NCT04079088

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Placebo	Administered as specified in the treatment arm.
DRUG	BIIB061	Administered as specified in the treatment arm.
BIOLOGICAL	Interferon-beta1	Stable dose as prescribed by the physician.
DRUG	Glatiramer acetate	Stable dose as prescribed by the physician.

Timeline

• Start date: 2021-06-30
• Primary completion: 2024-09-18
• Completion: 2024-09-18
• First posted: 2019-09-06
• Last updated: 2023-06-01

Regulatory

• FDA-regulated drug study