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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36127   clinical trials with a EudraCT protocol, of which   5940   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).
     
    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:2017-000372-29
    Sponsor's Protocol Code Number:JBT101-SSc-002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-02-02
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-000372-29
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
    Ensayo de fase 3 multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de lenabasum en la esclerosis sistémica cutánea difusa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of safety and efficacy of lenabasum in Systemic Sclerosis
    Estudio de seguridad y eficacia de lenabasum en la esclerosis sistémica
    A.3.2Name or abbreviated title of the trial where available
    A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis
    Estudio de fase 3 de Estudio de seguridad y eficacia de lenabasum en la esclerosis sistémica
    A.4.1Sponsor's protocol code numberJBT101-SSc-002
    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 SponsorCorbus pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCorbus Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTMC Pharma Services Ltd
    B.5.2Functional name of contact pointRegulatory Services
    B.5.3 Address:
    B.5.3.1Street AddressLodge Farm Barn, Elvetham Park Estate, Fleet Road
    B.5.3.2Town/ cityHartley Wintney, Hampshire
    B.5.3.3Post codeRG27 8AS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441252842255
    B.5.5Fax number+441252842277
    B.5.6E-mailregulatory.services@tmcpharma.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1808
    D.3 Description of the IMP
    D.3.1Product nameLenabasum 5 mg Powder in Capsule
    D.3.2Product code JBT-101
    D.3.4Pharmaceutical form Capsule
    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 INNLenabasum
    D.3.9.1CAS number 137945-48-3
    D.3.9.2Current sponsor codeJBT-101
    D.3.9.3Other descriptive nameresunab, ajulemic acid, anabasum
    D.3.9.4EV Substance CodeSUB178399
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 20
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1808
    D.3 Description of the IMP
    D.3.1Product nameLenabasum 20 mg Powder in Capsule
    D.3.2Product code JBT-101
    D.3.4Pharmaceutical form Capsule
    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 INNLenabasum
    D.3.9.1CAS number 137945-48-3
    D.3.9.2Current sponsor codeJBT-101
    D.3.9.3Other descriptive nameresunab, ajulemic acid, anabasum
    D.3.9.4EV Substance CodeSUB178399
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 20
    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 placeboCapsule
    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 Sclerosis (SSc)
    Esclerodermia
    E.1.1.1Medical condition in easily understood language
    A disease of the immune system attacking the connective tissue under the skin and around internal organs and blood vessels causing scarring and thickening of the tissue in these areas.
    Una enfermedad del sistema inmune que ataca el tejido conectivo subcutáneo y que rodea rodea los oganos internos y vasos sanguineos causando cicatrización y engrosamiento del tejido en esas areas.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012977
    E.1.2Term Diffuse systemic sclerosis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of lenabasum compared to placebo in the treatment of diffuse cutaneous systemic sclerosis (SSc) by assessing change from baseline in the modified Rodnan skin score (mRSS) at Week 52
    Evaluar la eficacia de lenabasum en comparación con placebo en el tratamiento de la esclerosis sistémica (ES) cutánea difusa mediante la evaluación de la variación respecto al momento basal de la puntuación de la escala cutánea de Rodnan modificada (mRSS) en la semana 52
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing the change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score at Week 52.
    2. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing the American College of Rheumatology (ACR) Provisional Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score at Week 52.
    3. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing the change from baseline in the forced vitality capacity (FVC) % score at Week 52.
    1. Evaluar la eficacia de lenabasum en comparación con placebo en el tratamiento de la ES mediante la evaluación de la variación respecto al momento basal de la puntuación del Cuestionario de evaluación de la salud-Índice de discapacidad (HAQ-DI) en la semana 52.
    2. Evaluar la eficacia de lenabasum en comparación con placebo en el tratamiento de la ES mediante la evaluación de la puntuación del Índice de la respuesta combinada provisional en la esclerosis sistémica cutánea difusa (CRISS) del Colegio americano de reumatología (ACR, American College of Rheumatology) en la semana 52.
    3. Evaluar la eficacia de lenabasum en comparación con placebo en el tratamiento de la ES mediante la evaluación de la variación respecto al momento basal del porcentaje del valor teórico de la capacidad vital forzada (CVF) en la semana 52.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Fulfills the 2013 American College of Rheumatology criteria for systemic sclerosis (van den Hoogen et al, 2013).
    2. Diffuse cutaneous SSc (skin thickening on upper arms proximal to the elbows, upper legs proximal to the knees, or trunk).
