Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43243   clinical trials with a EudraCT protocol, of which   7156   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-001808-11
    Sponsor's Protocol Code Number:ID-064A202
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-001808-11
    A.3Full title of the trial
    A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE)
    Studio di fase 2b, multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare l’efficacia, la sicurezza e la tollerabilità di cenerimod in soggetti con lupus eritematoso sistemico (LES) da moderato a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease
    Uno studio di ricerca per valutare gli effetti di un nuovo farmaco orale chiamato cenerimod negli adulti con con lupus eritematoso sistemico
    A.3.2Name or abbreviated title of the trial where available
    CARE:Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus
    CARE:Cenerimod Assessing S1P1 Receptor modulation nel Lupus Eritematoso Sistemico
    A.4.1Sponsor's protocol code numberID-064A202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03742037
    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 SponsorIDORSIA PHARMACEUTICALS 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 supportIdorsia Pharmaceuticals Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIdorsia Pharmaceuticals Ltd
    B.5.2Functional name of contact pointClinical Trial Disclosure Desk
    B.5.3 Address:
    B.5.3.1Street AddressHegenheimermattweg 91
    B.5.3.2Town/ cityAllschwil
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041588441977
    B.5.6E-mailclinical-trials-disclosure@idorsia.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 nameCenerimod
    D.3.2Product code [ACT-334441]
    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 INNCenerimod
    D.3.9.2Current sponsor codeACT-334441
    D.3.9.4EV Substance CodeSUB193350
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 nameCenerimod
    D.3.2Product code [ACT-334441]
    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 INNCenerimod
    D.3.9.2Current sponsor codeACT-334441
    D.3.9.4EV Substance CodeSUB193350
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 3
    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 nameCenerimod
    D.3.2Product code [ACT-334441]
    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 INNCenerimod
    D.3.9.2Current sponsor codeACT-334441
    D.3.9.4EV Substance CodeSUB193350
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 4
    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 nameCenerimod
    D.3.2Product code [ACT-334441]
    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 INNCenerimod
    D.3.9.2Current sponsor codeACT-334441
    D.3.9.4EV Substance CodeSUB193350
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Moderate to severe systemic lupus erythematosus
    Lupus eritematoso sistemico da moderato a grave
    E.1.1.1Medical condition in easily understood language
    Lupus
    Lupus
    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 assess the efficacy of 6 months cenerimod treatment given at 4 different dose levels (0.5, 1, 2, and 4 mg once daily) on disease activity in adult subjects with moderate to severe SLE concurrently receiving background therapy
    L’obiettivo primario è valutare l’efficacia di 6 mesi di trattamento con cenerimod somministrato a 4 diversi livelli di dosaggio (0,5, 1, 2 e 4 mg una volta al giorno) sull’attività della malattia in soggetti adulti con LES da moderato a grave, che ricevono una terapia di base concomitante.
    E.2.2Secondary objectives of the trial
    To evaluate over 6 months in adult subjects with moderate to severe SLE concurrently receiving background therapy:
    • the safety and tolerability of cenerimod treatment
    • the effect of cenerimod treatment on quality of life and fatigue using relevant patient reported outcome (PRO) instruments
    • the effect of cenerimod treatment on SLE biomarkers
    Gli obiettivi secondari dello studio sono valutare quanto segue, nell’arco di 6 mesi in soggetti adulti con LES da moderato a grave, che ricevono una terapia di base concomitante:
    • sicurezza e tollerabilità del trattamento con cenerimod
    • effetto del trattamento con cenerimod sulla qualità della vita e sull’affaticamento usando strumenti di valutazione degli esiti riferiti dal paziente (PRO)
    • effetto del trattamento con cenerimod sui biomarcatori del LES
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: At randomization, approximately 125 subjects will be assigned to the echocardiography ancillary study through the IRT system.
    The echocardiography ancillary study will run concurrently with the main study. Subjects assigned into the echocardiography ancillary study will undergo an echocardiography assessment at Month 6, or at premature End-of-Treatment (pEOT) visit in case of premature study treatment discontinuation during treatment period 1, in addition to echocardiography assessments that will be performed for all subjects during the screening period.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Alla randomizzazione, circa 125 soggetti saranno assegnati allo studio ecocardiografico ausiliario attraverso il sistema IRT.
