A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis (MS) (Mintaka)

Roche

Status and phase: Enrolling; Phase 2

Conditions: Progressive Multiple Sclerosis

Treatments: Drug: RO7268489; Drug: Ocrelizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07282574

BP46016

2025-521636-10-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The main purpose of this study is to assess the efficacy of RO7268489 in adults with progressive multiple sclerosis (PMS) receiving ocrelizumab. After the end of the double-blind period, an open-label (OL) extension may allow eligible participants to receive open-label RO7268489.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PMS, in accordance with the revised 2017 McDonald criteria
• Expanded disability status scale (EDSS) at screening between 3.0 and 6.0 inclusive

Exclusion criteria

• MS relapse during the 6 months preceding the randomization date
• Lack of peripheral venous access
• History of alcohol or other drug abuse, in the opinion of the investigator, within 5 years prior to screening
• Inability to complete an magnetic resonance imaging (MRI)
• Contraindications to ocrelizumab mandatory pre-medications
• Treatment with intravenous immunoglobulin (IV Ig) or plasmapheresis within 12 weeks prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 4 patient groups, including a placebo group

RO7268489 Dose 1 + Ocrelizumab

Experimental group

Description:

Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.

Treatment:

Drug: Ocrelizumab

Drug: RO7268489

RO7268489 Dose 2 + Ocrelizumab

Experimental group

Description:

Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.

Treatment:

Drug: Ocrelizumab

Drug: RO7268489

RO7268489 Dose 3 + Ocrelizumab

Experimental group

Description:

Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.

Treatment:

Drug: Ocrelizumab

Drug: RO7268489

Placebo + Ocrelizumab

Placebo Comparator group

Description:

Participants will receive RO7268489 matching placebo along with ocrelizumab as per the pre-defined regimen.

Treatment:

Drug: Placebo

Drug: Ocrelizumab