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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: NCT00234741
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : December 4, 2008
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Information provided by:
Synta Pharmaceuticals Corp.

Tracking Information
First Submitted Date  ICMJE October 5, 2005
First Posted Date  ICMJE October 7, 2005
Last Update Posted Date December 4, 2008
Study Start Date  ICMJE November 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2005)
To measure the changes from predose in peripheral blood and mucosal cytokines in subjects with active CD after administration of STA-5326 mesylate or placebo for 4 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00234741 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2005)
  • To measure changes in other immunologic parameters.
  • To explore the level of cell-surface markers and specific gene expression patterns.
  • To measure changes in laboratory surrogate efficacy markers.
  • To measure the proportion of subjects in clinical remission at Day 29.
  • To measure the proportion of subjects with a clinical response at Day 29.
  • To measure the proportion of subjects with both clinical remission and clinical response at Day 29.
  • To confirm STA-5326 mesylate (and metabolite) levels in blood following oral administration to CD patients.
  • To measure the changes in endoscopic scores from Baseline to Day 29.
  • To measure the changes in the Inflammatory Bowel Disease Questionnaire overall score from Baseline to Day 29.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
Official Title  ICMJE A Randomized, Double-Blind, Pilot Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, to Investigate Peripheral Blood and Mucosal Mononuclear Cell Phenotype and Cytokine Responses in Patients With Crohn's Disease
Brief Summary

STA-5326 is an oral 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, 4 treatment period visits over 4 weeks and a follow-up visit that will occur 7 days following the end of treatment. Subjects may continue treatment for an additional 4 weeks of open label STA-5326 mesylate administration that includes an additional 2 treatment period visits. Subjects will undergo a colonoscopy with biopsy collection at baseline, at the end of the 4 week blinded phase and at the end of the 4 week open label phase.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Condition  ICMJE Crohn's Disease
Intervention  ICMJE Drug: STA-5326 mesylate
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 5, 2005)
12
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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 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 subject 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00234741
Other Study ID Numbers  ICMJE 5326-11
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Synta Pharmaceuticals Corp.
Collaborators  ICMJE
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Peter Mannon, MD National Institute of Allergy and Infectious Diseases (NIAID)
PRS Account Synta Pharmaceuticals Corp.
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP