A clinical trial to compare fenebrutinib with teriflunomide in people with relapsing multiple sclerosis (RMS)

A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS)

  • Autoimmune Disorder
  • Multiple Sclerosis (MS)
  • Neurodegenerative Disorder
  • Relapsing Multiple Sclerosis (RMS)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Active, not recruiting

This trial runs in
Cities
  • Baltimore
  • Barcelona
  • Baton Rouge
  • bei-jing-shi
  • Beijing
  • Bellavista
  • Beograd
  • Berlin
  • Bern
  • Birmingham
  • Braga
  • Budapest
  • Buenos Aires
  • Bydgoszcz
  • Böblingen
  • Carlsbad
  • Catania
  • Centerville
  • chang-chun-shi
  • chang-sha-shi
  • Cheng Du Shi
  • chong-qing-shi
  • Ciudad de México
  • Coimbra
  • Columbus
  • Culiacán Rosales
  • Denver
  • Detroit
  • Dnipro
  • Dresden
  • Eger
  • El Palmar
  • Foggia
  • Fort Collins
  • Fort Wayne
  • Fountain Hill
  • Geleen
  • Gießen
  • Greenville
  • guang-zhou-shi
  • gui-yang-shi
  • Helsinki
  • Highland Park
  • Hong Kong Island
  • Irvine
  • Katowice
  • Kharkiv
  • Kiel
  • Kirkland
  • kirov-oblast
  • Kistarcsa
  • Knoxville
  • krosno
  • kun-ming-shi
  • Kyiv
  • L'Hospitalet de Llobregat
  • La Victoria
  • Lan Zhou Shi
  • Lazio
  • Lima
  • Lisboa
  • Lombardia
  • Lublin
  • Lugano
  • Lviv
  • Madrid
  • Maitland
  • Manouba
  • Milwaukee
  • Mississippi
  • Monastir
  • Mondovì
  • Málaga
  • Nairobi
  • nan-jing-shi
  • Napoli
  • New Territories
  • Novosibirsk
  • Odesa
  • Oklahoma City
  • Padova
  • Parma
  • Pasadena
  • Phoenix
  • Plano
  • Plewiska
  • Porto
  • Poznań
  • Pozuelo de Alarcón
  • pueblo-libre
  • Roma
  • Rosario
  • Saltillo
  • San Juan
  • San Juan de Miraflores
  • San Miguel de Tucumán
  • Sankt-Peterburg
  • santa-maria-da-feira
  • santiago-de-los-caballeros
  • Santo Domingo
  • Sevilla
  • Sfax
  • Sherman
  • shi-jia-zhuang-shi
  • Shreveport
  • shtip
  • Skopje
  • St. Louis
  • Stuttgart
  • Suzhou
  • Szeged
  • T'bilisi
  • Taiyuan
  • Tbilisi
  • Teaneck
  • tian-jin-shi
  • Tlaxcala
  • Tübingen
  • Ufa
  • Ulm
  • ulyanovsk
  • vienna
  • Vigo
  • Vinnytsia
  • Warszawa
  • Westerstede
  • Worcester
  • wu-han-shi
  • xi-an-shi
  • Zabrze
  • Zaporizhzhia
  • Ürümqi
  • Łódź
  • Żory
Trial Identifier:

NCT04586010 2019-004857-10 2022-502609-14-00 GN41851

      Show trial locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04586010, GN41851, 2019-004857-10,2022-502609-14-00 Trial Identifier
      Fenebrutinib, Teriflunomide, Placebo Treatments
      Relapsing Multiple Sclerosis Condition
      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

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 55 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • 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.
      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 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.

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