A study to compare different doses of RO7268489 with a placebo (as add-on therapy to ocrelizumab) in people with multiple sclerosis that has progressed

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

4 Feb 2026 → ongoing

Decision date (initial)

2026-01-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche Ltd

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Efficacy, Safety

To assess the efficacy of RO7268489 in adults with PMS receiving ocrelizumab on disability progression

Secondary objectives 4

1. To assess the effect of RO7268489 on cognition in adults with PMS receiving ocrelizumab
2. To assess the pharmacodynamics of RO7268489 in adults with PMS receiving ocrelizumab
3. To assess the safety and tolerability of RO7268489 in adults with PMS receiving ocrelizumab
4. To assess the plasma Pharmacokinetic (PK) of RO7268489 in adults with PMS receiving ocrelizumab

Conditions and MedDRA coding

Progressive Forms of Multiple Sclerosis (PMS)

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age 18 to 60 years, inclusive, at the time of signing the Informed Consent Form
2. Progressive multiple sclerosis, in accordance with the revised 2017 McDonald criteria (Thompson 2018)
3. Expanded Disability Status Scale (EDSS) at Screening between 3.0 and 6.0 inclusive
4. Documented evidence of disability progression independent of relapse activity over the 2 years before the screening visit, according to criteria provided in the protocol
5. For patients who received ocrelizumab in the past and stopped it more than 2 years prior to screening, the reason for stopping or interrupting ocrelizumab must have been unrelated to safety / lack of efficacy and such patients must have normal B cell count at screening
6. Agreement to wear digital gait assessment device as per study protocol

Exclusion criteria 6

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time from randomization to the first occurrence of composite confirmed disability progression confirmed for at least 12 weeks (cCDP12) according to at least one of the following three criteria: o 12-week confirmed disability progression (CDP12) o 12-week confirmed increase in Timed 25-Foot Walk Test (T25FWT) or o 12-week confirmed increase in 9-Hole Peg Test (9-HPT)

Secondary endpoints 9

1. Time from randomization to the first occurrence of 24-week confirmed ≥ 4-point decrease (worsening) in Symbol Digit Modalities Test (SDMT)
2. Plasma 2-arachidonoylglycreol (2-AG) levels
3. Change from baseline in plasma 2-AG levels
4. Incidence, severity, and causal relationship of adverse events (AEs)
5. Incidence of treatment discontinuations due to AEs
6. Changes in vital signs and ECG parameters
7. Incidence of abnormal laboratory findings
8. Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
9. Plasma concentrations of RO7268489 and its metabolite(s) as appropriate

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 10

Locations

7 EU/EEA countries · 93 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 106 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications