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Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis

Primary Purpose

Colitis, Ulcerative

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Placebo
Anti-IP-10 Antibody
Anti-IP-10 Antibody
Anti-IP-10 Antibody
Anti-IP-10 Antibody
Anti-IP-10 Antibody
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 Colitis, Ulcerative

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence
  • Mayo score ≥6 with an endoscopic subscore of ≥2
  • Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)

Exclusion Criteria:

  • Diagnosis of Crohn's Disease or Indeterminate Colitis
  • Diagnosis of UC that is limited to the rectum
  • Evidence of fulminant colitis, toxic megacolon, or bowel perforation
  • Current need for a colostomy or ileostomy
  • Previous total or subtotal colectomy

Sites / Locations

  • University Of California, San Diego
  • Santa Monica Research Institute
  • Western States Clinical Research Inc.
  • University Of Florida
  • Shafran Gasteroenterology Center
  • Atlanta Gastroenterology Associates
  • Health Science Research Center
  • University Of Kentucky
  • University Of Louisville
  • Gastroenterology Research Of New Orleans
  • Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr
  • Minnesota Gastroenterology, Pa
  • Westglen Gastrointestinal Consultants
  • Long Island Clinical Research Assoc., Llp
  • Mount Sinai School Of Medicine
  • University Of North Carolina At Chapel Hill
  • Charlotte Gastroenterology & Hepatology, Pllc
  • Consultants For Clinical Research
  • Gastroenterology Research Of Lima
  • Pharma Resource
  • Nashville Medical Research Institute
  • Gastroenterology Research Of San Antonio
  • Gastroenterology Research Of Tyler (Gerty)
  • Local Institution
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  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Other

Arm Label

Cohort 1: Induction

Cohort 2: Induction

Cohort 3: Induction

Maintenance

Open Label

Arm Description

Placebo or Anti-IP-10 Antibody

Placebo or Anti-IP-10 Antibody

Placebo or Anti-IP-10 Antibody

Placebo or Anti-IP-10 Antibody

Outcomes

Primary Outcome Measures

Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo

Secondary Outcome Measures

Proportion of the subjects with clinical response of BMS-936557 with that of the placebo
Defined as a reduction from baseline in Mayo score ≥3 points and ≥30% and decrease from baseline in rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1 point
Proportion of subjects with mucosal healing (defined as endoscopy subscore of ≤1 point) of BMS-936557 with that of the placebo
Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values
Mean change from baseline at Inflammatory Bowel Disease Questionnaire (IBDQ) of subjects treated with BMS-936557 and placebo

Full Information

First Posted
February 10, 2011
Last Updated
June 24, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01294410
Brief Title
Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis
Official Title
A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2012 (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 in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Induction
Arm Type
Experimental
Arm Description
Placebo or Anti-IP-10 Antibody
Arm Title
Cohort 2: Induction
Arm Type
Experimental
Arm Description
Placebo or Anti-IP-10 Antibody
Arm Title
Cohort 3: Induction
Arm Type
Experimental
Arm Description
Placebo or Anti-IP-10 Antibody
Arm Title
Maintenance
Arm Type
Experimental
Arm Description
Placebo or Anti-IP-10 Antibody
Arm Title
Open Label
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days
Intervention Type
Drug
Intervention Name(s)
Anti-IP-10 Antibody
Intervention Description
Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Intervention Type
Drug
Intervention Name(s)
Anti-IP-10 Antibody
Intervention Description
Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Intervention Type
Drug
Intervention Name(s)
Anti-IP-10 Antibody
Intervention Description
Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days
Intervention Type
Drug
Intervention Name(s)
Anti-IP-10 Antibody
Intervention Description
Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days
Intervention Type
Drug
Intervention Name(s)
Anti-IP-10 Antibody
Intervention Description
Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days
Intervention Type
Drug
Intervention Name(s)
Anti-IP-10 Antibody
Intervention Description
Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open
Primary Outcome Measure Information:
Title
Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo
Time Frame
End of Induction [Week 11, Induction Period-78 (IP-78)]
Secondary Outcome Measure Information:
Title
Proportion of the subjects with clinical response of BMS-936557 with that of the placebo
Description
Defined as a reduction from baseline in Mayo score ≥3 points and ≥30% and decrease from baseline in rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1 point
Time Frame
IP-78 (Week 11)
Title
Proportion of subjects with mucosal healing (defined as endoscopy subscore of ≤1 point) of BMS-936557 with that of the placebo
Time Frame
IP-78 (Week 11)
Title
Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values
Time Frame
IP-78 (Week 11)
Title
Mean change from baseline at Inflammatory Bowel Disease Questionnaire (IBDQ) of subjects treated with BMS-936557 and placebo
Time Frame
Baseline (IP-1, Week 1) and IP-78 (Week 11)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence Mayo score ≥6 with an endoscopic subscore of ≥2 Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist) Exclusion Criteria: Diagnosis of Crohn's Disease or Indeterminate Colitis Diagnosis of UC that is limited to the rectum Evidence of fulminant colitis, toxic megacolon, or bowel perforation Current need for a colostomy or ileostomy Previous total or subtotal colectomy
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
Santa Monica Research Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Western States Clinical Research Inc.
City
Wheatridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
University Of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Shafran Gasteroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Health Science Research Center
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
University Of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University Of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
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
Minnesota Gastroenterology, Pa
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Westglen Gastrointestinal Consultants
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64064
Country
United States
Facility Name
Long Island Clinical Research Assoc., Llp
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
Charlotte Gastroenterology & Hepatology, Pllc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
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 Lima
City
Lima
State/Province
Ohio
ZIP/Postal Code
45806
Country
United States
Facility Name
Pharma Resource
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Facility Name
Nashville Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
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
Gastroenterology Research Of Tyler (Gerty)
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Local Institution
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Local Institution
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Local Institution
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Local Institution
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Local Institution
City
South Brisbane
State/Province
Victoria
ZIP/Postal Code
4101
Country
Australia
Facility Name
Local Institution
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6959
Country
Australia
Facility Name
Local Institution
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Local Institution
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Local Institution
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Local Institution
City
Goiania
State/Province
Goias
ZIP/Postal Code
74535
Country
Brazil
Facility Name
Local Institution
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618
Country
Brazil
Facility Name
Local Institution
City
Rio De Janeiro
ZIP/Postal Code
21941
Country
Brazil
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
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Facility Name
Local Institution
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Local Institution
City
Clichy
ZIP/Postal Code
92110
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
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
20148
Country
Germany
Facility Name
Local Institution
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Local Institution
City
Muenster
ZIP/Postal Code
48155
Country
Germany
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Local Institution
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Local Institution
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
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
Mexico, D. F.
State/Province
Distrito Federal
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Local Institution
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
45040
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Local Institution
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Local Institution
City
Rzeszow
ZIP/Postal Code
35-068
Country
Poland
Facility Name
Local Institution
City
Sosnowiec
ZIP/Postal Code
41-200
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
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
Facility Name
Local Institution
City
Paarl
ZIP/Postal Code
7646
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
26721935
Citation
Sandborn WJ, Colombel JF, Ghosh S, Sands BE, Dryden G, Hebuterne X, Leong RW, Bressler B, Ullman T, Lakatos PL, Reinisch W, Xu LA, Luo A. Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study. J Crohns Colitis. 2016 Apr;10(4):418-28. doi: 10.1093/ecco-jcc/jjv224. Epub 2015 Dec 30.
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 Patients With Moderate to Severe Ulcerative Colitis

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