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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 Bristol-Myers Squibb:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	288
Study Start Date:	June 2012
Estimated Study Completion Date:	September 2017
Estimated Primary Completion Date:	June 2014 (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
Genders Eligible for Study:	Both
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

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

Show 56 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01545050 History of Changes
Other Study ID Numbers:	IM133-005, 2011-004763-72
Study First Received:	March 1, 2012
Last Updated:	May 8, 2013
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board United Kingdom: Medicines and Healthcare Products Regulatory Agency Korea: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Hungary: National Institute of Pharmacy Czech Republic: State Institute for Drug Control Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Russia: FSI Scientific Center of Expertise of Medical Application Switzerland: Swissmedic Germany: Federal Institute for Drugs and Medical Devices Germany: Federal Office for Radiation Protection Germany: Ministry of Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) South Africa: Medicines Control Council Israel: Ministry of Health Mexico: Federal Commission for Sanitary Risks Protection Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Institute of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency Hong Kong: Department of Health Taiwan: Department of Health Taiwan: National Bureau of Controlled Drugs Singapore: Clinical Trials & Epidemiology Research Unit (CTERU) Brazil: National Health Surveillance Agency India: Central Drugs Standard Control Organization India: Indian Council of Medical Research Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis

Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 22, 2013