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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00138840
First Posted: August 30, 2005
Last Update Posted: December 4, 2008
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.
Information provided by:
Synta Pharmaceuticals Corp.
  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
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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.
Investigators
OverallOfficial: Bruce Sands, MD Massachusetts General Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00138840     History of Changes
Other Study ID Numbers: 5326-07
First Submitted: August 26, 2005
First Posted: August 30, 2005
Last Update Posted: December 4, 2008
Last Verified: December 2008

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