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

Primary Purpose

Crohn's Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo matching with BMS-945429
Placebo matching with BMS-945429
Placebo matching with BMS-945429
Placebo matching with BMS-945429
BMS-945429
BMS-945429
BMS-945429
BMS-945429
BMS-945429
BMS-945429
BMS-945429
BMS-945429
BMS-945429
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Of California, San Diego
  • Precision Research Institute, Llc
  • South Denver Gastroenterology, Pc
  • University Of Florida
  • University Of Louisville
  • Premier Medical Group Of The Hudson Valley, Pc
  • Options Health Research, Llc
  • Gastro One
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

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

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

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

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

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

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

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

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

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
Number of Participants During the Induction Period With Anti-clazakizumab Antibodies
Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period
Observed Maximum Concentration (Cmax) of Clazakizumab During the Induction Period
Area Under the Plasma Concentration-time Curve in One Dosing Interval [AUC(TAU)] of Clazakizumab During the Induction Period

Full Information

First Posted
March 1, 2012
Last Updated
November 6, 2021
Sponsor
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT01545050
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
due to sponsor decision
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Induction Cohort: Placebo matching with BMS-945429 (Clazakizumab)
Arm Type
Experimental
Arm Title
Induction Cohort: BMS-945429 (Clazakizumab)(600 IV/200 SC mg)
Arm Type
Experimental
Arm Title
Induction Cohort: BMS-945429 (Clazakizumab)(300 IV/100 SC mg)
Arm Type
Experimental
Arm Title
Induction Cohort: BMS-945429 (Clazakizumab)(150 IV/100 SC mg)
Arm Type
Experimental
Arm Title
Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg)
Arm Type
Experimental
Arm Title
Maintenance Cohort: Placebo matching with BMS-945429 (Clazakizumab)
Arm Type
Experimental
Arm Title
Maintenance Cohort: BMS-945429 (Clazakizumab)(100 SC mg)
Arm Type
Experimental
Arm Title
Maintenance Cohort: BMS-945429 (Clazakizumab)(200 SC mg)
Arm Type
Experimental
Arm Title
Open Label Cohort: BMS-945429 (Clazakizumab)(200 SC mg)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Placebo matching with BMS-945429
Intervention Description
Injection, Intravenous (IV), 0 mg, Day One Only, One Day
Intervention Type
Biological
Intervention Name(s)
Placebo matching with BMS-945429
Intervention Description
Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, 8 weeks
Intervention Type
Biological
Intervention Name(s)
Placebo matching with BMS-945429
Intervention Description
Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day
Intervention Type
Biological
Intervention Name(s)
Placebo matching with BMS-945429
Intervention Description
Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, Up to 48 weeks
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Other Intervention Name(s)
Clazakizumab
Intervention Description
Injection, Intravenous (IV), 600 mg, Day One Only, One Day
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Other Intervention Name(s)
Clazakizumab
Intervention Description
Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Other Intervention Name(s)
Clazakizumab
Intervention Description
Injection, Intravenous (IV), 300 mg, Day One Only, One Day
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Other Intervention Name(s)
Clazakizumab
Intervention Description
Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Other Intervention Name(s)
Clazakizumab
Intervention Description
Injection, Subcutaneous (SC), 400 mg, Day One and Week 4, 4 weeks
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Other Intervention Name(s)
Clazakizumab
Intervention Description
Injection, Intravenous (IV), 150 mg, Day One Only, One Day
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Other Intervention Name(s)
Clazakizumab
Intervention Description
Injection, Subcutaneous (SC), 100 mg, Every 4 weeks, Up to 48 weeks
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Other Intervention Name(s)
Clazakizumab
Intervention Description
Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 48 weeks
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Other Intervention Name(s)
Clazakizumab
Intervention Description
Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period
Primary Outcome Measure Information:
Title
Percent of Participants With Clinical Remission (CDAI<150) as Measured by the Crohn's Disease Activity Index (CDAI)
Description
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
Time Frame
At 8 weeks during the Induction Period
Secondary Outcome Measure Information:
Title
Percent of Participants With Clinical Response (>100 Point Decrease in CDAI) During Induction Period as Measured by CDAI
Description
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
Time Frame
At 8 weeks during the Induction Period
Title
Change From Baseline at Week 8 and 12 of Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Description
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.
Time Frame
Week 8 and Week 12
Title
Number of Participants During the Induction Period With Anti-clazakizumab Antibodies
Time Frame
Up to Week 12
Title
Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period
Time Frame
Week 4, Week 8
Title
Observed Maximum Concentration (Cmax) of Clazakizumab During the Induction Period
Time Frame
Week 0 and Week 4
Title
Area Under the Plasma Concentration-time Curve in One Dosing Interval [AUC(TAU)] of Clazakizumab During the Induction Period
Time Frame
Week 0, Week 4, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University Of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Precision Research Institute, Llc
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
South Denver Gastroenterology, Pc
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
University Of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University Of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Premier Medical Group Of The Hudson Valley, Pc
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Options Health Research, Llc
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Local Institution
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Local Institution
City
Hradec Kralove
ZIP/Postal Code
50012
Country
Czechia
Facility Name
Local Institution
City
Clermont-ferrand Cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
Local Institution
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Local Institution
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Local Institution
City
St Priest En Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Local Institution
City
Duesseldorf
ZIP/Postal Code
40237
Country
Germany
Facility Name
Local Institution
City
Frankfurt A. M
ZIP/Postal Code
60431
Country
Germany
Facility Name
Local Institution
City
Herne
ZIP/Postal Code
44623
Country
Germany
Facility Name
Local Institution
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Local Institution
City
Muenster
ZIP/Postal Code
48155
Country
Germany
Facility Name
Local Institution
City
Hong Kong
Country
Hong Kong
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Local Institution
City
Debrecen
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Local Institution
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Local Institution
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500082
Country
India
Facility Name
Local Institution
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400020
Country
India
Facility Name
Local Institution
City
Ludhiana
ZIP/Postal Code
141001
Country
India
Facility Name
Local Institution
City
Mumbai
ZIP/Postal Code
400 029
Country
India
Facility Name
Local Institution
City
Pune
ZIP/Postal Code
411030
Country
India
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Local Institution
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Local Institution
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Local Institution
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Local Institution
City
San Donato Milanese (mi)
ZIP/Postal Code
20097
Country
Italy
Facility Name
Local Institution
City
San Giovanni Rotondo (fg)
ZIP/Postal Code
71013
Country
Italy
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Local Institution
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
31-864
Country
Poland
Facility Name
Local Institution
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Local Institution
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Local Institution
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
Local Institution
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Local Institution
City
Hull
State/Province
Kingston Upon Hull, City Of
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Local Institution
City
Harrow
ZIP/Postal Code
HA1 2UJ
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

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

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