Clinical trial • Phase III • Respiratory

BI 1015550 (chemical: 1-[[(5R)-2-[4-(5-CHLORO-2-PYRIMIDINYL)-1-PIPERIDINYL]-6,7-DIHYDRO-5-OXIDOTHIENO[3,2-D]PYRIMIDIN-4-YL]AMINO]-CYCLOBUTANEMETHANOL) for Idiopathic pulmonary fibrosis | Progressive pulmonary fibrosis

Phase III trial of BI 1015550 (chemical: 1-[[(5R)-2-[4-(5-CHLORO-2-PYRIMIDINYL)-1-PIPERIDINYL]-6,7-DIHYDRO-5-OXIDOTHIENO[3,2-D]PYRIMIDIN-4-YL]AMINO]-CYCLO…

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Idiopathic pulmonary fibrosis | Progressive pulmonary fibrosis
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
18-12-2023
First CTIS Authorization Date
19-04-2024

Trial design

open-label, none/not specified-controlled Phase III trial in Slovenia, Austria, Belgium and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
1307
Trial Duration For Participant
693

Eligibility

Recruits 1307 Vulnerable population selected. Signed and dated written informed consent is required prior to admission in accordance with ICH-GCP and local legislation. Caregiver agreement documents and other subject information forms are provided (country-specific ICF and caregiver agreement documents listed in the application), indicating caregiver/representative consent arrangements where applicable..

Vulnerable Population
Vulnerable population selected. Signed and dated written informed consent is required prior to admission in accordance with ICH-GCP and local legislation. Caregiver agreement documents and other subject information forms are provided (country-specific ICF and caregiver agreement documents listed in the application), indicating caregiver/representative consent arrangements where applicable.

Inclusion criteria

  • {"criterion_text":"- 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)"}
  • {"criterion_text":"- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial"}
  • {"criterion_text":"- 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

  • {"criterion_text":"- Any disease that may put the patient at risk when participating in this trial at investigator’s discretion."}
  • {"criterion_text":"- 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)"}
  • {"criterion_text":"- Patients with clinically relevant severe depression at investigator’s discretion or a HADS subscore >14 at Visit 1."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Patient will undergo lung transplantation, with an assigned date of surgery."}
  • {"criterion_text":"- Patients with a BMI <18.5 kg/m² that experienced an additional, unexplained and clinically significant (>10%) weight loss during the parent trial"}
  • {"criterion_text":"- 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"}
  • {"criterion_text":"- Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial."}
  • {"criterion_text":"- Further exclusion criteria apply."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Descriptive assessment of the incidence of patients with any adverse event while on treatment (primary objective: descriptively assess incidence of patients with any adverse event). Assessment up to the follow-up/end of study visit planned at week 99."}

Secondary endpoints

  • {"endpoint_text":"- Absolute change from baseline in FVC (mL) and in % predicted FVC over time","definition_or_measurement_approach":"Absolute change from baseline in forced vital capacity measured in mL and percentage predicted FVC measured over time versus baseline."}
  • {"endpoint_text":"- Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial","definition_or_measurement_approach":"Time-to-event analysis measuring time from baseline to first absolute decline in % predicted FVC >10%."}
  • {"endpoint_text":"- Time to first acute IPF/PPF exacerbation, first hospitalisation for respiratory cause, or death (whichever occurs first) over the duration of the trial","definition_or_measurement_approach":"Composite time-to-event endpoint: time from baseline to first occurrence of acute IPF/PPF exacerbation, first respiratory-related hospitalisation, or death."}
  • {"endpoint_text":"- Time to first acute IPF/PPF exacerbation or death over the duration of the trial","definition_or_measurement_approach":"Time from baseline to first acute IPF/PPF exacerbation or death."}
  • {"endpoint_text":"- Time to hospitalisation for respiratory cause or death over the duration of the trial","definition_or_measurement_approach":"Time from baseline to first hospitalisation for respiratory cause or death."}
  • {"endpoint_text":"- Time to absolute decline in FVC % predicted of >10% from baseline or death over the duration of the trial","definition_or_measurement_approach":"Time from baseline to either absolute decline >10% in % predicted FVC or death."}
  • {"endpoint_text":"- Time to relative decline in FVC % predicted of >10% from baseline or death over the duration of the trial","definition_or_measurement_approach":"Time from baseline to relative decline >10% in % predicted FVC or death."}

Recruitment

Planned Sample Size
1307
Recruitment Window Months
31
Consent Approach
Signed and dated written informed consent is required in accordance with ICH-GCP and local legislation prior to admission to the trial. Country-specific participant information and consent forms (including caregiver agreement and pregnant-partner information) are provided in the application in multiple languages.

