Actively Recruiting

Phase 2
Age: 18Years - 60Years
All Genders
NCT07282574

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)

Led by Hoffmann-La Roche · Updated on 2026-04-23

360

Participants Needed

47

Research Sites

220 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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)

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of progressive multiple sclerosis (PMS) according to the revised 2017 McDonald criteria
  • Expanded Disability Status Scale (EDSS) score between 3.0 and 6.0 inclusive at screening
Not Eligible

You will not qualify if you...

  • Multiple sclerosis relapse within 6 months before randomization
  • No peripheral venous access
  • History of alcohol or drug abuse within 5 years prior to screening, as judged by the investigator
  • Unable to complete a magnetic resonance imaging (MRI) scan
  • Contraindications to mandatory ocrelizumab pre-medications
  • Treatment with intravenous immunoglobulin (IV Ig) or plasmapheresis within 12 weeks before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 47 locations

1

Southern Neurology

Kogarah, New South Wales, Australia, 2217

Actively Recruiting

2

Groupe Hospitalier Pellegrin

Bordeaux, Gironde, France, 33800

Actively Recruiting

3

Hopital Purpan

Toulouse, Haute Garonne, France, 31059

Actively Recruiting

4

Hopital Gui de Chauliac

Montpellier, Herault, France, 34295

Actively Recruiting

5

Groupe Hospitalier Pitie-Salpetriere

Paris, France, 75013

Actively Recruiting

6

CHU Rennes - Hopital Pontchaillou

Rennes, France, 35033

Actively Recruiting

7

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy, 20133

Actively Recruiting

8

Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

Milan, Lombardy, Italy, 20162

Actively Recruiting

9

Optimal Clinical Trials - Christchurch

Christchurch Central City, South Island, New Zealand, 8011

Actively Recruiting

10

Optimal Clinical Trials - Central

Auckland, New Zealand, 1010

Actively Recruiting

11

Nmedis sp. z o.o.

Rzeszw, Podkarpackie Voivodeship, Poland, 35-323

Actively Recruiting

12

Centrum Medyczne Pratia Katowice I

Katowice, Silesian Voivodeship, Poland, 40-081

Actively Recruiting

13

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

Katowice, Silesian Voivodeship, Poland, 40-749

Actively Recruiting

14

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

Katowice, Poland, 40-571

Actively Recruiting

15

Resmedica NZOZ Kielce

Kielce, Poland, 25-726

Actively Recruiting

16

Samodzielny Publiczny Zakad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, Poland, 31-503

Actively Recruiting

17

Szpital Specjalistyczny im. L. Rydygiera w Krakowie

Krakow, Poland, 31-826

Actively Recruiting

18

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

Lublin, Poland, 20-410

Actively Recruiting

19

Zanamed Medical Clinic sp z o o

Lublin, Poland, 20-601

Actively Recruiting

20

Centrum Medyczne Medyk

Rzeszów, Poland, 35-055

Actively Recruiting

21

Centrum Medyczne NeuroProtect

Warsaw, Poland, 01-684

Actively Recruiting

22

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

Zabrze, Poland, 41-800

Actively Recruiting

23

Hospital Santa Caterina

Salt, Girona, Spain, 17190

Actively Recruiting

24

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain, 28223

Actively Recruiting

25

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain, 36312

Actively Recruiting

26

Complejo Hospitalario Universitario de Albacete

Albacete, Spain, 02008

Actively Recruiting

27

Hospital del Mar

Barcelona, Spain, 08003

Actively Recruiting

28

Hospital Universitari Vall d Hebron

Barcelona, Spain, 08035

Actively Recruiting

29

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Actively Recruiting

30

Hospital Universitario de la Princesa

Madrid, Spain, 28006

Actively Recruiting

31

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28007

Actively Recruiting

32

Hospital Clinico San Carlos

Madrid, Spain, 28040

Actively Recruiting

33

Hospital Regional Universitario de Malaga

Málaga, Spain, 29010

Actively Recruiting

34

Hospital Universitario Virgen Macarena

Seville, Spain, 41009

Actively Recruiting

35

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

Actively Recruiting

36

Kocaeli University Medical Faculty

Kocaeli, Izmit, Turkey (Türkiye), 41380

Actively Recruiting

37

Hacettepe University of Medicine

Ankara, Turkey (Türkiye), 06100

Actively Recruiting

38

Gazi University Medical Faculty

Ankara, Turkey (Türkiye), 06500

Actively Recruiting

39

Ankara City Hospital

Ankara, Turkey (Türkiye), 06800

Actively Recruiting

40

Istanbul University Istanbul Medical Faculty

Istanbul, Turkey (Türkiye), 34093

Actively Recruiting

41

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye), 34098

Actively Recruiting

42

Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital

Istanbul, Turkey (Türkiye), 34785

Actively Recruiting

43

Royal Cornwall Hospital

Truro, Cornwall, United Kingdom, TR1 3HD

Actively Recruiting

44

Charing Cross Hospital

London, Greater London, United Kingdom, W6 8RF

Actively Recruiting

45

Queen Elizabeth University Hospital

Glasgow, Strathclyde, United Kingdom, G51 4TF

Actively Recruiting

46

Salford Care Organisation

Salford, United Kingdom, M6 8HD

Actively Recruiting

47

Morriston Hospital

Swansea, United Kingdom, SA6 6NL

Actively Recruiting

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Research Team

R

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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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) | DecenTrialz