AzTrials
AzTrials

Progressive Multiple SclerosisPhase 2MintakaNCT07282574

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)

A Phase 2 study testing RO7268489 and Ocrelizumab in people with Progressive Multiple Sclerosis, run by Hoffmann-La Roche at 114 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Progressive Multiple Sclerosis
What is being tested?
RO7268489 and Ocrelizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
360 participants
Where
114 sitesin 12 countries
Study dates
10 Mar 2026to 30 May 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • PMS, in accordance with the revised 2017 McDonald criteria
  • Expanded disability status scale (EDSS) at screening between 3.0 and 6.0 inclusive
  • Documented evidence of disability progression independent of relapse activity over the 2 years before the screening visit

Who cannot join

  • MS relapse during the 6 months preceding the randomization date
  • Lack of peripheral venous access
  • History of alcohol or other drug abuse (substance use disorder) based on Diagnostic and Statistical Manual for Mental Disorders, fifth edition (DSM-5) criteria, within 5 years prior to screening
  • Inability to complete a magnetic resonance imaging (MRI)
  • Contraindications to ocrelizumab mandatory pre-medications
  • Treatment with intravenous immunoglobulin (IV Ig) or plasmapheresis within 12 weeks prior to screening

Trial locations and contacts

114 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: BP46016 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

114 sites in 12 countries

Spain20 sites, 20 recruiting

  • Complejo Hospitalario Universitario de Albacete

    Albacete, 02008

    Recruiting

  • Hospital de Cruces

    Barakaldo, Vizcaya, 48903

    Recruiting

  • Hospital del Mar

    Barcelona, 08003

    Recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

    Recruiting

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, Murcia, 30120

    Recruiting

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

    Recruiting

  • Hospital Universitari Arnau de Vilanova

    Lleida, Lerida, 25198

    Recruiting

  • Hospital Universitario de la Princesa

    Madrid, 28006

    Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

    Recruiting

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223

    Recruiting

  • Hospital Santa Caterina

    Salt, Girona, 17190

    Recruiting

  • Complejo Hospitalario Universitario de Santiago.

    Santiago de Compostela, LA Coruna, 15706

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

    Recruiting

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36312

    Recruiting

Other trials in Spain

Poland18 sites, 18 recruiting

  • SOMED - Lodzkie Centrum Osteoporozy

    ?ód?, 90-368

    Recruiting

  • ProNeuro Centrum Medyczne

    ?ory, 44-240

    Recruiting

  • Neurocentrum Bydgoszcz sp z o.o

    Bydgoszcz, 85-796

    Recruiting

  • COPERNICUS Podmiot Leczniczy Sp z o o

    Gda?sk, 80-803

    Recruiting

  • Centrum Medyczne Pratia Katowice I

    Katowice, Silesian Voivodeship, 40-081

    Recruiting

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

    Katowice, Silesian Voivodeship, 40-749

    Recruiting

  • M.A. LEK A.M.Maciejowscy SC.

    Katowice, 40-571

    Recruiting

  • Resmedica NZOZ Kielce

    Kielce, 25-726

    Recruiting

  • Samodzielny Publiczny Zakad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, 31-503

    Recruiting

  • Szpital Specjalistyczny im. L. Rydygiera w Krakowie

    Krakow, 31-826

    Recruiting

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

    Lublin, 20-410

    Recruiting

  • Zanamed Medical Clinic sp z o o

    Lublin, 20-601

    Recruiting

  • NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

    Poznan, Greater Poland Voivodeship, 61-853

    Recruiting

  • Centrum Medyczne Medyk

    Rzeszów, 35-055

    Recruiting

  • Nmedis sp. z o.o.

    Rzeszw, Podkarpackie Voivodeship, 35-323

    Recruiting

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-684

    Recruiting

  • Penta Hospitals Przychodnie, Wroclaw Wejherowska

    Wroc?aw, 54-239

    Recruiting

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

    Zabrze, 41-800

    Recruiting

Other trials in Poland

Germany17 sites, 17 recruiting

  • Charité Universitaetsmedizin Berlin - Campus Ch

    Berlin, 10117

    Recruiting

  • St. Josef-Hospital Universitaetsklinikum

    Bochum, North Rhine-Westphalia, 44791

    Recruiting

  • Universitaetsklinikum Bonn AoeR

    Bonn, North Rhine-Westphalia, 53127

    Recruiting

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, Saxony, 01307

    Recruiting

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

    Recruiting

  • Universitaetsklinikum Erlangen

    Erlangen, Bavaria, 91054

    Recruiting

  • Universitaetsklinkm Essen

    Essen, North Rhine-Westphalia, 45122

    Recruiting

  • Universitaetsklinikum Frankfurt Goethe-Universitaet

    Frankfurt am Main, Hesse, 60528

    Recruiting

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

    Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, Saxony, 04103

    Recruiting

  • Universitaetsmedizin Mannheim

    Mannheim, Baden-Wurttemberg, 68167

    Recruiting

  • LMU-Campus Grosshadern

    Munich, Bavaria, 81377

    Recruiting

  • Klinikum rechts der Isar der TU Muenchen

    Munich, Bavaria, 81675

    Recruiting

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

    Recruiting

  • Studienzentrum Neuropoint GmbH,

    Ulm, Baden-Wurttemberg, 89073

    Recruiting

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

    Recruiting

Other trials in Germany

France11 sites, 11 recruiting

  • Groupe Hospitalier Pellegrin

    Bordeaux, Gironde, 33800

    Recruiting

  • Hopital Neurologique Pierre Wertheimer

    Bron, 69500

    Recruiting

  • CHU Hopital Gabriel Montpied

    Clermont-Ferrand, Puy De Dome, 63003

    Recruiting

  • Hopital Gui de Chauliac

    Montpellier, Herault, 34295

    Recruiting

  • CHU Nancy Hôpital Central

    Nancy, Meurthe Et Moselle, 54035

    Recruiting

  • Hopital Caremeau

    Nîmes, Gard, 30029

    Recruiting

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013

    Recruiting

  • CHU Rennes - Hopital Pontchaillou

    Rennes, 35033

    Recruiting

  • CHU Nantes - Hopital Nord Laënnec

    Saint-Herblain, Loire Atlantique, 44800

    Recruiting

  • CHU Strasbourg Hpital Hautepierre

    Strasbourg, Bas Rhin, 67098

    Recruiting

  • Hopital Purpan

    Toulouse, Haute Garonne, 31059

    Recruiting

Other trials in France

Italy10 sites, 10 recruiting

  • Fondazione Università G. D'Annunzio

    Chieti, Abruzzo, 66013

    Recruiting

  • IRCCS AOM Azienda Ospedaliera Metropolitana

    Genoa, Liguria, 16132

    Recruiting

  • Ospedale San Raffaele

    Milan, Lombardy, 20132

    Recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, Lombardy, 20133

    Recruiting

  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

    Milan, Lombardy, 20162

    Recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Campania, 80131

    Recruiting

  • Azienda Ospedaliera Universitaria- Universit degli Studi della Campania Luigi Vanvitelli

    Naples, Campania, 80138

    Recruiting

  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino

    Pavia, Lombardy, 27100

    Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Roma, Emilia-Romagna, 00133

    Recruiting

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

    Salerno, Campania, 84131

    Recruiting

Other trials in Italy

Turkey (Türkiye)10 sites, 10 recruiting

  • Hacettepe University of Medicine

    Ankara, 06100

    Recruiting

  • Gazi University Medical Faculty

    Ankara, 06500

    Recruiting

  • Ankara City Hospital

    Ankara, 06800

    Recruiting

  • Istanbul University Istanbul Medical Faculty

    Istanbul, 34093

    Recruiting

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

    Recruiting

  • Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital

    Istanbul, 34785

    Recruiting

  • Ege University Medical Faculty

    Izmir, 35100

    Recruiting

  • Izmir Katip Celebi Universitesi Ataturk Research and Training Hospital

    Izmir, 35360

    Recruiting

  • Kocaeli University Medical Faculty

    Kocaeli, Izmit, 41380

    Recruiting

  • Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi

    Konya, 42075

    Recruiting

Other trials in Turkey (Türkiye)

Hungary8 sites, 8 recruiting

  • Clinexpert Kft.

    Budapest, 1033

    Recruiting

  • S-Medicon Egeszsegugyi Szolgaltato Kft.

