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    Summary
    EudraCT Number:2021-004648-27
    Sponsor's Protocol Code Number:MS200569_0003
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-12
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2021-004648-27
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo Controlled Dose-Ranging, Parallel and Adaptive Study to evaluate the Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus and in Cutaneous Lupus Erythematosus (Subacute Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus) Participants Receiving Standard of Care
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Enpatoran in Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
    A.3.2Name or abbreviated title of the trial where available
    WILLOW
    A.4.1Sponsor's protocol code numberMS200569_0003
    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 Healthcare 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 Healthcare KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Healthcare KGaA
    B.5.2Functional name of contact pointCommunication Center
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Str. 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 nameEnpatoran 25mg
    D.3.2Product code M5049
    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 INNEnpatoran
    D.3.9.1CAS number 2101938-42-3
    D.3.9.2Current sponsor codeM5049
    D.3.9.4EV Substance CodeSUB215545
    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.IMP: 2
    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 nameEnpatoran 50mg
    D.3.2Product code M5049
    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 INNEnpatoran
    D.3.9.1CAS number 2101938-42-3
    D.3.9.2Current sponsor codeM5049
    D.3.9.4EV Substance CodeSUB215545
    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 placeboFilm-coated tablet
    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) and cutaneous lupus erythematosus (CLE)
    E.1.1.1Medical condition in easily understood language
    Systemic lupus erythematosus (SLE) and cutaneous lupus
    erythematosus (CLE)
    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 10056509
    E.1.2Term Cutaneous lupus erythematosus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057903
    E.1.2Term Subacute cutaneous lupus erythematosus
    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 dose-response relationship of enpatoran in reducing disease activity based on CLASI-A

    To evaluate the dose-response relationship of enpatoran in reducing disease activity based on BICLA response rate
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of enpatoran compared to placebo

    To evaluate the efficacy in disease control of enpatoran compared to placebo in lupus participants with active lupus rash

    To demonstrate the effect of enpatoran compared with placebo on achieving both BICLA response and clinically meaningful CS reduction in SLE participants on prednisone ≥ 10 mg at Day 1

    To evaluate the efficacy in disease control of enpatoran compared to placebo in lupus participants with predominantly active lupus rash

    To evaluate the efficacy in disease control of enpatoran compared to placebo in participants with active SLE

    To evaluate the efficacy of enpatoran compared to placebo in patient-reported symptoms and functional status, in lupus participants with active lupus rash

    To evaluate the efficacy of enpatoran compared to placebo in patient-reported symptoms, in participants with active SLE
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age
    1.Are ≥ 18 to ≤ 75 years of age at the time of signing the informed consent. Sites should follow their local guidelines for the minimum age required to sign the informed consent.
    Vaccinations
    2.Are up to date, according to local guidelines, with vaccination against Streptococcus pneumoniae and influenza virus (as seasonally required for influenza virus).
    Active SCLE and/or DLE (Cohort A)
    3.Diagnosis of SCLE or DLE documented in medical history. Predominant findings of active lupus rash must be SCLE and/or DLE, but other skin manifestations of CLE will be allowed (e.g., lupus tumidus, ACLE, etc) on a case-by-case basis if their main diagnosis is active SCLE and/or DLE. Diagnosis must include one of the following options:
    a.Historical skin biopsy (i.e., pathology report; punch or shave biopsy) within 10 years prior to Screening visit and confirmation of current diagnosis by skin photography at Screening visit.
    OR
    b.Fresh punch skin biopsy at Screening visit.
    OR
    c.If target lesion is unsuitable for biopsy (e.g., malar rash, bridge of the nose), skin photography at Screening visit may be allowed on a case-by-case basis.
    4.Disease duration of ≥ 6 months from time of diagnosis to Screening.
    5.CLASI-A ≥ 8 at Screening Visit; this must be confirmed at Day 1 Visit.
    Active SLE
    6.Diagnosis of SLE and fulfil Systemic Lupus International Collaborating Clinics (SLICC) classification criteria (Petri 2006), and/or ≥ 4 ACR classification criteria (Hochberg 1997) and/or EULAR/ACR 2019 classification criteria (Aringer 2019).
    7.Disease duration of ≥ 6 months from when participant met 2012 SLICC, and/or 1997 ACR (Hochberg 1997), and/or 2019 EULAR/ACR classification criteria for SLE until Screening Visit.
    8.Positive test results for ANA (human epithelial cell-2 ANA ≥ 1:80) and/or anti dsDNA antibody (≥ 15 IU/mL) and/or anti-Smith antibody during Screening Period.
    9.Presence of either Scenario 1 OR Scenario 2 (See Figure 1). please refer to Protocol
    Weight
    10.Have a body mass index lower or equal to 40.0 kg/m2.
    Sex
    11.Are male or female at birth.
    12.Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies.
    a.Female participant:
    •Is not breastfeeding.
    •Is not pregnant (i.e., has a negative serum pregnancy test, as required by local regulations, within 24 hours before the first dose of study
    intervention).
    Additional requirements for pregnancy testing during and after study intervention are in Section 8.3.4.
    •Not a Woman of childbearing potential (WOCBP).
    •If a WOCBP, use a highly effective contraceptive method (i.e., with a failure rate of <1% per year), preferably with low user dependency (2
    methods may be considered to achieve optimal results i.e. <1% failure rate per year), as described in Appendix 3 for the following time periods:
    •Before the first dose of the study intervention, if using hormonal contraception:
    -Has completed at least one 4-Week cycle of an oral contraception pill and either had or has begun her menses.
    OR
    -Has used a depot contraceptive or extended-cycle oral contraceptive for least 28 days and has a documented negative pregnancy test using a
    highly sensitive assay.
    AND
    -A barrier method, as described in Appendix 3.
    •During the intervention period.
    •After the study intervention period (i.e., after the last dose of study intervention is administered): for at least 90 days after the last dose of study
    intervention and agree not to donate eggs (ova, oocytes) for reproduction during this period.
    The Investigator evaluates the appropriateness and effectiveness of the contraceptive method in relationship to the first dose of study intervention.
    The Investigator reviews the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a female with an early
    undetected pregnancy.
    b.Male Participants:
    Agree to the following during the study until at least 90 days (a spermatogenesis cycle) after the last dose of study intervention.
    •Refrain from donating fresh unwashed semen.
    PLUS, either:
    •Abstain from any activity that allows for exposure to ejaculate.
    OR
    •Use a male condom:
    -When having sexual intercourse with a WOCBP, who is not currently pregnant, and instruct her to use a highly effective method with a failure rate
    of <1% per year, as described in Appendix 3, since a condom may break or leak.
    -When engaging in any activity that allows for exposure to ejaculate.
    E.4Principal exclusion criteria
    Medical Conditions
    1.Primary diagnosis of autoimmune or rheumatic disease other than SLE or CLE (discuss with Medical Monitor if overlap syndrome). Note: Secondary Sjögren’s syndrome or an autoimmune thyroiditis are not exclusionary.
    2.Drug-induced lupus (SLE or CLE).
    3.Any condition including dermatological diseases other than cutaneous manifestations of SLE or CLE (e.g., psoriasis), or any uncontrolled disease (e.g., asthma, interstitial lung disease, pulmonary arterial hypertension, morbid obesity), that in Investigator’s or Sponsor/designee’s opinion constitutes inappropriate risk or contraindication for participation.
    4.Active lupus nephritis on induction therapy, or induction therapy completed within 3 months of Screening visit (stable maintenance therapy with mycophenolate or AZA allowed).
    5.UPCR > 339 mg/mmol, and/or eGFR < 45 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation by the central laboratory:
    eGFR = 175 × (serum creatinine in mg/dL)–1.154 × (age in years)–0.203 × 0.742 (if female) × 1.212 (if race is black).
    6.Any active signs, symptoms or diagnoses considered related to CNS lupus within past 3 months or any history of uncontrolled seizures.
    7.Any other history of epilepsy, other neurological disorder with seizure propensity, or neuropsychiatric conditions that may interfere with study evaluations.
    8.Significant cardiovascular events (e.g., acute myocardial infarction, unstable angina or peripheral vascular disease symptoms, hospitalization for congestive heart failure, uncontrolled or New York Heart Association Class 3 or 4 congestive heart failure, cardiac surgery, ischemic or hemorrhagic stroke, or transient ischemic attack), ≤ 6 months before Screening Visit.
    9.Active cardiac arrhythmia or clinically significant abnormality on ECG at Screening Visit or Day 1 that in the Investigator’s or Sponsor/designee’s opinion constitutes inappropriate risk or contraindication for study participation or could interfere with study objectives, conduct or evaluation (included but not limited to long QT syndrome, Wolff Parkinson White syndrome, or a malignant ventricular arrhythmia [e.g., ventricular fibrillation or tachycardia] unless treated). Note: any sinus bradycardia or tachycardia detected in the ECG will not be exclusionary unless other ECG abnormalities are identified.
    10.Significant suicide risk in the last year (including suicidal ideation and/or suicidal behavior on the C-SSRS during Screening or Day 1).
    11.History of or planned renal or solid organ transplant.

