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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521636-10-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO7268489 Dose 1 + Ocrelizumab | Experimental | Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen. |
|
| RO7268489 Dose 2 + Ocrelizumab | Experimental | Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen. |
|
| RO7268489 Dose 3 + Ocrelizumab | Experimental | Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen. |
|
| Placebo + Ocrelizumab | Placebo Comparator | Participants will receive RO7268489 matching placebo along with ocrelizumab as per the pre-defined regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7268489 | Drug | RO7268489 will be administered per schedule as specified in the arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Up to approximately 110 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Randomization to the First Occurrence of 24-Week Confirmed ≥4-Point Decrease (Worsening) in Symbol Digit Modalities Test (SDMT) | The SDMT is a performance measure of processing speed that is widely used to assess cognitive function in response to treatment. It's brief, easy to administer, and involves a simple substitution task that healthy children and adults can easily perform. Using a reference key, the participant has 90 seconds to pair specific numbers with given geometric figures. The total SDMT score is the total number of correct responses and ranges from 0 to 110, with a higher score indicating a higher level of processing speed. A four-point change from baseline is typically considered clinically meaningful. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: BP46016 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Neurology | Recruiting | Kogarah | New South Wales | 2217 | Australia | |
| John Hunter Hospital |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Ocrelizumab | Drug | Ocrelizumab will be administered per schedule as specified in the arms. |
|
|
| Placebo | Drug | Placebo will be administered per schedule as specified in the arms. |
|
| 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 |
| Time to ≥ 20% Increase in 12-week Confirmed Timed 25-Foot Walk Test (T25FWT) | The time taken to walk 25 feet, typically measured in seconds. The longer it takes to walk, higher the score, which indicates deterioration and greater impairment. Lower times indicate better performance and greater mobility. Lower the mean change in the score over time, the better performance. | Up to approximately 110 weeks |
| Time to ≥ 20% Increase in 24-week Confirmed T25FWT | The time taken to walk 25 feet, typically measured in seconds. The longer it takes to walk, higher the score, which indicates deterioration and greater impairment. Lower times indicate better performance and greater mobility. Lower the mean change in the score over time, the better performance. | Up to approximately 110 weeks |
| Time to ≥ 20% Increase in 12-week Confirmed 9-Hole Peg Test (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. Both the dominant and non-dominant hands are tested twice (two consecutive trials for each hand). The participants are required to complete two successful trials for each hand. The amount of time (in seconds) required to place and remove all nine pegs is recorded for each trial. More time = higher raw scores, which indicates deterioration. The lower mean change in the score over time, the better the performance. | Up to approximately 110 weeks |
| Time to ≥ 20% Increase in 24-week Confirmed 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. Both the dominant and non-dominant hands are tested twice (two consecutive trials for each hand). The participants are required to complete two successful trials for each hand. The amount of time (in seconds) required to place and remove all nine pegs is recorded for each trial. More time = higher raw scores, which indicates deterioration. The lower mean change in the score over time, the better the performance. | Up to approximately 110 weeks |
| Plasma 2-arachidonoylglycerol (2-AG) Levels | Up to approximately 110 weeks |
| Change From Baseline in Plasma 2-AG Levels | Up to approximately 110 weeks |
