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

This study has been completed.
Sponsor:
Information provided by:
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT00138840
First received: August 26, 2005
Last updated: December 3, 2008
Last verified: December 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
 Drug: STA-5326 mesylate
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:
  • Proportion of patients achieving clinical remission and clinical response at Day 29

Secondary Outcome Measures:
  • Proportion of patients achieving: a clinical remission at Days 29 and 43
  • a clinical response from Baseline to Day 29 and from Baseline to Day 43
  • a reduction in endoscopic scores from Baseline to Day 29
  • an increase in the Inflammatory Bowel Disease Questionnaire (IBDQ) score from Baseline to Days 29 and 43
  • a clinical remission or clinical response at Days 29 and 43 in the subset of patients with elevated C-reactive protein

Estimated Enrollment: 282
Study Start Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138840

  Show 35 Study Locations
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
Investigators
Investigator: Bruce Sands, MD Massachusetts General Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00138840     History of Changes
Other Study ID Numbers: 5326-07
Study First Received: August 26, 2005
Last Updated: December 3, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Czech Republic: Statni ustav pro kontrolu leciv
Belgium: Directorate general for the protection of Public health: Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Israel: Ministry of Health

Keywords provided by Synta Pharmaceuticals Corp.:
Crohn's disease
Gastroenterology

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013