    Budapest, 1045

    Recruiting

  • Semmelweis Egyetem

    Budapest, 1083

    Recruiting

  • Bajcsy-Zsilinszky Korhaz es Rendelointezet

    Budapest, 1106

    Recruiting

  • Budapesti Uzsoki Utcai Kórház

    Budapest, 1145

    Recruiting

  • Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus

    Debrecen, 4031

    Recruiting

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400

    Recruiting

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, Baranya, 7623

    Recruiting

Other trials in Hungary

United Kingdom7 sites, 7 recruiting

  • University Hospital of Wales

    Cardiff, CF14 4XW

    Recruiting

  • Queen Elizabeth University Hospital

    Glasgow, Strathclyde, G51 4TF

    Recruiting

  • Charing Cross Hospital

    London, Greater London, W6 8RF

    Recruiting

  • Royal London Hospital

    London, E1 2AT

    Recruiting

  • Salford Care Organisation

    Salford, M6 8HD

    Recruiting

  • Morriston Hospital

    Swansea, SA6 6NL

    Recruiting

  • Royal Cornwall Hospital

    Truro, Cornwall, TR1 3HD

    Recruiting

Other trials in United Kingdom

Australia5 sites, 5 recruiting

  • Box Hill Hospital

    Box Hill, Victoria, 3128

    Recruiting

  • Brain and Mind Centre

    Camperdown, New South Wales, 2050

    Recruiting

  • Austin Health

    Heidelberg, Victoria, 3084

    Recruiting

  • Southern Neurology

    Kogarah, New South Wales, 2217

    Recruiting

  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305

    Recruiting

Other trials in Australia

Portugal5 sites, 5 recruiting

  • Hospital de Braga

    Braga, 4710-243

    Recruiting

  • ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra

    Coimbra, 3004-561

    Recruiting

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

    Lisbon, 1169-050

    Recruiting

  • Hospital de Egas Moniz

    Lisbon, 1349-019

    Recruiting

  • Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião

    Santa Maria da Feira, 4520-211

    Recruiting

Other trials in Portugal

New Zealand2 sites, 2 recruiting

  • Optimal Clinical Trials - Central

    Auckland, 1010

    Recruiting

  • Optimal Clinical Trials - Christchurch

    Christchurch Central City, South Island, 8011

    Recruiting

Other trials in New Zealand

Brazil1 site, 1 recruiting

  • Centro de Pesquisas Clinicas - CPCLIN

    São Paulo, São Paulo, 01244-030

    Recruiting

Other trials in Brazil

About this study

Official title: A Multi-center, Double-blind, Placebo-controlled, Phase II Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489, a Monoacylglycerol Lipase Inhibitor, as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis

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.

Being tested
RO7268489, Ocrelizumab, Placebo
Medical subject headings
Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO7268489Drug

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

  • OcrelizumabDrug

    Also called RO4964913, Ocrevus

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

  • PlaceboDrug

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

Study groups in NCT07282574
Study groupRoleWhat they receive
RO7268489 Dose 1 + OcrelizumabExperimentalParticipants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.
Receives: Drug: RO7268489; Drug: Ocrelizumab
RO7268489 Dose 2 + OcrelizumabExperimentalParticipants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.
Receives: Drug: RO7268489; Drug: Ocrelizumab
RO7268489 Dose 3 + OcrelizumabExperimentalParticipants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.
Receives: Drug: RO7268489; Drug: Ocrelizumab
Placebo + OcrelizumabPlacebo comparatorParticipants will receive RO7268489 matching placebo along with ocrelizumab as per the pre-defined regimen.
Receives: Drug: Ocrelizumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 110 weeks

Secondary outcomes (15)

  1. 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.

    Measured: Up to approximately 110 weeks

  2. Time to Onset of 24-Week cCDP (cCDP24)

    Measured: Up to approximately 110 weeks

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

    Measured: Up to approximately 110 weeks

  4. Time to Onset of 24-Week CDP (CDP24)

    Measured: Up to approximately 110 weeks

  5. 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.

    Measured: Up to approximately 110 weeks

  6. 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.

    Measured: Up to approximately 110 weeks

  7. 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.

    Measured: Up to approximately 110 weeks

  8. 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, \& 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.

    Measured: Up to approximately 110 weeks

  9. Change From Baseline in Total Brain Volume

    Measured: Up to approximately 110 weeks

  10. Plasma 2-arachidonoylglycerol (2-AG) Levels

    Measured: Up to approximately 110 weeks

  11. Change From Baseline in Plasma 2-AG Levels

    Measured: Up to approximately 110 weeks

  12. Number of Participants With Adverse events (AEs)

    Measured: Up to 5 years

  13. Number of Participants With Treatment Discontinuations due to AEs

    Measured: Up to 5 years

  14. 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.

    Measured: Up to 5 years

  15. Plasma Concentrations of RO7268489 and Its Metabolite(s)

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2025
  2. Study start10 Mar 2026
  3. Primary completion30 May 2028 (estimated)
  4. Study completion30 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07282574
Sponsor's protocol ID
BP46016
Other IDs
2025-521636-10-00, 2025
Acronym
Mintaka
Status last verified
Oct 2026
First submitted
5 Dec 2025
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RO7268489 and Ocrelizumab in people with Progressive Multiple Sclerosis, run by Hoffmann-La Roche at 114 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in Spain, Poland, Germany, France, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: BP46016 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Randomization to the First Occurrence of Composite Confirmed Disability Progression (cCPD) Confirmed for at Least 12 Weeks (cCDP12) (time frame: Up to approximately 110 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07282574.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in