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

This study has suspended participant recruitment.

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01545050

First received: March 1, 2012

Last updated: May 8, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 1, 2012

Last Updated Date

May 8, 2013

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of subjects with clinical remission as measured by the Crohn's Disease Activity Index [ Time Frame: At 8 weeks during the Induction Period ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01545050 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of subjects with clinical response during Induction Period [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Safety during the Induction Period as measured by adverse events, vital signs, physical examinations and safety lab values [ Time Frame: Up to Week 12 ] [ Designated as safety issue: Yes ]
Immunogenicity during the Induction Period will be assessed based on levels of anti-BMS-945429 antibodies [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
Steady-state trough concentration (Cmin) of BMS-945429 during the Induction Period [ Time Frame: Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
Observed maximum concentration (Cmax) of BMS-945429 during the Induction Period [ Time Frame: Week 0 and Week 4 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Crohn's Disease

Intervention ^ICMJE

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
Biological: Placebo matching with BMS-945429
Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day
Biological: Placebo matching with BMS-945429
Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, Up to 48 weeks
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
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
Biological: BMS-945429
Injection, Subcutaneous (SC), 400 mg, Day One and Week 4, 4 weeks
Biological: BMS-945429
Injection, Intravenous (IV), 150 mg, Day One Only, One Day
Biological: BMS-945429
Injection, Subcutaneous (SC), 100 mg, Every 4 weeks, Up to 48 weeks
Biological: BMS-945429
Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 48 weeks
Biological: BMS-945429
Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period

Study Arm (s)

Experimental: Induction Cohort: Placebo matching with BMS-945429
Interventions:
- Biological: Placebo matching with BMS-945429
- Biological: Placebo matching with BMS-945429
Experimental: Induction Cohort: BMS-945429 (600 IV/200 SC mg)
Interventions:
- Biological: Placebo matching with BMS-945429
- Biological: BMS-945429
- Biological: BMS-945429
Experimental: Induction Cohort: BMS-945429 (300 IV/100 SC mg)
Interventions:
- Biological: Placebo matching with BMS-945429
- Biological: BMS-945429
- Biological: BMS-945429
Experimental: Induction Cohort: BMS-945429 (150 IV/100 SC mg)
Interventions:
- Biological: Placebo matching with BMS-945429
- Biological: BMS-945429
- Biological: BMS-945429
Experimental: Induction Cohort: BMS-945429 (400 SC/200 SC mg)
Interventions:
- Biological: Placebo matching with BMS-945429
- Biological: BMS-945429
- Biological: BMS-945429
Experimental: Maintenance Cohort: Placebo matching with BMS-945429
Intervention: Biological: Placebo matching with BMS-945429
Experimental: Maintenance Cohort: BMS-945429 (100 SC mg)
Intervention: Biological: BMS-945429
Experimental: Maintenance Cohort: BMS-945429 (200 SC mg)
Intervention: Biological: BMS-945429
Experimental: Open Label Cohort: BMS-945429 (200 SC mg)
Intervention: Biological: BMS-945429

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

288

Estimated Completion Date

September 2017

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Austria, Canada, Czech Republic, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Mexico, Singapore, Switzerland, Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01545050

Other Study ID Numbers ^ICMJE

IM133-005, 2011-004763-72

Has Data Monitoring Committee

Yes

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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