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    Summary
    EudraCT Number:2016-003403-66
    Sponsor's Protocol Code Number:1199.225
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-003403-66
    A.3Full title of the trial
    An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD)
    Estudio de extensión, abierto, para evaluar la seguridad a largo plazo de nintedanib en pacientes con "Enfermedad Pulmonar Intersticial asociada a Esclerosis Sistémica" (SSc-ILD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to evaluate the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis.
    Ensayo para evaluar la seguridad de un tratamiento a largo plazo con nintedanib en pacientes con fibrosis pulmonar asociada a esclerodermia.
    A.3.2Name or abbreviated title of the trial where available
    SENSCIS (TM)-ON
    SENSCIS (TM)-ON
    A.4.1Sponsor's protocol code number1199.225
    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 SponsorBoehringer-Ingelheim España, S.A.
    B.1.3.4CountrySpain
    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 supportBoehringer Ingelheim España, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+34934045100
    B.5.5Fax number+34934045580
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 Yes
    D.2.1.1.1Trade name Ofev
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1724
    D.3 Description of the IMP
    D.3.1Product nameNintedanib
    D.3.2Product code BIBF 1120
    D.3.4Pharmaceutical form Capsule, soft
    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 INNNintedanib
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.9.3Other descriptive nameNINTEDANIB
    D.3.9.4EV Substance CodeSUB120728
    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 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 Yes
    D.2.1.1.1Trade name Ofev
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1724
    D.3 Description of the IMP
    D.3.1Product nameNintedanib
    D.3.2Product code BIBF 1120
    D.3.4Pharmaceutical form Capsule, soft
    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 INNNintedanib
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.9.3Other descriptive nameNINTEDANIB
    D.3.9.4EV Substance CodeSUB120728
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Systemic Sclerosis associated Interstitial Lung Disease
    Enfermedad Pulmonar Intersticial asociada a Esclerosis Sistémica
    E.1.1.1Medical condition in easily understood language
    Scleroderma related lung fibrosis
    Fibrosis pulmonar asociada a esclerodermia
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012977
    E.1.2Term Diffuse systemic sclerosis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036814
    E.1.2Term Progressive systemic sclerosis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10042954
    E.1.2Term Systemic sclerosis pulmonary
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025109
    E.1.2Term Lung involvement in systemic sclerosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).
    El principial objetivo es evaluar la seguridad a largo plazo del tratamiento oral de nintedanib en pacientes con Enfermedad Pulmonar Intersticial asociada a Esclerosis Sistémica
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who completed the SENSCISTM trial per protocol and did not permanently discontinue blinded treatment
    2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
    3. Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly as well as one barrier method for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information.
    1. Pacientes que hayan completado el ensayo SENSCISTM por protocolo y no hayan discontinuado de forma permanente el tratamiento enmascarado.
    2.Consentimiento informado escrito siguiendo la normativa local, firmado antes de la participación en el ensayo.
    3. Las mujeres potencialmente fértiles dispuestas a utilizar métodos anticonceptivos altamente eficaces según la directriz M3(R2) de la ICH, es decir, aquellos con una tasa de fracaso baja, inferior al 1 %, cuando se utilizan correctamente y de forma sistemática así como métodos de barrera durante 28 días antes de y 3 meses despues de la administración de nintedanib. Se provee una lista de métodos anticonceptivos que cumplen estos criterios durante la información al paciente.
    E.4Principal exclusion criteria
    1. AST, ALT > 3 x ULN
    2. Bilirubin > 2 x ULN
    3. Creatinine clearance <30 mL/min
    4. Clinically relevant anaemia at investigators discretion.
    5. Bleeding risk, any of the following
    a. Known genetic predisposition to bleeding according to the judgement of the
    investigator
    b. Patients who require
    i. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K
    antagonists, direct thrombin inhibitors, heparin, hirudin)
    ii. High dose antiplatelet therapy.
    [Note: Prophylactic low dose heparin or heparin flush as needed for
    maintenance of an indwelling intravenous device (e.g. enoxaparin 4000
    I.U. s. c. per day), as well as prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid up to 325 mg/day, or clopidogrel at 75 mg/day, or equivalent doses of other antiplatelet therapy) are not prohibited].
    c. Hemorrhagic central nervous system (CNS) event after completion of the parent trial SENSCISTM
    d. Any of the following after last treatment of SENSCISTM:
    i. Haemoptysis or haematuria
    ii. Active gastro-intestinal bleeding or GI – ulcers
    iii. Gastric antral vascular ectasia (GAVE)
    iv. Major injury or surgery (investigators judgement).
    e. Coagulation parameters: International normalised ratio (INR) >2, prolongation
    of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x
    ULN at Visit 1.
