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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00138840
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : December 4, 2008
Information provided by:
Synta Pharmaceuticals Corp.

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: STA-5326 mesylate Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : August 2005

Resource links provided by the National Library of Medicine

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138840

  Show 35 Study Locations
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
OverallOfficial: Bruce Sands, MD Massachusetts General Hospital

ClinicalTrials.gov Identifier: NCT00138840     History of Changes
Other Study ID Numbers: 5326-07
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: December 4, 2008
Last Verified: December 2008

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

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