Summary

Eligibility
for people ages 18-55 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
completion around

Description

Summary

A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

Official Title

A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients With Relapsing Multiple Sclerosis

Keywords

Relapsing Multiple Sclerosis, Multiple Sclerosis, Sclerosis, Teriflunomide, Fenebrutinib

Eligibility

You can join if…

Open to people ages 18-55

  • Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening.
  • A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.
  • Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in < 240 seconds.
  • Ability to perform the 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.

You CAN'T join if...

  • 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 MS (PPMS) or non-active secondary progressive MS (SPMS).
  • Any known or suspected active infection 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).
  • History of cancer including hematologic malignancy and solid tumors within 10 years of screening.
  • Known presence of other neurological disorders, that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study and clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease.
  • Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
  • Hypoproteinemia.
  • Presence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert's Syndrome.
  • Participants with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia.
  • 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 human immunodeficiency virus (HIV) infection.
  • Inability to complete an MRI scan.
  • Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening (inhaled and topical corticosteroids are allowed).
  • 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.

    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.
  • Participants randomized to the teriflunomide treatment arm during the DBT phase must undergo the accelerated teriflunomide elimination procedure (ATEP) prior to the first administration of open-label 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.

Locations

  • University of California Irvine in progress, not accepting new patients
    Irvine California 92697 United States
  • SC3 Research Group, Inc in progress, not accepting new patients
    Pasadena California 91105 United States
  • Neurociencias Estudios Clinicos S.C. accepting new patients
    Culiacán Sinaloa 80020 Mexico
  • Clinical Research Institute Saltillo accepting new patients
    Saltillo Coahuila 25050 Mexico

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04586010
Phase
Phase 3 Multiple Sclerosis Research Study
Study Type
Interventional
Participants
Expecting 736 study participants
Last Updated