RECRUITINGPhase 2

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)

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.

Sponsor

Hoffmann-La Roche

Enrollment

360 participants

Sites

108 locations

Start Date

March 2026

Completion

May 2028

Progressive Multiple SclerosisRO7268489OcrelizumabPlacebo

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

360

participants

Sites

108

locations

Duration

4.2 years

total trial span

Rate

pts/month needed

Mar 2026Month 5 of 50May 2028

10% of trial timeline elapsed45 months to primary endpoint

At 108 sites, each site needs to enroll approximately 0.1 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

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Primary Outcomes

Time From Randomization to the First Occurrence of Composite Confirmed Disability Progression (cCPD) Confirmed for at Least 12 Weeks (cCDP12)

Up to approximately 110 weeks

Time from randomization to the first occurrence of cCDP12 according to at least one of the following 3 criteria: 1. 12-week confirmed disability progression (CDP12) 2. 12-week confirmed increase in Timed 25-Foot Walk Test (T25FWT) or 3. 12-week confirmed increase in 9-Hole Peg Test (9-HPT) The EDSS is a disability scale is based on a standard neurological examination that ranges in 0.5-point steps from 0 (normal) - 10 (death). T25FWT=time taken to walk 25 feet, typically measured in seconds. The longer it takes to walk, the higher score, which indicates deterioration. Lower times indicate better performance and greater mobility. In 9-HPT, participants are instructed to place pegs one by one into each of nine holes arranged in a board stabilized with a plastic nonslip sheet on a solid table, and then to remove these pegs from the holes. The shorter time it takes to complete the task indicates a better outcome.

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

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Fetching protocol from ClinicalTrials.gov…

RECRUITINGPhase 2

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)

Sponsor

Hoffmann-La Roche

Enrollment

360 participants

Sites

108 locations

Start Date

March 2026

Completion

May 2028

Progressive Multiple SclerosisRO7268489OcrelizumabPlacebo

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

360

participants

Sites

108

locations

Duration

4.2 years

total trial span

Rate

pts/month needed

Mar 2026Month 5 of 50May 2028

10% of trial timeline elapsed45 months to primary endpoint

At 108 sites, each site needs to enroll approximately 0.1 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Time From Randomization to the First Occurrence of Composite Confirmed Disability Progression (cCPD) Confirmed for at Least 12 Weeks (cCDP12)

Up to approximately 110 weeks

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

all

Healthy Volunteers

View full criteria

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

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Brain and Mind Centre

Camperdown, New South Wales, Australia

Southern Neurology

Kogarah, New South Wales, Australia

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

CHU Strasbourg Hpital Hautepierre

Strasbourg, Bas Rhin, France

Hopital Caremeau

Nîmes, Gard, France

Groupe Hospitalier Pellegrin

Bordeaux, Gironde, France

Hopital Purpan

Toulouse, Haute Garonne, France

Hopital Gui de Chauliac

Montpellier, Herault, France

+98 more sites

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)

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

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)

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (108)