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) (Mintaka)

August 13, 2026 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Brain and Mind Centre
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • Southern Neurology
      • New Lambton Heights, New South Wales, Australia, 2305
        • Recruiting
        • John Hunter Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Box Hill Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health
  • France
      • Bron, France, 69500
        • Recruiting
        • Hopital Neurologique Pierre Wertheimer
      • Paris, France, 75013
        • Recruiting
        • Groupe Hospitalier Pitie-Salpetriere
      • Rennes, France, 35033
        • Recruiting
        • CHU Rennes - Hôpital Pontchaillou
    • Bas Rhin
      • Strasbourg, Bas Rhin, France, 67098
        • Recruiting
        • CHU Strasbourg Hpital Hautepierre
    • Gard
      • Nîmes, Gard, France, 30029
        • Recruiting
        • Hopital Caremeau
    • Gironde
      • Bordeaux, Gironde, France, 33800
        • Recruiting
        • Groupe Hospitalier Pellegrin
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31059
        • Recruiting
        • Hopital Purpan
    • Herault
      • Montpellier, Herault, France, 34295
        • Recruiting
        • Hôpital Gui de Chauliac
    • Loire Atlantique
      • Saint-Herblain, Loire Atlantique, France, 44800
        • Recruiting
        • CHU Nantes - Hopital Nord Laënnec
    • Meurthe Et Moselle
      • Nancy, Meurthe Et Moselle, France, 54035
        • Recruiting
        • CHU Nancy Hôpital Central
    • Puy De Dome
      • Clermont-Ferrand, Puy De Dome, France, 63003
        • Recruiting
        • CHU Hopital Gabriel Montpied
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Universitaetsmedizin Berlin - Campus Ch
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitaetsklinikum Hamburg-Eppendorf
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Recruiting
        • Universitaetsklinikum Freiburg
      • Mannheim, Baden-Wurttemberg, Germany, 68167
        • Recruiting
        • Universitaetsmedizin Mannheim
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm
      • Ulm, Baden-Wurttemberg, Germany, 89073
        • Recruiting
        • Studienzentrum Neuropoint GmbH,
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Universitaetsklinikum Erlangen
      • Munich, Bavaria, Germany, 81675
        • Recruiting
        • Klinikum rechts der Isar der TU Muenchen
      • Munich, Bavaria, Germany, 81377
        • Recruiting
        • LMU-Campus Grosshadern
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Germany, 44791
        • Recruiting
        • St. Josef-Hospital Universitaetsklinikum
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Recruiting
        • Universitaetsklinikum Duesseldorf
      • Essen, North Rhine-Westphalia, Germany, 45122
        • Recruiting
        • Universitaetsklinkm Essen
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Universitaetsklinikum Leipzig
  • Hungary
      • Budapest, Hungary, 1033
        • Recruiting
        • Clinexpert Kft.
      • Budapest, Hungary, 1106
        • Recruiting
        • Bajcsy-Zsilinszky Korhaz es Rendelointezet
      • Budapest, Hungary, 1145
        • Recruiting
        • Budapesti Uzsoki Utcai Korhaz
      • Budapest, Hungary, 1045
        • Recruiting
        • S-Medicon Egeszsegugyi Szolgaltato Kft.
