Phase 3 Multiple Sclerosis Trials
7 Phase 3 trials for Multiple Sclerosis. Phase 3 trials are the final stage of testing before a treatment can be submitted for FDA approval.
What is a Phase 3 trial?
Phase 3 clinical trials study a treatment in large groups (hundreds to thousands of people) to confirm its effectiveness, monitor side effects, and compare it to standard treatments. These trials are the last major step before the FDA considers approving a new treatment.
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell...
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male...
Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1...
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous...
The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with...
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the...
RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.
The goal of this randomized clinical trial is to compare relapse remitting multiple sclerosis (RRMS) patients treated by ocrelizumab or by rituximab followed for 2 years. The main...
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of...