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    Summary
    EudraCT Number:2021-003772-14
    Sponsor's Protocol Code Number:GN43271
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-14
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCroatia - MIZ
    A.2EudraCT number2021-003772-14
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO
    INVESTIGATE THE EFFICACY OF FENEBRUTINIB IN RELAPSING MULTIPLE SCLEROSIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis
    A.4.1Sponsor's protocol code numberGN43271
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffman-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFenebrutinib
    D.3.2Product code RO7010939
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFENEBRUTINIB
    D.3.9.2Current sponsor codeRO7010939
    D.3.9.3Other descriptive nameGDC-0853
    D.3.9.4EV Substance CodeSUB190378
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis (MS) is a long-term disease that attacks the central nervous system, affecting the brain, spinal cord, and optic nerves.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10048393
    E.1.2Term Multiple sclerosis relapse
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10080700
    E.1.2Term Relapsing multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the efficacy of fenebrutinib compared with placebo on the
    total number of new gadolinium enhancing T1 magnetic resonance
    imaging (MRI) lesions
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of fenebrutinib on MRI lesions
    • To evaluate the safety of fenebrutinib compared with placebo
    • To characterize the fenebrutinib pharmacokinetics (PK) profile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participants who are aged 18 to 55 years inclusive at the time of signing Informed Consent Form
    • A diagnosis of relapsing MS (RMS) in accordance with the revised 2017 McDonald Criteria and one of the following:
    o At least two documented clinical relapses within the last 2 years or one documented clinical relapse within 12 months of screening (but not within the 30 days prior to screening)
    o Documented evidence of the presence of at least one T1 Gd+ lesion on MRI in the 6 months prior to randomization (may include the screening MRI)
    • Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points
    • For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs during the treatment period and for 28 days after the final dose of fenebrutinib
    • For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 28 days after the final dose of fenebrutinib to avoid exposing the embryo
    E.4Principal exclusion criteria
    •Disease duration of >10 years from the onset of symptoms and an EDSS score at screening <2.0
    •A diagnosis of primary progressive MS or non-active secondary progressive MS
    •Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti-microbials within 8 weeks prior to or during screening or treatment with oral anti-microbials within 2 weeks prior to or during screening
    •History of progressive multifocal leukoencephalopathy (PML)
    •History of cancer
    •Basal or squamous cell carcinoma of the skin that has been excised and is considered cured and in situ carcinoma of the cervix treated with apparent success by curative therapy >1 year prior to screening is not exclusionary
    •Presence of other neurological disorders
    •Evidence of clinically significant psychiatric, pulmonary, renal, hepatic, metabolic, gastrointestinal (GI), or cardiovascular disease, or endocrine disease that, in the investigator’s opinion, would preclude patient participation
    •Presence of the New York Heart Association Class III and Class IV criteria for congestive heart failure
    •Screening 12-lead ECG that demonstrates clinically relevant abnormalities that may affect patient safety or interpretation of study results
    •Current treatment with medications that are well known to prolong the QT interval at doses that have a clinically meaningful effect on QT, as determined by the investigator
    •History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
    •Participants undergoing dialysis or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m^2
    •Any of the following laboratory results: ALT or AST >2*upper limit of normal (ULN); Total bilirubin greater than 1.5*ULN; Hemoglobin <9.5 grams/deciliter; White blood cell count <2000 cells/mm^3 (µL); Platelet count <100*10^9/L; Absolute neutrophil count <=1500 cells/mm^3 (µL); IgG<500 mg/dL
    •Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the 12-week double-blind study period
    •History of alcohol or other drug abuse within 12 months prior to screening
    •Positive screening tests for active, latent, or inadequately treated hepatitis B
    •Positive screening tests for hepatitis C
    •Evidence of active or latent or inadequately treated infection with tuberculosis
    •Abnormalities in hepatic synthetic function tests judged by the investigator to be clinically significant
    •History of hospitalization or transfusion for a GI bleed
    •Known bleeding diathesis
    •Any condition possibly affecting oral drug absorption
    •History of or currently active primary or secondary (non−drug-related) immunodeficiency
    •Inability to complete an MRI scan or contraindication to Gd administration
    •Any previous history of organ transplantation
    •Any previous treatment with bone marrow transplantation or hematopoietic stem cell transplantation
    •Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening or during the screening period
    •Receiving an unstable dosing regimen of proton pump inhibitors or H2-receptor antagonist during the screening phase and/or no plan to remain at a stable dose for the duration of study treatment
    •Treatment with IVIg or plasmapheresis within 12 weeks prior to randomization
    •Sensitivity or intolerance to any ingredient (including excipients) of fenebrutinib
    •Receipt of a live-attenuated vaccine within 6 weeks prior to randomization
    •Need for systemic anticoagulation (oral or injectable) or anti-platelet agent other than nonsteroidal anti-inflammatory drugs, aspirin, and other salicylates
    •Previous treatment with fenebrutinib or another Brutons tyrosine kinase (BTK) inhibitor for any indication
    •Treatment with strong CYP3A4 inhibitors, strong or moderate CYP3A4 inducers, within 7 days or 5 drug-elimination half-lives (whichever is longer) prior to randomization
    •Treatment with CYP3A4 substrates with a narrow therapeutic window within 7 days or 5 drug-elimination half-lives (whichever is longer) prior to randomization
    •Previous use of anti-CD20 therapies, unless the last infusion was more than 2 years prior to screening and B-cell count is normal at screening
    •Previous use of fingolimod, siponimod, ozanimod, or ponesimod within 6 weeks of randomization
    •Previous use of natalizumab within 6 months of randomization
    •Previous treatment with azathioprine, mycophenolate mofetil, or methotrexate within 12 weeks of randomization
    •Previous use of teriflunomide, unless plasma concentrations < 0.02 mg/L
    •Any previous treatment with cladribine, mitoxantrone, daclizumab, alemtuzumab, or cyclophosphamide
    •Treatment with dimethyl fumarate or monomethyl fumarate within 4 weeks of randomization
    •Treatment with any investigational agent within 5 half-lives of randomization
    •Previous treatment with any other immunomodulatory or immunosuppressive medication
    E.5 End points
    E.5.1Primary end point(s)
    1. Total number of new gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 4, 8, and 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At Weeks 4, 8, and 12
    E.5.2Secondary end point(s)
    1.Total number of new or enlarging T2-weighted lesions observed on brain MRI at Weeks 4, 8, and 12
    2.Proportion of participants free from any new gadolinium-enhancing T1 lesions and new or enlarging T2-weighted lesions observed on brain MRI at Weeks 4, 8, and 12
    3.Incidence and severity of adverse events
    4.Change from baseline in vital signs
    5.Change from baseline in targeted clinical laboratory test results
    6.Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale
    7.Plasma concentration of fenebrutinib at specified timepoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-2. At Weeks 4, 8, and 12
    3. From the start of treatment until 28 days after the final dose of study treatment
    4-5. Double blind period: Baseline (Day -28 to Day -1) to Week 12; Open label period: Baseline (Week 0) to Week 96
    6. Double blind period: At Baseline (Day -28 to Day -1), Weeks 4, 8 and 12; Open label period: Baseline (Week 0), Weeks 12, 24, 48, 76 and 96
    7. At Days 1, 29, 57, 85, at early discontinuation visit
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Egypt
    Japan
    Kenya
    Morocco
    Serbia
    Croatia
    Czechia
    Norway
    Slovakia
    Slovenia
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 102
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 102
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participants may be eligible to receive fenebrutinib as part of an
    extension study within the current protocol, as described in Section 4.1
    of the protocol. In addition, participants will be moved to a program
    level OLE (separate protocol, protocol number TBD) as soon as it is
    available. The Roche Global Policy on Continued Access to
    Investigational Medicinal Product is available at the following website:
    http://www.roche.com/policy_continued_access_to_investigational_
    medicines.pdf
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-27
    P. End of Trial
    P.End of Trial StatusOngoing
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