NCT02792218

Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis

A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 930 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis

Detailed description

This was a randomized, double-blind, double-dummy, active comparator-controlled, parallel-group, multi-center study with variable treatment duration in approximately 900 patients with relapsing multiple sclorosis (RMS). The maximal treatment duration in the study for an individual patient was 2.5 years. Eligible patients were randomized to receive either experimental ofatumumab subcutaneous (s.c.) injections every 4 weeks or active comparator teriflunomide orally once daily. The dose regimen for ofatumumab for this study was a loading dose regimen of 20 mg at Day 1, Day 7 and Day 14, followed by a maintenance dose regimen of 20 mg administered every 4 weeks starting at Week 4. In order to blind for the different formulations, double-dummy masking was used i.e. all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo).

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Ofatumumab subcutaneous injection	Ofatumumab 20 mg pre-filled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter
DRUG	Teriflunomide-matching placebo capsules	Placebo capsule, matching in appearance to teriflunomide, taken orally once daily
DRUG	Teriflunomide capsule	Teriflunomide 14 mg oral capsule taken once daily
DRUG	Matching placebo of ofatumumab subcutaneous injections	Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter

Timeline

• Start date: 2016-09-20
• Primary completion: 2019-07-05
• Completion: 2020-07-20
• First posted: 2016-06-07
• Last updated: 2021-10-01
• Results posted: 2020-10-19

Locations

166 sites across 29 countries: United States, Argentina, Australia, Belgium, Bulgaria, Canada, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Puerto Rico, Russia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study