    Lo studio ecocardiografico ausiliario verra' eseguito in concomitanza con lo studio principale. I soggetti assegnati al sottostudio ecocardiografico saranno sottoposti a una valutazione ecocardiografica al mese 6, o alla visita prematura dell'EOT [pEOT] in caso di interruzione prematura del trattamento di studio durante il periodo 1, oltre alle valutazioni ecocardiografiche che verranno eseguite per tutti i soggetti durante il periodo di screening.
    E.3Principal inclusion criteria
    - Signed ICF prior to any study-mandated procedure
    - Diagnosis of SLE made at least 6 months prior to Screening, by fulfilling at least 4 of the 11 criteria for SLE as defined by the American College of Rheumatology (ACR) criteria
    - A mSLEDAI-2K score >= 6 of at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).
    - Currently treated with stable doses of one or more of the following background medications:
    • NSAIDs,
    • Anti-malarials (<= 400 mg/day hydroxychloroquine, <= 500 mg/day chloroquine, <= 100 mg/day quinacrine),
    • Mycophenolate mofetil (<= 2 g/day),
    • Mycophenolic acid (<= 1440 mg/day),
    • Azathioprine (<= 2 mg/kg/day),
    • Methotrexate (= 20 mg/week),
    • Corticosteroids (<= 40 mg/day prednisone or equivalent),
    • Belimumab (<=10 mg/kg every 4 weeks intravenously [i.v.], or 200 mg/week subcutaneouslt [s.c.])
    - Presence of at least one of the following autoantibodies measured by central laboratory defined as follows: (a) Positive antinuclear antibody (ANA) test measured by immunofluorescence assay (IFA) with titre >=1:80; or (b) positive anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies with titre >=30 IU/mL
    - Women of childbearing potential (WOCBP):
    • Must have a negative serum pregnancy test at Screening
    • Must agree to undertake monthly urine pregnancy tests during the study
    • Must use highly effective methods of contraception from the screening visit until 4 months after taking the last dose of study treatment.
    - Firma dell’ICF prima di qualsiasi procedura richiesta dallo studio
    - Diagnosi di LES formulata almeno 6 mesi prima dello screening, soddisfacendo almeno 4 degli 11 criteri per il LES definiti dal Collegio Americano di Reumatologia (ACR)
    - Un punteggio mSLEDAI-2K >= 6 di almeno 2 punti per le manifestazioni muscolo-scheletriche o mucocutanee (ovvero: miosite, artrite, eruzione cutanea, alopecia, ulcere mucosali)
    - Trattamento in corso con dosi stabili di uno o più dei seguenti farmaci di base:
    • farmaci antinfiammatori non steroidei (FANS);
    • antimalarici (<=400 mg/giorno di idroclorochina, <=500 mg/giorno di clorochina, <=100 mg/giorno di quinacrina);
    • micofenolato mofetile (<=2 g/giorno);
    • acido micofenolico (<=1440 mg/giorno);
    • azatioprina (<= 2 mg/kg/giorno);
    • metotrexato (<= 20 mg/settimana);
    • corticosteroidi (<=40 mg/giorno di prednisone o equivalente);
    • belimumab (<=10 mg/kg ogni 4 settimane per via endovenosa [i.v.], o 200 mg/settimana per via sottocutanea [s.c.]).
    - Presenza di almeno uno dei seguenti autoanticorpi misurati dal laboratorio centrale e definiti come segue: (a) positività al test degli ANA misurati mediante saggio di immunofluorescenza con titolo >=1:80; o (b) positività agli anticorpi anti-dsDNA con titolo >=30 UI/ml
    - Donne in età fertile (WOCBP):
    • Devono risultare negative al test di gravidanza su siero allo screening
    • Devono acconsentire a sottoporsi al test di gravidanza sulle urine ogni mese durante lo studio
    • Devono usare metodi contraccettivi altamente efficaci dalla visita di screening fino a 4 mesi dopo aver assunto l’ultima dose di trattamento dello studio.
    E.4Principal exclusion criteria
    - Active lupus nephritis or a renal biopsy demonstrating immune complex mediated glomerulonephritis compatible with lupus nephritis within 90 days prior to Screening.
    - Severe active central nervous system (CNS) lupus requiring therapeutic intervention (including aseptic meningitis, seizures, psychosis, cerebritis, cerebrovascular accident [CVA], organic brain syndrome, CNS vasculitis) and severe forms of vasculitis requiring systemic immunosuppressive treatment (including retinal vasculitis, coronary vasculitis, pulmonary vasculitis, mesenteric vasculitis) within 90 days prior to Screening.
    - A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with rheumatoid arthritis, erosive arthritis, scleroderma or autoimmune hepatitis.
    - History or presence of Mobitz type II or third-degree atrioventricular block, sick sinus syndrome, symptomatic bradycardia or syncope associated with cardiac disorders.
    - Subjects who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, vascular thrombosis, decompensated heart failure requiring hospitalization, or heart failure defined by the New York Heart Association Class III/IV within six months prior to Screening.
    - An elevated QT corrected for HR on the basis of Fridericia’s formula interval of > 470 ms (females) / > 450 ms (males).
    - History of clinically relevant bronchial asthma or chronic obstructive pulmonary disease that has required treatment with oral or parenteral corticosteroids for more than 2 weeks within the last 6 months prior to Screening.
    - History or presence of severe respiratory disease or pulmonary fibrosis.
    - Active or latent tuberculosis.
    - Ongoing bacterial, viral or fungal infection that is of clinical concern in the judgment of the investigator or history of any serious infection.
    - Subjects who have congenital or acquired severe immunodeficiency or known HIV infection or positive HIV testing.
    - Presence of macular edema or active uveitis.
    - Type 1 or 2 diabetes that is poorly controlled according to investigator judgment, or diabetes complicated with organ involvement such as diabetic nephropathy or retinopathy.
    - Significant hematology abnormality: Lymphocyte count < 800 /µL (0.8 × 10e9/L); hemoglobin < 9 g/dL; WBC count < 2500/µL (2.5 × 10e9/L) or platelets < 75000/µL (75 × 10e9/L).
    - Estimated glomerular filtration rate < 60 mL/min/1.73 m2.
    - Known allergy to S1P receptor modulators or any of the cenerimod formulation excipients.
    - Nefrite lupica attiva o una biopsia renale che dimostri glomerulonefrite mediata da immuno-complessi compatibile con nefrite lupica entro 90 giorni prima dello Screening.
    - Lupus del sistema nervoso centrale (SNC) attivo grave che richiede intervento terapeutico (tra cui meningite asettica, crisi convulsive, psicosi, cerebrite, incidente cerebrovascolare [CVA], sindrome cerebrale organica, vasculite del sistema nervoso centrale (SNC)) e forme gravi di vasculite che richiedono un trattamento con immunosoppressori sistemici (tra cui vasculite retinica, vasculite coronarica, vasculite polmonare, vasculite mesenterica) nei 90 giorni precedenti lo Screening.
    - Una diagnosi di malattia mista del tessuto connettivo o qualsiasi anamnesi di sindromi da sovrapposizione del LES con artrite reumatoide, artrite erosiva, scleroderma o epatite autoimmune.
    - Anamnesi o presenza di blocco atrio-ventricolare tipo Mobitz II o di terzo grado, sindrome del seno malato, bradicardia sintomatica o sincope associata a disturbi cardiaci.
    - Soggetti che hanno manifestato infarto miocardico, angina pectoris instabile, ictus, attacco ischemico transitorio, trombosi vascolare, insufficienza cardiaca scompensata che richiede il ricovero o insufficienza cardiaca di Classe III/IV secondo la New York Heart Association (NYHA) nei sei mesi precedenti lo Screening.
    - Un intervallo QT elevato corretto per la frequenza cardiaca (HR) in base alla formula di Fridericia (QTcF) >470 ms (donne)/>450 ms (uomini).
    - Anamnesi di asma bronchiale o broncopneumopatia cronica ostruttiva clinicamente rilevante che ha richiesto un trattamento con corticosteroidi orali o parenterali per un totale di 2 settimane negli ultimi 6 mesi prima dello Screening
    - Anamnesi o presenza di malattia respiratoria o fibrosi polmonare grave
    - Tubercolosi (TB) attiva o latente
    - Infezione batterica, virale o fungina in corso che desti preoccupazione clinica secondo il parere dello sperimentatore o anamnesi di qualsiasi infezione seria.
    - Soggetti affetti da una grave immunodeficienza congenita o acquisita o con infezione nota da virus dell’immunodeficienza umana (HIV) o che risultano positivi al test dell’HIV
    - Presenza di edema maculare o uveite acuta.
    - Diabete di tipo 1 o 2 scarsamente controllato secondo il giudizio dello sperimentatore, o diabete complicato con coinvolgimento di organi quali nefropatia diabetica o retinopatia.
    - Anomalia ematologica significativa: conta linfocitaria <800/µl (0,8 × 109/l); emoglobina <9 g/dl; conta dei globuli bianchi <2.500/µl (2,5 × 109/l) o piastrine <75.000/µl (75 × 109/l).
    - Velocità di filtrazione glomerulare stimata <60 ml/min/1,73 m².
    - Nota allergia ai modulatori del recettore della sfingosina-1-fosfato (S1P) o a qualsiasi degli eccipienti della formulazione di cenerimod
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Month 6 in the mSLEDAI-2K score
    Variazione dal basale al Mese 6 nel punteggio mSLEDAI-2K.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline (Baseline is defined as the last available measurement before the start of randomized) to Month 6 (Day 180).
    Dal Basale (Basale e' definito come l'ultima misurazione disponibile prima dell'inizio del trattamento randomizzato) al Mese 6 (Giorno 180).
    E.5.2Secondary end point(s)
    1. Response on Systemic Lupus Erythematosus Responder Index (SRI-4) at Month 6 as compared to baseline, defined as follows:
    - Reduction from baseline of at least 4 points in the mSLEDAI-2K

