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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00138840

Public ClinicalTrials.gov record NCT00138840. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 6, 2026, 4:28 PM EST

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00138840
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Synta Pharmaceuticals Corp.
Industry
Enrollment
282 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2005 (Type not available)
Primary completion
Not listed
Completion
Not listed
Last update posted
Dec 4, 2008

Started 2005

United States locations

U.S. sites
31
U.S. states
17
U.S. cities
31
Facility City State ZIP Site status
Gastroenterology Associates Little Rock Arkansas 72205 —
Advanced Clinical Research Institute Anaheim California 92801 —
Community Clinical Trials Orange California 92868 —
Medical Associates Research Group San Diego California 92123 —
Southern Clinical Research Consultants Hollywood Florida 33021 —
Borland Groover Clinic Jacksonville Florida 32204 —
Miami Research Associates Miami Florida 33173 —
Advanced Gastroenterology Highland Lakes Medical Center Palm Harbor Florida 34684 —
Shafran Gastroenterology Center Winter Park Florida 32789 —
Atlanta Gastroenterology Atlanta Georgia 30342 —
Univ. of Louisville Clinical Research Unit Louisville Kentucky 40202 —
Chevy Chase Clinical Research Chevy Chase Maryland 20815 —
Maryland Digestive Disease Research Laurel Maryland 20707 —
Capital Gastroenterology Consultants, P.A. Silver Spring Maryland 20901 —
Boston Medical Center Boston Massachusetts 02118 —
St. Louis Center for Clinical Research St Louis Missouri 63128 —
Gastroenterology Research Associates Cedar Knolls New Jersey 07927 —
Asher Kornbluth, MD New York New York 10128 —
Rochester Institute for Digestive Diseases and Sciences, Inc. Rochester New York 14607 —
Asheville Gastroenterology Associates, PA Asheville North Carolina 28801 —
Carolina Digestive Health Associates Charlotte North Carolina 28211 —
Pinehurst Medical Clinic Pinehurst North Carolina 28374 —
Wake Research Associates, LLC. Raleigh North Carolina 27612 —
Piedmont Medical Research Associates Winston-Salem North Carolina 27103 —
University of Pittsburgh Pittsburgh Pennsylvania 15213 —
Columbia Gastroenterology Associates, P.A. Columbia South Carolina 29203 —
Gastroenterology Center of the MidSouth Germantown Tennessee 38138 —
Nashville Medical Research Institute Nashville Tennessee 37205 —
Austin Gastroenterology Austin Texas 78745 —
New River Valley Research Institute Christiansburg Virginia 24073 —
Wisconsin Center for Advanced Research Milwaukee Wisconsin 53215 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00138840, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 4, 2008 · Synced Nov 6, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00138840 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →