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: June 7, 2013
Last verified: June 2013
  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: 71
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 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: June 7, 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 April 16, 2014