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    Summary
    EudraCT Number:2018-001817-33
    Sponsor's Protocol Code Number:GLPG1690-CL-204
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-001817-33
    A.3Full title of the trial
    A Phase 2a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of orally administered GLPG1690 for 24 weeks in subjects with systemic sclerosis
    Studio di Fase 2a, randomizzato, in doppio cieco, controllato con placebo, multicentrico per valutare l'efficacia, la sicurezza e la tollerabilità di GLPG1690 somministrato per via orale per 24 settimane nei soggetti affetti da sclerosi sistemica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to test how effective and safe GLPG1690 is for patients with Systemic Sclerosis
    Studio Clinico per valutare l’efficacia e la sicurezza di GLPG1690 in pazienti con sclerosi dermica
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberGLPG1690-CL-204
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03798366
    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 SponsorGALAPAGOS NV
    B.1.3.4CountryBelgium
    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 supportGalapagos NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalapagos NV
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressGeneraal De Wittelaan L11 A3
    B.5.3.2Town/ cityMechelen
    B.5.3.3Post code2800
    B.5.3.4CountryBelgium
    B.5.4Telephone number003215342900
    B.5.5Fax number003215342901
    B.5.6E-mailrd@glpg.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 nameGLPG1690
    D.3.2Product code [G451990]
    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.3.9.2Current sponsor codeG451990
    D.3.9.3Other descriptive nameGLPG1690
    D.3.9.4EV Substance CodeSUB166266
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number199
    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
    Systemic sclerosis
    Sclerosi sistemica
    E.1.1.1Medical condition in easily understood language
    Systemic sclerosis
    Sclerosi sistemica
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10042953
    E.1.2Term 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 GLPG1690 as evaluated by mRSS compared to placebo over 24 weeks for the treatment of subjects with systemic sclerosis
    Valutare l’efficacia di GLPG1690 secondo il Modified Rodnan Skin Score (mRSS) rispetto al placebo nell’arco di 24 settimane per il trattamento di soggetti affetti da sclerosi sistemica
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of GLPG1690 compared to placebo over 24 weeks in the treatment of subjects with systemic sclerosis
    Valutare la sicurezza e la tollerabilità di GLPG1690 rispetto al placebo nell'arco di 24 settimane di trattamento di soggetti affetti da sclerosi sistemica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Able and willing to comply with the protocol requirements and to sign the informed consent form (ICF) as approved by the IEC/IRB, prior to any screening evaluations.
    - Male and female subjects =18 years at the time of consent who meet the American College of Rheumatology (ACR)/EULAR 2013 diagnostic criteria (Van den Hoogen F. et al., 2013) for systemic sclerosis with diffuse cutaneous involvement (according to LeRoy’s criteria) and =5 years since the onset of the first systemic sclerosis manifestation other than Raynaud's phenomenon.
    - mRSS >10 at screening.
    - Active disease at screening, as defined by: Worsening of skin thickening (=2 mRSS points) as assessed by mRSS measured at screening versus a previous mRSS assessment made within 6 months prior to screening, or new areas of skin involvement within 6 months prior to screening as documented by physician note, or new-onset systemic sclerosis with symptoms or signs other than Raynaud’s phenomenon within 2 years prior to screening, or =1 tendon friction rub (palpated in the finger flexors or extensors, wrist flexors or extensors, olecranon bursa, shoulders, knees, anterior or posterior ankles with active motion).
    - Subject must be able and willing to comply with restrictions on prior and concomitant medication as described in the protocol
    - Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at the baseline visit.
    - Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
    - Female subjects of childbearing potential or male subjects with female partners of childbearing potential must be willing to comply with the contraceptive methods described in the protocol prior to the first dose of the IMP, during the clinical study, and for at least 90 days after the last dose of the IMP for male subjects and 30 days after the last dose of the IMP for female subjects.
    - A body mass index (BMI) between 18–35 kg/m2, inclusive, at screening.
    - Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered non-clinically significant in the opinion of the investigator.

    This list only contains the key inclusion criteria.
    - Capacità e volontà di rispettare i requisiti del protocollo e di firmare il modulo di consenso informato (ICF) come approvato dal CEI/dall’IRB, prima di qualsiasi valutazione di screening.
    - Soggetti di sesso maschile e femminile di età =18 anni al momento della firma del modulo di consenso che soddisfano i criteri diagnostici dell'American College of Rheumatology (ACR)/della European League Against Rheumatism (EULAR) del 2013
    (Van den Hoogen F. et al., 2013) per la sclerosi sistemica con coinvolgimento cutaneo diffuso (secondo i criteri di LeRoy) e =5 anni dall'insorgenza della prima manifestazione di sclerosi sistemica diversa dal fenomeno di Raynaud.
    - mRSS >10 allo screening.
    - Malattia attiva allo screening, definita da:
    • Peggioramento dell'ispessimento cutaneo (=2 punti mRSS) valutato mediante l'mRSS misurato allo screening rispetto a una precedente valutazione dell'mRSS effettuata nei 6 mesi precedenti lo screening, o
    • Nuove aree di coinvolgimento della pelle nei 6 mesi precedenti lo screening, come documentato dalla cartella clinica, o
    • Sclerosi sistemica di nuova insorgenza con sintomi o segni diversi dal fenomeno di Raynaud nei 2 anni precedenti lo screening, o =1 sfregamento del tendine (palpabile nei flessori o negli estensori delle dita, nei flessori o negli estensori del polso, nella borsa olecranica, nelle spalle, nelle ginocchia, nelle caviglie anteriori o posteriori con movimento attivo).
    - Il soggetto deve essere in grado e deve essere disposto ad attenersi alle restrizioni sui farmaci precedentemente assunti e concomitanti come descritto nel protocollo.
    - I soggetti di sesso femminile in età fertile devono presentare un test di gravidanza su siero negativo allo screening e un test di gravidanza sulle urine con esito negativo alla visita basale
    - I soggetti di sesso femminile in età fertile o i soggetti di sesso maschile con partner femminili in età fertile devono essere disposti a utilizzare i metodi contraccettivi descritti nel protocollo prima della prima dose di IMP, durante lo studio clinico e per almeno 90 giorni dopo l'ultima dose di IMP per i soggetti di sesso maschile e 30 giorni dopo l'ultima dose di IMP per i soggetti di sesso femminile.
    - Un indice di massa corporea (BMI) tra 18–35 kg/m2 incluso, allo screening.
    - Condizioni di salute giudicate buone dallo sperimentatore in base ai risultati dell'anamnesi medica, esame obiettivo, funzioni vitali, elettrocardiogramma a 12 derivazioni (ECG) e test clinici di laboratorio sulla sicurezza a digiuno. I risultati dei test clinici di laboratorio sulla sicurezza devono rientrare negli intervalli di riferimento; altrimenti i risultati del test al di fuori degli intervalli di riferimento devono essere considerati non clinicamente significativi secondo il parere dello sperimentatore.

    Il presente elenco contiene solo i criteri d’inclusione principali
    E.4Principal exclusion criteria
    - Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
    - Breastfeeding female or subject intending to become pregnant or breastfeed.
    - History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection, congenital, acquired).
    - Positive blood testing for hepatitis B surface antigen or hepatitis C virus (antibody, confirmed by hepatitis C virus RNA positivity). Note: Subjects with a resolved hepatitis A at least 3 months prior to screening can be screened.
    - History of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin that has been treated with no evidence of recurrence, prostate cancer medically managed through active surveillance or watchful waiting, and squamous
    cell carcinoma of the skin if fully resected and ductal carcinoma in situ).
    - Clinically significant abnormalities, in the opinion of the investigator, detected on ECG at screening of either rhythm or conduction, QTcF >450 ms, or a known long QT syndrome
    - Unstable cardiovascular, pulmonary, or other disease (other than systemic sclerosis-related), in the opinion of the investigator, within 6 months prior to the baseline visit (e.g. coronary heart disease, heart failure, stroke).
    - Severe pulmonary disease with FVC =45% of predicted within 6 months prior to the baseline visit.
    - Chronic or ongoing active infectious disease, including tuberculosis (requiring hospitalization or systemic treatment within 4 weeks prior to the baseline visit).
    - Abnormal liver function test (LFT) at screening, defined as aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT), and/or bilirubin, and/or alkaline phosphatase >2x upper limit of normal (ULN). Retesting is allowed once.

    This list only contains the key exclusion criteria.
    - Ipersensibilità nota ai principi attivi dell’IMP o anamnesi di reazione allergica significativa a qualsiasi farmaco determinata dallo sperimentatore, come anafilassi che richiede il ricovero in ospedale.
    -Soggetto di sesso femminile in allattamento o che intende iniziare una gravidanza o allattare.
    - Anamnesi di o attuale stato d’immunosoppressione (ad es. infezione da virus dell'immunodeficienza umana [HIV], congenita, acquisita).
    - Analisi del sangue positiva per antigene di superficie dell’epatite B o virus dell’epatite C (anticorpo confermato da positività a RNA del virus dell’epatite C). Nota: i sogg con epatite A risolta almeno 3 mesi prima dello screening possono essere sottoposti a screening
    - Anamnesi di tumore maligno negli ultimi 5 anni (ad eccezione di carcinoma in situ della cervice uterina, carcinoma a cellule basali della pelle trattato senza alcuna evidenza di recidiva, carcinoma prostatico gestito clinicamente tramite sorveglianza attiva (watchful waiting) e carcinoma a cellule squamose della pelle se completamente rescisso e carcinoma duttale in situ
    - Anomalie clinicamente significative, per lo sperimentatore, rilevate nell'ECG allo screening del ritmo o della conduzione, intervallo QT corretto per la frequenza cardiaca usando la formula di Fridericia (QTcF) > 450 ms o sindrome del QT lungo nota.
    - Malattia instabile cardiovascolare, polmonare o altra malattia (diversa da quelle correlate alla sclerosi sistemica), per lo sperimentatore, nei 6 mesi precedenti la visita basale (ad es. malattia coronarica, insufficienza cardiaca, ictus).
    - Grave malattia polmonare con FVC = 45% del valore previsto nei 6 mesi precedenti la visita basale.
    - Malattia infettiva attiva cronica o in corso, compresa la tubercolosi (che richiede il ricovero in ospedale o il trattamento sistemico entro le 4 settimane precedenti la visita basale).
    - Test della funzionalità epatica (LFT) anomalo allo screening, definito da aspartato aminotransferasi (AST) e/o alanina aminotransferasi (ALT) e/o bilirubina e/o fosfatasi alcalina >2x limite superiore della norma (ULN). La ripetizione del test è consentita
    una sola volta.

    Il presente elenco contiene solo i criteri d’inclusione principali
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in mRSS over 24 weeks
    Variazione rispetto al baseline dell'mRSS nell’arco di 24 settimane
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various timepoints during the trial as specified in the protocol
    Diverse tempistiche nel corso dello studio come specificato in protocollo
    E.5.2Secondary end point(s)
    Incidence of TEAEs, serious adverse events (SAEs), AEs, and tolerability of GLPG1690 over 24 weeks
    Incidenza di eventi avversi emergenti dal trattamento (TEAE), eventi avversi seri (SAE), eventi avversi (AE), e tollerabilità di GLPG1690 nell'arco di 24 settimane
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints during the trial as specified in the protocol
    Diverse tempistiche nel corso dello studio come specificato in protocollo
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    tollerabilità
    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 trial2
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    United States
    Belgium
    Germany
    Italy
    Spain
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 20
    F.4.2.2In the whole clinical trial 30
    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)
    Subjects who completed the Week 24 visit will be offered to continue treatment with GLPG1690 in an optional open-label extension.
    For subjects that will not participate in the LTE study there is no post trial treatment plan; treatment will revert to the standard of care.
    ai soggetti che hanno completato la visita della Settimana 24 sarà proposto di continuare il trattamento con GLPG1690 in un'estensione facoltativa in aperto. Per i soggetti che non parteciperanno all'estensione del trattamento non è previsto un piano di trattamento post trial, il trattamento sarà lo standard of care
    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 Decision2019-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
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    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
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