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A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis

Study Purpose

A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (and placebo) or intravenous (IV) ocrelizumab (and placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). Approximately 946 participants will be enrolled and will be recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- For sites in Germany and Italy only, enrollment is restricted to participants aged 46-65 years.

- A diagnosis of PPMS in accordance to the revised 2017 McDonald Criteria (Thompson et al.

2018).

- Disability progression in the 12 months prior to screening.

- Expanded Disability Status Scale (EDSS) score from 3.0 to 6.5 inclusive at screening.

- Pyramidal functional subscore >=2 at screening.

- For participants currently receiving proton pump inhibitors (PPIs), H2-receptor antagonists (H2RAs), symptomatic treatment for MS (e.g. fampridine, cannabis) and/or physiotherapy: treatment at a stable dose during the screening period prior to the initiation of study treatment and plans to remain at a stable dose for the duration of study treatment.

- Neurologically stable for at least 30 days prior to randomization and baseline assessments.

- Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in <240 seconds.

- Ability to perform Timed 25-Foot Walk Test (T25FWT) in <150 seconds.

- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs.

- For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm.

Exclusion Criteria:

- For participants enrolled in Germany and in Italy only: Presence of gadolinium-enhancing lesions on T1-weighted MRI (T1Gd +) lesion on the screening MRI.

- Any known or suspected active infection (excluding onychomycosis) at screening, including but not limited to a positive screening test for Hepatitis B and C, an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML).

- Participants with a previous history of a serious Infusion-Related Reaction (IRR) (Common Terminology Criteria for Adverse Events [CTCAE] Grade >= 4) and/or any hypersensitivity reaction to ocrelizumab.

- History of cancer including hematologic malignancy and solid tumors within 10 years of screening.

Exceptions: Basal/squamous cell carcinoma of skin cured by excision. In situ carcinoma of the cervix successfully treated by curative therapy >1 year prior to screening.

- Known presence of other neurological disorders, that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease.

- Presence of cirrhosis (Child-Pugh Class A, B, or C) - Any concomitant disease that may require chronic treatment with systemic corticosteroids, immunosuppressants or specific medication that could impact the primary evaluation of the study.

- History of alcohol or other drug abuse within 12 months prior to screening.

- Female participants who are pregnant or breastfeeding or intending to become pregnant during the study or 6 or 12 months (as applicable from the local label for ocrelizumab) after final dose of study drug.

- Male participants intending to father a child during the study or for 28 days after final dose of study drug.

- Lack of peripheral venous access.

- Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.

- Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.

- Immunocompromised state, history of primary or secondary (non-drug related) immunodeficiency, or history of transplantation or antirejection therapy.

- Known bleeding diathesis, anemia, or history of hospitalization or transfusion for gastrointestinal (GI) bleed.

- Any previous treatment with cladribine, mitoxantrone, daclizumab, alemtuzumab, or cyclophosphamide.

OLE

Inclusion Criteria:

- Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib.

- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs.

- For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04544449
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hoffmann-La Roche
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Trials
Principal Investigator Affiliation	Hoffmann-La Roche
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, North Macedonia, Peru, Poland, Portugal, Puerto Rico, Russian Federation, Spain, Switzerland, Turkey, Ukraine, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis, Primary Progressive

Arms & Interventions

Arms

Experimental: Fenebrutinib

Participants will receive oral fenebrutinib and intravenous (IV) ocrelizumab-matching placebo.

Active Comparator: Ocrelizumab

Participants will receive intravenous (IV) ocrelizumab and oral fenebrutinib-matching placebo.

Interventions

Drug: - Fenebrutinib

Participants will receive fenebrutinib.

Drug: - Ocrelizumab

Participants will receive ocrelizumab.

Drug: - Placebo matched to ocrelizumab

Participants will receive ocrelizumab-matching placebo.

Drug: - Placebo matched to fenebrutinib

Participants will receive fenebrutinib-matching placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Alabama Neurology Associates, Homewood, Alabama

Status

Active, not recruiting

Address

Alabama Neurology Associates

Homewood, Alabama, 35209

Site Contact

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A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis

Study Purpose

Recruitment Criteria

Inclusion Criteria:

Exclusion Criteria:

Inclusion Criteria:

Trial Details

Arms

Interventions

Contact a Trial Team

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