Efficacy and Safety of Remibrutinib After Switching from Ocrelizumab in Participants with Relapsing Multiple Sclerosis, Followed by an Open Treatment with Remibrutinib

Descrizione riassuntiva dello studio

Remibrutinib is an investigational drug being developed for various diseases, including Relapsing Multiple Sclerosis (RMS). The purpose of this research project is to determine whether Remibrutinib could be a safe and effective alternative therapy for use after Ocrelizumab in the aging RMS population (40 years or older). This is an open-label clinical trial (participants and doctors are aware of the treatment the participants are receiving), in which participants will be treated for up to 48 months (4 years). This clinical trial includes a screening phase (up to 5 weeks), a treatment period (up to 4 years), and a safety follow-up period (4 weeks after study completion for eligible participants). The treatment period consists of two parts: the first part, referred to as the main part, and the second part, referred to as the extension part. During the main part, 50% of participants will receive Remibrutinib for up to 2 years, and 50% will receive Ocrelizumab for the same duration. During the extension part, all participants who are eligible to continue (completion of the two-year study treatment in the main part) and are interested in continuing the study will receive Remibrutinib for up to two years. After the completion of the open treatment, participants may require an additional 4-week safety follow-up period after their last dose in the study treatment. Approximately 360 individuals (men and women) aged 40 years or older, who have received an RMS diagnosis and meet specific eligibility criteria, may participate in this trial. Participants must have received Ocrelizumab for at least 18 months, and the last administration of Ocrelizumab must have occurred within 5 to 9 months prior to enrollment in the study.

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Intervento studiato

Medication

The investigational drug is Remibrutinib, labeled as LOU064.

The comparator drug is Ocrelizumab.

For the first part of the study (main part), a computer program will be used to randomly assign each participant to one of the two study treatments (also referred to as randomization) for up to 2 years in this study:

• Remibrutinib is a film-coated tablet for oral administration.

• Ocrelizumab is administered as an intravenous infusion (injected into veins) or as a subcutaneous injection (under the skin), and is given every 6 months (at a dose of 600 mg/500 mL as an infusion or 920 mg/23 mL as an injection) according to clinical routine practice.

In the second part of the study (extension part), all participants who are eligible for the study (all participants who have completed the 24-month study treatment in the first part) and are interested in continuing the study will be treated with Remibrutinib for up to 2 years.

(BASEC)

Malattie studiate

Relapsing Multiple Sclerosis

(BASEC)

Sponsor

Novartis Pharma AG

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Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione etica Zurigo

(BASEC)

Data di approvazione del comitato etico

25.07.2025

(BASEC)

Risultati dello studio