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Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Placebo
BMS-936557 (Anti-IP-10 Antibody)
BMS-936557 (Anti-IP-10 Antibody)
BMS-936557 (Anti-IP-10 Antibody)
BMS-936557 (Anti-IP-10 Antibody)
BMS-936557 (Anti-IP-10 Antibody)
Sponsored by
Bristol-Myers Squibb
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:

  • Adults subjects with confirmed Crohn's Disease (CD) for at least 3 months
  • Moderate to severely active CD as defined by Crohn's Disease Activity Index (CDAI) 220 to 450
  • In the past have had insufficient response and or intolerance to ≥ 1 of the conventional therapy (immunosuppressants, corticosteroids and/or approved biologic therapy)

Exclusion Criteria:

  • Ulcerative colitis (UC) or indeterminate colitis
  • Short bowel syndrome
  • Known stricture or noninflammatory stenosis leading to symptoms of obstruction
  • Current stoma or current need for colostomy or ileostomy

Sites / Locations

  • Southern California Medical Gastroenterology Group
  • Shafran Gasteroenterology Center
  • Gastroenterology Research Of New Orleans
  • Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr
  • Midwest Center For Clinical Research
  • Nyu Langone Long Island Clinical Research Associates
  • Mount Sinai School Of Medicine
  • University Of North Carolina At Chapel Hill
  • Consultants For Clinical Research
  • Gastroenterology Research Of San Antonio
  • 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
  • University Of Puerto Rico School Of Medicine
  • 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 Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1: Induction

Cohort 2: Induction

Cohort 3: Induction

Cohort 1: Maintenance

Cohort 2: Maintenance

Cohort 3: Maintenance

Cohort 1: Open Label

Arm Description

Placebo

Anti-IP-10 Antibody

Anti-IP-10 Antibody

Placebo

Anti-IP-10 Antibody

Anti-IP-10 Antibody

Anti-IP-10 Antibody

Outcomes

Primary Outcome Measures

Clinical remission (CDAI score of <150)
CDAI: Crohn's Disease Activity Index

Secondary Outcome Measures

Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150)
Proportion of subjects in clinical response (defined as CDAI score reduction from Baseline of ≥ 100 points or an absolute CDAI score of < 150)
Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Safety of BMS-936557 in the induction period defined by proportion of subjects reporting AE, SAEs, AEs leading to discontinuation, and markedly abnormal laboratory values
AE - Adverse Event SAE - Serious Adverse Event

Full Information

First Posted
November 3, 2011
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01466374
Brief Title
Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease
Official Title
A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.
Detailed Description
Anti-IP10: Anti Interferon-inducible ligand 10

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
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Induction
Arm Type
Experimental
Arm Description
Placebo
Arm Title
Cohort 2: Induction
Arm Type
Experimental
Arm Description
Anti-IP-10 Antibody
Arm Title
Cohort 3: Induction
Arm Type
Experimental
Arm Description
Anti-IP-10 Antibody
Arm Title
Cohort 1: Maintenance
Arm Type
Experimental
Arm Description
Placebo
Arm Title
Cohort 2: Maintenance
Arm Type
Experimental
Arm Description
Anti-IP-10 Antibody
Arm Title
Cohort 3: Maintenance
Arm Type
Experimental
Arm Description
Anti-IP-10 Antibody
Arm Title
Cohort 1: Open Label
Arm Type
Experimental
Arm Description
Anti-IP-10 Antibody
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal Saline, Intravenous, 0 mg, Every other week, Up to 337days
Intervention Type
Drug
Intervention Name(s)
BMS-936557 (Anti-IP-10 Antibody)
Other Intervention Name(s)
Anti-IP-10 Antibody
Intervention Description
Solution for IV administration, Intravenous, 10 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-936557 (Anti-IP-10 Antibody)
Other Intervention Name(s)
Anti-IP-10 Antibody
Intervention Description
Solution for IV administration, Intravenous, 20 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-936557 (Anti-IP-10 Antibody)
Intervention Description
Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days
Intervention Type
Drug
Intervention Name(s)
BMS-936557 (Anti-IP-10 Antibody)
Intervention Description
Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days
Intervention Type
Drug
Intervention Name(s)
BMS-936557 (Anti-IP-10 Antibody)
Intervention Description
Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open
Primary Outcome Measure Information:
Title
Clinical remission (CDAI score of <150)
Description
CDAI: Crohn's Disease Activity Index
Time Frame
Week 11
Secondary Outcome Measure Information:
Title
Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150)
Time Frame
Week 7 and Week 11
Title
Proportion of subjects in clinical response (defined as CDAI score reduction from Baseline of ≥ 100 points or an absolute CDAI score of < 150)
Time Frame
Week 7 and Week 11
Title
Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame
Week 11
Title
Safety of BMS-936557 in the induction period defined by proportion of subjects reporting AE, SAEs, AEs leading to discontinuation, and markedly abnormal laboratory values
Description
AE - Adverse Event SAE - Serious Adverse Event
Time Frame
Week 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults subjects with confirmed Crohn's Disease (CD) for at least 3 months Moderate to severely active CD as defined by Crohn's Disease Activity Index (CDAI) 220 to 450 In the past have had insufficient response and or intolerance to ≥ 1 of the conventional therapy (immunosuppressants, corticosteroids and/or approved biologic therapy) Exclusion Criteria: Ulcerative colitis (UC) or indeterminate colitis Short bowel syndrome Known stricture or noninflammatory stenosis leading to symptoms of obstruction Current stoma or current need for colostomy or ileostomy
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
Southern California Medical Gastroenterology Group
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Shafran Gasteroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Gastroenterology Research Of New Orleans
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Midwest Center For Clinical Research
City
Lees Summit
State/Province
Missouri
ZIP/Postal Code
64064
Country
United States
Facility Name
Nyu Langone Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Mount Sinai School Of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University Of North Carolina At Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Consultants For Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Gastroenterology Research Of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Local Institution
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Local Institution
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Local Institution
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Local Institution
City
Pessac
ZIP/Postal Code
33064
Country
France
Facility Name
Local Institution
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Local Institution
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
H-1115
Country
Hungary
Facility Name
Local Institution
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Local Institution
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Local Institution
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Local Institution
City
Rzeszow
ZIP/Postal Code
35-068
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
University Of Puerto Rico School Of Medicine
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico
Facility Name
Local Institution
City
Overport
State/Province
Kwa Zulu Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Local Institution
City
Claremont
State/Province
Western Cape
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Local Institution
City
Panorama
State/Province
Western Cape
ZIP/Postal Code
7506
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
28333187
Citation
Sandborn WJ, Rutgeerts P, Colombel JF, Ghosh S, Petryka R, Sands BE, Mitra P, Luo A. Eldelumab [anti-interferon-gamma-inducible protein-10 antibody] Induction Therapy for Active Crohn's Disease: a Randomised, Double-blind, Placebo-controlled Phase IIa Study. J Crohns Colitis. 2017 Jul 1;11(7):811-819. doi: 10.1093/ecco-jcc/jjx005.
Results Reference
derived
PubMed Identifier
25935574
Citation
Khanna R, Zou G, D'Haens G, Rutgeerts P, McDonald JW, Daperno M, Feagan BG, Sandborn WJ, Dubcenco E, Stitt L, Vandervoort MK, Donner A, Luo A, Levesque BG. Reliability among central readers in the evaluation of endoscopic findings from patients with Crohn's disease. Gut. 2016 Jul;65(7):1119-25. doi: 10.1136/gutjnl-2014-308973. Epub 2015 May 2.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease

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