Clinical trial NCT01466374: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 121
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 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

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

Primary outcomes:
measure: Clinical remission (CDAI score of <150)
timeFrame: Week 11
Secondary outcomes:
measure: Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150)
timeFrame: Week 7 and Week 11
measure: Proportion of subjects in clinical response (defined as CDAI score reduction from Baseline of ≥ 100 points or an absolute CDAI score of < 150)
timeFrame: Week 7 and Week 11
measure: Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: Week 11
measure: 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
timeFrame: Week 11
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Southern California Medical Gastroenterology Group
state: California
city: Winter Park
country: United States
facility: Shafran Gasteroenterology Center
state: Florida
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: Lees Summit
country: United States
facility: Midwest Center For Clinical Research
state: Missouri
city: Great Neck
country: United States
facility: Nyu Langone Long Island Clinical Research Associates
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: Cincinnati
country: United States
facility: Consultants For Clinical Research
state: Ohio
city: San Antonio
country: United States
facility: Gastroenterology Research Of San Antonio
state: Texas
city: Brussel
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Amiens Cedex 1
country: France
facility: Local Institution
city: Clichy
country: France
facility: Local Institution
city: Nice
country: France
facility: Local Institution
city: Pessac
country: France
facility: Local Institution
city: Rouen
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
city: Budapest
country: Hungary
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: Haifa
country: Israel
facility: Local Institution
city: Kfar Saba
country: Israel
facility: Local Institution
city: Nazareth
country: Israel
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Rzeszow
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: University Of Puerto Rico School Of Medicine
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
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
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.
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.