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    Summary
    EudraCT Number:2015-003291-77
    Sponsor's Protocol Code Number:GLPG1837-CL-201
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-16
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2015-003291-77
    A.3Full title of the trial
    A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation
    Otevřené klinické hodnocení fáze IIa s různými dávkami přípravku GLPG1837 u pacientů s cystickou fibrózou a mutací G551D
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation
    A.4.1Sponsor's protocol code numberGLPG1837-CL-201
    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 L11A3
    B.5.3.2Town/ cityMechelen
    B.5.3.3Post code2800
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32(0)15 342 900
    B.5.5Fax number+32(0)15342 901
    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 nameGLPG1837
    D.3.2Product code GLPG1837
    D.3.4Pharmaceutical form 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 INNNot Applicable
    D.3.9.1CAS number 1654725-02-6
    D.3.9.2Current sponsor codeGLPG1837
    D.3.9.3Other descriptive nameGLPG1837
    D.3.9.4EV Substance CodeSUB169759
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGLPG1837
    D.3.2Product code GLPG1837
    D.3.4Pharmaceutical form 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 INNNot Applicable
    D.3.9.1CAS number 1654725-02-6
    D.3.9.2Current sponsor codeGLPG1837
    D.3.9.3Other descriptive nameGLPG1837
    D.3.9.4EV Substance CodeSUB169759
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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: 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 nameGLPG1837
    D.3.2Product code GLPG1837
    D.3.4Pharmaceutical form 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 INNNot Applicable
    D.3.9.1CAS number 1654725-02-6
    D.3.9.2Current sponsor codeGLPG1837
    D.3.9.3Other descriptive nameGLPG1837
    D.3.9.4EV Substance CodeSUB169759
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number62.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cystic fibrosis with the G551D mutation
    E.1.1.1Medical condition in easily understood language
    Cystic fibrosis with the G551D mutation
    E.1.1.2Therapeutic area Body processes [G] - Genetic Phenomena [G05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of multiple oral doses of GLPG1837 in subjects with CF and at least one copy of the G551D mutation.
    E.2.2Secondary objectives of the trial
    - To assess changes in sweat chloride from baseline (Day 1) as the biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) ion channel function
    - To explore changes in pulmonary function (forced expiratory volume in 1 second [FEV1]) from baseline.
    - To assess the pharmacokinetics (PK) profile of GLPG1837 and its metabolite G518480.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects ≥ 18 years of age, on the day of signing the Informed Consent Form (ICF), with a confirmed diagnosis of cystic fibrosis:
    a.Clinical diagnosis of cystic fibrosis with signs/symptoms involving at least two organ systems, and
    b.Medical history of elevated sweat chloride ≥60 mmol/L by quantitative pilocarpine iontophoresis (documented in the subject’s medical record) or 2 disease causing CFTR mutations (documented in the subject’s medical record).
    2.Gating G551D CFTR mutation on at least one allele in the CFTR gene (documented in the subject’s medical record or CF registry); any known or unknown mutation allowed on the 2nd allele. Subject inclusion can be performed, provided that genotype information is available in source data.
    3.Subject must meet one of the following:
    a.Subjects currently receiving treatment with ivacaftor must be on a stable regimen for at least 2 weeks prior to screening;
    Or
    b.Subjects not on a treatment regimen with ivacaftor for at least 2 weeks prior to screening.
    4.Weight ≥ 40.0 kg.
    5.Subjects on stable concomitant treatment regimen for at least 4 weeks prior to baseline (excluding ivacaftor), as defined in the study protocol.
    6.Pre- or post-bronchodilator FEV1 ≥ 40% of predicted normal for age, gender and height at screening.
    7.Female subjects must have a negative blood pregnancy test. Determination of serum follicle-stimulating hormone (FSH) will be done for any suspected postmenopausal female with at least 12 months of continuous spontaneous amenorrhea, with FSH levels > 40 IU/mL being confirmative for menopause. For hysterectomy and tubal ligation, documented confirmation will be requested.
    8.Subjects will have to use highly effective contraceptive methods prior to the first dose of the study drug, during the study, and for at least 12 weeks after the last dose of the study drug.
    a. If the subject is a sexually active woman of childbearing potential, she and her male partner are required to simultaneously use 2 effective contraceptive methods as defined in the protocol. Hormonal contraceptives will not be considered as an effective method; however, female subjects are not required to discontinue hormonal contraceptives. Female subjects who use contraception must have done so for at least 14 days prior to the first dose of the study drug.
    b.Non-vasectomized sexually active male subjects with female partners of childbearing potential must be willing to use a condom in addition to having their female partner use another form of contraception as defined in the protocol.
    E.4Principal exclusion criteria
    1.History of sensitivity to any component of the study drug, or a history of drug or other allergy that, in the investigator’s opinion, contraindicates the subject’s participation in the study.
    2.On an ivacaftor-containing treatment regimen and unable or unwilling to discontinue ivacaftor for the washout and treatment periods of the study.
    3.A history of a clinically meaningful unstable or uncontrolled chronic disease including underlying cystic fibrosis that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
    4.Liver cirrhosis and portal hypertension.
    5.History of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix and basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
    6.Any significant change in the medical regimen (including dose or frequency) for pulmonary health within 4 weeks of baseline, including: antibiotics, corticosteroids, inhaled bronchodilators, hypertonic saline, mannitol or dornase alfa; ibuprofen and airway clearance techniques. Individuals taking inhaled antibiotics for suppression of chronic airways infection must be on a stable regimen for at least 8 weeks prior to baseline and willing to continue the same antibiotic through Day 29.
    7.Unstable pulmonary status or respiratory tract infection (including pulmonary exacerbation), based on the investigator’s opinion, or changes in therapy for pulmonary disease within 4 weeks of baseline; as defined in the protocol.
    8.History of lung volume reduction surgery or lung transplant.
    9.Use of continuous (24 hours per day) supplemental oxygen therapy.
    10.Clinically significant abnormalities detected on electrocardiogram (ECG) regarding either rhythm or conduction (e.g., QTcF ≥ 450 ms, or a known long QT syndrome). A first degree heart block will not be considered as a significant abnormality.
    11.Use of medication known to prolong the QT interval (including herbal and naturopathic therapy).
    12.History of solid organ or haematological transplantation or currently on a transplantation waiting list.
    13.Abnormal liver function defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT) > 3 x upper limit of the normal range or bilirubin > 2x upper limit of the normal range.
    14.Abnormal renal function defined as creatinine clearance < 50mL/min using the Cockroft-Gault equation.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability will be assessed through:
    •Adverse events (AEs)
    •Physical examinations
    •Vital signs
    •12-lead ECG
    •Oxygen saturation
    •Safety laboratory assessments
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various time points throughout the trial as specified in the protocol
    E.5.2Secondary end point(s)
    Efficacy will be assessed through:
    •sweat Chloride Concentration Testing
    •measuring pulmonary function
    •pharmacokinetics
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various time points throughout the trial as specified in the protocol
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Czech Republic
    Germany
    Ireland
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    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: 5
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 32
    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 will continue with normal treatment
    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 Decision2016-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-06
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