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    Summary
    EudraCT Number:2017-000372-29
    Sponsor's Protocol Code Number:JBT101-SSc-002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-01-27
    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 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
    Studio di fase 3, multicentrico, randomizzato, in doppio cieco, controllato verso placebo per valutare l¿efficacia e la sicurezza di Lenabasum mella Sclerosi systemic cutanea diffusa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial to evaluate efficacy and eafety of Lenabasum in for the diffuse dutaneous systemic sclerosis, 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.
    Studio clinico per valutare l'efficacia del Lenabasum relativamente alla Sclerosi cutanea sistemica diffusa, una malattia del sistema immunitario che attacca i tessuti connettivi sotto la pelle, intorn agli organi interni e i vasi sanguigni causando ferite ed assottigliamento del tessuto in queste aree.
    A.3.2Name or abbreviated title of the trial where available
    A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis
    Studio di fase 3 sull'efficacia e la sicurezza di Lenabasum nella Sclerosi Sistemica Cutanea
    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 Pharmaceutical - Stati Uniti d'America
    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 number00441252842255
    B.5.5Fax number00441252842277
    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 5mg Powder in Capsule
    D.3.2Product code [JBT-101]
    D.3.4Pharmaceutical form Capsule, hard
    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 CodeSUB193005
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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, hard
    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.3.9.1CAS 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 CodeSUB193005
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboCapsule, hard
    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)
    Sclerosi Sistemica (SSc)
    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 malattia del sistema immunitario che attacca il tessuto connettivo sotto la pelle e attorno agli organi interni e ai vasi sanguigni causando cicatrici e ispessimento del tessuto in queste aree
    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 21.0
    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
    Valutare l'efficacia di lenabasum rispetto al placebo nel trattamento della sclerosi sistemica cutanea diffusa (SSc) valutando il cambiamento dal basale nel modified Rodnan skin score (mRSS) [Scala modificata di Rodnan] alla Settimana 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- Valutare l'efficacia di lenabasum rispetto al placebo nel trattamento della SSc valutando il cambiamento dal basale nel punteggio Health Assessment Questionnaire-Disability Index (HAQ-DI) [Questionario di valutazione della salute - Indice di disabilità] alla Settimana 52.
    2. Valutare l'efficacia di lenabasum rispetto al placebo nel trattamento della SSc valutando il Provisional Combined Response Index [Indice di risposta combinata provvisoria] dell'American College of Rheumatology (ACR) nel punteggio della sclerosi sistemica cutanea diffusa (CRISS) alla Settimana 52.
    3. Valutare l'efficacia di lenabasum rispetto al placebo nel trattamento della SSc valutando il cambiamento dal basale nella capacità vitale forzata (FVC) % prevista alla Settimana 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. Stable treatment for SSc = 28 days before Visit 1.
    8. 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.
    9. Willing not to use any cannabinoids including recreational marijuana, medical marijuana and other prescription cannabinoids from Screening through Visit 11.
    10. 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.
    11. 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.
    12. Able to adhere to the study visit schedule and other protocol requirements.
    1. Soddisfa i criteri dell'American College of Rheumatology 2013 per la sclerosi sistemica (van den Hoogen et al, 2013).
    2. SSc cutanea diffusa (ispessimento della pelle sulle braccia superiori, sulla parte superiore delle gambe o sul tronco).
    3. = 18 anni di età al momento della firma del Consenso Informato.
    4. Consenso informato scritto del soggetto
    5. Durata della malattia = 6 anni dal sintomo del primo non-Raynaud. Se la durata della malattia è > 3 anni e = 6 anni, allora mRSS = 15. Soggetti con durata della malattia > 3 anni e = 6 anni e mRSS = 15 saranno limitati a non più di 1/3 del soggetti.
    6. Valutazione globale del paziente = 3 o MDGA = 3.
    7. Trattamento stabile per SSc = 28 giorni prima della visita 1.
    8. Disposto a non iniziare o interrompere alcun farmaco immunosoppressivo per SSc dalla Visita 1 alla Visita 11, a meno che non si consideri una modifica per l'interesse medico del soggetto da parte dello sperimentatore del centro o di un altro medico che ha la responsabilità primaria nel trattamento dell'SSc del soggetto.
    9. Disposto a non usare cannabinoidi, compresi marijuana ricreativa, marijuana medica e altri cannabinoidi soggetti a prescrizione dallo Screening fino alla Visita 11.
    10. Le donne in età fertile non devono essere in gravidanza o in allattamento al seno alla Visita 1 e devono utilizzare almeno un metodo di contraccezione efficace (tasso di fallimento <1% all'anno) per almeno 28 giorni prima della visita 1 ed essere disposte a continuare ad utilizzare almeno un metodo contraccettivo altamente efficace durante lo studio e per almeno 28 giorni dopo la sospensione del prodotto in studio.
    11. I partecipanti maschi devono essere disposti a seguire i requisiti contraccettivi e non devono indurre nessuna gravidanza mentre stanno prendendo il farmaco in studio o entro 28 giorni dall'assunzione dell'ultima dose del farmaco in studio, durante il quale periodo o il partner o i soggetti stessi devono essere disposto a utilizzare almeno un metodo di contraccezione altamente efficace.
    12. In grado di aderire al programma delle visite di studio e ad altri requisiti del protocollo.
    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 intraarticular 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. Concomitant inflammatory myositis, rheumatoid arthritis, or systemic lupus erythematosus when definite classification criteria for those diseases are met [Bohan and Peters criteria for polymyositis and dermatomyositis (Bohan and Peter, 1975a; Bohan and Peter, 1975b); 2010 rheumatoid arthritis classification criteria of American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) (Aletaha, 2010); ACR revised criteria for the classification of systemic
    lupus erythematosus (Hochberg, 1997)].
    4. SSc-like illnesses related to exposures or ingestions.
    5. A positive test for anti-centromere antibody at Screening. If the subject is anti-centromere antibody positive and clearly has diffuse
    cutaneous SSc, then the subject may be eligible and the investigator must discuss this situation with the Medical Monitor to determine eligibility.
    6. 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.
    7. 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 g/dL in females.
    c. Neutrophils < 1.0 × 1000,000,000/L.
    d. Platelets < 75 × 1000,000,000/L.
    e. Creatinine clearance in blood < 50 mL/min per the Modification of Diet in Renal Disease (MDRD) Study equation. Creatinine clearance may be assessed in a 24 hour urine collection to confirm eligibility (creatinine clearance = 50 ml/min) if screening blood test is < 50 mL/min.
    f. Aspartate aminotransferase or alanine aminotransferase > 2.0 × upper limit of normal.
    8. Any investigational agent within 30 days or 5 therapeutic half-lives of that agent whichever is longer, before Visit 1.
    9. Prior exposure to lenabasum.
    10. Significant diseases or conditions other than SSc or concurrent medical therapies at Screening or Visit 1, including a history of noncompliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
    1. SSc instabile o SSc con coinvolgimento dell’organo in stadio finale allo Screening o alla Visita 1, come:
    a. In una lista di attesa per il trapianto degli organi o ha ricevuto un trapianto degli organi
    b. Crisi renale entro 1 anno
    c. Malattia polmonare che richiede un trattamento costante con ossigeno. Questo esclude l'ossigeno usato per conciliare il sonno o per l'allenamento
    d. Ipertensione polmonare che richiede un trattamento costante con ossigeno. Questo esclude l'ossigeno usato per conciliare il sonno o per l'allenamento
    e. Dismotilità gastrointestinale che richiedono una nutrizione parenterale totale
    2. Trattamenti al momento dello Screening o della visita 1, fra cui:
    a. Qualsiasi trattamento con prednisone orale <10mg al giorno o equivalente entro 28 giorni prima della visita 1. Il trattamento intravenoso con corticosteroidi entro 28 giorni dalla visita 1 non è consentito, mentre il trattamento intrarticolare con corticosteroidi entro 28 giorni prima della visita 1 è consentito
    b. L'inizio o l'incremento di dose di qualsiasi trattamento immunosopressivo non-corticosteroide entro 8 settimane prima dello screening
    c. Trattamento con ciclofosfamide entro 3 mesi prima della visita 1
    3. Concomitanza di miosite infiammatoria, artrite reumatoide o lupus eritematoso sistemico nel caso in cui siano rispettati i criteri di classificazione di queste malattie [Bohan and Peters criteria for polymyositis and dermatomyositis (Bohan and Peter, 1975a; Bohan and Peter, 1975b); 2010 rheumatoid arthritis classification criteria of American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) (Aletaha, 2010); ACR revised criteria for the classification of systemic
    lupus erythematosus (Hochberg, 1997)].
    4. Malattia simile a SSc dovuta da esposizione o ingestione.
    5. Test positivo per l'anticorpo anti-centromero allo screening. Se il soggetto è positivo all'anticorpo anti-centromero e mostra chiaramente SSc cutanea diffusa, allora il soggetto può essere elegibile e lo sperimentatore deve discutere la situazione con il Medical Monitor per determinarne l'elegibilità.
    6. Malattie o condizioni significative diverse dalla SSc che possono influenzare la risposta al prodotto in studio o la sicurezza, come ad esempio: [...]
    7. Uno dei seguenti valori per i test di laboratorio allo screening:
    a. Test di gravidanza positivo in WOCBP (anche alla Visita 1)
    b. Emoglobina <9 g / dL nei maschi e <8 g / dL nelle femmine
    c. Neutrofili <1,0 × 10^9/L
    d. Piastrine <75 × 10^9/L
    e. Clearance della creatinina <50 ml/min per la Modification of Diet in Renal Disease (MDRD) Study equation
    f. Aspartato aminotransferasi o alanina amminotransferasi >2,0 × superiore limite del normale. La clearance della creatinina può essere valutata tramite la raccolta di urine nelle 24 ore per confermare l'elegibilità (clearance creatinina =50 ml/min) se al test del sangue è <50 mL/min.
    8. Qualsiasi prodotto in studio entro 30 giorni o 5 emivite terapeutiche di quel prodotto, qualunque sia il più lungo, prima della Visita 1.
    9. Precedente esposizione al lenabasum.
    10. Malattie o condizioni significative diverse dalla SSc o concomitanti terapie mediche allo Screening o Visita 1, inclusa una storia di non conformità ai trattamenti medici, che possono mettere il soggetto a un grande rischio per la sicurezza, influenzare la risposta al prodotto in studio o interferire con valutazioni dello studio.
    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
    DI EFFICACIA:
    mRSS alla Settimana 52 (lenabasum 20 mg BID).
    DI SICUREZZA
    TEAE dal Giorno 1 alla Settimana 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Settimana 52
    E.5.2Secondary end point(s)
    Efficacy:
    - modified Rodnan skin score (mRSS) (lenabasum 20 mg BID and 5 mg BID)
    - 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 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 or 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 (Part A) and Week 1, Week 4, Week 20, Week 36, Week 52, Week 68, Week 84, and Week 100 (Part B)
    - 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 (Part A); Week 12, Week 44, Week 76, and Week 108 (Part B)
    DI EFFICACIA:
    - puntegio della scala modificata di Rodnan (mRSS) (lenabasum 20 mg BID and 5 mg BID)
    - punteggio HAQ-DI alla Settimana 52 (lenabasum 20 mg BID e 5 mg BID)
    -punteggio ACR CRISS alla Settimana 52 (lenabasum 5 mg BID)
    -mRSS alla Settimana 52 (lenabasum 5 mg BID)
    -FVC % prevista alla Settimana 52 (lenabasum 20 mg BID e 5 mg BID)
    DI SICUREZZA:
    -Tollerabilità (percentuale di soggetti che interrompono il trattamento di studio a seguito dei TEAE probabilmente o chiaramente correlati con il prodotto di studio) del trattamento con lenabasum o con placebo
    -Segni vitali (pressione sistolica e diastolica, pulsazione, frequenza respiratoria, temperature corporea e peso) registrati a ogni visita
    -Test di laboratorio sulla sicurezza ottenuti a ogni visita (Parte A) e alla Settimana 1, Settimana 4, Settimana 20, Settimana 36, Settimana 52, Settimana 68, Settimana 84, e Settimana 100 (Parte B)
    -Emocromo completo con conta differenziale e piastrine
    - Pannello metabolico che include funzione renale, elettroliti e test della funzione epatica
    - Test su striscia reattiva immersa nell'urina per sangue, albumina/proteina e glucosio
    -Visite mediche a Giorno 1, Settimana 26 e Settimana 52
    -ECG a 12 derivazioni al Giorno 1, Settimana 26, e Settimana 52 (Parte A); Settimana 12, Settimana 44, Settimana 76, e Settimana 108 (Parte B)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A: Week 52
    Part B: Week 108
    Parte A: Settimana 52
    Parte B: Settimana 108
    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 concerned3
    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 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
    Australia
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Spain
    Switzerland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    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 months0
    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 months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 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 state20
    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).
    Al termine della Sperimentazione i soggetti continueranno ad essere trattati dal loro medico curante per la scelrosi sistemica. I soggetti continueranno con il loro trattamento di base durante la sperimentazione per ridurre il rischio di riacutizzazione della malattia laddove il trattamento sia interrotto. E' intenzione del Promotore offrire la partecipazione ad uno studio in aperto con lenabasum per i soggetti che completano questa sperimentazione fino alla visita 11 (giorno365/settimana52)
    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 Decision2018-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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