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    Summary
    EudraCT Number:2016-002950-19
    Sponsor's Protocol Code Number:MS200527-0018
    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:2017-03-28
    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 number2016-002950-19
    A.3Full title of the trial
    A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Study of M2951 in SLE
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberMS200527-0018
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02975336
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+496151725200
    B.5.5Fax number+496151722000
    B.5.6E-mailservice@merckgroup.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 nameEvobrutinib
    D.3.2Product code M2951
    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 INNEvobrutinib
    D.3.9.1CAS number 1415823-73-2
    D.3.9.2Current sponsor codeM2951
    D.3.9.3Other descriptive nameM2951
    D.3.9.4EV Substance CodeSUB180032
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 (SLE)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus (SLE)
    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 and dose response of M2951 compared to placebo in reducing disease activity in adult subjects with active, autoantibody-positive SLE who are receiving SoC therapy based on SRI-4 response at Week 52 in all subjects, or on SRI-6 response at Week 52 in the HDA subgroup, defined as SLEDAI-2K ≥ 10.
    - To evaluate the safety of M2951 in subjects with SLE on SoC therapy.
    E.2.2Secondary objectives of the trial
    Key secondary objectives:
    •To evaluate the efficacy and dose response of M2951 compared to placebo in delaying time to first severe flare during the Treatment Period,in subjects with SLE on SoC therapy,where a severe flare is defined as at least one BILAG 2004 A in any organ system due to items that are new or worse,compared to the BILAG evaluation at the previous visit
    •To evaluate the efficacy and dose response of M2951 compared to placebo in reducing disease activity,based on the SRI-4 response at W52,in the serologically active subgroup,which is defined as subjects with positive anti-dsDNA and/or low complement levels
    Other secondary objectives:
    •To evaluate the efficacy of M2951 compared to placebo on changes in disease activity and in organ-specific disease activity over52W
    •To evaluate the effect of M2951 compared to placebo on the annualized flare rate and on CS usage over52W
    •To evaluate the impact of M2951 treatment compared to placebo on subject reported HRQoL over52W
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible male and female subjects, aged 18 to 75 years; must have diagnosis of SLE with either the SLICC criteria for SLE, or at least four of the 11 ACR classification criteria for SLE, of at least six months duration prior to Screening; SLEDAI-2K total score ≥ 6 (including clinical SLEDAI ≥ 4) at Screening Visit; and have positive test results for anti doublestranded DNA (anti-dsDNA) antibody and/or anti nuclear antibody
    (human epithelial cell-2 ANA ≥ 1:80) and/or anti-Smith (anti Sm)
    antibody at the time of Screening
    E.4Principal exclusion criteria
    Subjects are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension; proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg); acutely
    worsened renal function; active central nervous system SLE (to be
    severe or progressive including history of transverse myelitis, seizures,
    and/or associated with significant cognitive impairment); or within two weeks prior to Screening or during Screening: use of oral corticosteroids
    > 30 mg daily prednisone equivalent; use of injectable corticosteroids, or
    change in dose of corticosteroids.
    E.5 End points
    E.5.1Primary end point(s)
    1) Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): All Subjects
    2) Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6): High Disease Activity (HDA) Subgroup Subjects
    3) Occurrences of Subjects With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs)
    4) Occurrences of Treatment-emergent Adverse Events (TEAEs) According to Severity
    5) Number of Subjects With Clinically Significant Vital signs, Electrocardiogram (ECG) and Laboratory Abnormalities
    6) Serum Total Immunoglobulin (Ig) levels
    7) Total B Cell Counts
    8) Change From Baseline to Week 56 in Serum total Immunoglobulin (Ig) levels
    9) Change From Baseline to Week 56 in Total B Cell Counts
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 2: Week 52
    3 to 9: Baseline up to Week 56
    E.5.2Secondary end point(s)
    1) Time to First Severe Flare
    2) Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): Serologically Active Subgroup
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: Baseline up to Week 52
    2: Week 52
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Pharmacodynamic, effect in annualized flare rate, effect corticosteroid,impact on quality of life; Health resource utilization (HRU); effects in exploratory marker.
    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 Yes
    E.8.2.3.1Comparator description
    Different dosage of IMP (25mg QD, 75 mg QD, 50 mg BID)
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Mauritius
    Mexico
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    South Africa
    Taiwan
    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
    last contact date with the last subject who participates in this
    study
    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 months5
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days21
    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: 464
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    the elderly
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 99
    F.4.2.2In the whole clinical trial 468
    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)
    After a subject has completed the study or has withdrawn early, the subject is free to access further treatment as deemed appropriate by the Treating Investigator. The Sponsor will not provide any additional care to subjects after they leave the study because such care should not differ from what is normally SoC for subjects with SLE.
    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 Decision2017-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-22
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