Crohn's DiseasePhase 2NCT00138840
Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
A Phase 2 study testing STA-5326 mesylate in people with Crohn's Disease, run by Synta Pharmaceuticals Corp. at 35 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- STA-5326 mesylate
- How many people
- 282 participants
- Where
- 35 sitesin 2 countries
- Study dates
- Aug 2005to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States31 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801
Atlanta Gastroenterology
Atlanta, Georgia, 30342
Austin Gastroenterology
Austin, Texas, 78745
Boston Medical Center
Boston, Massachusetts, 02118
Gastroenterology Research Associates
Cedar Knolls, New Jersey, 07927
Carolina Digestive Health Associates
Charlotte, North Carolina, 28211
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
New River Valley Research Institute
Christiansburg, Virginia, 24073
Columbia Gastroenterology Associates, P.A.
Columbia, South Carolina, 29203
Gastroenterology Center of the MidSouth
Germantown, Tennessee, 38138
Southern Clinical Research Consultants
Hollywood, Florida, 33021
Borland Groover Clinic
Jacksonville, Florida, 32204
Maryland Digestive Disease Research
Laurel, Maryland, 20707
Gastroenterology Associates
Little Rock, Arkansas, 72205
Univ. of Louisville Clinical Research Unit
Louisville, Kentucky, 40202
Miami Research Associates
Miami, Florida, 33173
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
Nashville Medical Research Institute
Nashville, Tennessee, 37205
Asher Kornbluth, MD
New York, New York, 10128
Community Clinical Trials
Orange, California, 92868
Advanced Gastroenterology Highland Lakes Medical Center
Palm Harbor, Florida, 34684
Pinehurst Medical Clinic
Pinehurst, North Carolina, 28374
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Wake Research Associates, LLC.
Raleigh, North Carolina, 27612
Rochester Institute for Digestive Diseases and Sciences, Inc.
Rochester, New York, 14607
Medical Associates Research Group
San Diego, California, 92123
Capital Gastroenterology Consultants, P.A.
Silver Spring, Maryland, 20901
St. Louis Center for Clinical Research
St Louis, Missouri, 63128
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
Shafran Gastroenterology Center
Winter Park, Florida, 32789
Canada4 sites
University of Calgary Health Sciences
Calgary, Alberta, T2N4N1
London Health Science Center South Street Campus
London, Ontario, N6A 4G5
London Health Science Center University Campus
London, Ontario, N6A 5A5
Saskatoon Medical Specialists
Saskatoon, Saskatchewan, S7K1N4
About this study
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
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.
- Conditions
- Crohn's Disease
- Being tested
- STA-5326 mesylate
- Keywords
- Crohn's disease, Gastroenterology
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STA-5326 mesylateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving clinical remission and clinical response at Day 29
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 282 participants
Sponsor and investigators
- Lead sponsor
- Synta Pharmaceuticals Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bruce Sands, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138840
- Sponsor's protocol ID
- 5326-07
- Status last verified
- Dec 2008
- First submitted
- 26 Aug 2005
- Last updated
- 4 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00138840
- Acronym / sponsor ID
- 5326-07
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, Gastroenterology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants
- Lead sponsor
- Synta Pharmaceuticals Corp.Industry (pharma, biotech, devices)
- Study start
- Aug 2005
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STA-5326 mesylate | Drug | – |
Primary outcome
Proportion of patients achieving clinical remission and clinical response at Day 29
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Sands, MD
Massachusetts General Hospital
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STA-5326 mesylate in people with Crohn's Disease, run by Synta Pharmaceuticals Corp. at 35 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving clinical remission and clinical response at Day 29. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2008.