We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05119569
Recruitment Status : Recruiting
First Posted : November 15, 2021
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a study evaluating the effect of fenebrutinib on brain 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.

Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis Drug: fenebrutinib Drug: placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Sponsor will also be blinded.
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : November 25, 2022
Estimated Study Completion Date : September 26, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: fenebrutinib
Participants will receive oral fenebrutinib.
Drug: fenebrutinib
fenebrutinib will be administered orally.

Placebo Comparator: placebo
Participants will receive oral placebo.
Drug: placebo
placebo will be administered orally.




Primary Outcome Measures :
  1. Total number of new gadolinium-enhancing T1 lesions observed on MRI scans of the brain [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Number of new or enlarging T2-weighted lesions observed on MRI scans of the brain [ Time Frame: Weeks 4, 8 and 12 ]
  2. 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 [ Time Frame: Weeks 4, 8 and 12 ]
  3. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 96 weeks ]
  4. Plasma Concentrations of fenebrutinib at specified timepoints [ Time Frame: Up to 96 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • Known presence of other neurological disorders, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05119569


Contacts
Layout table for location contacts
Contact: Reference Study ID Number: GN43271 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05119569    
Other Study ID Numbers: GN43271
2021-003772-14 ( EudraCT Number )
First Posted: November 15, 2021    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases