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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7259   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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    EudraCT Number:2014-003933-24
    Sponsor's Protocol Code Number:DRI11772
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-22
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGreece - EOF
    A.2EudraCT number2014-003933-24
    A.3Full title of the trial
    Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study
    Η αποτελεσματικότητα και η ασφάλεια του SAR156597 στη θεραπεία της ιδιοπαθούς πνευμονικής ίνωσης (ΙΠΙ): Μια τυχαιοποιημένη, διπλά-τυφλή, ελεγχόμενη με εικονικό φάρμακο μελέτη κυμαινόμενης δόσης διάρκειας 52 εβδομάδων
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis
    Η αποτελεσματικότητα και η ασφάλεια του SAR156597 στη θεραπεία της ιδιοπαθούς πνευμονικής ίνωσης
    A.4.1Sponsor's protocol code numberDRI11772
    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 Sponsorsanofi-aventis recherche & développement
    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 supportsanofi-aventis recherche & développement
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Aventis
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street Address348 Syngrou Avenue, Building A
    B.5.3.2Town/ cityAthens
    B.5.3.3Post code17674
    B.5.4Telephone number00302109001650
    B.5.5Fax number00302109243712
    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.3.2Product code SAR156597
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSAR156597
    D.3.9.4EV Substance CodeSUB33159
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous 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
    Ιδιοπαθής Πνευμονική Ίνωση
    E.1.1.1Medical condition in easily understood language
    Lung scarring of unknown origin.
    ανάπτυξη ινώδους ιστού στον πνεύμονα αγνώστου αιτιολογίας
    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 18.0
    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, in comparison with placebo, the efficacy of 2 dose levels of SAR156597 administered subcutaneously during 52 weeks on lung function of patients with IPF.
    Η αξιολόγηση, σε σύγκριση με το εικονικό φάρμακο, της αποτελεσματικότητας 2 δοσολογικών επιπέδων/σχημάτων του SAR156597 χορηγούμενο υποδορίως κατά τη διάρκεια 52 εβδομάδων στην πνευμονική λειτουργία ασθενών με ΙΠΙ
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of 2 dose levels of SAR156597 compared to placebo on IPF disease progression.
    To evaluate the safety of 2 dose levels of SAR156597 compared to placebo in patients with IPF.
    Η αξιολόγηση της αποτελεσματικότητας 2 δοσολογικών επιπέδων/σχημάτων του SAR156597 σε σύγκριση με το εικονικό φάρμακο στην εξέλιξη της νόσου ΙΠΙ
    Η αξιολόγηση της ασφάλειας 2 δοσολογικών επιπέδων/σχημάτων του SAR156597 σε σύγκριση με το εικονικό φάρμακο σε ασθενείς με ΙΠΙ
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult male or female patients.
    Documented diagnosis of IPF according to the current American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ American Latin Thoracic Association (ATS/ERS/JRS/ALAT) guidelines.
    Signed written informed consent.
    Ενήλικες άρρενες ή γυναίκες ασθενείς.
    Τεκμηριωμένη διάγνωση ΙΠΙ σύμφωνα με τις υφιστάμενες κατευθυντήριες οδηγίες της Αμερικάνικης Θωρακικής Εταιρείας / Ευρωπαϊκής Αναπνευστικής Εταιρείας / Ιαπωνικής Αναπνευστικής Εταιρείας / Αμερικάνικης Λατινικής Θωρακικής Εταιρείας (ATS/ERS/JRS/ALAT).
    Υπογεγραμμένη συγκατάθεση κατόπιν ενημέρωσης.
    E.4Principal exclusion criteria
    Age ≤40 years.
    IPF disease diagnosis >5 years.
    Forced vital capacity (FVC) <40% of predicted value.
    Carbon monoxide diffusing lung capacity (DLco) corrected for hemoglobin <30% of predicted value.
    Severe chronic obstructive bronchitis as characterized by forced expiratory volume in 1 second /forced vital capacity (FEV1/FVC) <0.70.
    Need for 24 hrs of oxygen therapy or oxygen saturation <88% after 10 minutes breathing ambient air at rest.
    Known diagnosis of significant respiratory disorders other than IPF.
    Pulmonary artery hypertension requiring a specific treatment.
