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)

Phase
Recruitment status
Participants
Lead sponsor
Hoffmann-La Roche
Start date
Number of sites

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.
Acronym
Short 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)
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

Control arm
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Hoffmann-La Roche
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design

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

    Timeframe: 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.

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

    Timeframe: 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.

  2. Change From Baseline in Total Brain Volume

    Timeframe: Up to approximately 110 weeks

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

    Timeframe: Up to approximately 110 weeks

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

    Timeframe: Up to approximately 110 weeks

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

    Timeframe: Up to approximately 110 weeks

  6. Time to ≥ 20% Increase in 12-week Confirmed Timed 25-Foot Walk Test (T25FWT)

    Timeframe: 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.

  7. Time to ≥ 20% Increase in 24-week Confirmed T25FWT

    Timeframe: 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.

  8. Time to ≥ 20% Increase in 12-week Confirmed 9-Hole Peg Test (9-HPT)

    Timeframe: 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.

  9. Time to ≥ 20% Increase in 24-week Confirmed 9-HPT

    Timeframe: 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.

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

    Timeframe: Up to approximately 110 weeks

  11. Change From Baseline in Plasma 2-AG Levels

    Timeframe: Up to approximately 110 weeks

  12. Number of Participants With Adverse events (AEs)

    Timeframe: Up to 5 years

  13. Number of Participants With Treatment Discontinuations due to AEs

    Timeframe: Up to 5 years

  14. Proportion of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

    Timeframe: 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.

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

    Timeframe: Up to 5 years

Sources for outcomes

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
60 Years
Healthy volunteers
No

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

  • 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
Sources for eligibility

  • Brain and Mind CentreCamperdown, AustraliaRecruiting
  • Southern NeurologyKogarah, AustraliaRecruiting
  • John Hunter HospitalNew Lambton Heights, AustraliaRecruiting
  • Box Hill HospitalBox Hill, AustraliaRecruiting
  • Austin HealthHeidelberg, AustraliaRecruiting
  • CHU Strasbourg Hpital HautepierreStrasbourg, FranceRecruiting
  • Hopital CaremeauNîmes, FranceRecruiting
  • Groupe Hospitalier PellegrinBordeaux, FranceRecruiting
  • Hopital PurpanToulouse, FranceRecruiting
  • Hopital Gui de ChauliacMontpellier, FranceRecruiting
  • CHU Nantes - Hopital Nord LaënnecSaint-Herblain, FranceRecruiting
  • CHU Nancy Hôpital CentralNancy, FranceRecruiting
  • CHU Hopital Gabriel MontpiedClermont-Ferrand, FranceRecruiting
  • Hopital Neurologique Pierre WertheimerBron, FranceRecruiting
  • Groupe Hospitalier Pitie-SalpetriereParis, FranceRecruiting
  • CHU Rennes - Hopital PontchaillouRennes, FranceRecruiting
  • Universitaetsklinikum FreiburgFreiburg im Breisgau, GermanyRecruiting
  • Universitaetsmedizin MannheimMannheim, GermanyRecruiting
  • Universitaetsklinikum TuebingenTübingen, GermanyRecruiting
  • Studienzentrum Neuropoint GmbH,Ulm, GermanyRecruiting
  • Universitaetsklinikum UlmUlm, GermanyRecruiting
  • Universitaetsklinikum ErlangenErlangen, GermanyRecruiting
  • LMU-Campus GrosshadernMunich, GermanyRecruiting
  • Klinikum rechts der Isar der TU MuenchenMunich, GermanyRecruiting
  • St. Josef-Hospital UniversitaetsklinikumBochum, GermanyRecruiting

And 83 more, listed on the interactive page.

Sources for sites

  • 2025
  • 2025-521636-10-00
Sources for references

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (1)