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

Sponsor
Synta Pharmaceuticals Corp. (Industry)
Overall Status
Completed
CT.gov ID
NCT00138840
Collaborator
(none)
282
Enrollment
35
Locations
8.1
Patients Per Site

Study Details

Study Description

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
  • Drug: STA-5326 mesylate
 Phase 2

Study Design

Study Type:
Interventional
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 :
Aug 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gastroenterology Associates Little Rock Arkansas United States 72205
2 Advanced Clinical Research Institute Anaheim California United States 92801
3 Community Clinical Trials Orange California United States 92868
4 Medical Associates Research Group San Diego California United States 92123
5 Southern Clinical Research Consultants Hollywood Florida United States 33021
6 Borland Groover Clinic Jacksonville Florida United States 32204
7 Miami Research Associates Miami Florida United States 33173
8 Advanced Gastroenterology Highland Lakes Medical Center Palm Harbor Florida United States 34684
9 Shafran Gastroenterology Center Winter Park Florida United States 32789
10 Atlanta Gastroenterology Atlanta Georgia United States 30342
11 Univ. of Louisville Clinical Research Unit Louisville Kentucky United States 40202
12 Chevy Chase Clinical Research Chevy Chase Maryland United States 20815
13 Maryland Digestive Disease Research Laurel Maryland United States 20707
14 Capital Gastroenterology Consultants, P.A. Silver Spring Maryland United States 20901
15 Boston Medical Center Boston Massachusetts United States 02118
16 St. Louis Center for Clinical Research St. Louis Missouri United States 63128
17 Gastroenterology Research Associates Cedar Knolls New Jersey United States 07927
18 Asher Kornbluth, MD New York New York United States 10128
19 Rochester Institute for Digestive Diseases and Sciences, Inc. Rochester New York United States 14607
20 Asheville Gastroenterology Associates, PA Asheville North Carolina United States 28801
21 Carolina Digestive Health Associates Charlotte North Carolina United States 28211
22 Pinehurst Medical Clinic Pinehurst North Carolina United States 28374
23 Wake Research Associates, LLC. Raleigh North Carolina United States 27612
24 Piedmont Medical Research Associates Winston-Salem North Carolina United States 27103
25 University of Pittsburgh Pittsburgh Pennsylvania United States 15213
26 Columbia Gastroenterology Associates, P.A. Columbia South Carolina United States 29203
27 Gastroenterology Center of the MidSouth German Town Tennessee United States 38138
28 Nashville Medical Research Institute Nashville Tennessee United States 37205
29 Austin Gastroenterology Austin Texas United States 78745
30 New River Valley Research Institute Christiansburg Virginia United States 24073
31 Wisconsin Center for Advanced Research Milwaukee Wisconsin United States 53215
32 University of Calgary Health Sciences Calgary Alberta Canada T2N4N1
33 London Health Science Center South Street Campus London Ontario Canada N6A 4G5
34 London Health Science Center University Campus London Ontario Canada N6A 5A5
35 Saskatoon Medical Specialists Saskatoon Saskatchewan Canada S7K1N4

Sponsors and Collaborators

  • Synta Pharmaceuticals Corp.

Investigators

  • : Bruce Sands, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00138840
Other Study ID Numbers:
  • 5326-07
First Posted:
Aug 30, 2005
Last Update Posted:
Dec 4, 2008
Last Verified:
Dec 1, 2008
Keywords provided by , ,
Crohn's disease
Gastroenterology
Additional relevant MeSH terms:
Crohn Disease

Study Results

No Results Posted as of Dec 4, 2008