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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT01545050

Run by

CSL Behring

People needed

72

Starts

2012-06-01

Expected to finish

2013-12-01

Last updated by the study team

2021-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Precision Research Institute, Llc — San Diego, California, United States
• South Denver Gastroenterology, Pc — Lone Tree, Colorado, United States
• University Of Florida — Gainesville, Florida, United States
• University Of Louisville — Louisville, Kentucky, United States
• Premier Medical Group Of The Hudson Valley, Pc — Poughkeepsie, New York, United States
• Options Health Research, Llc — Tulsa, Oklahoma, United States
• Gastro One — Germantown, Tennessee, United States
• Local Institution — Vienna, Austria
• Local Institution — Calgary, Alberta, Canada
• Local Institution — Vancouver, British Columbia, Canada
• Local Institution — Saskatoon, Saskatchewan, Canada
• Local Institution — Hradec Králové, Czechia
• Local Institution — Clermont-Ferrand, France
• Local Institution — Lille, France
• Local Institution — Nice, France
• Local Institution — Pessac, France
• Local Institution — Saint-Priest-en-Jarez, France
• Local Institution — Düsseldorf, Germany
• Local Institution — Frankfurt A. M, Germany
• Local Institution — Herne, Germany
• Local Institution — Kiel, Germany
• Local Institution — Magdeburg, Germany
• Local Institution — Münster, Germany
• Local Institution — Hong Kong, Hong Kong
• University Of California, San Diego — La Jolla, California, United States

Full record on ClinicalTrials.gov

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