SUB190378 (RO7010939 / fenebrutinib) for Relapsing multiple sclerosis

Inclusion criteria

• {"criterion_text":"- Participants who are aged 18 to 55 years inclusive at the time of signing Informed Consent Form"}
• {"criterion_text":"- A diagnosis of relapsing MS (RMS) in accordance with the revised 2017 McDonald Criteria and one of the following: • At least two documented clinical relapses within the last 2 years or one documented clinical relapse within 12 months of screening (but not within the 30 days prior to screening) • Documented evidence of the presence of at least one T1 Gd+ lesion on MRI in the 6 months prior to randomization (may include the screening MRI)"}
• {"criterion_text":"- Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points"}
• {"criterion_text":"- For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs during the treatment period and for 28 days after the final dose of fenebrutinib"}
• {"criterion_text":"- For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 28 days after the final dose of fenebrutinib to avoid exposing the embryo"}

Exclusion criteria

• {"criterion_text":"- Disease duration of >10 years from the onset of symptoms and an EDSS score at screening < 2.0"}
• {"criterion_text":"- A diagnosis of primary progressive MS or non-active secondary progressive MS"}
• {"criterion_text":"- Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti-microbials within 8 weeks prior to or during screening or treatment with oral anti-microbials within 2 weeks prior to or during screening"}
• {"criterion_text":"- History of progressive multifocal leukoencephalopathy (PML)"}
• {"criterion_text":"- History of cancer"}
• {"criterion_text":"- Presence of other neurological disorders, that could interfere with the diagnosis of MS or with the assessments of efficacy or safety during the study, evidence of clinically significant psychiatric, pulmonary, renal, hepatic, metabolic, gastrointestinal (GI), or cardiovascular disease, or endocrine disease"}

Primary endpoints

• {"endpoint_text":"- 1. Total number of new gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 4, 8, and 12","definition_or_measurement_approach":"Measured as the total count of new gadolinium-enhancing T1 lesions on brain MRI performed at Weeks 4, 8 and 12."}

Secondary endpoints

• {"endpoint_text":"- 1. Total number of new or enlarging T2- weighted lesions observed on brain MRI at Weeks 4, 8, and 12","definition_or_measurement_approach":"Measured as count of new or enlarging T2-weighted lesions on brain MRI at Weeks 4, 8 and 12."}
• {"endpoint_text":"- 2. Proportion of participants free from any new gadolinium-enhancing T1 lesions and new or enlarging T2-weighted lesions observed on brain MRI at Weeks 4, 8, and 12","definition_or_measurement_approach":"Proportion (%) of participants without any new Gd+ T1 lesions and without new/enlarging T2 lesions on brain MRI at Weeks 4, 8 and 12."}
• {"endpoint_text":"- 3. Incidence and severity of adverse events","definition_or_measurement_approach":"Safety assessed by recording incidence and severity grading of adverse events during the study."}
• {"endpoint_text":"- 4. Change from baseline in vital signs","definition_or_measurement_approach":"Change from baseline values in standard vital signs (e.g., blood pressure, heart rate) at scheduled visits."}
• {"endpoint_text":"- 5. Change from baseline in targeted clinical laboratory test results","definition_or_measurement_approach":"Change from baseline in prespecified clinical laboratory parameters at scheduled timepoints."}
• {"endpoint_text":"- 6. Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale","definition_or_measurement_approach":"Proportion (%) assessed using the Columbia-Suicide Severity Rating Scale at scheduled assessments."}
• {"endpoint_text":"- 7. Plasma concentration of fenebrutinib at specified timepoints","definition_or_measurement_approach":"Pharmacokinetic measurement: plasma fenebrutinib concentrations at specified PK sampling timepoints."}

Slovakia

Earliest CTIS Part Ii Submission Date

16-07-2024

Latest Decision Or Authorization Date

02-03-2026

Processing Time Days

594

Number Of Sites

1

Number Of Participants

2

Czechia

Earliest CTIS Part Ii Submission Date

16-07-2024

Latest Decision Or Authorization Date

20-01-2026

Processing Time Days

553

Number Of Sites

4

Number Of Participants

46

Croatia

Earliest CTIS Part Ii Submission Date

16-07-2024

Latest Decision Or Authorization Date

23-02-2026

Processing Time Days

587

Number Of Sites

4

Number Of Participants

19

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

PPD Global Limited

Responsibilities

Global CRO; code 15; code 4

Third parties

• {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"code 15 (Global CRO); code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"MicroCoat Biotechnologie GmbH","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"code 13","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Neurostatus-UHB AG","duties_or_roles":"code 13; code 15 (Study data analysis)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}