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

Purpose

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	Intervention	Phase
Crohn's Disease	Biological: Placebo matching with BMS-945429 Biological: BMS-945429	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

Further study details as provided by Vitaeris INC:

Primary Outcome Measures:

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:

Proportion of subjects with clinical response during Induction Period [ Time Frame: Week 8 ]
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 ]
Safety during the Induction Period as measured by adverse events, vital signs, physical examinations and safety lab values [ Time Frame: Up to Week 12 ]
Immunogenicity during the Induction Period will be assessed based on levels of anti-BMS-945429 antibodies [ Time Frame: Up to Week 12 ]
Steady-state trough concentration (Cmin) of BMS-945429 during the Induction Period [ Time Frame: Week 4, Week 8, Week 12 ]
Observed maximum concentration (Cmax) of BMS-945429 during the Induction Period [ Time Frame: Week 0 and Week 4 ]
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 ]


Enrollment:	72
Study Start Date:	June 2012
Study Completion Date:	December 2013
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545050

Show 56 Study Locations

Sponsors and Collaborators

Vitaeris INC

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS clinical trial educational resource This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site


Responsible Party:	Vitaeris INC
ClinicalTrials.gov Identifier:	NCT01545050 History of Changes
Other Study ID Numbers:	IM133-005 2011-004763-72 ( EudraCT Number )
Study First Received:	March 1, 2012
Last Updated:	September 13, 2017

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 21, 2017