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    Summary
    EudraCT Number:2020-005760-57
    Sponsor's Protocol Code Number:CA42750
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-21
    Trial 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 number2020-005760-57
    A.3Full title of the trial
    A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus Erythematosus
    A.4.1Sponsor's protocol code numberCA42750
    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 Yes
    D.2.1.1.1Trade name Gazyvaro
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOBINUTUZUMAB
    D.3.9.1CAS number 949142-50-1
    D.3.9.2Current sponsor codeRo 507-2759/F06-01
    D.3.9.4EV Substance CodeSUB32751
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous 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 (SLE)
    E.1.1.1Medical condition in easily understood language
    SLE is an autoimmune disease in which the immune system attacks its own tissues, causing tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys and blood vessels.
    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 21.1
    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 efficacy of obinutuzumab compared with placebo based on proportion of participants who achieve systemic lupus erythematosus responder index (SRI) (4)
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of obinutuzumab compared with placebo based on proportion of participants who achieve SRI (6), SRI (4), and SRI (8), proportion of participants who achieve sustained corticosteroid control, proportion of participants who achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA), proportion of participants who achieve Lupus Low Disease Activity State (LLDAS), time to first British Isles Lupus Assessment Group (BILAG) flare, change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale from baseline, change in 36-Item Short Form Survey, Version 2 (SF-36 v2) Bodily Pain domain scale from baseline and change in SF-36 v2 Physical Component Summary scale from baseline
    • To evaluate the safety of obinutuzumab compared with placebo
    • To characterize the obinutuzumab pharmacokinetics (PK) profile
    • To evaluate the immune response to obinutuzumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participants who are age 18-75 years at the time of signing Informed Consent Form
    • Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria >=12 weeks prior to screening
    • Anti-nuclear antibody (ANA) >=1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN), as determined by the central laboratory at screening
    • Low C3, C4, and/or CH50 as determined by the central laboratory at screening
    • High disease activity at screening, based on; BILAG-2004 (level A disease in >=1 organ system and/or Level B disease in >=2 organ systems), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (score >=8) and Physician’s Global Assessment (PGA) (score >=1.0 on a 0 to 3 visual analogue scale [VAS])
    • High disease activity on Day 1, based on; SLEDAI-2K (score >=8) and PGA (score >=1.0 on a 0 to 3 VAS)
    • Current receipt of >=1 of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroid (OCS), antimalarials, conventional immunosuppressants
    • For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception including at least one method with a failure rate of <1% per year, during the treatment period and for 18 months after the final dose of obinutuzumab or placebo
    E.4Principal exclusion criteria
    • Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 18 months after the final dose of obinutuzumab or placebo
    • Presence of significant lupus-associated renal disease and/or renal impairment
    • Active severe or unstable lupus-associated neuropsychiatric disease or where, in the opinion of the investigator, it is likely to require treatment with protocol-disallowed therapies
    • Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening
    • Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening
    • History of non-SLE inflammatory skin or joint disease within one year of Day 1 that, in the opinion of the investigator, could interfere with assessments of skin or joint manifestations of SLE
    • History of any non-SLE disease treated with oral, intravenous (IV), or intramuscular (IM) corticosteroids for more than 14 days in total during the one year prior to Day 1
    • Receipt of any of the following excluded therapies: a) Any B-cell depleting (e.g., anti-CD20, anti-CD19) or anti-plasma cell therapy such as, but not limited to, obinutuzumab, rituximab, ocrelizumab, ofatumumab, or bortezomib less than 9 months prior to screening or during screening; b) Cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening; c) Any biologic therapy (other than anti-CD20, anti-CD19, or anti-plasma cell) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept during the 2 months prior to screening or during screening; d) Inhibitors of Janus-associated kinase (JAK), Bruton’s tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2), including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib or any investigational agent during the 2 months prior to screening or during screening; e) Any live vaccine during the 28 days prior to screening or during screening
    • High risk for clinically significant bleeding or any condition requiring plasmapheresis, intravenous immunoglobulin, or acute blood product transfusions
    • Significant or uncontrolled medical disease which, in the investigator’s opinion, would preclude patient participation
    • Human immunodeficiency virus (HIV) infection
    • Tuberculosis (TB) infection
    • Active infection of any kind, excluding fungal infection of the nail beds
    • Any major episode of infection
    • History of serious recurrent or chronic infection
    • History of progressive multifocal leukoencephalopathy (PML)
    • History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years
    • Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening
    • Current alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening or during screening
    • Intolerance or contraindication to study therapies
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of participants who achieve SRI (4) at Week 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At Week 52
    E.5.2Secondary end point(s)
    1. Percentage of participants who achieve SRI (6) at Week 52
    2. Percentage of participants who achieve Sustained Corticosteroid Control from Week 40 through Week 52
    3. Percentage of participants who achieve Sustained SRI (4) response from Week 40 through Week 52
    4. Percentage of participants who achieve BICLA at Week 52
    5. Percentage of participants who achieve SRI (8) at Week 52
    6. Percentage of participants who achieve SRI (4) at Week 24
    7. Percentage of participants who achieve clinical SRI (4) at Week 52
    8. Percentage of participants who achieve SRI (4) at Week 52 on low-dose corticosteroids
    9. Percentage of participants who achieve LLDAS at Week 52
    10. Time to first BILAG flare over 52 weeks
    11. Change in FACIT-F scale from baseline to Week 52
    12. Change in SF-36 v2 Bodily Pain domain scale from baseline to Week 52
    13. Change in SF-36 v2 Physical Component Summary scale from baseline to Week 52
    14. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
    15. Percentage of participants with adverse events of special interest, including, among others, infusion-related reactions (IRRs), neutropenia, infections, and thrombocytopenia
    16. Change from baseline in targeted vital signs
    17. Change from baseline in targeted clinical laboratory test results
    18. Serum concentration of obinutuzumab at specified timepoints
    19. Prevalence of anti-drug antibodies (ADAs) against obinutuzumab at baseline
    20. Incidence of ADAs against obinutuzumab during the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At Week 52
    2-3. From Week 40 to Week 52
    4-5. At Week 52
    6. At Week 24
    7-9. At Week 52
    10. Up to Week 52
    11-13. Baseline (Day 1) to Week 52
    14-15. Through completion of Study Follow Up
    16-17. Baseline (Day 1) through completion of Study Follow Up
    18. Double blind period: At Weeks 2, 4, 12, 24, 26, 36, 52 and at early study discontinuation visit; Open label period: At Weeks 54, 56, 58, 66, 78, 80, 90, 104 and at early study discontinuation visit
    19. Baseline (Day 1)
    20. Double blind period: At Weeks 2, 4, 12, 24, 26, 52 and at early study discontinuation visit; Open label period: At Weeks 54, 56, 66, 78, 80, 104 and at early study 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 EEA27
    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
    Australia
    Brazil
    France
    Italy
    Mexico
    New Zealand
    Peru
    Poland
    Russian Federation
    South Africa
    Spain
    United Kingdom
    United States
    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
    The end of this study is defined as the date of the scheduled last participant, last visit (LPLV) or when all participants are discontinued from the study, whichever occurs earlier. No further study follow up visits will occur after the following date: 18 months after all participants have completed or discontinued study drug infusions (blinded and open-label). The end of the study is expected to occur approximately 3 years after the last participant
    is enrolled.
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The study allows for LAR to provide consent on behalf of participants.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 200
    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)
    Upon completion of the study, the Sponsor will offer continued access to Roche IMP (obinutuzumab) free of charge to eligible participants in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Products (see Section 6.6 in the Protocol).
    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 Decision2021-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-23
    P. End of Trial
    P.End of Trial StatusOngoing
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