NCT00138840 is a Phase 2 clinical trial of STA-5326 mesylate in Crohn's Disease, sponsored by Synta Pharmaceuticals Corp..

Who is sponsoring NCT00138840?

NCT00138840 is sponsored by Synta Pharmaceuticals Corp..

What drugs are being tested in NCT00138840?

Interventions in NCT00138840: STA-5326 mesylate.

What condition does NCT00138840 study?

NCT00138840 studies Crohn's Disease.

Is NCT00138840 still recruiting?

NCT00138840 is currently completed. Last updated 3 December 2008.

Last reviewed 2008-12-03 · How we verify

NCT00138840

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 3 December 2008

What this trial tests

Phase 2 trial testing STA-5326 mesylate in Crohn's Disease in 282 participants. Completed.

Timeline

1 August 2005

Quick facts

Lead sponsor	Synta Pharmaceuticals Corp.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	282
Start date	1 August 2005
Sites	35 locations across United States, Canada

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. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Proportion of patients achieving clinical remission and clinical response at Day 29

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Health-Related Quality of Life of Patients Treated with Biological Agents and New Small-Molecule Drugs for Moderate to Severe Crohn's Disease: A Systematic Review.
Aladraj H, Abdulla M, Guraya SY, Guraya SS. · · 2022 · cited 10× · PMID 35807044 · DOI 10.3390/jcm11133743

Verify or expand the search:

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00138840 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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/NCT00138840.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing