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    Summary
    EudraCT Number:2016-004624-35
    Sponsor's Protocol Code Number:GS39684
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-18
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-004624-35
    A.3Full title of the trial
    A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PILOT AND DOSE-RANGING STUDY OF GDC-0853 IN PATIENTS WITH REFRACTORY CHRONIC SPONTANEOUS URTICARIA (CSU)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of GDC-0853 in Patients With Chronic Spontaneous Urticaria Refractory to Anti-histamines
    A.4.1Sponsor's protocol code numberGS39684
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03137069
    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 SponsorGenentech, Inc.
    B.1.3.4CountryUnited States
    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 supportGenentech Inc. c/o F. Hoffman-La Roche Ltd.
    B.4.2CountryUnited States
    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 codeBasel
    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 nameGDC-0853
    D.3.2Product code RO701-0939/F13 & RO701-0939/F14
    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.3.9.1CAS number 1434048-34-6
    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 number50
    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 placeboTablet
    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
    Chronic spontaneous urticaria (CSU)
    E.1.1.1Medical condition in easily understood language
    Chronic spontaneous urticaria is a distressing skin condition that causes red, swollen, itchy and sometimes painful hives or “wheals”
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10072757
    E.1.2Term Chronic spontaneous urticaria
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue 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 in patients with CSU who are refractory to anti-histamines
    E.2.2Secondary objectives of the trial
    •To evaluate the safety of fenebrutinib compared with placebo
    •To characterize the pharmacokinetics (PK) of fenebrutinib in CSU patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged 18−75 years, inclusive
    - Diagnosis of CSU refractory to H1 antihistamines at the time of randomization, as defined by all of the following:
    •The presence of itch and hives for > 6 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamines
    •Urticaria Activity Score over 7 days (UAS7 score)>=16 during the 7 days prior to randomization (Day 1)
    •Patients must have been on daily stable doses of H1 antihistamines, consistent with standard-of-care therapy for CSU, starting at least 3 consecutive days immediately prior to the screening visit through Day 1 and must document current use on all visits.
    •CSU diagnosis for >= 6 months
    -Willing and able to complete an Urticaria Patient Daily eDiary for the duration of the study
    - Completion of 7 days of the Urticaria Patient Daily eDiary entries in the 7 days prior to randomization
    - No evidence of active or latent or inadequately treated infection with tuberculosis (TB)
    - Only for patients currently receiving proton-pump inhibitors or H2 receptor antagonists: Treatment must be at a stable dose during the 2-week screening period prior to randomization and with a plan to remain at a stable dose for the duration of the study
    -For women of childbearing potential: Agreement to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 4 weeks after the last dose of study drug. Women must refrain from donating eggs during this same period.
    -For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm for at least 4 weeks after the last dose of study treatment
    E.4Principal exclusion criteria
    -Treatment with omalizumab or other monoclonal antibody therapies used to treat CSU within 4 months prior to screening or primary nonresponse to omalizumab
    -Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days prior to study drug administration on Day 1
    -Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 90 days or 5 half-lives, whichever is greater, prior to study drug administration on Day 1
    -Previous treatment with fenebrutinib or other Bruton’s tyrosine kinase inhibitors
    -Patients whose urticaria is solely due to physical urticaria
    -Other diseases with symptoms of urticaria or angioedema, including urticarial vasculitis, urticarial pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, or leukemia
    -Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, or other skin disease associated with itch such as psoriasis
    -Routine doses of the following medications within 30 days prior to screening: systemic or cutaneous corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide
    -Prior utilization of intravenous steroids for treatment of laryngeal angioedema
    -Intravenous immunoglobulin G or plasmapheresis within 30 days prior to screening
    -History of anaphylactic shock without clearly identifiable avoidable antigen
    -Hypersensitivity to fenebrutinib or any component of the formulation
    -Require any prohibited concomitant medications
    -History of live attenuated vaccine within 6 weeks prior to randomization or requirement to receive these vaccinations at any time during study drug treatment
    -Evidence of clinically significant cardiac, neurologic, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal (GI) disease
    -Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
    -History of vasculitis and opportunistic infections
    -Current liver disease and any known active infection
    -History of recurrent bacterial, viral, mycobacterial or fungal infections and any opportunistic infections, with the exception of recurrent oral or genital herpes or uncomplicated urinary tract infections in females
    -Any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening
    -Known history of HIV infection
    -Evidence of chronic and/or active hepatitis B or C
    -History of cancer, including hematologic malignancy and solid tumors, within 10 years before screening
    -Need for systemic anti-coagulation with warfarin, other oral or injectable anti-coagulants, or anti-platelet agents other than non-steroidal anti-inflammatory drug, aspirin, and other salicylates
    -History of non-gallstone−related pancreatitis or chronic pancreatitis and hospitalizations or transfusion for a GI bleed
    -History of cerebrovascular accident (CVA), spontaneous intracranial hemorrhage or history of traumatic intracranial hemorrhage within 10 years or any history of hemorrhagic CVA
    -Known bleeding diathesis
    -Screening 12-lead electrocardiogram that demonstrates clinically relevant abnormalities
    -History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
    -Any uncontrolled clinically significant laboratory abnormality
    -Current treatment with astemizole, terfenadine, and/or ebastine
    E.5 End points
    E.5.1Primary end point(s)
    1.Change from baseline in the UAS7 at Day 57 (Week 8)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.Baseline and Day 57 (Week 8)
    E.5.2Secondary end point(s)
    1.Proportion of patients who are well controlled (UAS7 <= 6) at Day 57
    2.Change from baseline in the UAS7 at Day 29 (Week 4)
    3.The nature, frequency, timing, and severity of adverse events
    4.Change from baseline in targeted vital signs, physical examination findings, ECGs, and clinical laboratory results following fenebrutinib administration
    5. Plasma concentrations of fenebrutinib at specified timepoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Day 57 (Week 8)
    2.Baseline and Day 29 (Week 4)
    3.Up to 14 weeks
    4.From Baseline to 14 weeks
    5-10.Day 1 (Week 0), Day 8 (Week 1), Day 57 (Week 8) or at early termination
    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 Yes
    E.6.13.1Other scope of the trial description
    BIOMARKER ANALYSES
    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 Yes
    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 trial6
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Canada
    Germany
    Poland
    United States
    E.8.7Trial has a data monitoring committee No
    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
    The end of this study is defined as the date when all patients have completed the study completion visit or early termination visit or have otherwise been discontinued from the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days5
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 165
    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)
    Patients may be eligible to receive fenebrutinib as part of open-label extension study (GS40868) offered by the Sponsor (Genentech, a member of the Roche Group). 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 Decision2019-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-25
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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