Locations

Sponsors and Collaborators

Vitaeris INC

Investigators

Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

BMS Clinical Trial Information 

BMS clinical trial educational resource 

Investigator Inquiry form 

FDA Safety Alerts and Recalls 

Responsible Party:	Vitaeris INC
ClinicalTrials.gov Identifier:	NCT01545050 History of Changes
Other Study ID Numbers:	IM133-005; 2011-004763-72 ( EudraCT Number )
First Posted:	March 6, 2012
Last Update Posted:	April 24, 2018
Last Verified:	April 2018

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis	Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases