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    Summary
    EudraCT Number:2016-001039-11
    Sponsor's Protocol Code Number:GA30044
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-11-08
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2016-001039-11
    A.3Full title of the trial
    A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH
    MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus
    A.4.1Sponsor's protocol code numberGA30044
    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 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 nameGDC-0853
    D.3.2Product code RO7010939/F13
    D.3.4Pharmaceutical form 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 INNnot available yet
    D.3.9.1CAS number 1434048-34-6
    D.3.9.2Current sponsor codeGDC-0853, RO7010939
    D.3.9.3Other descriptive nameGDC-0853 RO7010939
    D.3.9.4EV Substance CodeSUB181260
    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
    Systemic Lupus Erythematosus
    E.1.1.1Medical condition in easily understood language
    Systemic lupus erythematosus (SLE) is an autoimmune disease in which the body's immune system mistakenly attacks healthy tissue
    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 10042945
    E.1.2Term Systemic lupus erythematosus
    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
    To evaluate the clinical efficacy of GDC-0853 in combination with standard of care (SOC)
    E.2.2Secondary objectives of the trial
    •To evaluate the clinical efficacy of GDC-0853 over time using the Systemic Lupus Erythematosus Responder Index (SRI-4) as a standardized disease activity measure
    •To evaluate the clinical efficacy of GDC 0853 over time using BICLA and SRI-6 as standardized disease activity measures
    •To evaluate if patients with high plasmablast signature levels have an enhanced clinical response to GDC-0853 relative to patients with low levels
    •To evaluate the safety of GDC-0853 in combination with SOC therapy in patients with moderate to severe active SLE
    •To characterize the pharmacokinetics (PK) of GDC-0853 in patients using a population PK approach
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18−75 years, inclusive
    - American College of Rheumatology (ACR) or Systemic Lupus
    International Collaborating Clinics (SLICC) criteria at any time prior to or
    at screening
    - At least one serologic marker of SLE at screening as follows: positive antinuclear antibody (ANA) test by immunofluorescent assay with titer >= 1:80; or positive anti-double-stranded DNA (anti-dsDNA) antibodies; or positive anti-smith antibody
    - At both screening and Day 1, moderate to severe active SLE, defined as meeting all of the following unless indicated otherwise: SLE Disease Activity Index (SLEDAI) -2K score >=8 (at screening only) with clinical
    SLEDAI-2K score >= 4.0 (at both screening and Day 1); Physician's global assessment >= 1.0 (out of 3); and currently receiving at least one standard oral treatment (e.g., corticosteroids, anti-malarials, and/or
    immunosuppressants) for SLE within specified dose ranges
    - Participants must be willing to avoid pregnancy
    - If on oral corticosteroids (OCS), the dose must be <= 40 mg/day prednisone (or equivalent)
    Stable doses of anti-malarial or immunosuppressive therapies
    E.4Principal exclusion criteria
    - Evidence of significant and active lupus-related renal disease or unstable renal disease prior to screening
    - Neuropsychiatric or central nervous system lupus manifestations
    - History of receiving a solid organ transplant
    - Newly diagnosed (within the last 24 weeks) transverse myelitis
    - Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB)
    - History of cancer, including hematological malignancy and solid tumors, within 10 years of screening
    - Need for systemic anticoagulation with warfarin, other oral or injectable anticoagulants, or anti-platelet agents
    - Evidence of chronic and/or active hepatitis B or C
    E.5 End points
    E.5.1Primary end point(s)
    1. SRI-4 response at Week 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Week 48
    E.5.2Secondary end point(s)
    1. SRI-4 response at Week 48 with a sustained reduction of OCS dose to < 10 mg/day and <= Day 1 dose during Week 36 through Week 48
    2. SRI-4 response at Week 24 with a sustained reduction of OCS dose to < 10 mg/day and <= Day 1 dose during Week 12 through Week 24
    3. SRI-4 response at Week 24
    4. SRI-4 response at Week 48 in patients with high vs. low plasmablast signature levels
    5. SRI-4 response with a sustained reduction of OCS dose to ≤ 10 mg/day and ≤ Day 1 dose during Week 36 through 48 in patients with
    high vs. low plasmablast signature levels
    6. SRI-6 response at Weeks 24 and 48
    7. BICLA response at Weeks 24 and 48
    8. Incidence of adverse events using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale to grade
    adverse events
    9. Changes in vital signs, physical findings, electrocardiogram (ECGs), and clinical laboratory results following GDC-0853 administration
    10. Plasma concentrations of GDC-0853 at specified timepoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 48
    2-3. Week 24
    4-5. Week 48
    6-7. Week 24 and Week 48
    8-9. Up to 60 weeks
    10. Pre dose at Week 1, Week 4, Week 24, and Week 48; at unscheduled or flare or early termination 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 trial3
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Argentina
    Brazil
    Bulgaria
    Chile
    Colombia
    Germany
    Korea, Republic of
    Mexico
    Portugal
    Spain
    Taiwan
    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 study is defined as the last patient, last safety follow-up visit in this protocol, last patient to discontinue from the study, or the last patient enrolled into an OLE, whichever occurs latest.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 240
    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 screened for enrollment into an OLE study. If they meet all OLE eligibility criteria, they may be enrolled if considered appropriate for participation, according to the investigator. Currently, it is not planned to provide GDC-0853 or any other study treatments/interventions to patients who have completed the study and are not qualified or elect not to enter an OLE 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 Decision2017-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-16
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