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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01545050
• Other study ID #: IM133-005
• Secondary ID: 2011-004763-72
• Status: Terminated
• Phase: Phase 2
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2021
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Placebo matching with BMS-945429
Injection, Intravenous (IV), 0 mg, Day One Only, One Day
• Placebo matching with BMS-945429
Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, 8 weeks
• Placebo matching with BMS-945429
Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day
• Placebo matching with BMS-945429
Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, Up to 48 weeks
• BMS-945429
Injection, Intravenous (IV), 600 mg, Day One Only, One Day
• BMS-945429
Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day
• BMS-945429
Injection, Intravenous (IV), 300 mg, Day One Only, One Day
• BMS-945429
Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day
• BMS-945429
Injection, Subcutaneous (SC), 400 mg, Day One and Week 4, 4 weeks
• BMS-945429
Injection, Intravenous (IV), 150 mg, Day One Only, One Day
• BMS-945429
Injection, Subcutaneous (SC), 100 mg, Every 4 weeks, Up to 48 weeks
• BMS-945429
Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 48 weeks
• BMS-945429
Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period

Locations

Country	Name	City	State
Austria	Local Institution	Wien
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Saskatoon	Saskatchewan
Canada	Local Institution	Vancouver	British Columbia
Czechia	Local Institution	Hradec Kralove
France	Local Institution	Clermont-ferrand Cedex 1
France	Local Institution	Lille Cedex
France	Local Institution	Nice
France	Local Institution	Pessac
France	Local Institution	St Priest En Jarez
Germany	Local Institution	Duesseldorf
Germany	Local Institution	Frankfurt A. M
Germany	Local Institution	Herne
Germany	Local Institution	Kiel
Germany	Local Institution	Magdeburg
Germany	Local Institution	Muenster
Hong Kong	Local Institution	Hong Kong
Hungary	Local Institution	Budapest
Hungary	Local Institution	Debrecen
Hungary	Local Institution	Pecs
India	Local Institution	Hyderabad	Andhra Pradesh
India	Local Institution	Ludhiana
India	Local Institution	Mumbai
India	Local Institution	Mumbai	Maharashtra
India	Local Institution	Pune
Israel	Local Institution	Jerusalem
Israel	Local Institution	Rehovot
Israel	Local Institution	Tel Aviv
Italy	Local Institution	Firenze
Italy	Local Institution	Padova
Italy	Local Institution	Roma
Italy	Local Institution	San Donato Milanese (mi)
Italy	Local Institution	San Giovanni Rotondo (fg)
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Mexico	Local Institution	Mexico	Distrito Federal
Mexico	Local Institution	Monterrey	Nuevo Leon
Netherlands	Local Institution	Nijmegen
Poland	Local Institution	Krakow
Poland	Local Institution	Lodz
Poland	Local Institution	Wroclaw
Poland	Local Institution	Wroclaw
Switzerland	Local Institution	Zuerich
Taiwan	Local Institution	Kaohsiung
Taiwan	Local Institution	Taipei
United Kingdom	Local Institution	Harrow
United Kingdom	Local Institution	Hull	Kingston Upon Hull, City Of
United States	University Of Florida	Gainesville	Florida
United States	Gastro One	Germantown	Tennessee
United States	University Of California, San Diego	La Jolla	California
United States	South Denver Gastroenterology, Pc	Lone Tree	Colorado
United States	University Of Louisville	Louisville	Kentucky
United States	Premier Medical Group Of The Hudson Valley, Pc	Poughkeepsie	New York
United States	Precision Research Institute, Llc	San Diego	California
United States	Options Health Research, Llc	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Czechia,  France,  Germany,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Participants With Clinical Remission (CDAI<150) as Measured by the Crohn's Disease Activity Index (CDAI)	CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity	At 8 weeks during the Induction Period
Secondary	Percent of Participants With Clinical Response (>100 Point Decrease in CDAI) During Induction Period as Measured by CDAI	CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity	At 8 weeks during the Induction Period
Secondary	Change From Baseline at Week 8 and 12 of Inflammatory Bowel Disease Questionnaire (IBDQ) Score	IBDQ consists of 32 questions divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items) and social function (5 items). Every question has graded responses from 1 (worst situation) to 7 (best situation), and thus the total score is ranging from 32 to 224 with higher scores representing better quality of life.	Week 8 and Week 12
Secondary	Number of Participants During the Induction Period With Anti-clazakizumab Antibodies		Up to Week 12
Secondary	Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period		Week 4, Week 8
Secondary	Observed Maximum Concentration (Cmax) of Clazakizumab During the Induction Period		Week 0 and Week 4
Secondary	Area Under the Plasma Concentration-time Curve in One Dosing Interval [AUC(TAU)] of Clazakizumab During the Induction Period		Week 0, Week 4, Week 8

External Links

•   BMS clinical trial educational resource