Multiple Sclerosis Clinical Trial

A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)

Summary

This is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (MRI) in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated. Participants will be randomized to receive either fenebrutinib or placebo.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.
Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening.
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:

Disease duration of > 10 years from the onset of symptoms and an EDSS score at screening < 2.0.
Female participants who are pregnant or breastfeeding, or intending to become pregnant.
Male participants who intend to father a child during the study.
A diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (SPMS).
Any known or suspected active infection at screening, including but not limited to a positive screening tests for Hepatitis B and C, an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML).
History of cancer including hematologic malignancy and solid tumors within 10 years of screening.
Presence of other neurological disorders that could interfere with the diagnosis of MS or with the assessments of safety or efficacy during the study.
Clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease.
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
History of alcohol or other drug abuse within 12 months prior to screening.
History of or currently active primary or secondary (non-drug-related) immunodeficiency, including known history of HIV infection.
Inability to complete an MRI scan.
Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening.
Receipt of a live-attenuated vaccine within 6 weeks prior to randomization.
Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

109

Study ID:

NCT05119569

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 16 Locations for this study

See Locations Near You

Fullerton Neurology and Headache Center
Fullerton California, 92835, United States
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas Nevada, 89106, United States
University Clinical Centre of the Republic of Srpska
Banja Luka , 78000, Bosnia and Herzegovina
Clinical Hospital Center Rijeka - PPDS
Rijeka , 51000, Croatia
General Hospital Varazdin
Varazdin , 42000, Croatia
Klinicki bolnicki centar Zagreb
Zagreb , 10000, Croatia
Poliklinika Solmed
Zagreb , 10000, Croatia
Fakultni nemocnice u sv. Anny v Brne
Brno , 656 9, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Nemocnice Jihlava
Jihlava , 586 3, Czechia
Vseobecna Fakultni Nemocnice V Praze - CRC - PPDS
Praha , 128 0, Czechia
Clinical Center of Serbia
Belgrade , 11000, Serbia
Military Medical Academy
Belgrade , 11040, Serbia
Clinical center Kragujevac
Kragujevac , 34000, Serbia
Clinical Center Nis
NIS , 18000, Serbia
Clinical Hospital Centre Zemun
Zemun , 11080, Serbia
Univerzitna nemocnica Bratislava
Bratislava , 813 6, Slovakia

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

109

Study ID:

NCT05119569

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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