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

What Was Tested

In this phase 2 trial, researchers set out to test Glatiramer Acetate for multiple sclerosis.

It had four arms (groups): Placebo (placebo comparator), one (experimental), one (experimental) and one (experimental).

Participants will receive BIIB061-matched placebo, orally once daily in addition to IFN-β1 injection or glatiramer acetate for up to 72 weeks.

The registry classes the interventions as biological and drug.

Who Took Part

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosed with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS). Have a Baseline Expanded Disability Status Scale (EDSS) score of 2.0 to 6.0. Have a MS disease duration of ≤20 years from first MS symptom(s). Must have at least one of the following occurring within 12 months prior to. Interferon-beta1 (IFN-β1): Avonex, Plegridy, Betaferon/Betaseron, Extavia, or Rebif.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: history or a positive test result at screening for human immunodeficiency virus; history of systemic hypersensitivity reaction to biib061; history of suicidal ideation or an episode of clinically severe depression (as determined by the investigator) within 12 weeks of screening.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Glatiramer Acetate study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the multiple sclerosis participants stayed in one arm throughout.

As a double-blind Glatiramer Acetate study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2021-06-30 with completion listed for 2024-09-18.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs). Overall Disability Response Score (ODRS) at Week 48 (time frame: Baseline, Week 48).

It also tracked 9 secondary outcomes, for example Change from Baseline in Normalized Magnetization Transfer Ratio (nMTR) at Week 48, Change from Baseline in Diffusion Tensor Imaging Radial Diffusivity (DTI-RD) at Week 48, Change from Baseline in Normalized T1 (nT1) Intensity at Week 48, Change from Baseline in T1 Hypointense Volume at Week 48 and Percentage of Participants with 12-week Confirmed Worsening in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glatiramer Acetate in people with multiple sclerosis.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glatiramer Acetate compound page, Multiple sclerosis research.