    3. ≥ 18 years of age at the time Informed Consent is signed.
    4. Written informed consent from the subject.
    5. Disease duration ≤ 6 years from the first non-Raynaud’s symptom. If disease duration is > 3 years and ≤ 6 years, then mRSS ≥ 15. Subjects with disease duration > 3 years and ≤ 6 years and mRSS ≥ 15 will be limited to no more than 1/3rd of the subjects.
    6. Patient Global Assessment ≥ 3 or MDGA ≥ 3.
    7. Overlap with polymyositis, systemic lupus erythematosus, Sjogren’s syndrome, or rheumatoid arthritis is allowed only if the dominant clinical disease is diffuse cutaneous SSc.
    8. Stable treatment for SSc ≥ 28 days before Visit 1.
    9. Willing to not start or stop any immunosuppressive medications for SSc from Visit 1 through Visit 11, unless a change is considered in the subject’s best medical interest by the site investigator or another physician who has primary responsibility for treating the subject’s SSc.
    10. Willing not to use any cannabinoids including recreational marijuana, medical marijuana and other prescription cannabinoids from Screening through Visit 11.
    11. Women of childbearing potential must not be pregnant or breastfeeding at Visit 1 and must be using at least one highly effective method of contraception (failure rate < 1% per year) for
    at least 28 days before Visit 1 and be willing to continue to use at least one highly effective method of contraception throughout the study and for at least 28 days after discontinuation of study product.
    12. Male participants must be willing to follow contraceptive requirements and should not get anyone pregnant while they are taking the study drug or within 28 days after taking the last dose of the study drug, during which time period they or their partner must be willing to use at least one highly effective method of contraception.
    13. Able to adhere to the study visit schedule and other protocol requirements.
    1. Cumplir con los criterios del American College of Rheumatology criteria for systemic sclerosis 2013 para la esclerosis sistémica (van den Hoogen et al, 2013).
    2. ES cutánea difusa (engrosamiento de la piel en la parte superior de los brazos, la parte superior de las piernas o el tronco).
    3. ≥ 18 años de edad en el momento de la firma del consentimiento informado.
    4. Consnetimiento informado escrito del paciente
    5. Duración de la enfermedad ≤ 6 años desde la aparición del primer síntoma que no corresponde al fenómeno de Raynaud. Si la duración de la enfermedad es > 3 años y ≤ 6 años, entonces mRSS ≥ 15.
    6. Evaluación global del paciente ≥ 3 o MDGA ≥ 3.
    7. La superposición con la polimiositis, lupus eritematoso sistémico, l síndrome de Sjogren o artritis reumatoide solo se permite si la enfermedad clínica dominante es la ES cutánea difusa.
    8. Tratamiento estable para ES ≥ 28 días antes de la Visita 1.
    9. Disposición a no comenzar o suspender ningún medicamento inmunosupresor para ES desde la Visita 1 hasta la Visita 11, a menos que un cambio sea considerado lo mejor por el investigador del centro u otro médico que tenga la responsabilidad principal de tratar la ES.
    10. Disposición a no usar ningún cannabinoide incluyendo marihuana recreativa, marihuana medicinal y otros cannabinoides recetados desde la Selección hasta la Visita 11.
    11. Las mujeres en edad fértil no deben estar embarazadas o dando el pecho en la visita 1 y deben usar al menos un método anticonceptivo altamente eficaz (tasa de fracaso <1% por año) durante al menos 28 días antes de la visita 1 y estar dispuestos a continuar.
    12. Los participantes masculinos deben estar dispuestos a seguir los requisitos anticonceptivos y no deben dejar embarazada a nadie mientras toman el medicamento del estudio o dentro de los 28 días posteriores a la última dosis del medicamento del estudio, durante los cuales su pareja o ellos deben estar dispuestos a usarlos.
    13. Ser capaz cumplir con el calendario de visitas de estudio y otros requisitos de protocolo.
    E.4Principal exclusion criteria
    1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1, such as:
    a. On an organ transplantation list or has received an organ transplant
    b. Renal crisis within 1 year
    c. Interstitial lung disease requiring constant oxygen treatment. This excludes oxygen used to aid sleep or exercise.
    d. Pulmonary hypertension requiring constant oxygen treatment. This excludes oxygen used to aid sleep or exercise.
    e. Gastrointestinal dysmotility requiring total parenteral nutrition or hospitalization within 6 months before Visit 1.
    2. Certain medications at Screening or Visit 1, including:
    a. Treatment with any oral prednisone > 10 mg per day or equivalent within 28 days before Visit 1. Treatment with intravenous corticosteroids within 28 days before Visit 1 is not allowed, and treatment with intra-articular corticosteroids within 28 days before Visit 1 is allowed.
    b. New or increase in doses of any non-corticosteroid immunosuppressive medication within 8 weeks before Screening.
    c. Treatment with cyclophosphamide within 3 months before Visit 1.
    3. Patients with SSc-like illnesses related to exposures or ingestions.
    4. Significant diseases or conditions other than SSc that may influence response to the study product or safety, such as:
    a. A new bacterial or viral infection that was treated with oral or intravenous antibiotics or anti-viral treatments within 28 days before Visit 1. This does not include prophylactic antibiotic or anti-viral treatments.
    b. Acute or chronic hepatitis B or C infection.
    c. Human immunodeficiency virus (HIV) infection.
    d. History of active tuberculosis or positive tuberculosis test without a completed course of appropriate treatment or already completed at least 1 month of ongoing appropriate treatment.
    e. Evidence of required treatment for cancer (except for treated basal or squamous cell carcinoma of the skin or cervical carcinoma in situ) within 3 years of Visit 1.
    5. Any of the following values for laboratory tests at Screening:
    a. A positive pregnancy test in WOCBP (also at Visit 1).
    b. Hemoglobin < 9 g/dL in males and < 8 gm/dL in females.
    c. Neutrophils < 1.0 × 1000000000/L.
    d. Platelets < 75 × 1000000000/L.
    e. Creatinine clearance < 50 mL/min per the Modification of Diet in Renal Disease (MDRD) Study equation.
    f. Aspartate aminotransferase or alanine aminotransferase > 2.0 × upper limit of normal.
    6. Any investigational agent within 30 days or 5 therapeutic half-lives of that agent whichever is longer, before Visit 1.
    7. Significant diseases or conditions other than SSc or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
    1. ES inestable o ES con afectación orgánica terminal en la selección o la visita 1; tales como:
    a. Estar incluido en una lista de trasplantes de órganos o haber recibido un trasplante de órganos
    b. Crisis renal en el año anterior
    c. Enfermedad pulmonar que precisa tratamiento constante con oxígeno. Esto excluye el oxígeno utilizado para ayudar a dormir o hacer ejercicio.
    d. Hipertensión pulmonar que precisa tratamiento constante con oxígeno. Esto excluye el oxígeno utilizado para ayudar a dormir o hacer ejercicio.
    e. Malabsorción o dismotilidad gastrointestinal que precisa nutrición parenteral total u hospitalización dentro de los 6 meses anteriores a la Visita 1.
    2. Ciertas medicaciones en la Visita de selección o Visita 1, incluyendo:
    a. Tratamiento con cualquier prednisona oral> 10 mg por día o equivalente dentro de los 28 días previos a la Visita 1. No se permite el tratamiento con corticosteroides intravenosos dentro de los 28 días previos a la Visita 1, y se permite el tratamiento con corticosteroides intraarticulares 28 días antes de la Visita 1.
    b. Nueva dosis o aumento de ésta de cualquier medicamento inmunosupresor no corticosteroideo dentro de las 8 semanas previas a la Selección.
    c. Tratamiento con ciclofosfamida dentro de los 3 meses anteriores a la Visita 1.
    3. Pacientes con enfermedades similares a ES relacionadas a exposiciones o ingestiones.
    4. Enfermedades o afecciones significativas distintas de la ES que puedan influir en la respuesta al producto del estudio o la seguridad, tales como:
    a. Una nueva infección bacteriana o vírica que se trató con antibióticos orales o intravenosos o tratamientos antivirales dentro de los 28 días anteriores a la Visita 1. Esto no incluye tratamientos antibióticos o antivirales profilácticos.
    b. Infección aguda o crónica por hepatitis B o C.
    c. Infección por el virus de la inmunodeficiencia humana (VIH).
    d. Historial de tuberculosis activa o prueba de tuberculosis positiva sin un curso completo de tratamiento apropiado o ya completado de al menos 1 mes de tratamiento apropiado continuo.
    e. Evidencia del tratamiento requerido para el cáncer (excepto el carcinoma basocelular o de células escamosas tratado o el carcinoma cervical in situ) dentro de los 3 años posteriores a la visita 1.
    5. Cualquiera de los siguientes valores de las pruebas analíticas en la selección:
    a. Un resultado positivo en la prueba de embarazo en las mujeres en edad fértil (también en la Visita 1)
    b. Hemoglobina < 9 g/dl para los varones y < 8 g/dl para las mujeres
    c. Neutrófilos < 1.0 × 1000000000/L.
    d. Plaquetas < 75 × 1000000000/L.
    e. Aclaramiento de creatinina < 50 ml/min de acuerdo con la ecuación del estudio Modificación de la dieta en la enfermedad renal(MDRD, Modification of Diet in Renal Disease)
    f. Aspartato aminotransferasa o alanina aminotransferasa > 2,0 × límite superior de la normalidad.
    6. Cualquier agente en investigación destro de los 30 dias o 5 vidas medias terapéuticas de ese agente, el que sea mayor, antes de la Visita 1.
    7. enfermedades significativas o afecciones distintas al ES o tratamiento médico concurrente en la selección o la visita 1, incluidos los antecedentes de incumplimiento de tratamientos médicos, que pudiera implicar un aumento del riesgo para la seguridad del sujeto, influir en la respuesta al producto del estudio o interferir en las evaluaciones del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Efficacy: Modified Rodnan Skin Score (mRSS) (lenabasum 20 mg BID)
    - Safety: Treatment Emergent Adverse Events (TEAE) from Day 1
    - Eficacia: Puntuación en la escala cutánea de Rodnan modificada (mRSS) (lenabasum 20 mg 2vd)
    -Seguridad: Tratamiento de Acontecimientos adversos emergentes (TEAE) desde el día 1
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 52
    En la Semana 52
    E.5.2Secondary end point(s)
    Efficacy:
    - Health Assessment Questionanaire-Disability Index (HAQ-DI) score (lenabasum 20 mg BID and 5 mg BID)
    - American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score (lenabasum 20 mg BID and 5 mg BID)
    - mRSS (lenabasum 5 mg BID)
    - Forced Vital Capacity (FVC) % predicted (lenabasum 20 mg BID and 5 mg BID)
    Safety:
    - Tolerability (percentage of subjects discontinuing study treatment due to a TEAE probably or definitely related to study product) of lenabasum treatment and placebo treatment
    - Vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, body temperature, and weight) recorded at each visit
    - Laboratory safety tests obtained at each visit
    - Complete blood count with cell differential and platelets
    - Metabolic panel that includes renal function, electrolytes, and liver function tests
    - Urine dipstick testing for blood, albumin/protein, and glucose
    - Physical examinations at Day 1, Week 26, and Week 52
    - 12-lead ECGs at Day 1, Week 26, and Week 52
    Eficacia:
    -Puntuación del Health Assessment Questionanaire-Disability Index (HAQ-DI) (lenabasum 20 mg 2vd y 5 mg 2vd)
    -Índice de respuesta combinada del American College of Rheumatology (ACR) en la puntuación de esclerosis sistémica cutánea difusa (CRISS) (lenabasum 20 mg 2vd y 5 mg 2vd)
    -mRSS (lenabasum 5 mg 2vd)
    -Porcentaje del valor teórico de CVF (lenabasum 20 mg 2vd y 5 mg 2vd)
    Seguridad:
    -Tolerabilidad (porcentaje de sujetos que suspenden el tratamiento del estudio debido a un AAST probablemente o indudablemente relacionado con el producto del estudio) del tratamiento con lenabasum y del tratamiento con placebo
    -Las constantes vitales (presión arterial sistólica y diastólica, frecuencia cardíaca, frecuencia respiratoria, temperatura corporal y peso) registradas en cada visita
    -Pruebas analíticas de seguridad obtenidas en cada visita
    -Hemograma completo con fórmula leucocitaria y recuento de plaquetas
    -Pruebas metabólicas que incluyen función renal, electrolitos y pruebas de la función hepática
    -Análisis de orina con tira reactiva para la detección de sangre, albúmina/proteínas y glucosa
    -Exploraciones físicas el día 1, la semana 26 y la semana 52
    -ECG de 12 derivaciones el día 1, la semana 26 y la semana 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Week 52
    En la Semana 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 Yes
    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 trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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
    Australia
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Spain
    Sweden
    Switzerland
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 329
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 354
    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 trial, subjects will continue to receive care for systemic sclerosis from their treating physician. Subjects will remain on their baseline treatment for systemic sclerosis during the trial to reduce the risk of disease flare where study product is discontinued. It is the intent of the Sponsor to offer participation in a separate open-label trial with lenabasum for subjects who complete this trial through to visit 11 (Day 365/Week 52).
    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 Decision2018-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-11
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA