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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01545050
• Date of registration: 01/03/2012
• Prospective Registration: Yes
• Primary sponsor: CSL Behring
• Public title: Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
• Scientific 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
• Date of first enrolment: June 2012
• Target sample size: 72
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01545050
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Austria, Brazil, Canada, Czech Republic, Czechia, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Russian Federation, Singapore, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Primary Outcome(s)

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

Secondary Outcome(s)

Proportion of subjects with clinical response during Induction Period [Time Frame: Week 8]

Safety during the Induction Period as measured by adverse events, vital signs, physical examinations and safety lab values [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]

Immunogenicity during the Induction Period will be assessed based on levels of anti-BMS-945429 antibodies [Time Frame: Up to 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]

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]

Secondary ID(s)

IM133-005

2011-004763-72

Source(s) of Monetary Support

Please refer to primary and secondary sponsors