NCT02425644

Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis

Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Teriflunomide in Subjects With Relapsing Multiple Sclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,133 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	ponesimod	film-coated tablet with 20 mg ponesimod, administered orally once daily in the morning
DRUG	teriflunomide	film-coated tablet with 14 mg teriflunomide, administered orally once daily in the morning

Timeline

• Start date: 2015-06-04
• Primary completion: 2019-05-16
• Completion: 2019-05-16
• First posted: 2015-04-24
• Last updated: 2025-03-30
• Results posted: 2021-06-11

Locations

162 sites across 28 countries: United States, Belarus, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czechia, Finland, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Poland, Portugal, Romania, Russia, Serbia, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study