Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138840
• Other study ID #: 5326-07
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2005
• Last updated: December 3, 2008
• Start date: August 2005

Study information

• Verified date: December 2008
• Source: Synta Pharmaceuticals Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaCzech Republic: Statni ustav pro kontrolu lecivBelgium: Federal Agency for Medicines and Health Products, FAMHPFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: National Institute of PharmacyIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• STA-5326 mesylate

Locations

Country	Name	City	State
Canada	University of Calgary Health Sciences	Calgary	Alberta
Canada	London Health Science Center South Street Campus	London	Ontario
Canada	London Health Science Center University Campus	London	Ontario
Canada	Saskatoon Medical Specialists	Saskatoon	Saskatchewan
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Asheville Gastroenterology Associates, PA	Asheville	North Carolina
United States	Atlanta Gastroenterology	Atlanta	Georgia
United States	Austin Gastroenterology	Austin	Texas
United States	Boston Medical Center	Boston	Massachusetts
United States	Gastroenterology Research Associates	Cedar Knolls	New Jersey
United States	Carolina Digestive Health Associates	Charlotte	North Carolina
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	New River Valley Research Institute	Christiansburg	Virginia
United States	Columbia Gastroenterology Associates, P.A.	Columbia	South Carolina
United States	Gastroenterology Center of the MidSouth	German Town	Tennessee
United States	Southern Clinical Research Consultants	Hollywood	Florida
United States	Borland Groover Clinic	Jacksonville	Florida
United States	Maryland Digestive Disease Research	Laurel	Maryland
United States	Gastroenterology Associates	Little Rock	Arkansas
United States	Univ. of Louisville Clinical Research Unit	Louisville	Kentucky
United States	Miami Research Associates	Miami	Florida
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Nashville Medical Research Institute	Nashville	Tennessee
United States	Asher Kornbluth, MD	New York	New York
United States	Community Clinical Trials	Orange	California
United States	Advanced Gastroenterology Highland Lakes Medical Center	Palm Harbor	Florida
United States	Pinehurst Medical Clinic	Pinehurst	North Carolina
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Wake Research Associates, LLC.	Raleigh	North Carolina
United States	Rochester Institute for Digestive Diseases and Sciences, Inc.	Rochester	New York
United States	Medical Associates Research Group	San Diego	California
United States	Capital Gastroenterology Consultants, P.A.	Silver Spring	Maryland
United States	St. Louis Center for Clinical Research	St. Louis	Missouri
United States	Piedmont Medical Research Associates	Winston-Salem	North Carolina
United States	Shafran Gastroenterology Center	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Synta Pharmaceuticals Corp.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving clinical remission and clinical response at Day 29
Secondary	Proportion of patients achieving: a clinical remission at Days 29 and 43
Secondary	a clinical response from Baseline to Day 29 and from Baseline to Day 43
Secondary	a reduction in endoscopic scores from Baseline to Day 29
Secondary	an increase in the Inflammatory Bowel Disease Questionnaire (IBDQ) score from Baseline to Days 29 and 43
Secondary	a clinical remission or clinical response at Days 29 and 43 in the subset of patients with elevated C-reactive protein