Clinical trial NCT01545050: Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2012-03-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Percent of Participants With Clinical Remission (CDAI<150) as Measured by the Crohn's Disease Activity Index (CDAI)
timeFrame: At 8 weeks during the Induction Period
Secondary outcomes:
measure: Percent of Participants With Clinical Response (>100 Point Decrease in CDAI) During Induction Period as Measured by CDAI
timeFrame: At 8 weeks during the Induction Period
measure: Change From Baseline at Week 8 and 12 of Inflammatory Bowel Disease Questionnaire (IBDQ) Score
timeFrame: Week 8 and Week 12
measure: Number of Participants During the Induction Period With Anti-clazakizumab Antibodies
timeFrame: Up to Week 12
measure: Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period
timeFrame: Week 4, Week 8
measure: Observed Maximum Concentration (Cmax) of Clazakizumab During the Induction Period
timeFrame: Week 0 and Week 4
measure: Area Under the Plasma Concentration-time Curve in One Dosing Interval [AUC(TAU)] of Clazakizumab During the Induction Period
timeFrame: Week 0, Week 4, Week 8
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University Of California, San Diego
state: California
city: San Diego
country: United States
facility: Precision Research Institute, Llc
state: California
city: Lone Tree
country: United States
facility: South Denver Gastroenterology, Pc
state: Colorado
city: Gainesville
country: United States
facility: University Of Florida
state: Florida
city: Louisville
country: United States
facility: University Of Louisville
state: Kentucky
city: Poughkeepsie
country: United States
facility: Premier Medical Group Of The Hudson Valley, Pc
state: New York
city: Tulsa
country: United States
facility: Options Health Research, Llc
state: Oklahoma
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Wien
country: Austria
facility: Local Institution
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Hradec Kralove
country: Czechia
facility: Local Institution
city: Clermont-ferrand Cedex 1
country: France
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Nice
country: France
facility: Local Institution
city: Pessac
country: France
facility: Local Institution
city: St Priest En Jarez
country: France
facility: Local Institution
city: Duesseldorf
country: Germany
facility: Local Institution
city: Frankfurt A. M
country: Germany
facility: Local Institution
city: Herne
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Magdeburg
country: Germany
facility: Local Institution
city: Muenster
country: Germany
facility: Local Institution
city: Hong Kong
country: Hong Kong
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Debrecen
country: Hungary
facility: Local Institution
city: Pecs
country: Hungary
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
state: Andhra Pradesh
city: Mumbai
country: India
facility: Local Institution
state: Maharashtra
city: Ludhiana
country: India
facility: Local Institution
city: Mumbai
country: India
facility: Local Institution
city: Pune
country: India
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Rehovot
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Firenze
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: San Donato Milanese (mi)
country: Italy
facility: Local Institution
city: San Giovanni Rotondo (fg)
country: Italy
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Nijmegen
country: Netherlands
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: Zuerich
country: Switzerland
facility: Local Institution
city: Kaohsiung
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Hull
country: United Kingdom
facility: Local Institution
state: Kingston Upon Hull, City Of
city: Harrow
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: