Clinical Trials Logo
  1. Home
  2. Relapsing Multiple Sclerosis
  3. NCT04079088

Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS)

Relapsing Multiple Sclerosis Clinical Trial

Official title:
A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis

Clinical Trial Summary

The primary objectives of the study are to evaluate the safety of BIIB061 versus placebo in participants with Relapsing Multiple Sclerosis (RMS), and to evaluate the efficacy of BIIB061 to improve disability outcome versus placebo in participants with RMS. The secondary objectives of the study are to evaluate the effects of BIIB061 versus placebo on brain magnetic resonance imaging (MRI) markers of remyelination and axon preservation in chronic Multiple Sclerosis lesions and to evaluate the effects of BIIB061 versus placebo on additional measures of improved disability outcome.

Clinical Trial Description

BIIB061's unique mechanism of action may provide a pharmacological intervention to overcome the failure of remyelination in all forms of multiple sclerosis by blocking mechanisms that prevent differentiation of oligodendrocytes progenitors. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04079088
Study type Interventional
Source Biogen
Contact
Status Withdrawn
Phase Phase 2
Start date June 30, 2021
Completion date September 18, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04121065 - Role of ADA SNPs in Subjects With Relapsing Multiple Sclerosis (RMS)
Active, not recruiting NCT03996291 - Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis Phase 2
Recruiting NCT04510220 - 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis Phase 3
Terminated NCT02241785 - Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis (MS) After Failure on Other Therapies Phase 4
Completed NCT02792218 - Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis Phase 3
Completed NCT01412333 - A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis Phase 3
Completed NCT03257358 - A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod Phase 4
Completed NCT01628393 - Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients Phase 2/Phase 3
Completed NCT04626921 - A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis Phase 2/Phase 3
Withdrawn NCT02234869 - Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon Therapy Phase 4
Withdrawn NCT05077956 - Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis
Active, not recruiting NCT04486716 - A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis Phase 3
Recruiting NCT04121403 - Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS) Phase 3
Recruiting NCT05809986 - Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
Terminated NCT00988052 - A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course Phase 3
Active, not recruiting NCT05232825 - A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis Phase 3
Terminated NCT01047319 - A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis Phase 3
Completed NCT04847596 - A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
Completed NCT01006941 - Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study Phase 2
Completed NCT01127750 - Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients Phase 3