Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01545050
First received: March 1, 2012
Last updated: November 19, 2014
Last verified: November 2014
  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:


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 ]

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
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
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
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
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: November 19, 2014
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
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014