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

NCT ID: NCT01545050

Last Updated: 2021-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

Placebo matching with BMS-945429

Intervention Type BIOLOGICAL

Injection, Intravenous (IV), 0 mg, Day One Only, One Day

Placebo matching with BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, 8 weeks

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

Group Type EXPERIMENTAL

Placebo matching with BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day

BMS-945429

Intervention Type BIOLOGICAL

Injection, Intravenous (IV), 600 mg, Day One Only, One Day

BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day

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

Group Type EXPERIMENTAL

Placebo matching with BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day

BMS-945429

Intervention Type BIOLOGICAL

Injection, Intravenous (IV), 300 mg, Day One Only, One Day

BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day

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

Group Type EXPERIMENTAL

Placebo matching with BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day

BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day

BMS-945429

Intervention Type BIOLOGICAL

Injection, Intravenous (IV), 150 mg, Day One Only, One Day

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

Group Type EXPERIMENTAL

Placebo matching with BMS-945429

Intervention Type BIOLOGICAL

Injection, Intravenous (IV), 0 mg, Day One Only, One Day

BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day

BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous (SC), 400 mg, Day One and Week 4, 4 weeks

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

Group Type EXPERIMENTAL

Placebo matching with BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, Up to 48 weeks

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

Group Type EXPERIMENTAL

BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous (SC), 100 mg, Every 4 weeks, Up to 48 weeks

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

Group Type EXPERIMENTAL

BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 48 weeks

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

Group Type EXPERIMENTAL

BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period

Interventions

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Placebo matching with BMS-945429

Injection, Intravenous (IV), 0 mg, Day One Only, One Day

Intervention Type BIOLOGICAL

Placebo matching with BMS-945429

Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, 8 weeks

Intervention Type BIOLOGICAL

Placebo matching with BMS-945429

Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day

Intervention Type BIOLOGICAL

Placebo matching with BMS-945429

Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, Up to 48 weeks

Intervention Type BIOLOGICAL

BMS-945429

Injection, Intravenous (IV), 600 mg, Day One Only, One Day

Intervention Type BIOLOGICAL

BMS-945429

Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day

Intervention Type BIOLOGICAL

BMS-945429

Injection, Intravenous (IV), 300 mg, Day One Only, One Day

Intervention Type BIOLOGICAL

BMS-945429

Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day

Intervention Type BIOLOGICAL

BMS-945429

Injection, Subcutaneous (SC), 400 mg, Day One and Week 4, 4 weeks

Intervention Type BIOLOGICAL

BMS-945429

Injection, Intravenous (IV), 150 mg, Day One Only, One Day

Intervention Type BIOLOGICAL

BMS-945429

Injection, Subcutaneous (SC), 100 mg, Every 4 weeks, Up to 48 weeks

Intervention Type BIOLOGICAL

BMS-945429

Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 48 weeks

Intervention Type BIOLOGICAL

BMS-945429

Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period

Intervention Type BIOLOGICAL

Other Intervention Names

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Clazakizumab Clazakizumab Clazakizumab Clazakizumab Clazakizumab Clazakizumab Clazakizumab Clazakizumab Clazakizumab

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Frankfurt A. M, , Germany

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Herne, , Germany

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Kiel, , Germany

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Magdeburg, , Germany

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Münster, , Germany

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Hong Kong, , Hong Kong

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Budapest, , Hungary

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Debrecen, , Hungary

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Pécs, , Hungary

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Hyderabad, Andhra Pradesh, India

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Mumbai, Maharashtra, India

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Ludhiana, , India

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Mumbai, , India

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Pune, , India

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Jerusalem, , Israel

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Rehovot, , Israel

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Tel Aviv, , Israel

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Florence, , Italy

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University Of California, San Diego

La Jolla, California, United States

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Precision Research Institute, Llc

San Diego, California, United States

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South Denver Gastroenterology, Pc

Lone Tree, Colorado, United States

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University Of Florida

Gainesville, Florida, United States

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University Of Louisville

Louisville, Kentucky, United States

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Premier Medical Group Of The Hudson Valley, Pc

Poughkeepsie, New York, United States

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Options Health Research, Llc

Tulsa, Oklahoma, United States

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Gastro One

Germantown, Tennessee, United States

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Vienna, , Austria

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Saskatoon, Saskatchewan, Canada

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Hradec Králové, , Czechia

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Clermont-Ferrand, , France

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Lille, , France

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Nice, , France

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Pessac, , France

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Saint-Priest-en-Jarez, , France

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Düsseldorf, , Germany

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Padua, , Italy

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Roma, , Italy

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San Donato Milanese (mi), , Italy

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San Giovanni Rotondo (fg), , Italy

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Nijmegen, , Netherlands

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Krakow, , Poland

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Lodz, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Zurich, , Switzerland

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Kaohsiung City, , Taiwan

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Taipei, , Taiwan

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Hull, Kingston Upon Hull, City of, United Kingdom

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Harrow, , United Kingdom

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Countries

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Australia Brazil Russia Singapore United States Austria Canada Czechia France Germany Hong Kong Hungary India Israel Italy Mexico Netherlands Poland South Korea Switzerland Taiwan United Kingdom

Related Links

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http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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2011-004763-72

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IM133-005

Identifier Type: -

Identifier Source: org_study_id