    6. New major thrombo-embolic events developed after completion of the parent trial
    SENSCISTM :
    a. Stroke;
    b. Deep vein thrombosis;
    c. Pulmonary embolism;
    d. Myocardial infarction.
    7. Major surgery (major according to the investigator’s assessment) performed within the next 3 months
    8. Time period > 12 weeks between last drug intake in SENSCISTM and Visit 2 of this trial.
    9. Usage of any investigational drug after completion of the parent trial SENSCISTM or
    planned usage of an investigational drug during the course of this trial.
    10. A disease or condition which in the opinion of investigator may put the patient at risk
    because of participation in this trial (e.g. clinically relevant intestinal pseudoobstruction)
    or limit the patient’s ability to participate in this trial
    11. Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, makes them an unreliable trial subject or unlikely to complete the trial
    12. Known hypersensitivity to the trial medication or its components (i.e. soya lecithin).
    13. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
    14. Previous enrolment in this trial
    1. AST, ALT > 3 x ULN
    2. Bilirrubina > 2 x ULN
    3. Aclaramiento de creatinina <30 mL/min
    4. Anemia clínicamente relevante según criterio del investigador
    5. Cualquiera de los siguientes riesgos de sangrado:
    a) Predisposición genética conocida al sangrado, de acuerdo con el juicio del investigador
    b) Pacientes que requieran:
    i.Fibrinolisis, dosis completa de tratamiento anticoagulante (p. ej. antagonistas de vitamina K, inhibidores directos de la trombina, heparina, hirudina)
    ii. Tratamiento antiagregante plaquetario a dosis elevadas.
    [Nota: no están prohibidas las dosis profilácticas bajas de heparina o las infusiones de heparina para el mantenimiento de dispositivos intravenosos permanentes (p.ej. enoxaparina 4000 U.I. vía subcutánea al día), así como el uso profiláctico de terapia antiplaquetaria (p.ej. ácido acetilsalicílico hasta 325 mg/día, clopidogrel a 75 mg/día o dosis equivalentes de otra terapia antiplaquetaria).]
    c)Antecedentes de un episodio hemorrágico del Sistema nervioso central (CNS) tras completar el ensayo SENSCISTM
    d) Cualquiera de los siguientes casos ocurridos tras el último tratamiento en SENSCISTM:
    i. Hemoptisis o hematuria
    ii. Sangrado gastrointestinal activo o úlceras gastrointestinales
    iii. Ectasia vascular antral gástrica (GAVE)
    iv. Operación o herida grave (a juicio del investigador)
    6. Nuevos eventos tromboembólicos graves desarrollados tras la finalización del ensayo padre SENSCISTM:
    a. Ictus
    b. Trombosis venos profunda
    c. Embolia pulmonary
    d. Infarto de miocardio
    7. Operación grave (de acuerdo a la evaluación del investigador) prevista para los próximos 3 meses.
    8. Periodo de tiempo> 12 semanas entre la última toma de medicamento en SENSCISTM y la visita 2 de este ensayo.
    9. Uso de cualquier medicamento en investigación tras la finalización del ensayo padre SENSCISTM o uso planificado de un medicamento en investigación durante el trascurso de este ensayo.
    10. Enfermedad o condición que en opinión del investigador pueda poner en riesgo al paciente debido a su participación en este ensayo (p.ej. pseudo-obstrucción intestinal clínicamente relevante) o limitar la habilidad del paciente de participar en este ensayo.
    11. Alcoholismo o abuso de fármacos o cualquier condición que, en opinión del investigador, les convierta en un paciente poco fiable o con pocas posibilidades de finalizar el ensayo.
    12. Hipersensibilidad conocida a la medicación de este ensayo o a sus compuestos (p.ej. lecitina de soja).
    13. Mujeres embarazadas, en periodo de lactancia o que prevean quedarse embarazadas durante el periodo del estudio.
    14. Inclusión previa en este ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    1) The primary endpoint is the incidence of overall adverse events over the course of this extension trial.
    1) El objetivo principal es la incidencia de eventos adversos en general durante el transcurso del estudio de extensión.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) up to 34 months
    1) hasta 34 meses
    E.5.2Secondary end point(s)
    1) n/a
    1) no aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) n/a
    1) no aplica
    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 No
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.2.4Number of treatment arms in the trial1
    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 EEA85
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    China
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Greece
    Hungary
    India
    Ireland
    Israel
    Italy
    Japan
    Malaysia
    Mexico
    Netherlands
    Norway
    Poland
    Portugal
    Spain
    Sweden
    Switzerland
    Thailand
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 250
    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 Decision2018-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
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