Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

Conditions

• Relapsing Multiple Sclerosis

Eligibility Criteria

Sex

ALL

Age

40 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Remibrutinib oral treatment — DRUG
  Remibrutinib tablet taken daily
• Ocrelizumab — DRUG
  Ocrelizumab 600mg infusion or 920mg injection

Study Details

The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).

Key Dates

First listed

Feb 26, 2025

Start date

Jun 23, 2025

Status verified

Aug 2026

Primary completion

Jul 25, 2029

Completion

Jun 25, 2031

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Remibrutinib Core
  Remibrutinib tablet taken orally
• Active Comparator: Ocrelizumab Core
  Ocrelizumab at standard dose and route of administration (i.v. or s.c) per label
• Experimental: Remibrutinib Extension
  Remibrutinib tablet taken orally
• Experimental: Remibrutinib Extension (Ocrelizumab in Core)
  Remibrutinib tablet taken orally

Primary Outcome Measure

Annualized rate of new or enlarging T2 lesions_Core Part [ Time Frame: Baseline up to month 24 ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111

Locations (44)

Find similar trials in Scottsdale, AZ

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