Clinical trial NCT00138840: Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, for the Induction of Clinical Response in Patients With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's disease
Gastroenterology
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2005-08-30
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: STA-5326 is an experimental drug that has been shown to block the release of interleukin-12 from peripheral blood mononuclear cells. Given this activity on the immune system, STA-5326 mesylate is a potential treatment for various autoimmune diseases, such as Crohn's disease, that are mediated by the inappropriate expression of Th1 cytokines.

This study is evaluating the use of STA-5326 mesylate in patients with moderate to severe, active Crohn's disease. Study visits include a screening visit, 9 treatment period visits over 6 months and a follow-up visit that will occur 30 days following the end of treatment. Study drug treatment will continue for up to 6 months.


Eligibility criteria: Inclusion Criteria:

* Is male or female aged 18 through 75 years.
* Has Crohn's disease diagnosed definitively prior to Screening (based upon clinical, endoscopic, radiologic imaging, or histological assessments).
* Has a Crohn's Disease Activity Index (CDAI) score of 220 to 450, inclusive at Baseline.

Exclusion Criteria:

* Has any clinically significant disease (eg, renal, hepatic, neurological, cardiovascular, pulmonary, endocrinologic, psychiatric, hematologic, urologic, or other acute or chronic illness) that, in the opinion of the investigator, would make the patient an unsuitable candidate for this study.
* Is a woman who has a positive pregnancy test, who is breast-feeding, or who is sexually active without using birth control during the course of the study and Follow-Up period.
* Is a woman of childbearing potential or a man who does not agree to use 2 forms of contraception during the course of the study and Follow-Up period.
* Has clinically significant hematologic, hepatic or renal laboratory abnormalities.

Primary outcomes:
measure: Proportion of patients achieving clinical remission and clinical response at Day 29
Secondary outcomes:
measure: Proportion of patients achieving: a clinical remission at Days 29 and 43
measure: a clinical response from Baseline to Day 29 and from Baseline to Day 43
measure: a reduction in endoscopic scores from Baseline to Day 29
measure: an increase in the Inflammatory Bowel Disease Questionnaire (IBDQ) score from Baseline to Days 29 and 43
measure: a clinical remission or clinical response at Days 29 and 43 in the subset of patients with elevated C-reactive protein
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Gastroenterology Associates
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: Hollywood
country: United States
facility: Southern Clinical Research Consultants
state: Florida
city: Jacksonville
country: United States
facility: Borland Groover Clinic
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Palm Harbor
country: United States
facility: Advanced Gastroenterology Highland Lakes Medical Center
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology
state: Georgia
city: Louisville
country: United States
facility: Univ. of Louisville Clinical Research Unit
state: Kentucky
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Laurel
country: United States
facility: Maryland Digestive Disease Research
state: Maryland
city: Silver Spring
country: United States
facility: Capital Gastroenterology Consultants, P.A.
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: St. Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Cedar Knolls
country: United States
facility: Gastroenterology Research Associates
state: New Jersey
city: New York
country: United States
facility: Asher Kornbluth, MD
state: New York
city: Rochester
country: United States
facility: Rochester Institute for Digestive Diseases and Sciences, Inc.
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Medical Clinic
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC.
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Gastroenterology Associates, P.A.
state: South Carolina
city: German Town
country: United States
facility: Gastroenterology Center of the MidSouth
state: Tennessee
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Austin
country: United States
facility: Austin Gastroenterology
state: Texas
city: Christiansburg
country: United States
facility: New River Valley Research Institute
state: Virginia
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
city: Calgary
country: Canada
facility: University of Calgary Health Sciences
state: Alberta
city: London
country: Canada
facility: London Health Science Center South Street Campus
state: Ontario
city: London
country: Canada
facility: London Health Science Center University Campus
state: Ontario
city: Saskatoon
country: Canada
facility: Saskatoon Medical Specialists
state: Saskatchewan
Study officials:
affiliation: Massachusetts General Hospital
name: Bruce Sands, MD
References: