Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
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ClinicalTrials.gov Identifier: NCT01545050 |
Recruitment Status
:
Terminated
(due to sponsor decision)
First Posted
: March 6, 2012
Last Update Posted
: April 24, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Biological: Placebo matching with BMS-945429 Biological: BMS-945429 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
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 |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
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
|
- Proportion of subjects with clinical remission as measured by the Crohn's Disease Activity Index [ Time Frame: At 8 weeks during the Induction Period ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545050

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Responsible Party: | Vitaeris INC |
ClinicalTrials.gov Identifier: | NCT01545050 History of Changes |
Other Study ID Numbers: |
IM133-005 2011-004763-72 ( EudraCT Number ) |
First Posted: | March 6, 2012 Key Record Dates |
Last Update Posted: | April 24, 2018 |
Last Verified: | April 2018 |
Additional relevant MeSH terms:
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |