NCT00642629

A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, Administered to Patients With Rheumatoid Arthritis to Determine Safety, Tolerability, Pharmacokinetic and Synovial Tissue Outcomes

Completed Phase 2 Last updated 3 February 2014

What this trial tests

Phase 2 trial testing STA 5326 mesylate in Active, Moderate to Severe Rheumatoid Arthritis in 35 participants. Completed.

Timeline

1 December 2005

Quick facts

Lead sponsor	Synta Pharmaceuticals Corp.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	35
Start date	1 December 2005
Sites	1 location across Netherlands

Drugs / interventions tested

• STA 5326 mesylate — full drug profile →
• Placebo

Conditions studied

• Active, Moderate to Severe Rheumatoid Arthritis — all drugs for Active, Moderate to Severe Rheumatoid Arthritis →

Sponsor

Synta Pharmaceuticals Corp. — full company profile →

Who can join

18 and older, any sex, with Active, Moderate to Severe Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It is not fully clear how rheumatoid arthritis originates and develops, but it is understood that multiple genetic and environmental factors interact to trigger its onset. The immune system attacks the joint synovium, which damages the cartilage and bone in the joint by increasing the number of inflammatory cells and forming new blood vessels in the joint space. STA-5326 mesylate inhibits the production of IL-12 and IL-23 and therefore may inhibit Th-1 cytokine production. A reduction in the Th-1 response has the potential to minimize or eliminate joint damage caused by the immune response in rheumatoid arthritis. This study is designed to assess whether the proposed mechanism of action is associated with a reduction in inflammation in the synovium of patients who have rheumatoid arthritis.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exploring the magic bullets to identify Achilles' heel in SARS-CoV-2: Delving deeper into the sea of possible therapeutic options in Covid-19 disease: An update.
   Thakur S, Thakur S, Mayank, Sarkar B, et al · · 2021 · cited 10× · PMID 33253764 · DOI 10.1016/j.fct.2020.111887
2. Applying CRISPR-Cas9 screens to dissect hematological malignancies.
   Iyer DN, Schimmer AD, Chang H. · · 2023 · cited 6× · PMID 36355853 · DOI 10.1182/bloodadvances.2022008966