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

Relapsing Multiple Sclerosis Clinical Trial

— FENopta  

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05119569
• Other study ID #: GN43271
• Secondary ID: 2021-003772-14
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 1, 2022
• Est. completion date: December 2, 2026

Study information

• Verified date: March 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 109
• Est. completion date: December 2, 2026
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Fenebrutinib
Fenebrutinib will be administered orally.
• Placebo
Placebo will be administered orally.

Locations

Country	Name	City	State
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska	Banja Luka
Croatia	Clinical Hospital Center Rijeka - PPDS	Rijeka
Croatia	General Hospital Varazdin	Varazdin
Croatia	Klinicki bolnicki centar Zagreb	Zagreb
Croatia	Poliklinika Solmed	Zagreb
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Nemocnice Jihlava	Jihlava
Czechia	Vseobecna Fakultni Nemocnice V Praze - CRC - PPDS	Praha
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	Clinical center Kragujevac	Kragujevac
Serbia	Clinical Center Nis	NIS
Serbia	Clinical Hospital Centre Zemun	Zemun
Slovakia	Univerzitna nemocnica Bratislava	Bratislava
United States	Fullerton Neurology and Headache Center	Fullerton	California
United States	Cleveland Clinic Lou Ruvo; Center for Brain Research	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Bosnia and Herzegovina,  Croatia,  Czechia,  Serbia,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of New Gadolinium-Enhancing T1 Lesions Observed on MRI Scans of the Brain		12 weeks
Secondary	Number of New or Enlarging T2-Weighted Lesions Observed on MRI Scans of the Brain		Weeks 4, 8 and 12
Secondary	Percentage of Participants Free From any New Gadolinium-enhancing T1 Lesions and New or Enlarging T2-Weighted Lesions Observed on MRI Scans of the Brain		Weeks 4, 8 and 12
Secondary	Percentage of Participants with Adverse Events (AEs)		Up to 192 weeks
Secondary	Plasma Concentrations of Fenebrutinib at Specified Timepoints		Up to 192 weeks