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    Summary
    EudraCT Number:2015-004476-30
    Sponsor's Protocol Code Number:BP30037
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-18
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-004476-30
    A.3Full title of the trial
    A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s Syndrome
    A.4.1Sponsor's protocol code numberBP30037
    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. Hoffmann-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 nameCathepsin S Inhibitor
    D.3.2Product code RO545-9072/F03
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNot applicable
    D.3.9.1CAS number 1252637-35-6
    D.3.9.2Current sponsor codeRO5459072/F03
    D.3.9.3Other descriptive nameRO5459072
    D.3.9.4EV Substance CodeSUB168602
    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 placeboCapsule, hard
    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
    Primary Sjögren’s syndrome
    E.1.1.1Medical condition in easily understood language
    Sjögren’s syndrome is an autoimmune disease that causes dry eyes and a dry mouth as well as problems with other organs
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10040767
    E.1.2Term Sjogren's syndrome
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective 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
    1.To investigate the effects of RO5459072 treatment on disease activity and symptoms of primary Sjögren’s syndrome
    E.2.2Secondary objectives of the trial
    1.To investigate the effects of RO5459072 treatment on quality of life measures, auto-antibody concentrations, and pharmacodynamic measures of exocrine gland function
    2.To collect samples for population modelling of RO5459072 pharmacokinetics
    3.To investigate the safety and tolerability of RO5459072 treatment
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    At selected participating study centers, patients may also enroll into an optional sub-study. All sub-study related information is included in the main protocol (there is no any separated version).

    The objective of the optional sub-study is:
    • To investigate the effects of RO5459072 treatment on salivary gland structure, inflammation and the organization of inflammatory foci assessed by histology and immunohistochemistry of labial biopsy samples.
    E.3Principal inclusion criteria
    -Males and females 18 to 75 years of age
    -Primary Sjögren's syndrome diagnosed previously according to the revised American-European Consensus Group (AECG) criteria
    -European League against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) score >= 5
    -EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score >= 5
    -Elevated serum titres at screening of anti-Sjögren's-syndrome-related antigen A (anti-SSA) and/or anti-SSB antibodies at screening
    -Negative pregnancy test at screening and baseline, and agreement to comply with measures to prevent pregnancy and restrictions on sperm donation
    E.4Principal exclusion criteria
    -A diagnosis of secondary Sjögren's syndrome according to the revised
    AECG criteria
    -Severe complications of Sjögren's syndrome, such as vasculitis with
    renal, neurologic or cardiac involvement; interstitial lung disease and
    severe myositis
    -Systemic immunosuppressant therapy, cyclophosphamide or B cell
    depleting therapy within 6 months prior to the screening visit. Low dose
    methotrexate treatment is, however, permitted
    -Corticosteroid therapy exceeding 7.5 milligram (mg) prednisone
    equivalents per day
    -Mechanically stimulated whole salivary flow rate at baseline of < 0.1
    millilitre/minute (mL/min)
    -A positive test result for hepatitis B (HBV), hepatitis C (HCV), or human
    immunodeficiency virus (HIV), or tuberculosis, or any other active viral,
    fungal, yeast or bacterial infection at the screening visit
    -A history of recurring or chronic infections, any other indication of
    reduced immune function, or any other underlying conditions which may
    predispose participants to serious infection
    -A history of lymphoma, myeloma (monoclonal
    hypergammaglobulinemia) or monoclonal gammopathy of unknown
    significance (MGUS), or any other malignancies within the past 5 years
    (except basal cell or squamous cell carcinoma of the skin that has been
    cured)
    -A diagnosis of fibromyalgia, or a diagnosis of significant depression or
    anxiety that would confound the interpretation of the study results
    -Severe renal impairment, moderate or severe hepatic impairment or
    other clinically significant hepatic disease
    -Any other concomitant disease or condition or any clinically significant
    finding that could interfere with the conduct of the study, or pose an
    unacceptable risk to the individual in this study
    -Participation in an investigational drug or device study within 3 months
    prior to screening
    -Inability to comply with the study protocol for any other reason
    -Women who are lactating.
    -Use of other prohibited medication (moderate or potent inhibitors of
    CYP3A4; strong inducers of CYP3A4; strong inhibitors of the transporter
    P-glycoprotein [P-gp]; sensitive substrates of CYP3A4 with a narrow
    therapeutic index).
    E.5 End points
    E.5.1Primary end point(s)
    1.Proportion of participants showing a clinically relevant decrease in the ESSDAI score from baseline after 12 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.Week 12
    E.5.2Secondary end point(s)
    1.Proportion of participants showing a clinically relevant decrease in ESSPRI score after 12 weeks
    2.Change from baseline in ESSDAI score after 12 weeks
    3.Change from baseline in ESSPRI score after 12 weeks
    4.Change from baseline in each of the individual components of the ESSPRI (dryness, fatigue and pain) after 12 weeks
    5.Change from baseline in Short Form-36 Health Survey score after 12 weeks
    6.Change from baseline in tear flow rate
    7.Change from baseline in salivary flow rate
    8.Change from baseline in auto-antibody titres
    9.Plasma concentration of RO5459072
    10.Incidence of adverse events
    11.Incidence of serious adverse events or withdrawals because of adverse events
    12.Incidence of out-of-reference-range values for vital signs and electrocardiograms, and laboratory tests
    13.Change from baseline in vital signs and electrocardiograms, and laboratory tests
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 12
    2-5. Baseline (Week -1), Week 12
    6-7. Baseline, Week 2, Week 6, and Week 12
    8. Baseline, Week 6, and Week 12
    9. Week 2, Week 6, and Week 12
    10-13. Up to Week 14
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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
    tolerability
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    France
    Germany
    Italy
    Poland
    Portugal
    United Kingdom
    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 the study is defined as the date of the last study center visit of the last patient participating in the study (includes the safety follow-up visit).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 70
    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)
    RO5459072 will not be provided to participants after conclusion of the study.
    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 Decision2016-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-10
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