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, 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234741
• Other study ID #: 5326-11
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2005
• Last updated: December 3, 2008
• Start date: November 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 Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• 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 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• STA-5326 mesylate

Locations

Country	Name	City	State
United States	Nih/Niaid	Bethesda	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Synta Pharmaceuticals Corp.	National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	To measure changes in other immunologic parameters.
Secondary	To explore the level of cell-surface markers and specific gene expression patterns.
Secondary	To measure changes in laboratory surrogate efficacy markers.
Secondary	To measure the proportion of subjects in clinical remission at Day 29.
Secondary	To measure the proportion of subjects with a clinical response at Day 29.
Secondary	To measure the proportion of subjects with both clinical remission and clinical response at Day 29.
Secondary	To confirm STA-5326 mesylate (and metabolite) levels in blood following oral administration to CD patients.
Secondary	To measure the changes in endoscopic scores from Baseline to Day 29.
Secondary	To measure the changes in the Inflammatory Bowel Disease Questionnaire overall score from Baseline to Day 29.