    Currently listed and/or anticipated to be listed for lung transplantation within the next 6 months (on an active list).
    History of vasculitis or connective tissue disorders.
    Known human immunodeficiency virus (HIV) or chronic viral hepatitis.
    Patients with active tuberculosis or incompletely treated latent tuberculosis infection.
    Use of any cytotoxic/immunosuppressive agent including but not limited to azathioprine, cyclophosphamide, methotrexate, and cyclosporine within 4 weeks prior to screening.
    Use of any cytokine modulators (etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab, rituximab) within 12 weeks or 5 half-lives of screening (24 weeks for rituximab and 24 months for alefacept).
    Ηλικία ≤ 40 ετών.
    Διάγνωση της νόσου ΙΠΙ >5 έτη
    Δυναμικά εκπνεόμενη ζωτική χωρητικότητα (FVC) <40% της προβλεπόμενης τιμής
    Ικανότητα διάχυσης στους πνεύμονες, με χρήση μονοξειδίου του άνθρακα (DLCO), διορθωμένη ως προς την αιμοσφαιρίνη <30% της προβλεπόμενης τιμής.
    Σοβαρή χρόνια αποφρακτική βρογχίτιδα σύμφωνα με το χαρακτηρισμό βάσει FEV1/FVC <0,70
    Ανάγκη για οξυγονοθεραπεία 24 ωρών ή κορεσμός οξυγόνου <88% μετά από 10 λεπτά αναπνοής ατμοσφαιρικού αέρα σε κατάσταση ηρεμίας.
    Γνωστή διάγνωση σημαντικών αναπνευστικών διαταραχών (π.χ. άσθμα, φυματίωση,
    σαρκοείδωση, ασπεργίλλωση ή κυστική ίνωση), εκτός από ΙΠΙ.
    Πνευμονική αρτηριακή υπέρταση για την οποία απαιτείται ειδική θεραπεία.
    Ασθενείς επί του παρόντος σε λίστα αναμονής ή/και ασθενείς που αναμένεται να μπουν σε λίστα αναμονής για μεταμόσχευση πνεύμονα εντός των επόμενων 6 μηνών (ενεργή λίστα).
    Ιστορικό αγγειίτιδας ή διαταραχών του συνδετικού ιστού ή ασθενείς θετικοί για ANCA.
    Ιστορικό HIV ή χρόνιας ιογενούς ηπατίτιδας.
    Ασθενείς με ενεργό φυματίωση ή ιστορικό ανεπιτυχούς θεραπείας της φυματίωσης.
    Χρήση οποιουδήποτε κυτταροτοξικού/ανοσοκατασταλτικού παράγοντα, στους οποίους περιλαμβάνονται αλλά όχι περιοριστικά, αζαθειοπρίνη, κυκλοφωσφαμίδη, μεθοτρεξάτη, κυκλοσπορίνη, σε διάστημα 4 μηνών πριν από τη διαλογή.
    Χρήση οποιασδήποτε κυττοκίνης-ρυθμιστή (ετανερσέπτη, αδαλιμουμάμπη, εφαλιζουμάμπη, ινφλιξιμάμπη, γολιμουμάμπη, κερτολιζουμάμπη, ριτουξιμάμπη) σε διάστημα 12 εβδομάδων ή 5 ημίσειων ζωών από τη διαλογή (24 εβδομάδες για τη ριτουξιμάμπη και 24 μήνες για την αλεφασέπτη).
    E.5 End points
    E.5.1Primary end point(s)
    Mean absolute change from baseline in percent predicted FVC at 52 weeks
    Απόλυτη μεταβολή από την έναρξη της % προβλεπόμενης FVC στις 52 εβδομάδες
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 έτος
    E.5.2Secondary end point(s)
    Proportion of patients with disease progression
    Number of deaths (all causes)
    Ποσοστό ασθενών με πρόοδο της νόσου.
    Αριθμός θανάτων (πάσης αιτιολογίας).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year
    1 έτος
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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. 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Czech Republic
    Korea, Republic of
    United Kingdom
    United States
    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
    Τελευταία Επίσκεψη Τελευταίου Ασθενούς
    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 months28
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months28
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 132
    F.4.2.2In the whole clinical trial 300
    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)
    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 Decision2015-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-14
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