      • Debrecen, Hungary, 4031
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus
    • Baranya
      • Pécs, Baranya, Hungary, 7623
        • Recruiting
        • Pécsi Tudományegyetem Klinikai Központ
  • Italy
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66013
        • Recruiting
        • Fondazione Università G. D'Annunzio
    • Campania
      • Naples, Campania, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II
      • Naples, Campania, Italy, 80138
        • Recruiting
        • Azienda Ospedaliera Universitaria- Universit degli Studi della Campania Luigi Vanvitelli
      • Salerno, Campania, Italy, 84131
        • Recruiting
        • Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona
    • Emilia-Romagna
      • Roma, Emilia-Romagna, Italy, 00133
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
    • Liguria
      • Genoa, Liguria, Italy, 16132
        • Recruiting
        • IRCCS AOM Azienda Ospedaliera Metropolitana
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
      • Milan, Lombardy, Italy, 20162
        • Recruiting
        • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
      • Pavia, Lombardy, Italy, 27100
        • Recruiting
        • Fondazione Istituto Neurologico Nazionale Casimiro Mondino
  • New Zealand
      • Auckland, New Zealand, 1010
        • Recruiting
        • Optimal Clinical Trials - Central
    • South Island
      • Christchurch Central City, South Island, New Zealand, 8011
        • Recruiting
        • Optimal Clinical Trials - Christchurch
  • Poland
      • ?ory, Poland, 44-240
        • Recruiting
        • ProNeuro Centrum Medyczne
      • ?ód?, Poland, 90-368
        • Recruiting
        • SOMED - Lodzkie Centrum Osteoporozy
      • Bydgoszcz, Poland, 85-796
        • Recruiting
        • Neurocentrum Bydgoszcz sp z o.o
      • Gda?sk, Poland, 80-803
        • Recruiting
        • COPERNICUS Podmiot Leczniczy Sp z o o
      • Katowice, Poland, 40-571
        • Recruiting
        • M.A. LEK A.M.Maciejowscy SC.
      • Kielce, Poland, 25-726
        • Recruiting
        • Resmedica NZOZ Kielce
      • Krakow, Poland, 31-503
        • Recruiting
        • Samodzielny Publiczny Zakad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
      • Krakow, Poland, 31-826
        • Recruiting
        • Szpital Specjalistyczny im. L. Rydygiera w Krakowie
      • Lublin, Poland, 20-410
        • Recruiting
        • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
      • Lublin, Poland, 20-601
        • Recruiting
        • Zanamed Medical Clinic sp z o o
      • Rzeszów, Poland, 35-055
        • Recruiting
        • Centrum Medyczne Medyk
      • Warsaw, Poland, 01-684
        • Recruiting
        • Centrum Medyczne NeuroProtect
      • Wroc?aw, Poland, 54-239
        • Recruiting
        • Penta Hospitals Przychodnie, Wroclaw Wejherowska
      • Zabrze, Poland, 41-800
        • Recruiting
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa SzyszkoSUM w Katowicach
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-853
        • Recruiting
        • NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
    • Podkarpackie Voivodeship
      • Rzeszw, Podkarpackie Voivodeship, Poland, 35-323
        • Recruiting
        • Nmedis sp. z o.o.
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-749
        • Recruiting
        • NEURO-CARE Sp. z o.o. Sp. Komandytowa
      • Katowice, Silesian Voivodeship, Poland, 40-081
        • Recruiting
        • Centrum Medyczne Pratia Katowice I
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • Hospital de Braga
      • Coimbra, Portugal, 3004-561
        • Recruiting
        • ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
      • Lisbon, Portugal, 1349-019
        • Recruiting
        • Hospital de Egas Moniz
      • Lisbon, Portugal, 1169-050
        • Recruiting
        • ULS São José - Hospital de Sto António dos Capuchos;CRI Esclerose Múltipla
      • Santa Maria da Feira, Portugal, 4520-211
        • Recruiting
        • Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião
  • Spain
      • Albacete, Spain, 02008
        • Recruiting
        • Complejo Hospitalario Universitario de Albacete
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital Del Mar
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall D Hebron
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de La Princesa
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Málaga
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge
    • Girona
      • Salt, Girona, Spain, 17190
        • Recruiting
        • Hospital Santa Caterina
    • LA Coruna
      • Santiago de Compostela, LA Coruna, Spain, 15706
        • Recruiting
        • Complejo Hospitalario Universitario de Santiago.