    AND

    - No new British Isles Lupus Assessment Group (BILAG) A organ domain score and no more than one new BILAG B organ domain score compared
    with baseline

    AND

    - No increase of more than 0.3 points on the Physician's Global Assessment (PGA) since baseline

    2. Response (no worsening) at Month 6 on BILAG-2004 disease activity index defined as no new BILAG A organ domain score and no more than
    one new BILAG B organ domain score compared with baseline.
    1. Risposta sull’Indice di rispondenti nel LES (SRI)-4 al Mese 6 rispetto al Basale, definito come segue:
    - riduzione rispetto al basale di almeno 4 punti nel mSLEDAI-2K

    E

    - nessun nuovo punteggio nel dominio dell’organo del Gruppo di valutazione del lupus delle isole britanniche (BILAG) A e non più di un nuovo punteggio nel dominio dell’organo BILAG B rispetto al basale

    E

    - nessun aumento superiore a 0,3 punti sulla Valutazione globale del medico (PGA) dopo il basale

    2. Risposta (nessun peggioramento) al Mese 6 sull'indice di attivita' della malattia BILAG-2004 definito come nessun nuovo punteggio nel dominio dell'organo BILAG A e non piu' di un nuovo punteggio nel dominio dell'organo BILAG B rispetto al Basale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Response on Systemic Lupus Erythematosus Responder Index (SRI-4) at Month 6 (Day 180) after start of treatment
    2. Response on BILAG-2004 disease activity index at Month 6 (Day 180) after start of treatment
    1. Risposta sull'indice Systemic Lupus Erythematosus Responder Index (SRI-4) al Mese 6 (Giorno 180) dopo l'inizio del trattamento
    2. Risposta sull’indice di attivita' della malattia BILAG-2004 al Mese 6 (Giorno 180) dopo l'inizio del trattamento
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    Biomarkers; tolerability; patient reported outcomes; quality of life
    Biomarcatori; tollerabilità; risultati riferiti dai pazienti; qualità della vita
    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 trial5
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Chile
    China
    Colombia
    Georgia
    Israel
    Mexico
    Philippines
    Russian Federation
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    Bulgaria
    Czechia
    France
    Germany
    Greece
    Hungary
    Italy
    Poland
    Romania
    Spain
    United Kingdom
    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
    LVLS
    LVLS
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 500
    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 the subject’s study completion or premature withdrawal from the study, whichever applies, the investigator/delegate will explain to subjects what treatment(s) / medical care is necessary and available according to local practice
    Dopo il completamento o uscita prematura dallo studio da parte del soggetto, qualunque sia il caso, lo sperimentatore/delegato spiegherà ai soggetti quale terapia(e)/cura medica è necessaria e disponibile, secondo la pratica locale
    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 Decision2019-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA