NCT01590459

24-week Study With Open Label Extension of VX-509, an Oral JAK3 Inhibitor, in Subjects Taking Methotrexate

A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy With 104-Week Open Label Extension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 359 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety and efficacy of VX-509, an oral JAK3 inhibitor, for treatment of subjects with active RA who have had an inadequate response to Methotrexate.

Detailed description

VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This cascade ultimately contributes to abnormal immune response that results in chronic inflammation and, in the case of rheumatoid arthritis (RA), irreversible damage to cartilage and bones. Selective inhibition of JAK3 offers a new disease modifying approach to the treatment of RA, and a broad range of other autoimmune diseases.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	VX-509	50 mg oral tablet
DRUG	VX-509 matching placebo	0 mg oral tablet

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-05-03
• Last updated: 2015-11-20

Locations

94 sites across 14 countries: United States, Argentina, Bulgaria, Czechia, Estonia, Germany, Hungary, Mexico, Poland, Romania, Russia, Serbia, Slovakia, Ukraine