A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis

Conditions

• Multiple Sclerosis, Primary Progressive

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Fenebrutinib — DRUG
  Participants will receive fenebrutinib.
• Ocrelizumab — DRUG
  Participants will receive ocrelizumab.
• Placebo matched to ocrelizumab — DRUG
  Participants will receive ocrelizumab-matching placebo.
• Placebo matched to fenebrutinib — DRUG
  Participants will receive fenebrutinib-matching placebo

Study Details

A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (and placebo) or intravenous (IV) ocrelizumab (and placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). 985 participants were enrolled and recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

Key Dates

Start date

Oct 26, 2020

Status verified

Mar 2026

Primary completion

Sep 17, 2025

Completion

Jul 21, 2027

Study Design

Enrollment

985 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Fenebrutinib
  Participants will receive oral fenebrutinib and intravenous (IV) ocrelizumab-matching placebo.
• Active Comparator: Ocrelizumab
  Participants will receive intravenous (IV) ocrelizumab and oral fenebrutinib-matching placebo.

Primary Outcome Measure

Time to Onset of Composite 12-week Confirmed Disability Progression (cCDP12) [ Time Frame: Minimum of 120 weeks ]

Locations (43)

Related coverage on Hipa.ai

• Fenebrutinib Phase 3 Trial for Primary Progressive MS Reaches Primary Completion
  Fenebrutinib · Sep 17, 2025 · ClinicalTrials.gov

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