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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
STA-5326 mesylate
Sponsored by
Synta Pharmaceuticals Corp.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, Gastroenterology

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gastroenterology Associates
  • Advanced Clinical Research Institute
  • Community Clinical Trials
  • Medical Associates Research Group
  • Southern Clinical Research Consultants
  • Borland Groover Clinic
  • Miami Research Associates
  • Advanced Gastroenterology Highland Lakes Medical Center
  • Shafran Gastroenterology Center
  • Atlanta Gastroenterology
  • Univ. of Louisville Clinical Research Unit
  • Chevy Chase Clinical Research
  • Maryland Digestive Disease Research
  • Capital Gastroenterology Consultants, P.A.
  • Boston Medical Center
  • St. Louis Center for Clinical Research
  • Gastroenterology Research Associates
  • Asher Kornbluth, MD
  • Rochester Institute for Digestive Diseases and Sciences, Inc.
  • Asheville Gastroenterology Associates, PA
  • Carolina Digestive Health Associates
  • Pinehurst Medical Clinic
  • Wake Research Associates, LLC.
  • Piedmont Medical Research Associates
  • University of Pittsburgh
  • Columbia Gastroenterology Associates, P.A.
  • Gastroenterology Center of the MidSouth
  • Nashville Medical Research Institute
  • Austin Gastroenterology
  • New River Valley Research Institute
  • Wisconsin Center for Advanced Research
  • University of Calgary Health Sciences
  • London Health Science Center South Street Campus
  • London Health Science Center University Campus
  • Saskatoon Medical Specialists

Outcomes

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

Full Information

First Posted
August 26, 2005
Last Updated
December 3, 2008
Sponsor
Synta Pharmaceuticals Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT00138840
Brief Title
Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
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 Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Synta Pharmaceuticals Corp.

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease, Gastroenterology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
282 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
STA-5326 mesylate
Primary Outcome Measure Information:
Title
Proportion of patients achieving clinical remission and clinical response at Day 29
Secondary Outcome Measure Information:
Title
Proportion of patients achieving: a clinical remission at Days 29 and 43
Title
a clinical response from Baseline to Day 29 and from Baseline to Day 43
Title
a reduction in endoscopic scores from Baseline to Day 29
Title
an increase in the Inflammatory Bowel Disease Questionnaire (IBDQ) score from Baseline to Days 29 and 43
Title
a clinical remission or clinical response at Days 29 and 43 in the subset of patients with elevated C-reactive protein

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Sands, MD
Organizational Affiliation
Massachusetts General Hospital
Facility Information:
Facility Name
Gastroenterology Associates
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Community Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Medical Associates Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Southern Clinical Research Consultants
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Borland Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Advanced Gastroenterology Highland Lakes Medical Center
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Atlanta Gastroenterology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Univ. of Louisville Clinical Research Unit
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Maryland Digestive Disease Research
City
Laurel
State/Province
Maryland
ZIP/Postal Code
20707
Country
United States
Facility Name
Capital Gastroenterology Consultants, P.A.
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20901
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
St. Louis Center for Clinical Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Gastroenterology Research Associates
City
Cedar Knolls
State/Province
New Jersey
ZIP/Postal Code
07927
Country
United States
Facility Name
Asher Kornbluth, MD
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Rochester Institute for Digestive Diseases and Sciences, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14607
Country
United States
Facility Name
Asheville Gastroenterology Associates, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Carolina Digestive Health Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Pinehurst Medical Clinic
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Wake Research Associates, LLC.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Piedmont Medical Research Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Columbia Gastroenterology Associates, P.A.
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Gastroenterology Center of the MidSouth
City
German Town
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Nashville Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Austin Gastroenterology
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
New River Valley Research Institute
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
University of Calgary Health Sciences
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N1
Country
Canada
Facility Name
London Health Science Center South Street Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
London Health Science Center University Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Saskatoon Medical Specialists
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K1N4
Country
Canada

12. IPD Sharing Statement

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

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