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

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ClinicalTrials.gov Identifier: NCT04586023
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE October 8, 2020
First Posted Date  ICMJE October 14, 2020
Last Update Posted Date September 16, 2021
Actual Study Start Date  ICMJE March 24, 2021
Estimated Primary Completion Date September 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2020)
  • Annualized Relapse Rate (ARR) [ Time Frame: Minimum of 96 weeks ]
  • Time to onset of composite 12-week confirmed disability progression (cCDP12) [ Time Frame: Minimum of 96 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2020)
  • Time to onset of composite 24-week confirmed disability progression (cCDP24) [ Time Frame: Minimum of 96 weeks ]
  • Time to onset of 12-week confirmed disability progression (CDP12) [ Time Frame: Minimum of 96 weeks ]
  • Time to onset of 24-week confirmed disability progression (CDP24) [ Time Frame: Minimum of 96 weeks ]
  • Total Number of T1Gd+ lesions, new and/or enlarging T2-weighted lesions as detected by MRI [ Time Frame: Baseline, Weeks 12, 24, 48 and 96 ]
  • Percentage Change in Total Brain Volume from Week 24 as assessed by MRI [ Time Frame: From Week 24 to Week 96 ]
  • Change from Baseline in Participant-Reported Physical Impacts of Multiple Sclerosis (MS) [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96 ]
    Measured by the Multiple Sclerosis, 29-Item [MSIS-29] physical scale.
  • Time to onset of 12-week confirmed 4-point worsening in Symbol Digit Modality Test (SDMT) score [ Time Frame: Minimum of 96 weeks ]
  • Change from Baseline to Week 48 in the Concentration of Serum Neurofilament Light chain (NfL) [ Time Frame: Up to 48 weeks ]
  • Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 3.5 years ]
  • Plasma Concentrations of fenebrutinib at specified timepoints [ Time Frame: Up to 3.5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS)
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Sponsor will also be blinded.
Primary Purpose: Treatment
Condition  ICMJE Relapsing Multiple Sclerosis
Intervention  ICMJE
  • Drug: fenebrutinib
    Participants will receive fenebrutinib.
  • Drug: teriflunomide
    Participants will receive teriflunomide.
  • Drug: placebo
    Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.
Study Arms  ICMJE
  • Experimental: fenebrutinib
    Participants will receive oral fenebrutinib with teriflunomide-matching placebo.
    Interventions:
    • Drug: fenebrutinib
    • Drug: placebo
  • Active Comparator: teriflunomide
    Participants will receive oral teriflunomide with fenebrutinib-matching placebo in a blinded fashion.
    Interventions:
    • Drug: teriflunomide
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 8, 2020)
734
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 10, 2024
Estimated Primary Completion Date September 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
  • 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.
  • 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.
  • Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
  • Hypoproteinemia.
  • Participants with severe renal or hepatic disease impairment.
  • 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 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.

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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: GN42272 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Austria,   Brazil,   Bulgaria,   Canada,   Denmark,   France,   Greece,   Italy,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04586023
Other Study ID Numbers  ICMJE GN42272
2020-001168-28 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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).
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP