Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,858
Countries
20
Sites
133
idiopathic pulmonary fibrosis (IPF)
The main objective is to assess the long-term tolerability, safety, and efficacy of oral nerandomilast treatment in patients with IPF and other types of PPF who have completed planned treatment (and did not prematurely discontinue trial medication permanently in the pivotal Phase III parent trials, 1305-0014 [FIBRONEER…
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH, Boehringer Ingelheim RCV GmbH & Co. KG, Boehringer Ingelheim Espana S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 10 Sep 2024 → ongoing
- Decision date (initial)
- 2024-04-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507353-15-00
- WHO UTN
- U1111-1295-8894
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
The main objective is to assess the long-term tolerability, safety, and efficacy of oral nerandomilast treatment in patients with IPF and other types of PPF who have completed planned treatment (and did not prematurely discontinue trial medication permanently in the pivotal Phase III parent trials, 1305-0014 [FIBRONEER™-IPF] and 1305-0023 [FIBRONEER™-ILD]), and phase IIa 1305-0035.
The primary objective of the trial is to descriptively assess the incidence of patients with any adverse event. There will be no treatment comparison and the assessment will be while on treatment.
Secondary objectives 1
- Descriptively assess efficacy of nerandomilast treatment
Conditions and MedDRA coding
idiopathic pulmonary fibrosis (IPF)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10021240 | Idiopathic pulmonary fibrosis | 100000004855 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment Open label
|
Not Applicable | None | All participants: All participants | |
| 2 | Follow-up Follow-up
|
Not Applicable | None | All participants: All participants |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed “Document Sharing Agreement”. Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website. Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program. Access Criteria: For study documents – upon signing of a ‚Document Sharing Agreement‘. For study data – 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-001091-34 | A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Idiopathic Pulmonary Fibrosis (IPF), Etude en double aveugle, randomisée, contrôlée versus placebo, évaluant l’efficacité et la sécurité du BI 1015550 pendant au moins 52 semaines chez des patients présentant une Fibrose Pulmonaire Idiopathique (FPI), Ensayo doble ciego, aleatorizado y controlado con placebo para evaluar la eficacia y seguridad del BI 1015550 durante al menos 52 semanas en pacientes con Fibrosis Pulmonar Idiopática (FPI), Dvojno slepo, randomizirano, s placebom kontrolirano preskušanje, ki ocenjuje učinkovitost in varnost BI 1015550 v vsaj 52 tednih pri bolnikih z idiopatsko pljučno fibrozo (IPF), Dvojitě zaslepené, randomizované, placebem kontrolované klinické hodnocení posuzující účinnost a bezpečnost přípravku BI 1015550 po dobu nejméně 52 týdnů u pacientů s idiopatickou plicní fibrózou (IPF) , Dvojitě zaslepené, randomizované, placebem kontrolované klinické hodnocení posuzující účinnost a bezpečnost přípravku BI 1015550 po dobu nejméně 52 týdnů u pacientů s idiopatickou plicní fibrózou (IPF) , Dvojitě zaslepené, randomizované, placebem kontrolované klinické hodnocení posuzující účinnost a bezpečnost přípravku BI 1015550 po dobu nejméně 52 týdnů u pacientů s idiopatickou plicní fibrózou (IPF) , Kettős vak, randomizált, placebo-kontrollált vizsgálat a BI 1015550 hatásosságának és biztonságosságának értékelésére legalább 52 héten keresztül, idiopathiás pulmonalis fibrosisban (IPF) szenvedő betegek esetében, Studio in doppio cieco, randomizzato, controllato verso placebo volto a valutare l'efficacia e la sicurezza di BI 1015550 somministrato per almeno 52 settimane in pazienti con fibrosi polmonare idiopatica (FPI), Dvostruko slijepo, randomizirano, placebom kontrolirano ispitivanje kojim se procjenjuje učinkovitost i sigurnost lijeka BI 1015550 tijekom najmanje 52 tjedna u bolesnika s idiopatskom plućnom fibrozom (IPF) | |
| 2022-001134-11 | A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs), Etude en double aveugle, randomisée, contrôlée versus placebo, évaluant l’efficacité et la sécurité du BI 1015550 pendant au moins 52 semaines chez des patients présentant une Pneumopathie Interstitielle Diffuse Fibrosante Progressive (PID-FP), Estudio doble ciego, aleatorizado y controlado con placebo que evalúa la eficacia y seguridad de BI 1015550 durante al menos 52 semanas en pacientes con enfermedades pulmonares intersticiales fibrosantes progresivas (EPI-FP), Dvojno slepo, randomizirano, s placebom kontrolirano preskušanje, ki ocenjuje učinkovitost in varnost BI 1015550 v vsaj 52 tednih pri bolnikih s progresivno fibrozno intersticijsko pljučno boleznijo (PF-ILD), Dvojitě zaslepené, randomizované, placebem kontrolované klinické hodnocení posuzující účinnost a bezpečnost přípravku BI 1015550 po dobu nejméně 52 týdnů u pacientů s progresivní fibrotizující intersticiální plicní nemocí (PF-ILD), Dvojitě zaslepené, randomizované, placebem kontrolované klinické hodnocení posuzující účinnost a bezpečnost přípravku BI 1015550 po dobu nejméně 52 týdnů u pacientů s progresivní fibrotizující intersticiální plicní nemocí (PF-ILD), Kettős vak, randomizált, placebo-kontrollált vizsgálat, a BI 1015550 hatásosságának és bizton-ságosságának értékelésére legalább 52 héten keresztül progresszív fibrotizáló intersticiális tüdőbetegségekben (PF-ILD-k) szenvedő betegek esetében, Studio in doppio cieco, randomizzato, controllato verso placebo volto a valutare l'efficacia e la sicurezza di BI 1015550 somministrato per almeno 52 settimane in pazienti con pneumopatie interstiziali fibrosanti progressive (PF-ILDs), Dvostruko slijepo, randomizirano, placebom kontrolirano ispitivanje kojim se procjenjuje učinkovitost i sigurnost lijeka BI 1015550 tijekom najmanje 52 tjedna u bolesnika s progresivnom intersticijskom bolesti pluća s fibroznim promjenama (PF-ILD) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Women of childbearing potential (WOCBP) 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. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information. For France, fertile males must be ready and able to use acceptable methods of birth control
Exclusion criteria 9
- Any disease that may put the patient at risk when participating in this trial at investigator’s discretion.
- Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1: - any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour) - any suicidal ideation of type 4 or 5 in the C-SSRS (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
- Patients with clinically relevant severe depression at investigator’s discretion or a HADS subscore >14 at Visit 1.
- An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.
- Patient will undergo lung transplantation, with an assigned date of surgery.
- Patients with a BMI <18.5 kg/m² that experienced an additional, unexplained and clinically significant (>10%) weight loss during the parent trial
- At Visit 1, patients with ongoing AESI except for latent tuberculosis (suspected vasculitis, DILI, severe infections) that led to temporary treatment interruption in the parent trial
- Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- Further exclusion criteria apply.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- any adverse event over the course of the extension trial (yes/no) i.e. up until the follow-up/end of study visit planned at the latest at week 99.
Secondary endpoints 7
- Absolute change from baseline in FVC (mL) and in % predicted FVC over time
- Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial
- Time to first acute IPF/PPF exacerbation, first hospitalisation for respiratory cause, or death (whichever occurs first) over the duration of the trial
- Time to first acute IPF/PPF exacerbation or death over the duration of the trial
- Time to hospitalisation for respiratory cause or death over the duration of the trial
- Time to absolute decline in FVC % predicted of >10% from baseline or death over the duration of the trial
- Time to relative decline in FVC % predicted of >10% from baseline or death over the duration of the trial
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10855744 · Product
- Active substance
- 1-5R-2-4-5-CHLORO-2-PYRIMIDINYL-1-PIPERIDINYL-67- DIHYDRO-5-OXIDOTHIENO32-DPYRIMIDIN-4- Yl]Amino]-Cyclobutanemethanol
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 18 mg milligram(s)
- Max total dose
- 13140 mg milligram(s)
- Max treatment duration
- 98 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
PRD10442862 · Product
- Active substance
- BI 1015550
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 36 mg milligram(s)
- Max total dose
- 26280 mg milligram(s)
- Max treatment duration
- 98 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Other |
Boehringer Ingelheim RCV GmbH & Co. KG
- Sponsor organisation
- Boehringer Ingelheim RCV GmbH & Co. KG
- Address
- Dr.-Boehringer-Gasse 5-11, Meidling Meidling
- City
- Vienna
- Postcode
- 1121
- Country
- Austria
Scientific contact point
- Organisation
- Boehringer Ingelheim RCV GmbH & Co. KG
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim RCV GmbH & Co. KG
- Contact name
- CT Disclosure & Data Transparency
Boehringer Ingelheim Espana S.A.
- Sponsor organisation
- Boehringer Ingelheim Espana S.A.
- Address
- Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles
- City
- Barcelona
- Postcode
- 08174
- Country
- Spain
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Sponsor responsibilities
- Article 77 compliance
- Boehringer Ingelheim International GmbH
- Contact point sponsor
- Boehringer Ingelheim International GmbH
- Article 77 implementation
- Boehringer Ingelheim International GmbH
Locations
20 EU/EEA countries · 133 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 23 | 6 |
| Belgium | Ongoing, recruiting | 23 | 7 |
| Croatia | Ongoing, recruiting | 5 | 3 |
| Czechia | Ongoing, recruiting | 2 | 1 |
| Denmark | Ongoing, recruiting | 11 | 3 |
| Estonia | Ongoing, recruiting | 5 | 1 |
| Finland | Ongoing, recruiting | 14 | 4 |
| France | Ongoing, recruiting | 109 | 22 |
| Germany | Ongoing, recruitment ended | 104 | 19 |
| Greece | Ongoing, recruiting | 9 | 4 |
| Hungary | Ongoing, recruiting | 7 | 3 |
| Ireland | Ongoing, recruiting | 3 | 2 |
| Italy | Ongoing, recruiting | 53 | 14 |
| Netherlands | Ongoing, recruiting | 24 | 4 |
| Norway | Ongoing, recruiting | 17 | 3 |
| Poland | Ongoing, recruiting | 8 | 5 |
| Portugal | Ongoing, recruiting | 8 | 5 |
| Slovenia | Ended | 1 | 1 |
| Spain | Ongoing, recruiting | 120 | 24 |
| Sweden | Ongoing, recruiting | 5 | 2 |
| Rest of world
Georgia, Turkey, Korea, Republic of, Japan, Canada, Switzerland, South Africa, Chile, New Zealand, Australia, Singapore, China, Malaysia, Taiwan, Saudi Arabia, United Kingdom, Argentina, Mexico, United States, Israel, India, Thailand, Brazil, Serbia
|
— | 1,307 | — |
Investigational sites
Universitaetsklinikum Krems
Clinical Department for Pneumology, Mitterweg 10, 3500, Krems An Der Donau
Stadt Wien Wiener Gesundheitsverbund
Abteilung für Atemwegs- und Lungenkrankheiten, Sanatoriumstrasse 2, Penzing, Vienna
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Department for Pneumology, Muellner Hauptstrasse 48, 5020, Salzburg
Klinikum Wels-Grieskirchen GmbH
Department for Pulmology, Grieskirchner Strasse 42, 4600, Wels
Medical University Of Vienna
Internal Medicine II - Department for Pulmonology, Waehringer Guertel 18-20, Alsergrund, Vienna
Krankenhaus Nord Klinik Floridsdorf
Department for Internal Medicine and Pneumology, Bruenner Strasse 68, Floridsdorf, Vienna
CHU De Liege
Pneumologie department, Avenue De L'hopital 1, 4000, Liege
UZ Leuven
Department Functiemetingen Pneumologie, Herestraat 49, 3000, Leuven
Hopital Erasme
Pneumology department Level -1, Route 693, Lennikse Baan 808, 1070, Anderlecht
UCL Mont-Godinne
Pneumologie Route 27, Avenue Dr-Gaston-Therasse 1, 5530, Yvoir
Cliniques Universitaires Saint-Luc
Route 608, level -2, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Het Ziekenhuisnetwerk Antwerpen
Department of Pneumology (consultatie), Lindendreef 1, 2020, Antwerp
Universitair Ziekenhuis Gent
department of Rheumatology, Corneel Heymanslaan 10, 9000, Gent
Clinical Hospital Dubrava
Department of Pulmonology, Avenija Gojka Suska 6, Zagreb, Grad Zagreb
University Hospital Centre Zagreb
Department of Pulmonology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Poliklinika Solmed d.o.o.
Department of Clinical Immunology, Pulmonology and Rheumatology, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Odense University Hospital
Lungemedicinsk Forskning, Afd-J, Indgang 87-88, Kloevervaenget 2, Odense C
Gentofte Hospital
Lungemedicinsk Forskningsafdeling, Gentofte Hospitalsvej 1, 2900, Hellerup
Aarhus Universitetshospital
Lungesygdomme, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
North Estonia Medical Centre Foundation
Department of Pulmonology, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn
Oulu University Hospital
neurologian tutkimusyksikkö / S4 R43, Kajaanintie 50, 90220, Oulu
Turku University Hospital
keuhkosairauksien klinikka, T-sairaala, Hameentie 11, 20520, Turku
Tampere University Hospital
TKI-keskuksen Tutkimusvastaanotto,, Biokatu 12 5 6, 33520, Tampere
HUS-Yhtymae
Biomedicum Helsinki 2C, P. O. Box 705, 00029, Helsinki
Centre Hospitalier Universitaire De Rennes
Service de Pneumologie, 2 Rue Henri Le Guilloux, 35000, Rennes
University Hospital Of Montpellier
Département de Pneumologie, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Nantes
Centre d’Investigation Clinique - Centre de Référence – RCB, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Bordeaux
Service Pneumologie, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire Grenoble Alpes
Service de Pneumologie, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire Reims
Service des Maladies Respiratoires, Rue Du General Koenig, 51092, Reims Cedex
Assistance Publique Hopitaux De Paris
Not applicable, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Centre Hospitalier Universitaire D'Angers
Not applicable, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Regional Et Universitaire De Brest
Centre d’Investigation Clinique, Boulevard Tanguy Prigent, 29609, Brest Cedex 2
Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
Service de Pneumologie - Allergologie - Oncologie Thoracique, 185 Rue Raymond Losserand, 75674, Paris Cedex 14
CHU De Rouen
Not applicable, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Toulouse
Service de Pneumologie, 24 Chemin De Pouvourville, 31400, Toulouse
Centre Hospitalier Universitaire De Caen Normandie
Centre de Recherche Clinique, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Dijon
Service Pneumologie, 14 Rue Paul Gaffarel, 21000, Dijon
Bicetre Hospital
Service de Pneumologie, Réanimation respiratoire, 78 Rue Du General Leclerc, 94275, Le Kremlin Bicetre Cedex
Centre Hospitalier Universitaire De Lille
Service Pneumo Immuno Allergologie, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Assistance Publique Hopitaux De Paris
Hôpital de jour - Service de Pneumologie et Soins Intensifs, 20 Rue Leblanc, 75015, Paris
Assistance Publique Hopitaux De Paris
Unité de Médecine Ambulatoire Pair Pneumologie, 125 Rue De Stalingrad, 93000, Bobigny
Centre Hospitalier Universitaire De Nice
Service de Pneumologie, 30 Voie Romaine, 06000, Nice
Hospital Foch
Service de Pneumologie, 40 Rue Worth, 92150, Suresnes
Assistance Publique Hopitaux De Marseille
Service de Pneumologie - Maladies Rares Respiratoires, 265 Chemin Des Bourrely, 13015, Marseille
Hospices Civils De Lyon
Service de Pneumologie, 59 Boulevard Pinel, 69500, Bron
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Lungenzentrum Stuttgart, Auerbachstrasse 112, Bad Cannstatt, Stuttgart
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Abteilung Pneumologie und Allergologie, Tueschener Weg 40, Heidhausen, Essen
Universitaetsklinikum Tuebingen AöR
Medizinische Klinik Innere Medizin VIII, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Velocity Clinical Research Germany GmbH
Standort Grosshansdorf, Pneumologisches Forschungsinstitut, Klaus-Groth-Strasse 2-4, 22926, Ahrensburg
GWT-Tud GmbH
Zentrum für Pneumologie, Allergologie, Neucoswiger Strasse 21, 01640, Coswig
University Medical Center Hamburg-Eppendorf
Zentrum für Onkologie Abteilung für Pneumologie, Martinistrasse 52, Eppendorf, Hamburg
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
Zentrum für Pneumologie und Thoraxchirurgie, Theo-Funccius-Strasse 1, 58675, Hemer
Klinikum Region Hannover GmbH
Klinik für Pneumologie, Intensiv- und Schlafmedizin, Stadionbruecke 4, Linden-Sued, Hanover
Medizinische Hochschule Hannover
Klinik für Pneumologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Klinikum Konstanz GmbH
Gesundheitsverbund Landkreis Konstanz gGmbH, Mainaustrasse 35, Petershausen, Konstanz
Klinikum Nuernberg
Klinik für Innere Medizin 3, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Lungenfachklinik Immenhausen
Lungenfachklinik Immenhausen, Robert-Koch-Str. 3, 34376, Immenhausen
Thoraxklinik Heidelberg gGmbH
am Universitätsklinikum Heidelberg, Roentgenstrasse 1, Rohrbach, Heidelberg
HELIOS Hanseklinikum Stralsund GmbH
Pneumologie, Grosse Parower Strasse 47 - 53, Knieper, Stralsund
CIMS Studienzentrum Bamberg GmbH
Gemeinschaftspraxis, Buger Strasse 82, Berg, Bamberg
Krankenhaus Bethanien gGmbH
Klinik für Pneumologie und Allergologie, Aufderhoeher Strasse 169, Ohligs/Aufderhoehe, Solingen
Universitaetsklinikum Bonn AöR
Sektion Pneumologie, Venusberg-Campus 1, Venusberg, Bonn
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik V - Pneumologie, Marchioninistrasse 15, Hadern, Munich
Vivantes Netzwerk fuer Gesundheit GmbH
Klinik für Innere Medizin – Pneumologie und Infektiologie, Rudower Strasse 48, Buckow, Berlin
Ippokratio General Hospital Of Thessaloniki
General Hospital of Thessaloniki "Hippokrateio", Konstadinoupoleos 49, 546 42, Thessaloniki
University General Hospital Of Heraklion
Pulmonary Department, Stavrakia And Voutes, 715 00, Heraklion
University General Hospital Of Ioannina
Respiratory outpatient department, Niarchou Stavrou Avenue, 455 00, Ioannina
General University Hospital Of Patras
University Pulmonology Clinic, Rio, 265 04, Patras
University Of Debrecen
Pulmonology Clinic, Nagyerdei Korut 98, 4032, Debrecen
Semmelweis University
Faculty of General Medicine, Clinic of Pulmonology, Tomo Utca 25-29, 1083, Budapest VIII
Koranyi National Institute For Pulmonology
IV. Pulmonology Department, Koranyi Frigyes Ut 1, 1121, Budapest XII
Mater Misericordiae University Hospital
Catherine McAuley Centre, Eccles Street, D07 R2WY, Dublin 7
Connolly Hospital
Respiratory Department / Research, Mill Road, D15 X40D, Dublin 15
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Via Santa Sofia 78, Via Santa Sofia 78, 95123, Catania
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
Clinica di Malattie Respiratorie dell’Università degli Studi di Milano, Via Antonio Di Rudini' 8, 20142, Milan
Azienda Ospedaliera Universitaria Senese
U.O.C. Malattie Respiratorie e Trapianto Polmonare, Strada Delle Scotte 14, 53100, Siena
Azienda Ospedaliera Universitaria Federico II Di Napoli
Clinica di Malattie dell’Apparato Respiratorio, Via Sergio Pansini 5, 80131, Naples
Careggi University Hospital
Pneumologia Interventistica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero Universitaria Ospedali Riuniti
Pneumologia 4, Viale Luigi Pinto 1, 71122, Foggia
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
U. O. di Pneumologia, Via Filippo Corridoni 11, 60123, Ancona
Multimedica S.p.A.
U.O. di Pneumologia, Via San Vittore 12, 20123, Milan
Ospedale Giovan Battista Morgagni-Luigi Pierantoni Di Forlì
Dipartimento Toracico - AUSL di Forlì, Via Carlo Forlanini 34, 47121, Forli'
Azienda Ospedaliero Universitaria Di Modena
Clinica Malattie Apparato Respiratorio, Largo Del Pozzo 71, 41124, Modena
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
U.O. di Pneumologia e Fisiopatologia Respiratoria, Piazzale Spedali Civili 1, 25123, Brescia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
U.O.C. Pneumologia, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedale-Universita Padova
U.O. Pneumologia, Via Nicolo' Giustiniani 2, 35128, Padova
Fondazione IRCCS San Gerardo Dei Tintori
U.O. di Pneumologia, Via Giovanni Battista Pergolesi 33, 20900, Monza
Academisch Ziekenhuis Leiden
Not applicable, Albinusdreef 2, 2333 ZA, Leiden
Zuyderland Medisch Centrum Stichting
Not applicable, Henri Dunantstraat 5, 6419 PC, Heerlen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Not applicable, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Sint Antonius Ziekenhuis Stichting
Afdeling Longziekten, Koekoekslaan 1, 3435 CM, Nieuwegein
Oslo University Hospital HF
Lungeavdelingen, Sognsvannsveien 20, 0372, Oslo
Akershus University Hospital
Lungepoliklinikken B105, Sykehusveien 25, 1474, Loerenskog
Helse Bergen HF
Outpatient Clinic, Dept. of Thoracic Medicine, Jonas Lies Vei 65, 5021, Bergen
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Department of Pneumology, Ul. Ziolowa 45/47, 40-635, Katowice
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Dept of Internal Medicine, Pulmonary Diseases and Allergy, Ul. Ulica Stefana Banacha 1a, 02-097, Warsaw
Uniwersyteckie Centrum Kliniczne
Alergology and Pneumonology Department, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
National Institute Of Tuberculosis And Lung Diseases
1st Department of Lung Diseases, Ul. Plocka 26, 01-138, Warsaw
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.
Practice, Ul. Kolejowa 3, 21-047, Swidnik
CCAB Centro Clinico Academico Braga Associacao
Not applicable, Lugar De Sete Fontes S Victor, 4710-243, Braga
Centro Hospitalar E Universitario De Coimbra E.P.E.
Serviço de Pneumologia, Praceta Professor Mota Pinto, 3000-459, Coimbra
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
Serviço de Pneumologia, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Hospital Pedro Hispano
Serviço de Nefrologia, Rua Doutor Eduardo Torres 1, 4450-113, Matosinhos
Centro Hospitalar Universitario Lisboa Central E.P.E.
Serviço de Pneumologia, Rua Jose Antonio Serrano, 1150-199, Lisbon
Bellvitge University Hospital
Servicio de Neumología, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
Hospital Universitario Virgen De Las Nieves
Servicio de Neumología, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Servei De Salut De Les Illes Balears
Servicio de Neumología, Carretera Valldemossa 79, 07120, Palma
University Clinical Hospital Virgen De La Arrixaca
Servicio de Neumología, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital General Universitario Gregorio Maranon
Servicio de Neumología, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital General Universitario De Valencia
Servicio de Neumología, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital Universitario Central De Asturias
Servicio de Neumología, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario Marques De Valdecilla
Servicio de Neumología, Avenida Valdecilla Sn, 39008, Santander
Hospital Del Mar
Servicio de Neumología, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital De Galdakao Usansolo
Servicio de Neumología, Leku Barrio Labeaga 46 A, 48960, Galdakao
Hospital Universitari Vall D Hebron
Servicio de Neumología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Ramon Y Cajal
Servicio de Neumología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Quironsalud Madrid
Servicio de Neumología, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario 12 De Octubre
Servicio de Neumología, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario De La Princesa
Servicio de Neumología, Calle De Diego De Leon 62, 28006, Madrid
Hospital Clinic De Barcelona
Servicio de Neumología, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Virgen De Valme
Servicio de Neumología, Avenida Bellavista S/n, 41014, Sevilla
University Hospital Virgen Del Rocio S.L.
Servicio de Neumología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Infanta Leonor
Servicio de Neumología, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital General Universitario Dr. Balmis
Servicio de Neumología, Avinguda Del Pintor Baeza 12, 03010, Alicante
Universidade De Santiago De Compostela
Servicio de Neumología, Rua Da Choupana Sn, 15706, Santiago De Compostela
Hospital Universitario Basurto
Servicio de Neumología, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital Universitario Virgen De La Victoria
Servicio de Neumología, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitari De Girona Doctor Josep Trueta
Servicio de Neumología, Avinguda De Franca S/n, 17007, Girona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-09-30 | 2024-10-30 | |||
| Belgium | 2024-09-12 | 2024-09-26 | |||
| Croatia | 2025-02-11 | 2025-02-17 | |||
| Czechia | 2025-03-19 | 2025-03-19 | |||
| Denmark | 2024-09-13 | 2024-10-08 | |||
| Estonia | 2024-09-20 | 2024-09-30 | |||
| Finland | 2024-09-17 | 2024-10-16 | |||
| France | 2024-09-10 | 2024-09-30 | |||
| Germany | 2024-09-17 | 2024-09-26 | 2025-03-13 | ||
| Greece | 2024-09-25 | 2024-11-20 | |||
| Hungary | 2024-10-04 | 2024-10-14 | |||
| Ireland | 2024-11-08 | 2025-02-06 | |||
| Italy | 2024-09-25 | 2024-10-02 | |||
| Netherlands | 2024-09-13 | 2024-09-30 | |||
| Norway | 2024-09-13 | 2024-10-08 | |||
| Poland | 2024-09-19 | 2024-10-30 | |||
| Portugal | 2024-10-14 | 2024-11-18 | |||
| Slovenia | 2025-02-20 | 2025-03-10 | 2025-02-24 | ||
| Spain | 2024-09-25 | 2024-10-08 | |||
| Sweden | 2024-09-26 | 2024-11-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 248 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-507353-15-00-GR-public | 5 |
| Protocol (for publication) | D1_Protocol 2023-507353-15-00-public | 5 |
| Protocol (for publication) | D1_Protocol-local amendment-EU-2023-507353-15-00-public | 2 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-EE-est-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-EE-est-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-EE-russ-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-EE-russ-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-english-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-english-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swed-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swed-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HR-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HR-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NL-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NL-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PT-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PT-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SI-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SI-lpf-symptoms | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-AT | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-BE | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-CZ | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-DE | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-DK | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-EE | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-ES | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-FI | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-FR | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-GR | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-HR | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-HU | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-ic-agreement-HR | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-IE | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-IT | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-NL | 3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-NO | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-PL | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-PT | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-SE | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-SI | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-DE-mock-up-ICF | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-DE-process-description | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-appendix-finnish-FI-public | 7-1 |
| Subject information and informed consent form (for publication) | L1_ ICF-AT-public | 8-1 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver agreem-AT | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver agreem-FR-fre | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver agreem-NL | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver agreement-GR | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver-agreem-DK | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver-agreem-ES | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver-agreem-SE | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver-agreem-SI | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver-agreement-dutch-BE-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver-agreement-english-BE-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver-agreement-finnish-FI | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver-agreement-french-BE-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver-agreement-NO | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver-HU | 1-3 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver-IT | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver-PT | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-CZ | 8-1 |
| Subject information and informed consent form (for publication) | L1_ ICF-DE-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-DK-public | 8-1 |
| Subject information and informed consent form (for publication) | L1_ ICF-dutch-BE-public | 8-1 |
| Subject information and informed consent form (for publication) | L1_ ICF-ecoa-CZ | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-EE-public | 8-1 |
| Subject information and informed consent form (for publication) | L1_ ICF-EE-russ-public | 8-1 |
| Subject information and informed consent form (for publication) | L1_ ICF-english-BE-public | 8-1 |
| Subject information and informed consent form (for publication) | L1_ ICF-ES-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-finnish-FI-public | 7-1 |
| Subject information and informed consent form (for publication) | L1_ ICF-french-BE-public | 8-1 |
| Subject information and informed consent form (for publication) | L1_ ICF-gdpr-CZ | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-GR-public | 8-5 |
| Subject information and informed consent form (for publication) | L1_ ICF-greenphire-IE | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-HR-public | 8-1 |
| Subject information and informed consent form (for publication) | L1_ ICF-HU-public | 8-3 |
| Subject information and informed consent form (for publication) | L1_ ICF-IE-public | 8-7 |
| Subject information and informed consent form (for publication) | L1_ ICF-IT-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-FR-fre-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-NO-public | 8-1 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-PT-public | 8-1 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-reconsent-FR-public | 8-1 |
| Subject information and informed consent form (for publication) | L1_ ICF-NL-public | 8-2 |
| Subject information and informed consent form (for publication) | L1_ ICF-optional-caregiver-HR | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-optional-sub-study-GR | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-optional-substudy-CZ | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-optional-substudy-ES | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-optional-substudy-IE | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-optional-substudy-NL | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-optional-substudy-SE | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-optional-use-of-travel-services-HR | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-patient-reimb-ES-public | 4 |
| Subject information and informed consent form (for publication) | L1_ ICF-patient-reimb-privacy-policy-ES-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant partner-AT | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant partner-FR-fre-public | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant partner-HU | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant partner-NL | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-ES | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-participant-HR | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-participant-PT-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-CZ | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-DE-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-DK | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-dutch-BE-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-EE | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-english-BE-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-finnish-FI | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-french-BE-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-GR | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-HR | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-IE | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-IT | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-NO | 4 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-PL | 1-2 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-PT-public | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-SE | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-SI | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-proof-insurance-SE | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-public | 8-2 |
| Subject information and informed consent form (for publication) | L1_ ICF-russ-pregnant-partner-EE | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-russ-substudy-EE | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-SE-public | 8-1 |
| Subject information and informed consent form (for publication) | L1_ ICF-SI-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-sponsor-english-BE-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-sub-study-SI | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-AT | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-DK | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-EE | 2-2 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-FR-fre-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-HR | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-hrct-dutch-BE-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-hrct-english-BE-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-hrct-finnish-FI | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-hrct-french-BE-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-HU | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-IT | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-NO | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-PL | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-PT-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-travel-services-GR | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-travel-services-IT | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-travel-services-SI | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-travelservices-HU | 1 |
| Subject information and informed consent form (for publication) | l1_icf-caregiver-pl | 1 |
| Subject information and informed consent form (for publication) | l1_icf-main-es-public | 8-1 |
| Subject information and informed consent form (for publication) | l1_icf-other-at | 2 |
| Subject information and informed consent form (for publication) | l1_icf-other-hr-DTP-shipping-services | 1 |
| Subject information and informed consent form (for publication) | l1_icf-re-consent-be-dut-public | 6 |
| Subject information and informed consent form (for publication) | l1_icf-re-consent-be-eng-public | 6 |
| Subject information and informed consent form (for publication) | l1_icf-re-consent-be-fre-public | 6 |
| Subject information and informed consent form (for publication) | l1_icf-re-consent-de-public | 8 |
| Subject information and informed consent form (for publication) | l1_icf-re-consent-ES-public | 8-1 |
| Subject information and informed consent form (for publication) | l1_icf-re-consent-fi-public | 6 |
| Subject information and informed consent form (for publication) | l1_icf-re-consent-gr-public | 3 |
| Subject information and informed consent form (for publication) | l1_icf-re-consent-ie-public | 8-7 |
| Subject information and informed consent form (for publication) | L1_icf-re-consent-it-public | 8-1 |
| Subject information and informed consent form (for publication) | l1_icf-re-consent-NL | 6 |
| Subject information and informed consent form (for publication) | l1_icf-re-consent-NO-public | 6 |
| Subject information and informed consent form (for publication) | l1_icf-re-consent-PT-public | 6 |
| Subject information and informed consent form (for publication) | l1_icf-re-consent-SE | 6 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-application-electronic-assessment | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-trialidcard-HU | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-trialidcard-letter-HU-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-ecoa | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-ecoa-application-DK | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-ecoa-application-PT | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-ecoa-dutch-BE | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-ecoa-english-BE | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-ecoa-finnish-FI | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-ecoa-french-BE | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-ecoa-NO | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-ecoa-participant-manual-ES | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-gp-letter-PT-public | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-HR | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-IT-ecoa | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-IT-travelservices | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-leaflet-DK | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-PL | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-travel-services-FR-fre | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-travel-services-GR | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-ecoa-HU | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-IT-letter to gp-public | 4 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-summary-IE | 3 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-travelservices-AT | 1 |
| Subject information and informed consent form (for publication) | L2_ Other-subject-information-material-ecoa-application-SE | 1 |
| Subject information and informed consent form (for publication) | L2_ Sites-list-AT | 6 |
| Subject information and informed consent form (for publication) | l2_other-subject-info-patient-privacy-fi-public | 4 |
| Synopsis of the protocol (for publication) | D1_ Protocol summary_2023-507353-15-00-SI-public | 4 |
| Synopsis of the protocol (for publication) | D1_ Protocol summary_AT 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol summary_CZ 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol summary_HR 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol summary_HU 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol summary_IT 2023-507353-15-00-public | 4 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_AT 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_BE dutch 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_BE french 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_BE german 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_CZ 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_DE 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_DK 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_EE 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ES 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_FI 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_FI-swe-2023-507353-15-00 | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_FR 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_GR 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_HR 2023-507353-15-00 | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_HU 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_IE 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_IT 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_NL 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_NO 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_PL 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_PT 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_SE 2023-507353-15-00-public | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_SI 2023-507353-15-00-public | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-summary-2023-507353-15-00-public | 4 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-18 | Czechia | Acceptable with conditions 2024-04-19
|
2024-04-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-04 | Czechia | Acceptable 2024-09-06
|
2024-09-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-04 | Czechia | Acceptable 2025-05-06
|
2025-05-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-17 | Czechia | Acceptable 2025-10-23
|
2025-10-23 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-01 | Acceptable | 2026-01-23 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-01 | Acceptable | 2025-12-12 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-01 | Acceptable | 2026-01-16 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-02-04 | Acceptable | 2026-03-09 |