    • Lerida
      • Lleida, Lerida, Spain, 25198
        • Recruiting
        • Hospital Universitari Arnau de Vilanova
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Recruiting
        • Hospital Universitario Quironsalud Madrid
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Universitario Virgen de la Arrixaca
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Recruiting
        • Hospital Alvaro Cunqueiro
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Recruiting
        • Hospital De Cruces
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06500
        • Recruiting
        • Gazi University Medical Faculty
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara City Hospital
      • Ankara, Turkey (Türkiye), 06100
        • Recruiting
        • Hacettepe University of Medicine
      • Istanbul, Turkey (Türkiye), 34098
        • Recruiting
        • Istanbul University Cerrahpasa Medical Faculty
      • Istanbul, Turkey (Türkiye), 34093
        • Recruiting
        • Istanbul University Istanbul Medical Faculty
      • Istanbul, Turkey (Türkiye), 34785
        • Recruiting
        • Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital
      • Izmir, Turkey (Türkiye), 35100
        • Recruiting
        • Ege University Medical Faculty
      • Konya, Turkey (Türkiye), 42075
        • Recruiting
        • Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi
    • Izmit
      • Kocaeli, Izmit, Turkey (Türkiye), 41380
        • Recruiting
        • Kocaeli University Medical Faculty
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • University Hospital of Wales
      • London, United Kingdom, E1 2AT
        • Recruiting
        • Royal London Hospital
      • Salford, United Kingdom, M6 8HD
        • Recruiting
        • Salford Care Organisation
      • Swansea, United Kingdom, SA6 6NL
        • Recruiting
        • Morriston Hospital
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3HD
        • Recruiting
        • Royal Cornwall Hospital
    • Greater London
      • London, Greater London, United Kingdom, W6 8RF
        • Recruiting
        • Charing Cross Hospital
    • Strathclyde
      • Glasgow, Strathclyde, United Kingdom, G51 4TF
        • Recruiting
        • Queen Elizabeth University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RO7268489 Dose 1 + Ocrelizumab
Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.
Drug: RO7268489
RO7268489 will be administered per schedule as specified in the arms.
Drug: Ocrelizumab
Ocrelizumab will be administered per schedule as specified in the arms.
Other Names:
  • RO4964913, Ocrevus
Experimental: RO7268489 Dose 2 + Ocrelizumab
Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.
Drug: RO7268489
RO7268489 will be administered per schedule as specified in the arms.
Drug: Ocrelizumab
Ocrelizumab will be administered per schedule as specified in the arms.
Other Names:
  • RO4964913, Ocrevus
Experimental: RO7268489 Dose 3 + Ocrelizumab
Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.
Drug: RO7268489
RO7268489 will be administered per schedule as specified in the arms.
Drug: Ocrelizumab
Ocrelizumab will be administered per schedule as specified in the arms.
Other Names:
  • RO4964913, Ocrevus
Placebo Comparator: Placebo + Ocrelizumab
Participants will receive RO7268489 matching placebo along with ocrelizumab as per the pre-defined regimen.
Drug: Ocrelizumab
Ocrelizumab will be administered per schedule as specified in the arms.
Other Names:
  • RO4964913, Ocrevus
Drug: Placebo
Placebo will be administered per schedule as specified in the arms.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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 Frame: 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.
Up to approximately 110 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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)
Time Frame: Up to approximately 110 weeks
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.
Up to approximately 110 weeks
Change From Baseline in Total Brain Volume
Time Frame: Up to approximately 110 weeks
Up to approximately 110 weeks
Time to Onset of 24-Week cCDP (cCDP24)
Time Frame: Up to approximately 110 weeks
Up to approximately 110 weeks
Time to Onset of 12-Week Confirmed Disability Progression CDP (CDP12)
Time Frame: Up to approximately 110 weeks
Up to approximately 110 weeks
Time to Onset of 24-Week CDP (CDP24)
Time Frame: Up to approximately 110 weeks
Up to approximately 110 weeks
Time to ≥ 20% Increase in 12-week Confirmed Timed 25-Foot Walk Test (T25FWT)
Time Frame: Up to approximately 110 weeks
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
Time Frame: Up to approximately 110 weeks
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)
Time Frame: Up to approximately 110 weeks
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
Time Frame: Up to approximately 110 weeks
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
Time Frame: Up to approximately 110 weeks
Up to approximately 110 weeks
Change From Baseline in Plasma 2-AG Levels
Time Frame: Up to approximately 110 weeks
Up to approximately 110 weeks
Number of Participants With Adverse events (AEs)
Time Frame: Up to 5 years
Up to 5 years
Number of Participants With Treatment Discontinuations due to AEs
Time Frame: Up to 5 years
Up to 5 years
Proportion of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Up to 5 years
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)
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BP46016
  • 2025-521636-10-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings