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)

NCT07282574 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: BP460162025-521636-10-00
• Study Type: interventional
• Target: 360
• Locations: 11 countries
• Sites: 73

Brief Summary

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.

Conditions

Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to approximately 110 weeks

Secondary Outcomes (15)

• Time From Randomization to the First Occurrence of 24-Week Confirmed ≥4-Point Decrease (Worsening) in Symbol Digit Modalities Test (SDMT)

  Up to approximately 110 weeks

• Change From Baseline in Total Brain Volume

  Up to approximately 110 weeks

• Time to Onset of 24-Week cCDP (cCDP24)

  Up to approximately 110 weeks

• Time to Onset of 12-Week Confirmed Disability Progression CDP (CDP12)

  Up to approximately 110 weeks

• Time to Onset of 24-Week CDP (CDP24)

  Up to approximately 110 weeks

Study Arms (4)

RO7268489 Dose 1 + Ocrelizumab

EXPERIMENTAL

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

Drug: RO7268489; Drug: Ocrelizumab

RO7268489 Dose 2 + Ocrelizumab

EXPERIMENTAL

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

Drug: RO7268489; Drug: Ocrelizumab

RO7268489 Dose 3 + Ocrelizumab

EXPERIMENTAL

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

Drug: RO7268489; Drug: Ocrelizumab

Placebo + Ocrelizumab

PLACEBO COMPARATOR

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

Drug: Ocrelizumab; Drug: Placebo

Interventions

Ocrelizumab DRUG

Ocrelizumab will be administered per schedule as specified in the arms.

Also known as: RO4964913, Ocrevus

Placebo + Ocrelizumab; RO7268489 Dose 1 + Ocrelizumab; RO7268489 Dose 2 + Ocrelizumab; RO7268489 Dose 3 + Ocrelizumab

Placebo DRUG

Placebo will be administered per schedule as specified in the arms.

Placebo + Ocrelizumab

RO7268489 DRUG

RO7268489 will be administered per schedule as specified in the arms.

RO7268489 Dose 1 + Ocrelizumab; RO7268489 Dose 2 + Ocrelizumab; RO7268489 Dose 3 + Ocrelizumab

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (73)

Southern Neurology

Kogarah, New South Wales, 2217, Australia

RECRUITING

Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

Hopital Caremeau

Nîmes, Gard, 30029, France

RECRUITING

Groupe Hospitalier Pellegrin

Bordeaux, Gironde, 33800, France

RECRUITING

Hopital Purpan

Toulouse, Haute Garonne, 31059, France

RECRUITING

Hopital Gui de Chauliac

Montpellier, Herault, 34295, France

RECRUITING

CHU Nantes - Hopital Nord Laënnec

Saint-Herblain, Loire Atlantique, 44800, France

RECRUITING

CHU Nancy Hôpital Central

Nancy, Meurthe Et Moselle, 54035, France

RECRUITING

CHU Hopital Gabriel Montpied

Clermont-Ferrand, Puy De Dome, 63003, France

RECRUITING

Hopital Neurologique Pierre Wertheimer

Bron, 69500, France

RECRUITING

Groupe Hospitalier Pitie-Salpetriere

Paris, 75013, France

RECRUITING

CHU Rennes - Hopital Pontchaillou

Rennes, 35033, France

RECRUITING

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Studienzentrum Neuropoint GmbH,

Ulm, Baden-Wurttemberg, 89073, Germany

RECRUITING

Universitaetsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

Klinikum rechts der Isar der TU Muenchen

Munich, Bavaria, 81675, Germany

RECRUITING

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Charité Universitaetsmedizin Berlin - Campus Ch

Berlin, 10117, Germany

RECRUITING

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, Baranya, 7623, Hungary

RECRUITING

Clinexpert Kft.

Budapest, 1033, Hungary

RECRUITING

S-Medicon Egeszsegugyi Szolgaltato Kft.

Budapest, 1045, Hungary

RECRUITING

Azienda Ospedaliera Universitaria Federico II

Naples, Campania, 80131, Italy

RECRUITING

Azienda Ospedaliera Universitaria- Universit degli Studi della Campania Luigi Vanvitelli

Naples, Campania, 80138, Italy

RECRUITING

Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona

Salerno, Campania, 84131, Italy

RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, 20133, Italy

RECRUITING

Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

Milan, Lombardy, 20162, Italy

RECRUITING

Optimal Clinical Trials - Christchurch

Christchurch Central City, South Island, 8011, New Zealand

RECRUITING

Optimal Clinical Trials - Central

Auckland, 1010, New Zealand

RECRUITING

Nmedis sp. z o.o.

Rzeszw, Podkarpackie Voivodeship, 35-323, Poland

RECRUITING

Centrum Medyczne Pratia Katowice I

Katowice, Silesian Voivodeship, 40-081, Poland

RECRUITING

NEURO-CARE Sp. z o.o. Sp. Komandytowa

Katowice, Silesian Voivodeship, 40-749, Poland

RECRUITING

ProNeuro Centrum Medyczne

?ory, 44-240, Poland

RECRUITING

SOMED - Lodzkie Centrum Osteoporozy

?ód?, 90-368, Poland

RECRUITING

M.A. LEK A.M.Maciejowscy SC.

Katowice, 40-571, Poland

RECRUITING

Resmedica NZOZ Kielce

Kielce, 25-726, Poland

RECRUITING

Samodzielny Publiczny Zakad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, 31-503, Poland

RECRUITING

Szpital Specjalistyczny im. L. Rydygiera w Krakowie

Krakow, 31-826, Poland

RECRUITING

Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

Lublin, 20-410, Poland

RECRUITING

Zanamed Medical Clinic sp z o o

Lublin, 20-601, Poland

RECRUITING

Centrum Medyczne Medyk

Rzeszów, 35-055, Poland

RECRUITING

Centrum Medyczne NeuroProtect

Warsaw, 01-684, Poland

RECRUITING

Penta Hospitals Przychodnie, Wroclaw Wejherowska

Wroc?aw, 54-239, Poland

RECRUITING

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa SzyszkoSUM w Katowicach

Zabrze, 41-800, Poland

RECRUITING

Hospital de Braga

Braga, 4710-243, Portugal

RECRUITING

ULS São José - Hospital de Sto António dos Capuchos;CRI Esclerose Múltipla

Lisbon, 1169-050, Portugal

RECRUITING

Hospital Santa Caterina

Salt, Girona, 17190, Spain

RECRUITING

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia, 30120, Spain

RECRUITING

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

RECRUITING

Complejo Hospitalario Universitario de Albacete

Albacete, 02008, Spain

RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Hospital Universitari Vall d Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital Universitario de la Princesa

Madrid, 28006, Spain

RECRUITING

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

RECRUITING

Kocaeli University Medical Faculty

Kocaeli, Izmit, 41380, Turkey (Türkiye)

RECRUITING

Hacettepe University of Medicine

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Gazi University Medical Faculty

Ankara, 06500, Turkey (Türkiye)

RECRUITING

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Istanbul University Istanbul Medical Faculty

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital

Istanbul, 34785, Turkey (Türkiye)

RECRUITING

Royal Cornwall Hospital

Truro, Cornwall, TR1 3HD, United Kingdom

RECRUITING

Charing Cross Hospital

London, Greater London, W6 8RF, United Kingdom

RECRUITING

Queen Elizabeth University Hospital

Glasgow, Strathclyde, G51 4TF, United Kingdom

RECRUITING

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

RECRUITING

Salford Care Organisation

Salford, M6 8HD, United Kingdom

RECRUITING

Morriston Hospital

Swansea, SA6 6NL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: BP46016 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 15, 2025
• Study Start: March 10, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

AU (2); TU (7); FR (10); IT (5); GB (6); NZ (2); DE (6); PL (15); PT (2); ES (15); HU (3)