Clinical trial NCT01294410: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colitis, Ulcerative
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 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
timeFrame: End of Induction [Week 11, Induction Period-78 (IP-78)]
Secondary outcomes:
measure: Proportion of the subjects with clinical response of BMS-936557 with that of the placebo
timeFrame: IP-78 (Week 11)
measure: Proportion of subjects with mucosal healing (defined as endoscopy subscore of ≤1 point) of BMS-936557 with that of the placebo
timeFrame: IP-78 (Week 11)
measure: Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values
timeFrame: IP-78 (Week 11)
measure: Mean change from baseline at Inflammatory Bowel Disease Questionnaire (IBDQ) of subjects treated with BMS-936557 and placebo
timeFrame: Baseline (IP-1, Week 1) and IP-78 (Week 11)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University Of California, San Diego
state: California
city: Santa Monica
country: United States
facility: Santa Monica Research Institute
state: California
city: Wheatridge
country: United States
facility: Western States Clinical Research Inc.
state: Colorado
city: Gainesville
country: United States
facility: University Of Florida
state: Florida
city: Winter Park
country: United States
facility: Shafran Gasteroenterology Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Pratt
country: United States
facility: Health Science Research Center
state: Kansas
city: Lexington
country: United States
facility: University Of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: University Of Louisville
state: Kentucky
city: Hammond
country: United States
facility: Gastroenterology Research Of New Orleans
state: Louisiana
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr
state: Maryland
city: Plymouth
country: United States
facility: Minnesota Gastroenterology, Pa
state: Minnesota
city: Lee's Summit
country: United States
facility: Westglen Gastrointestinal Consultants
state: Missouri
city: Great Neck
country: United States
facility: Long Island Clinical Research Assoc., Llp
state: New York
city: New York
country: United States
facility: Mount Sinai School Of Medicine
state: New York
city: Chapel Hill
country: United States
facility: University Of North Carolina At Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology & Hepatology, Pllc
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants For Clinical Research
state: Ohio
city: Lima
country: United States
facility: Gastroenterology Research Of Lima
state: Ohio
city: East Providence
country: United States
facility: Pharma Resource
state: Rhode Island
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: San Antonio
country: United States
facility: Gastroenterology Research Of San Antonio
state: Texas
city: Tyler
country: United States
facility: Gastroenterology Research Of Tyler (Gerty)
state: Texas
city: Garran
country: Australia
facility: Local Institution
state: Australian Capital Territory
city: Concord
country: Australia
facility: Local Institution
state: New South Wales
city: Herston
country: Australia
facility: Local Institution
state: Queensland
city: Parkville
country: Australia
facility: Local Institution
state: Victoria
city: South Brisbane
country: Australia
facility: Local Institution
state: Victoria
city: Fremantle
country: Australia
facility: Local Institution
state: Western Australia
city: Graz
country: Austria
facility: Local Institution
city: Vienna
country: Austria
facility: Local Institution
city: Bonheiden
country: Belgium
facility: Local Institution
city: Edegem
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Goiania
country: Brazil
facility: Local Institution
state: Goias
city: Botucatu
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Kingston
country: Canada
facility: Local Institution
state: Ontario
city: Vaughan
country: Canada
facility: Local Institution
state: Ontario
city: Clichy
country: France
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Nice
country: France
facility: Local Institution
city: Pessac
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Muenster
country: Germany
facility: Local Institution
city: Muenster
country: Germany
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Debrecen
country: Hungary
facility: Local Institution
city: Szeged
country: Hungary
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: San Donato Milanese (mi)
country: Italy
facility: Local Institution
city: San Giovanni Rotondo (fg)
country: Italy
facility: Local Institution
city: Mexico, D. F.
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Veracruz
country: Mexico
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Rotterdam
country: Netherlands
facility: Local Institution
city: Rzeszow
country: Poland
facility: Local Institution
city: Sosnowiec
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Overport
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Claremont
country: South Africa
facility: Local Institution
state: Western Cape
city: Panorama
country: South Africa
facility: Local Institution
state: Western Cape
city: Paarl
country: South Africa
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
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.