    Please refer to the Protocol for the full list.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change from baseline in CLASI-A at Week 16

    BICLA response at Week 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16 and Week 24
    E.5.2Secondary end point(s)
    From Day 1 to the end of Safety Follow-up period
    •Occurrence of TEAEs, SAEs and AESI
    •Occurrence of abnormalities (Grade 3) in laboratory parameters
    •Occurrence of Clinically Important increases in QT Interval Corrected Using Fridericia's Formula (QTcF)

    •Change from baseline in CLA-IGA at Week 16 and Week 24
    •Change from baseline in Physician’s Global Assessment of Cutaneous Lupus Disease Activity at Week 16 and 24

    •BICLA response and clinically meaningful CS reduction, defined as reduction of daily prednisone-equivalent dose from ≥ 10 mg at Day 1 to ≤ 5 mg by the Week 12 visit and sustained through Week 24

    •Clinically meaningful CS reduction, defined as reduction of daily prednisone-equivalent dose from ≥ 10 mg at Day 1 to ≤ 5 mg by the Week 12 visit and sustained through Week 24
    •Occurrence of CLA-IGA 0 or 1 at Week 16 and Week 24

    •SRI-4 response at Week 24
    •LLDAS attainment at Week 24
    •Remission attainment at Week 24
    •Clinically meaningful CS reduction, defined as reduction of daily prednisone-equivalent dose from ≥ 10 mg at Day 1 to < 5 mg by the Week 12 visit and sustained through Week 24
    •Change from baseline in Physician’s Global Assessment at Week 24
    •Change in the number of joints which are tender and swollen in 28-joint count from Baseline at Week 24
    •Time to first moderate/severe BILAG flare from Day 1 through Week 24
    •Time to first SFI severe flare from Day 1 through Week 24

    •Change from Baseline in the Skindex 29+3 Symptom domain score at Week 24
    •Change from Baseline in the Skindex 29+3 Functioning and Emotion domain scores at Week 24
    •Change from Baseline in the Skindex 29+3 lupus-specific domain score at Week 24
    •Change from Baseline in the FACIT Fatigue scores at Week 24

    •Change from Baseline in the FACIT Fatigue scores Week 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    As described in section E.5.2.
    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 Yes
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Basket.
    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 trial4
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Chile
    China
    Colombia
    Israel
    Japan
    Mexico
    Philippines
    South Africa
    United States
    Moldova, Republic of
    Serbia
    Mauritius
    Bulgaria
    Greece
    Poland
    Spain
    Korea, Republic of
    Taiwan
    Romania
    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 scheduled procedure for the last participant in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days23
    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: 430
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 532
    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)
    None.
    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 Decision2022-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-24
    P. End of Trial
    P.End of Trial StatusOngoing
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