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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7272   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).

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    Summary
    EudraCT Number:2015-004157-41
    Sponsor's Protocol Code Number:GLPG1690­CL­202
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-02
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-004157-41
    A.3Full title of the trial
    Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
    A.4.1Sponsor's protocol code numberGLPG1690­CL­202
    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 number+3215 342 900
    B.5.5Fax number+3215 342 901
    B.5.6E-mailrd@glgpg.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 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.3.9.2Current 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 number200
    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
    Idiopathic pulmonary fibrosis (IPF)
    E.1.1.1Medical condition in easily understood language
    Idiopathic pulmonary fibrosis (IPF)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 safety and tolerability of GLPG1690
    - to characterize the PK and PD properties of GLPG1690
    E.2.2Secondary objectives of the trial
    - to evaluate the change from baseline in FVC
    - to explore the change in biomarkers in blood and BALF
    - to evaluate the change in quality of life measures
    - to evaluate the change in FRI parameters
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who are able and willing to sign the ICF as approved by the independent ethics committee (IEC).
    2. Male or female subjects of non-child-bearing potential aged ≥ 40 years on the day of signing the ICF.
    Note: Female subjects will be considered of non-childbearing potential if they are either sterilized, ovariectomized, hysterectomized, or postmenopausal (i.e., at least 24 months of amenorrhea in the absence of other biological or physiological causes [in case of doubt, the subject’s follicle stimulating hormone [FSH] levels will be determined and the subject will be considered postmenopausal if the FSH level is ≥ 35 mIU/mL).
    3. Subjects with a chest HRCT performed within 12 months prior to Screening visit.
    4. Subjects with IPF diagnosed by a multidisciplinary team and confirmed by central review of the subject’s HRCT pattern and SLB (if available)
    5. Subjects meeting all of the following criteria:
    a. FVC ≥50% predicted of normal
    b. Diffusing capacity for the lungs for carbon monoxide (DLCO) ≥ 30% predicted of normal (corrected for hemoglobin) (see Appendix 3 for additional details)
    6. Subjects with a forced expiratory volume in 1 second (FEV1)/FVC (Tiffeneau-Pinelli index) ratio ≥ 0.70 (based on pre-bronchodilator spirometry).
    7. Subjects who are on stable supportive care (e.g., supplemental oxygen, pulmonary rehabilitation) for at least 3 weeks prior to screening and during screening period.
    8. Subjects must be in a stable condition and acceptable for study participation based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation.
    9. Subjects must have an estimated minimum life expectancy of 12 months in the opinion of the investigator.
    10. Male subjects and their female partners must use a highly effective method of birth control.
    11. Subjects who are able to understand the importance of adherence to study treatment, study procedures and requirements, including the concomitant medication restrictions.
    E.4Principal exclusion criteria
    1. Subjects with a known hypersensitivity to any of the study drug ingredients or a history of a significant allergic reaction to any drug as determined by the investigator (e.g., anaphylaxis requiring hospitalization).
    2. Subjects with a history of or a current immunosuppressive condition (e.g., human immunodeficiency virus [HIV] infection).
    3. Subjects with a 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, and prostate cancer medically managed through active surveillance or watchful waiting).
    4. Subjects with clinically significant abnormalities detected on ECG regarding either rhythm or conduction (e.g., QT interval corrected for heart rate using Fridericia’s formula [QTcF] ≥450 ms, or a known long QT syndrome).
    Note: A first degree heart block will not be considered as a significant abnormality.
    5. Subjects with acute IPF exacerbation within 6 weeks prior to screening and during the screening period.
    6. Subject with a lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and during the screening period.
    7. Subjects who have been smoking within 3 months prior to screening.
    8. Interstitial lung disease (ILD) associated with known primary diseases (e.g., sarcoidosis, amyloidosis, etc.), exposures (e.g., radiation, silica, asbestos, coal dust, etc.), and drugs (e.g., amiodarone, etc.).
    9. Subjects with a history of lung volume reduction surgery or lung transplant.
    10. Subjects with an unstable cardiac or pulmonary disease (other than IPF) within 6 months prior to screening or during the screening period, including but not limited to:
    a. unstable angina pectoris, myocardial infarction
    b. congestive heart failure requiring hospitalization
    11. Subjects with any clinical condition or circumstance that in the opinion of the investigator may make a subject unsuitable for inclusion or unable to complete the study or comply with study procedures and requirements.
    12. Subjects with a contra-indication for bronchoscopy and bronchoalveolar lavage in the opinion of the investigator.
    13. Subjects with an abnormal liver function defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin >3 x upper limit of the normal range (ULN).
    14. Subjects with an abnormal renal function defined as creatinine clearance < 50 mL/min using the Cockroft-Gault equation.
    15. Subjects participating in a drug/device or biologic investigational research study (concurrently with the current study or within 8 weeks prior to screening).
    16. Subjects using of any of the following therapies within 4 weeks before screening:
    a. Pirfenidone
    b. Nintedanib
    c. Warfarin
    d. Imatinib
    e. Ambrisentan
    f. Azathioprine
    g. Cyclophosphamide
    h. Cyclosporine A
    i. Prednisone at steady dose > 15 mg/day (for details, see Section 4.2.4)
    j. Any experimental IPF therapy
    17. Subjects with active alcohol or substance abuse in the opinion of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    1. Evaluation of Safety and tolerability
    - AE monitoring
    - Clinical laboratory examinations
    - Vital signs
    - Physical examination
    - 12-lead ECG
    2. Characterisation of PK and PD properties of the IMP
    - Blood sampling (PK)
    - Blood sampling (PD)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - AE monitoring: From signing informed consent until follow-up visit at multiple timepoints
    - Clinical laboratory examinations, vital signs, physical examination: Screening, Baseline, W1 D7, W2 D14, W4 D28, W8 D56, W12 D84, Early Discontinuation Visit, Follow-up (W14 D98)
    - 12-lead ECG: Screening, W1 D7, W2 D14, W4 D28, W8 D56, W12 D84, Early Discontinuation Visit, Follow-up (W14 D98)
    - Blood sampling (PK): Baseline, W1 D7, W2 D14, W4 D28, W8 D56, W12 D84, Early Discontinuation Visit, Follow-up (W14 D98)
    - Blood sampling (PD): Baseline, W4 D28, W12 D84, Early Discontinuation Visit, Follow-up (W14 D98)
    E.5.2Secondary end point(s)
    - change from baseline in FVC, through spirometry
    - change in biomarkers in blood and BALF
    - change in FRI Parameters through HRCT
    - change in quality of life (QOL) measures through SGRQ
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Spirometry: Screening, Baseline, W1 D7, W2 D14, W4 D28, W8 D56, W12 D84, Early Discontinuation Visit, Follow-up (W14 D98)
    - Biomarker blood samples: Baseline, W4 D28, W12 D84, Early Discontinuation Visit, Follow-up (W14 D98)
    - BALF sample: Baseline, W12 D84, Early Discontinuation Visit
    - HRCT: Baseline, W12 D84, Early Discontinuation Visit
    - SGRQ (QOL assessment): Baseline, W4 D28, W12 D84, Early Discontinuation Visit, Follow-up (W14 D98)
    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 Yes
    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
    Biomarker analysis
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Ukraine
    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
    last contact with the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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: 19
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 9
    F.4.2.2In the whole clinical trial 24
    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)
    none
    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 Decision2016-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-02
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