drugset / Trial / NCT04788615

Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS

NCT04788615 ↗

Phase 3 Completed 185 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupSingle-blindTreatment

Summary

This study will compare ofatumumab vs. European approved platform first line self-administered disease modifying therapy (DMT) in newly diagnosed MS patients

Timeline

Start
2021-07-23
Primary completion
2025-11-04
Completion
2025-11-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Diroximel fumarate Small molecule 231 mg —
Comparator Diroximel fumarate Small molecule 462 mg —
Comparator Glatiramer Acetate Small molecule 20 mg —
Comparator Glatiramer Acetate Small molecule 40 mg —
Subject Ofatumumab Monoclonal antibody 20 mg Subcutaneous
Comparator Teriflunomide Small molecule 14 mg —
Comparator dimethyl fumarate Unknown 120 mg —
Comparator dimethyl fumarate Unknown 240 mg —
Comparator peginterferon beta-1a Protein / enzyme biologic 63 ug —
Comparator peginterferon beta-1a Protein / enzyme biologic 125 ug —

Indications