| Number of Participants With Adverse events (AEs) | Up to 5 years |
| Number of Participants With Treatment Discontinuations due to AEs | Up to 5 years |
| Proportion of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS is an assessment tool used to assess lifetime suicidality of participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, and attempts with actual/potential lethality. Categories have binary responses (yes/no) and include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher indicate suicidal ideation or behavior. | Up to 5 years |
| Plasma Concentrations of RO7268489 and Its Metabolite(s) | Up to 5 years |
| Recruiting |
| New Lambton Heights |
| New South Wales |
| 2305 |
| Australia |
| Box Hill Hospital | Recruiting | Box Hill | Victoria | 3128 | Australia |
| Austin Health | Recruiting | Heidelberg | Victoria | 3084 | Australia |
| CHU Strasbourg Hpital Hautepierre | Recruiting | Strasbourg | Bas Rhin | 67098 | France |
| Hopital Caremeau | Recruiting | Nîmes | Gard | 30029 | France |
| Groupe Hospitalier Pellegrin | Recruiting | Bordeaux | Gironde | 33800 | France |
| Hopital Purpan | Recruiting | Toulouse | Haute Garonne | 31059 | France |
| Hopital Gui de Chauliac | Recruiting | Montpellier | Herault | 34295 | France |
| CHU Nantes - Hopital Nord Laënnec | Recruiting | Saint-Herblain | Loire Atlantique | 44800 | France |
| CHU Nancy Hôpital Central | Recruiting | Nancy | Meurthe Et Moselle | 54035 | France |
| CHU Hopital Gabriel Montpied | Recruiting | Clermont-Ferrand | Puy De Dome | 63003 | France |
| Hopital Neurologique Pierre Wertheimer | Recruiting | Bron | 69500 | France |
| Groupe Hospitalier Pitie-Salpetriere | Recruiting | Paris | 75013 | France |
| CHU Rennes - Hopital Pontchaillou | Recruiting | Rennes | 35033 | France |
| Universitaetsklinikum Freiburg | Recruiting | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Universitaetsklinikum Tuebingen | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Studienzentrum Neuropoint GmbH, | Recruiting | Ulm | Baden-Wurttemberg | 89073 | Germany |
| Universitaetsklinikum Erlangen | Recruiting | Erlangen | Bavaria | 91054 | Germany |
| LMU-Campus Grosshadern | Recruiting | Munich | Bavaria | 81377 | Germany |
| Klinikum rechts der Isar der TU Muenchen | Recruiting | Munich | Bavaria | 81675 | Germany |
| St. Josef-Hospital Universitaetsklinikum | Recruiting | Bochum | North Rhine-Westphalia | 44791 | Germany |
| Universitaetsklinikum Carl Gustav Carus TU Dresden | Recruiting | Dresden | Saxony | 01307 | Germany |
| Universitaetsklinikum Leipzig | Recruiting | Leipzig | Saxony | 04103 | Germany |
| Charité Universitaetsmedizin Berlin - Campus Ch | Recruiting | Berlin | 10117 | Germany |
| Pecsi Tudomanyegyetem Klinikai Kozpont | Recruiting | Pécs | Baranya | 7623 | Hungary |
| Clinexpert Kft. | Recruiting | Budapest | 1033 | Hungary |
| S-Medicon Egeszsegugyi Szolgaltato Kft. | Recruiting | Budapest | 1045 | Hungary |
| Budapesti Uzsoki Utcai Kórház | Recruiting | Budapest | 1145 | Hungary |
| Azienda Ospedaliera Universitaria Federico II | Recruiting | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliera Universitaria- Universit degli Studi della Campania Luigi Vanvitelli | Recruiting | Naples | Campania | 80138 | Italy |
| Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona | Recruiting | Salerno | Campania | 84131 | Italy |
| IRCCS AOM Azienda Ospedaliera Metropolitana | Recruiting | Genoa | Liguria | 16132 | Italy |
| Ospedale San Raffaele | Recruiting | Milan | Lombardy | 20132 | Italy |
| Fondazione IRCCS Istituto Neurologico Carlo Besta | Recruiting | Milan | Lombardy | 20133 | Italy |
| Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) | Recruiting | Milan | Lombardy | 20162 | Italy |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino | Recruiting | Pavia | Lombardy | 27100 | Italy |
| Optimal Clinical Trials - Christchurch | Recruiting | Christchurch Central City | South Island | 8011 | New Zealand |
| Optimal Clinical Trials - Central | Recruiting | Auckland | 1010 | New Zealand |
| Nmedis sp. z o.o. | Recruiting | Rzeszw | Podkarpackie Voivodeship | 35-323 | Poland |
| Centrum Medyczne Pratia Katowice I | Recruiting | Katowice | Silesian Voivodeship | 40-081 | Poland |
