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

March 1, 2012
June 7, 2013
June 2012
June 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01545050 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
71
September 2017
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Canada,   Czech Republic,   France,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Mexico,   Singapore,   Switzerland,   Taiwan
 
NCT01545050
IM133-005, 2011-004763-72
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2013

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