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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - 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
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [3] 0 0
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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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Texas
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Austria
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Graz
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Austria
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Vienna
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Belgium
State/province [19] 0 0
Bonheiden
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Belgium
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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
State/province [25] 0 0
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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Budapest
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Debrecen
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Szeged
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Padova
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Roma
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San Donato Milanese (mi)
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San Giovanni Rotondo (fg)
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Distrito Federal
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Jalisco
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Veracruz
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Netherlands
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Amsterdam
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Rotterdam
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Poland
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Rzeszow
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Sosnowiec
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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
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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/show/NCT01294410
Trial related presentations / publications
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
Other publications