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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01294410




Registration number
NCT01294410
Ethics application status
Date submitted
10/02/2011
Date registered
11/02/2011
Date last updated
25/06/2015

Titles & IDs
Public title
Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis
Scientific 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)
Secondary ID [1] 0 0
2010-022506-41
Secondary ID [2] 0 0
IM129-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Anti-IP-10 Antibody
Treatment: Drugs - Anti-IP-10 Antibody
Treatment: Drugs - Anti-IP-10 Antibody
Treatment: Drugs - Anti-IP-10 Antibody
Treatment: Drugs - Anti-IP-10 Antibody
Treatment: Drugs - Anti-IP-10 Antibody

Experimental: Cohort 1: Induction - Placebo or Anti-IP-10 Antibody

Experimental: Cohort 2: Induction - Placebo or Anti-IP-10 Antibody

Experimental: Cohort 3: Induction - Placebo or Anti-IP-10 Antibody

Experimental: Maintenance - Placebo or Anti-IP-10 Antibody

Other: Open Label -


Treatment: Drugs: Placebo
Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks

Treatment: Drugs: Placebo
Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days

Treatment: Drugs: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks

Treatment: Drugs: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks

Treatment: Drugs: Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days

Treatment: Drugs: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days

Treatment: Drugs: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days

Treatment: Drugs: Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
End of Induction [Week 11, Induction Period-78 (IP-78)]
Secondary outcome [1] 0 0
Proportion of the subjects with clinical response of BMS-936557 with that of the placebo
Timepoint [1] 0 0
IP-78 (Week 11)
Secondary outcome [2] 0 0
Proportion of subjects with mucosal healing (defined as endoscopy subscore of =1 point) of BMS-936557 with that of the placebo
Timepoint [2] 0 0
IP-78 (Week 11)
Secondary outcome [3] 0 0
Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values
Timepoint [3] 0 0
IP-78 (Week 11)
Secondary outcome [4] 0 0
Mean change from baseline at Inflammatory Bowel Disease Questionnaire (IBDQ) of subjects treated with BMS-936557 and placebo
Timepoint [4] 0 0
Baseline (IP-1, Week 1) and IP-78 (Week 11)

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
305
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Garran
Recruitment hospital [2] 0 0
Local Institution - Concord
Recruitment hospital [3] 0 0
Local Institution - Herston
Recruitment hospital [4] 0 0
Local Institution - Parkville
Recruitment hospital [5] 0 0
Local Institution - South Brisbane
Recruitment hospital [6] 0 0
Local Institution - Fremantle
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
6959 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
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United States of America
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Florida
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United States of America
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Georgia
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Kansas
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Kentucky
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Louisiana
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Maryland
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Minnesota
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Missouri
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New York
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North Carolina
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Ohio
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Rhode Island
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Tennessee
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United States of America
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Texas
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Austria
State/province [17] 0 0
Graz
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Austria
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Vienna
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Belgium
State/province [19] 0 0
Bonheiden
Country [20] 0 0
Belgium
State/province [20] 0 0
Edegem
Country [21] 0 0
Belgium
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Leuven
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Brazil
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Goias
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Brazil
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Sao Paulo
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Brazil
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Rio De Janeiro
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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France
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Clichy
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France
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Lille Cedex
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France
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Nice
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France
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Pessac
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France
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Vandoeuvre Les Nancy
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Germany
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Hamburg
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Germany
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Kiel
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Germany
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Muenster
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Szeged
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Italy
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Padova
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Italy
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Roma
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Italy
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San Donato Milanese (mi)
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Italy
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San Giovanni Rotondo (fg)
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Mexico
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Veracruz
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Netherlands
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Amsterdam
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Netherlands
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Rotterdam
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Poland
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Rzeszow
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Poland
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Sosnowiec
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Poland
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Warszawa
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South Africa
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Kwa Zulu Natal
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South Africa
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Western Cape
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South Africa
State/province [54] 0 0
Paarl

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT01294410
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01294410