| NEURO-CARE Sp. z o.o. Sp. Komandytowa | Recruiting | Katowice | Silesian Voivodeship | 40-749 | Poland |
| ProNeuro Centrum Medyczne | Recruiting | ?ory | 44-240 | Poland |
| SOMED - Lodzkie Centrum Osteoporozy | Recruiting | ?ód? | 90-368 | Poland |
| M.A. LEK A.M.Maciejowscy SC. | Recruiting | Katowice | 40-571 | Poland |
| Resmedica NZOZ Kielce | Recruiting | Kielce | 25-726 | Poland |
| Samodzielny Publiczny Zakad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie | Recruiting | Krakow | 31-503 | Poland |
| Szpital Specjalistyczny im. L. Rydygiera w Krakowie | Recruiting | Krakow | 31-826 | Poland |
| Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. | Recruiting | Lublin | 20-410 | Poland |
| Zanamed Medical Clinic sp z o o | Recruiting | Lublin | 20-601 | Poland |
| Centrum Medyczne Medyk | Recruiting | Rzeszów | 35-055 | Poland |
| Centrum Medyczne NeuroProtect | Recruiting | Warsaw | 01-684 | Poland |
| Penta Hospitals Przychodnie, Wroclaw Wejherowska | Recruiting | Wroc?aw | 54-239 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa SzyszkoSUM w Katowicach | Recruiting | Zabrze | 41-800 | Poland |
| Hospital de Braga | Recruiting | Braga | 4710-243 | Portugal |
| ULS São José - Hospital de Sto António dos Capuchos;CRI Esclerose Múltipla | Recruiting | Lisbon | 1169-050 | Portugal |
| Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião | Recruiting | Santa Maria da Feira | 4520-211 | Portugal |
| Hospital Universitari de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Santa Caterina | Recruiting | Salt | Girona | 17190 | Spain |
| Hospital Universitari Arnau de Vilanova | Recruiting | Lleida | Lerida | 25198 | Spain |
| Hospital Universitario Quironsalud Madrid | Recruiting | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Universitario Virgen de La Arrixaca | Recruiting | El Palmar | Murcia | 30120 | Spain |
| Hospital Alvaro Cunqueiro | Recruiting | Vigo | Pontevedra | 36312 | Spain |
| Hospital de Cruces | Recruiting | Barakaldo | Vizcaya | 48903 | Spain |
| Complejo Hospitalario Universitario de Albacete | Recruiting | Albacete | 02008 | Spain |
| Hospital del Mar | Recruiting | Barcelona | 08003 | Spain |
| Hospital Universitari Vall d Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08041 | Spain |
| Hospital Universitario de la Princesa | Recruiting | Madrid | 28006 | Spain |
| Hospital General Universitario Gregorio Maranon | Recruiting | Madrid | 28007 | Spain |
| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
| Hospital Clinico San Carlos | Recruiting | Madrid | 28040 | Spain |
| Hospital Regional Universitario de Malaga | Recruiting | Málaga | 29010 | Spain |
| Hospital Universitario Virgen Macarena | Recruiting | Seville | 41009 | Spain |
| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
| Kocaeli University Medical Faculty | Recruiting | Kocaeli | Izmit | 41380 | Turkey (Türkiye) |
| Hacettepe University of Medicine | Recruiting | Ankara | 06100 | Turkey (Türkiye) |
| Gazi University Medical Faculty | Recruiting | Ankara | 06500 | Turkey (Türkiye) |
| Ankara City Hospital | Recruiting | Ankara | 06800 | Turkey (Türkiye) |
| Istanbul University Istanbul Medical Faculty | Recruiting | Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical Faculty | Recruiting | Istanbul | 34098 | Turkey (Türkiye) |
| Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital | Recruiting | Istanbul | 34785 | Turkey (Türkiye) |
| Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi | Recruiting | Konya | 42075 | Turkey (Türkiye) |
| Royal Cornwall Hospital | Recruiting | Truro | Cornwall | TR1 3HD | United Kingdom |
| Charing Cross Hospital | Recruiting | London | Greater London | W6 8RF | United Kingdom |
| Queen Elizabeth University Hospital | Recruiting | Glasgow | Strathclyde | G51 4TF | United Kingdom |
| University Hospital of Wales | Recruiting | Cardiff | CF14 4XW | United Kingdom |
| Royal London Hospital | Recruiting | London | E1 2AT | United Kingdom |
| Salford Care Organisation | Recruiting | Salford | M6 8HD | United Kingdom |
| Morriston Hospital | Recruiting | Swansea | SA6 6NL | United Kingdom |
| ID | Term |
|---|---|
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C533411 | ocrelizumab |
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