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

CSL Behring

Status and phase: Terminated; Phase 2

Conditions: Crohn's Disease

Treatments: Biological: BMS-945429; Biological: Placebo matching with BMS-945429

Study type: Interventional

Funder types: Industry

Identifiers

NCT01545050

IM133-005

2011-004763-72 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 9 patient groups

Induction Cohort: Placebo matching with BMS-945429 (Clazakizumab)

Experimental group

Treatment:

Biological: Placebo matching with BMS-945429

Biological: Placebo matching with BMS-945429

Biological: Placebo matching with BMS-945429

Biological: Placebo matching with BMS-945429

Induction Cohort: BMS-945429 (Clazakizumab)(600 IV/200 SC mg)

Experimental group

Treatment:

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Induction Cohort: BMS-945429 (Clazakizumab)(300 IV/100 SC mg)

Experimental group

Treatment:

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Induction Cohort: BMS-945429 (Clazakizumab)(150 IV/100 SC mg)

Experimental group

Treatment:

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg)

Experimental group

Treatment:

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Biological: Placebo matching with BMS-945429

Biological: BMS-945429

Maintenance Cohort: Placebo matching with BMS-945429 (Clazakizumab)

Experimental group

Treatment:

Biological: Placebo matching with BMS-945429

Biological: Placebo matching with BMS-945429

Biological: Placebo matching with BMS-945429

Biological: Placebo matching with BMS-945429

Maintenance Cohort: BMS-945429 (Clazakizumab)(100 SC mg)

Experimental group

Treatment:

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Maintenance Cohort: BMS-945429 (Clazakizumab)(200 SC mg)

Experimental group

Treatment:

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Open Label Cohort: BMS-945429 (Clazakizumab)(200 SC mg)

Experimental group

Treatment:

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429