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Research & Innovation

GN41851 Fenebrutinib

Clinical Trials

GN41851 Fenebrutinib

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

Physician & Study Coordinator
Synopsis

Synopsis: The purpose of this study is to compare the effects, good or bad, of fenebrutinib versus teriflunomide on patients with RMS. In this study, you will get either fenebrutinib (and teriflunomide-matching placebo) or teriflunomide (and fenebrutinib-matching placebo). A placebo looks like a drug but has no active ingredient.

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Eligibility Criteria

Inclusion Criteria

  • 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 PPMS or non-active SPMS.
  • 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.
  • Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
  • Hypoproteinemia.
  • Participants with severe renal or hepatic disease impairment or Gilbert's Syndrome.
  • Participants with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia, or thrombocytopenia.

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