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

NCT01545050 | Terminated Phase 2 Results DMC

• 2 other identifiers: IM133-0052011-004763-72
• Study Type: interventional
• Target: 72
• Locations: 18 countries
• Sites: 56

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percent of Participants With Clinical Response (>100 Point Decrease in CDAI) During Induction Period as Measured by CDAI

  At 8 weeks during the Induction Period

• Change From Baseline at Week 8 and 12 of Inflammatory Bowel Disease Questionnaire (IBDQ) Score

  Week 8 and Week 12

• Number of Participants During the Induction Period With Anti-clazakizumab Antibodies

  Up to Week 12

• Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period

  Week 4, Week 8

• Observed Maximum Concentration (Cmax) of Clazakizumab During the Induction Period

  Week 0 and Week 4

Study Arms (9)

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

EXPERIMENTAL

Biological: Placebo matching with BMS-945429

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

Biological: Placebo matching with BMS-945429

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

EXPERIMENTAL

Biological: BMS-945429

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

EXPERIMENTAL

Biological: BMS-945429

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

EXPERIMENTAL

Biological: BMS-945429

Interventions

Placebo matching with BMS-945429 BIOLOGICAL

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

Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg); Induction Cohort: Placebo matching with BMS-945429 (Clazakizumab)

BMS-945429 BIOLOGICAL

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

Also known as: Clazakizumab

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (56)

University Of California, San Diego

La Jolla, California, 92093, United States

Location

Precision Research Institute, Llc

San Diego, California, 92114, United States

Location

South Denver Gastroenterology, Pc

Lone Tree, Colorado, 80124, United States

Location

University Of Florida

Gainesville, Florida, 32610, United States

Location

University Of Louisville

Louisville, Kentucky, 40202, United States

Location

Premier Medical Group Of The Hudson Valley, Pc

Poughkeepsie, New York, 12601, United States

Location

Options Health Research, Llc

Tulsa, Oklahoma, 74104, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Local Institution

Vienna, 1090, Austria

Location

Local Institution

Calgary, Alberta, T2N 4Z6, Canada

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Vancouver, British Columbia, V6Z 2K5, Canada

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Saskatoon, Saskatchewan, S7N 0W8, Canada

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Hradec Králové, 50012, Czechia

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Clermont-Ferrand, 63003, France

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Lille, 59037, France

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Nice, 06200, France

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Pessac, 33600, France

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Saint-Priest-en-Jarez, 42270, France

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Düsseldorf, 40237, Germany

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Frankfurt A. M, 60431, Germany

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Herne, 44623, Germany

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Kiel, 24105, Germany

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Magdeburg, 39120, Germany

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Münster, 48155, Germany

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Hong Kong, Hong Kong

Location

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Budapest, 1136, Hungary

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Debrecen, 4025, Hungary

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Pécs, 7623, Hungary

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Hyderabad, Andhra Pradesh, 500082, India

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Mumbai, Maharashtra, 400020, India

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Ludhiana, 141001, India

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Mumbai, 400 029, India

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Pune, 411030, India

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Jerusalem, 91031, Israel

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Rehovot, 76100, Israel

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Tel Aviv, 64239, Israel

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Florence, 50134, Italy

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Padua, 35128, Italy

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Roma, 00152, Italy

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San Donato Milanese (mi), 20097, Italy

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San Giovanni Rotondo (fg), 71013, Italy

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Mexico City, Mexico City, 14080, Mexico

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Monterrey, Nuevo León, 64460, Mexico

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Nijmegen, 6500 HB, Netherlands

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Krakow, 31-864, Poland

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Lodz, 90-302, Poland

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Wroclaw, 50-556, Poland

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Wroclaw, 53-114, Poland

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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Zurich, 8091, Switzerland

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Kaohsiung City, 80756, Taiwan

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Taipei, 100, Taiwan

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Hull, Kingston Upon Hull, City of, HU3 2JZ, United Kingdom

Location

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Harrow, HA1 2UJ, United Kingdom

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Crohn Disease

Interventions

clazakizumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Limitations and Caveats

The interpretation of the PK analysis is limited for several reasons. First, the concentration data that was collected only allowed for reporting of Cmin concentrations. Second, the sample size was limited.

Results Point of Contact

• Title: Study Director
• Organization: CSL behring

clinicaltrials@cslbehring.com

610-878-4000

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 6, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 3, 2021
• Results First Posted: December 3, 2021

Record last verified: 2021-11

Locations

TW (2); US (8); IN (5); CZ (1); HU (3); KR (3); GB (2); NL (1); CH (1); PL (4); AU (1); FR (5); HK (1); CA (3); DE (6); ME (2); IL (3); IT (5)