Last reviewed · How we verify
NCT00234741
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
Phase 2 trial testing STA-5326 mesylate in Crohn's Disease in 12 participants. Completed.
Quick facts
| Lead sponsor | Synta Pharmaceuticals Corp. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Enrollment | 12 |
| Start date | 1 November 2005 |
| Sites | 1 location across United States |
Drugs / interventions tested
- STA-5326 mesylate
Conditions studied
- Crohn's Disease — all drugs for Crohn's Disease →
Sponsor
Synta Pharmaceuticals Corp. — full company profile →
Who can join
Adults 18 to 75, any sex, with Crohn's Disease.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- 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
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00234741
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Crohn's Disease
Currently open trials in the same condition.
- NCT07273188 — 68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in Crohn's Disease · EARLY_PHASE1 · recruiting
- NCT07184944 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
- NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disea · recruiting
- NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
- NCT07184931 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00234741 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Synta Pharmaceuticals Corp.
- Last refreshed: 3 December 2008
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00234741.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing