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    Summary
    EudraCT Number:2017-004302-18
    Sponsor's Protocol Code Number:GLPG1205-CL-220
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-01
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-004302-18
    A.3Full title of the trial
    A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis.
    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 GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)
    A.4.1Sponsor's protocol code numberGLPG1205-CL-220
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03725852
    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+3215342900
    B.5.5Fax number+3215342901
    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 nameGLPG1205
    D.3.2Product code G321605
    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 INNNA
    D.3.9.1CAS number 1445847-37-9
    D.3.9.2Current sponsor codeG321605
    D.3.9.3Other descriptive nameGLPG1205
    D.3.9.4EV Substance CodeSUB121444
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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, 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
    Idiopathic pulmonary fibrosis
    E.1.1.1Medical condition in easily understood language
    Idiopathic pulmonary fibrosis
    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 21.1
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of GLPG1205 treatment in subjects with IPF on pulmonary function as evaluated by FVC compared to placebo over 26 weeks.
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety and tolerability of GLPG1205 treatment
    compared to placebo over 26 weeks.
    2. To evaluate the impact of GLPG1205 treatment compared to placebo on time to any major events (whichever occurs first) defined as:
     a. Mortality (all cause and respiratory-related)
     b. Hospitalization (all-cause and respiratory related)
    3. To evaluate the changes from baseline in functional exercise capacity
    measured by the 6-Minute Walk Test (6MWT), in IPF subjects treated with GLPG1205 compared to placebo at Week 26.
    4. To evaluate the changes in quality of life measures in IPF subjects treated with GLPG1205 compared to placebo over 26 weeks.
    5. To evaluate the PK of GLPG1205, nintedanib and pirfenidone in IPF subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who meet all of the following criteria are eligible for the study:
    - Signed informed consent form (ICF) obtained prior to any study-related
    procedures and/or assessments performed.
    - Males or females of non-child-bearing potential, aged ≥40 years on the day of signing the ICF.
    - A diagnosis of IPF within 5 years prior to the screening visit as per applicable American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guideline. Subjects receiving local standard of care for the treatment of IPF, defined as either pirfenidone, or nintedanib at a stable dose for at least 8 weeks before screening, and during screening; or neither pirfenidone nor nintedanib (for any reason). A stable dose is defined as the highest tolerated dose. Prednisone at
    steady dose ≤10 mg/day or equivalent glucocorticoid dose is allowed
    (stabilized 4 weeks prior to screening and continued without variation of
    dose or regimen). Supportive care like supplemental oxygen or pulmonary rehabilitation is allowed.
    - Chest HRCT historically performed within 12 months prior to the screening visit and according to the minimum requirements for IPF diagnosis by central review based on subject's HRCT only (if no lung biopsy [LB] available), or based on both HRCT and LB (with application of the different criteria in either situation). If an evaluable HRCT <12 months is not available, a HRCT can be performed at screening to determine eligibility, according to the same requirements as the
    historical HRCT.
    - Meeting all of the following criteria at screening and during the screening period:
    * FVC ≥50% predicted of normal
    * Disease progression, defined as a decline of FVC (% predicted or mL) at the investigator's discretion, during the 9 months prior to the screening period and confirmed at the screening visit
    * Diffusing capacity for the lungs for carbon monoxide (DLCO) ≥30% predicted of normal (corrected for hemoglobin)
    * Ratio of forced expiratory volume in one second (FEV1) to FVC ≥0.70
    - In a stable condition and suitable for study participation based on the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation. Stable condition is based on the clinical judgment of the investigator, co-morbidities should be treated according to the local applicable guidelines. Concomitant medication for chronic comorbidities should be stabilized from 4 weeks before screening and during the screening period (stable defined as no clinically relevant change according to the investigator's judgement).
    - Able to walk at least 150 meters during the 6MWT at screening;
    without having a contraindication to perform the 6MWT, or without a condition putting the subject at risk of falling during the test (at investigator's discretion). The use of a cane is allowed, the use of a stroller is not allowed at all under any circumstances.

    For a complete overview of the inclusion criteria refer to the protocol.
    E.4Principal exclusion criteria
    Subjects meeting one or more of the following criteria cannot be selected for this study:
    - Known hypersensitivity to any of the IMP ingredients or a history of a
    significant allergic reaction to any drug as determined by the investigator (e.g. anaphylaxis requiring hospitalization).
    - Current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection, congenital, acquired, medication induced, organ transplantation).
    - Positive blood testing for hepatitis B surface antigen (HBs Ag) or hepatitis virus antibody (if positive, confirmed by hepatitis C virus (HCV) RNA positivity). Note: Subjects with a resolved hepatitis A at least 3 months prior to first dosing of the IMP can be included.
    - 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, and squamous cell carcinoma of the skin if fully resected).
    - Acute IPF exacerbation within 3 months prior to screening and during the screening period.
    - Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period.
    - Interstitial lung disease associated with known primary diseases (e.g.
    sarcoidosis, amyloidosis), exposures (e.g. radiation, silica, asbestos, coal dust), and drugs (e.g. amiodarone).
    - History of lung volume reduction surgery or lung transplant.
    - Unstable cardiovascular, pulmonary (other than IPF) or other disease within 6 months prior to screening or during the screening period (e.g. coronary heart disease, heart failure, stroke).
    - Subject participating in a drug, device or biologic investigational research study, concurrently with the current study, within 12 weeks or 5-half-lives of the agent whichever is longer, prior to screening, or prior participation in an investigational drug antibody/biologic study within 6 months prior to screening.

    For a complete overview of the exclusion criteria refer to the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in FVC (mL) over 26 weeks compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various time points throughout the clinical study as specified in the protocol
    E.5.2Secondary end point(s)
    - Safety and tolerability changes over time (baseline to 26 weeks).
    - Time to any of major events (whichever occurs first) defined as:
    * Death (all-cause and respiratory-related)
    * First hospitalization (all-cause and respiratory-related)
    - Change from baseline 26 weeks in functional exercise capacity, assessed by the 6MWT at Week 26.
    - Change from baseline until 26 weeks in quality of life measures, assessed by the St. George's Respiratory Questionnaire (SGRQ) total score and domains and proportion of SGRQ responders.
    - Plasma concentrations of GLPG1205, nintedanib and pirfenidone
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various time points throughout the clinical study 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 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
    tolerability
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Bulgaria
    Croatia
    Egypt
    Finland
    France
    Oman
    Romania
    Slovakia
    Sweden
    Ukraine
    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
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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: 39
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 60
    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 Decision2018-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-14
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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