Geography

Total Number Of Sites
131
Total Number Of Participants
551

Slovenia

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
22-04-2024
Processing Time Days
98
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
University Clinic Golnik
Department Name
Not applicable
Contact Person Name
Katarina Osolnik

Austria

Earliest CTIS Part Ii Submission Date
26-03-2024
Latest Decision Or Authorization Date
24-04-2024
Processing Time Days
29
Number Of Sites
6
Number Of Participants
23

Sites

Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
Department for Pulmology
Contact Person Name
Monika Steinmaurer
Site Name
Universitaetsklinikum Krems
Department Name
Clinical Department for Pneumology
Contact Person Name
Sabin Handzhiev
Contact Person Email
sabin.handzhiev@krems.lknoe.at
Site Name
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Department Name
Department for Pneumology
Contact Person Name
Michael Studnicka
Contact Person Email
m.studnicka@salk.at
Site Name
Medical University Of Vienna
Department Name
Internal Medicine II - Department for Pulmonology
Contact Person Name
Marco Idzko
Contact Person Email
marco.idzko@meduniwien.ac.at
Site Name
Krankenhaus Nord Klinik Floridsdorf
Department Name
Department for Internal Medicine and Pneumology
Contact Person Name
Arschang Valipour
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Abteilung für Atemwegs- und Lungenkrankheiten
Contact Person Name
Marie-Kathrin Breyer

Belgium

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
23-04-2024
Processing Time Days
32
Number Of Sites
7
Number Of Participants
23

Sites

Site Name
CHU De Liege
Department Name
Pneumologie department
Contact Person Name
Julien Guiot
Contact Person Email
j.guiot@chuliege.be
Site Name
Universitair Ziekenhuis Gent
Department Name
department of Rheumatology
Contact Person Name
Vanessa Smith
Contact Person Email
vanessa.smith@ugent.be
Site Name
Hopital Erasme
Department Name
Pneumology department Level -1, Route 693
Contact Person Name
Benjamin Bondue
Site Name
UZ Leuven
Department Name
Department Functiemetingen Pneumologie
Contact Person Name
Wim Wuyts
Contact Person Email
wim.wuyts@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Route 608, level -2
Contact Person Name
Antoine Froidure
Contact Person Email
antoine.froidure@uclouvain.be
Site Name
UCL Mont-Godinne
Department Name
Pneumologie Route 27
Contact Person Name
Caroline Dahlqvist
Site Name
Het Ziekenhuisnetwerk Antwerpen
Department Name
Department of Pneumology (consultatie)
Contact Person Name
Hans Slabbynck
Contact Person Email
hans.slabbynck@zna.be

Croatia

Earliest CTIS Part Ii Submission Date
26-03-2024
Latest Decision Or Authorization Date
22-04-2024
Processing Time Days
27
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Poliklinika Solmed d.o.o.
Department Name
Department of Clinical Immunology, Pulmonology and Rheumatology
Contact Person Name
Marija Gomercic Palcic
Contact Person Email
marijagomercic@yahoo.com
Site Name
Clinical Hospital Dubrava
Department Name
Department of Pulmonology
Contact Person Name
Divo Ljubicic
Contact Person Email
divo.ljubicic@gmail.com
Site Name
University Hospital Centre Zagreb
Department Name
Department of Pulmonology
Contact Person Name
Ana Hecimovic
Contact Person Email
anahecimovic1978@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
26-03-2024
Latest Decision Or Authorization Date
23-04-2024
Processing Time Days
28
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Fakultni Thomayerova nemocnice
Department Name
Pneumology Clinic 1.LF a TN
Contact Person Name
Martina Sterclova
Contact Person Email
martina.sterclova@ftn.cz

Denmark

Earliest CTIS Part Ii Submission Date
26-03-2024
Latest Decision Or Authorization Date
19-04-2024
Processing Time Days
24
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Aarhus Universitetshospital
Department Name
Lungesygdomme
Contact Person Name
Elisabeth Bendstrup
Contact Person Email
karbends@rm.dk
Site Name
Odense University Hospital
Department Name
Lungemedicinsk Forskning, Afd-J
Contact Person Name
Ingrid Titlestad
Contact Person Email
ingrid.titlestad@rsyd.dk
Site Name
Gentofte Hospital
Department Name
Lungemedicinsk Forskningsafdeling
Contact Person Name
Saher Burhan Shaker
Contact Person Email
saher.burhan.shaker@regionh.dk

Estonia

Earliest CTIS Part Ii Submission Date
20-03-2024
Latest Decision Or Authorization Date
23-04-2024
Processing Time Days
34
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
North Estonia Medical Centre Foundation
Department Name
Department of Pulmonology
Contact Person Name
Martti Jaanus

Finland

Earliest CTIS Part Ii Submission Date
25-03-2024
Latest Decision Or Authorization Date
23-04-2024
Processing Time Days
29
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Oulu University Hospital
Department Name
neurologian tutkimusyksikkö / S4 R43
Contact Person Name
Riitta Kaarteenaho
Contact Person Email
riitta.kaarteenaho@oulu.fi
Site Name
Turku University Hospital
Department Name
keuhkosairauksien klinikka, T-sairaala
Contact Person Name
Maritta Kilpeläinen
Contact Person Email
maritta.kilpelainen@tyks.fi
Site Name
HUS-Yhtymae
Department Name
Biomedicum Helsinki 2C
Contact Person Name
Marjukka Myllärniemi
Contact Person Email
marjukka.myllarniemi@hus.fi
Site Name
Tampere University Hospital
Department Name
TKI-keskuksen Tutkimusvastaanotto,
Contact Person Name
Ismo Strander
Contact Person Email
Ismo.Strander@pirha.fi

France

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
24-04-2024
Processing Time Days
100
Number Of Sites
20
Number Of Participants
109

Sites

Site Name
Centre Hospitalier Universitaire Reims
Department Name
Service des Maladies Respiratoires
Contact Person Name
François Lebargy
Contact Person Email
flebargy@chu-reims.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Centre d’Investigation Clinique
Contact Person Name
Francis Couturaud
Contact Person Email
francis.couturaud@chu-brest.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service de Pneumologie
Contact Person Name
Stéphane Jouneau
Contact Person Email
stephane.jouneau@chu-rennes.fr
Site Name
Assistance Publique Hopitaux De Marseille
Department Name
Service de Pneumologie - Maladies Rares Respiratoires
Contact Person Name
Martine Reynaud-Gaubert
Contact Person Email
MartineLouise.Reynaud@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Centre de Recherche Clinique
Contact Person Name
Emmanuel Bergot
Contact Person Email
bergot-e@chu-caen.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Service Pneumologie
Contact Person Name
Philippe Bonniaud
Contact Person Email
philippe.bonniaud@chu-dijon.fr
Site Name
University Hospital Of Montpellier
Department Name
Département de Pneumologie
Contact Person Name
Arnaud Bourdin
Contact Person Email
a-bourdin@chu-montpellier.fr
Site Name
Hospices Civils De Lyon
Department Name
Service de Pneumologie
Contact Person Name
Vincent Cottin
Contact Person Email
vincent.cottin@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service Pneumo Immuno Allergologie
Contact Person Name
Lidwine Stervinou-Wemeau
Contact Person Email
Lidwine.WEMEAU@chu-lille.fr
Site Name
Assistance Publique Hopitaux De Paris (Bobigny)
Department Name
Unité de Médecine Ambulatoire Pair Pneumologie
Contact Person Name
Hilario Nunes
Contact Person Email
hilario.nunes@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris (Paris Cedex 18)
Department Name
Not applicable
Contact Person Name
Bruno Crestani
Contact Person Email
bruno.crestani@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service Pneumologie
Contact Person Name
Elodie Blanchard
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service de Pneumologie
Contact Person Name
Grégoire Prevot
Site Name
Hospital Foch
Department Name
Service de Pneumologie
Contact Person Name
Alexandre Chabrol
Contact Person Email
a.chabrol@hopital-foch.com
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service de Pneumologie
Contact Person Name
Sylvie Leroy
Contact Person Email
leroy.s2@chu-nice.fr
Site Name
Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
Department Name
Service de Pneumologie - Allergologie - Oncologie Thoracique
Contact Person Name
Jean-Marc Naccache
Contact Person Email
jmnaccache@ghpsj.fr
Site Name
Assistance Publique Hopitaux De Paris (20 Rue Leblanc)
Department Name
Hôpital de jour - Service de Pneumologie et Soins Intensifs
Contact Person Name
Dominique Israel-Biet
Site Name
Bicetre Hospital
Department Name
Service de Pneumologie, Réanimation respiratoire
Contact Person Name
David Montani
Contact Person Email
david.montani@aphp.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Not applicable
Contact Person Name
Frédéric Gagnadoux
Contact Person Email
frgagnadoux@chu-angers.fr

Greece

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
23-04-2024
Processing Time Days
99
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
University General Hospital Of Heraklion
Department Name
Pulmonary Department
Contact Person Name
Katerina Antoniou
Contact Person Email
kantoniou@med.uoc.gr
Site Name
University General Hospital Of Ioannina
Department Name
Respiratory outpatient department
Contact Person Name
Konstantinos Kostikas
Contact Person Email
ktkostikas@uoi.gr
Site Name
General University Hospital Of Patras
Department Name
University Pulmonology Clinic
Contact Person Name
Argyrios Tzouvelekis
Contact Person Email
atzouvelekis@upatras.gr
Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
General Hospital of Thessaloniki "Hippokrateio"
Contact Person Name
Theodoros Dimitroulas
Contact Person Email
dimitroul@hotmail.com

Ireland

Earliest CTIS Part Ii Submission Date
08-03-2024
Latest Decision Or Authorization Date
24-04-2024
Processing Time Days
47
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Connolly Hospital
Department Name
Respiratory Department / Research
Contact Person Name
Eoin Judge
Contact Person Email
ejudge@crp.healthcare
Site Name
Mater Misericordiae University Hospital
Department Name
Catherine McAuley Centre
Contact Person Name
Kate O'Reilly
Contact Person Email
koreilly@mater.ie

Portugal

Earliest CTIS Part Ii Submission Date
08-03-2024
Latest Decision Or Authorization Date
23-04-2024
Processing Time Days
46
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Centro Hospitalar E Universitario De Coimbra E.P.E.
Department Name
Serviço de Pneumologia
Contact Person Name
Tiago Alfaro
Contact Person Email
alfarotm@gmail.com
Site Name
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
Department Name
Serviço de Pneumologia
Contact Person Name
Sérgio Campainha Fernandes
Site Name
Centro Hospitalar Universitario Lisboa Central E.P.E.
Department Name
Serviço de Pneumologia
Contact Person Name
Alexandra Borba
Contact Person Email
borba.alexandra@gmail.com
Site Name
Hospital Pedro Hispano
Department Name
Serviço de Nefrologia
Contact Person Name
Inês Neves
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Not applicable
Contact Person Name
Rui Rolo
Contact Person Email
rui.rolo@hb.min-saude.pt

Spain

Earliest CTIS Part Ii Submission Date
14-03-2024
Latest Decision Or Authorization Date
19-04-2024
Processing Time Days
36
Number Of Sites
24
Number Of Participants
120

Sites

Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Servicio de Neumología
Contact Person Name
José Velasco
Contact Person Email
jlvelascogarrido@hotmail.com
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Servicio de Neumología
Contact Person Name
Saioa Eizaguirre
Site Name
Hospital Universitario De La Princesa
Department Name
Servicio de Neumología
Contact Person Name
Claudia Valenzuela
Contact Person Email
claudiavale@hotmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio de Neumología
Contact Person Name
José Antonio Rodríguez Portal
Contact Person Email
josearportal@gmail.com
Site Name
Hospital De Galdakao Usansolo
Department Name
Servicio de Neumología
Contact Person Name
Myriam Aburto
Site Name
Hospital Universitario Infanta Leonor
Department Name
Servicio de Neumología
Contact Person Name
Belén López Muñiz
Contact Person Email
belenlmb@yahoo.es
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Servicio de Neumología
Contact Person Name
Ana Dolores Romero Ortiz
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Servicio de Neumología
Contact Person Name
Javier De Miguel Díaz
Contact Person Email
javier.miguel@salud.madrid.org
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Servicio de Neumología
Contact Person Name
José Antonio Ros
Contact Person Email
sleepfq@yahoo.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Neumología
Contact Person Name
Íñigo Ojanguren
Contact Person Email
inigo.ojanguren@vallhebron.cat
Site Name
Hospital General Universitario De Valencia
Department Name
Servicio de Neumología
Contact Person Name
Estrella Fernández Fabrellas
Contact Person Email
esferfa@gmail.com
Site Name
Hospital Universitario Basurto
Department Name
Servicio de Neumología
Contact Person Name
Begoñe Salinas
Contact Person Email
begosalinas@hotmail.com
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Servicio de Neumología
Contact Person Name
Raquel García Sevila
Contact Person Email
raquelgsevila@gmail.com
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Servicio de Neumología
Contact Person Name
José Echave Sustaeta
Contact Person Email
jose.echave@quironsalud.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Servicio de Neumología
Contact Person Name
José Cifrián
Contact Person Email
josemanuel.cifrian@scsalud.es
Site Name
Universidade De Santiago De Compostela
Department Name
Servicio de Neumología
Contact Person Name
Juan Suárez Antelo
Contact Person Email
jsuaantelo@yahoo.es
Site Name
Servei De Salut De Les Illes Balears
Department Name
Servicio de Neumología
Contact Person Name
Jaume Sauleda
Contact Person Email
jaume.sauleda@ssib.es
Site Name
Hospital Universitario Central De Asturias
Department Name
Servicio de Neumología
Contact Person Name
Miguel Arias
Contact Person Email
miguelariasguillen@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Servicio de Neumología
Contact Person Name
Juan Rigual
Contact Person Email
jrigual1989@gmail.com
Site Name
Hospital Universitario Virgen De Valme
Department Name
Servicio de Neumología
Contact Person Name
Zulema Palacios
Contact Person Email
ialfageme@separ.es
Site Name
Hospital Clinic De Barcelona
Department Name
Servicio de Neumología
Contact Person Name
Jacobo Sellares
Contact Person Email
SELLARES@clinic.cat
Site Name
Bellvitge University Hospital
Department Name
Servicio de Neumología
Contact Person Name
María Molina-Molina
Contact Person Email
mariamolinamolina@hotmail.com

Sweden

Earliest CTIS Part Ii Submission Date
26-03-2024
Latest Decision Or Authorization Date
24-04-2024
Processing Time Days
29
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Region Oestergoetland
Department Name
Lungmedicinska kliniken
Contact Person Name
Marietta Kokkala
Site Name
CTC Clinical Trial Consultants AB
Department Name
Department Lung- och allergy diseases
Contact Person Name
Emil Ekbom
Contact Person Email
emil.ekbom@akademiska.se

Netherlands

Earliest CTIS Part Ii Submission Date
11-04-2024
Latest Decision Or Authorization Date
19-04-2024
Processing Time Days
8
Number Of Sites
4
Number Of Participants
24

Sites

Site Name
Zuyderland Medisch Centrum Stichting
Department Name
Not applicable
Contact Person Name
R.L.M. Mostard
Contact Person Email
r.mostard@zuyderland.nl
Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
Afdeling Longziekten
Contact Person Name
Marcel Veltkamp
Site Name
Academisch Ziekenhuis Leiden
Department Name
Not applicable
Contact Person Name
Emiel Marges
Contact Person Email
e.r.marges@lumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Not applicable
Contact Person Name
Marlies Wijsenbeek-Lourens

Norway

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
22-04-2024
Processing Time Days
31
Number Of Sites
3
Number Of Participants
17

Sites

Site Name
Akershus University Hospital
Department Name
Lungepoliklinikken B105
Contact Person Name
Ragnhild Gagama
Contact Person Email
Ragnhild.Gagama@ahus.no
Site Name
Helse Bergen HF
Department Name
Outpatient Clinic, Dept. of Thoracic Medicine
Contact Person Name
Tomas Lind Eagan
Contact Person Email
tomas.eagan@helse-bergen.no
Site Name
Oslo University Hospital HF
Department Name
Lungeavdelingen
Contact Person Name
Phuong Diep
Contact Person Email
phudie@ous-hf.no

Poland

Earliest CTIS Part Ii Submission Date
18-03-2024
Latest Decision Or Authorization Date
24-04-2024
Processing Time Days
37
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Department Name
Department of Pneumology
Contact Person Name
Adam Barczyk
Contact Person Email
adagne@icloud.com
Site Name
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.
Department Name
Practice
Contact Person Name
Barbara Mackiewicz
Contact Person Email
b.mack@wp.pl
Site Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
Dept of Internal Medicine, Pulmonary Diseases and Allergy
Contact Person Name
Katarzyna Gorska
Contact Person Email
drkpgorska@gmail.com
Site Name
National Institute Of Tuberculosis And Lung Diseases
Department Name
1st Department of Lung Diseases
Contact Person Name
Malgorzata Sobiecka
Contact Person Email
m.sobiecka@igichp.edu.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Alergology and Pneumonology Department
Contact Person Name
Amelia Szymanowska-Narloch
Contact Person Email
aszymanowska@gumed.edu.pl

Germany

Earliest CTIS Part Ii Submission Date
20-03-2024
Latest Decision Or Authorization Date
22-04-2024
Processing Time Days
33
Number Of Sites
19
Number Of Participants
104

Sites

Site Name
Klinikum Konstanz GmbH
Department Name
Gesundheitsverbund Landkreis Konstanz gGmbH
Contact Person Name
Stephan Walterspacher
Contact Person Email
stephan.walterspacher@glkn.de
Site Name
GWT-Tud GmbH
Department Name
Zentrum für Pneumologie, Allergologie
Contact Person Name
Dirk Koschel
Site Name
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
Department Name
Zentrum für Pneumologie und Thoraxchirurgie
Contact Person Name
Michael Westhoff
Contact Person Email
michael.westhoff@lkhemer.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinik für Innere Medizin – Pneumologie und Infektiologie
Contact Person Name
Sven Gläser
Contact Person Email
sven.glaeser@vivantes.de
Site Name
Klinikum Nuernberg
Department Name
Klinik für Innere Medizin 3
Contact Person Name
Joachim Ficker
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik V - Pneumologie
Contact Person Name
Jürgen Behr
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Sektion Pneumologie
Contact Person Name
Dirk Skowasch
Contact Person Email
dirk.skowasch@ukbonn.de
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
am Universitätsklinikum Heidelberg
Contact Person Name
Felix Herth
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Zentrum für Onkologie Abteilung für Pneumologie
Contact Person Name
Tim Oqueka
Contact Person Email
t.oqueka@uke.de
Site Name
HELIOS Hanseklinikum Stralsund GmbH
Department Name
Pneumologie
Contact Person Name
Christian Warnke
Site Name
Lungenfachklinik Immenhausen
Department Name
Lungenfachklinik Immenhausen
Contact Person Name
Peter Hammerl
Site Name
CIMS Studienzentrum Bamberg GmbH
Department Name
Gemeinschaftspraxis
Contact Person Name
Joachim Kirschner
Contact Person Email
kirschner@besser-luft.de
Site Name
Krankenhaus Bethanien gGmbH
Department Name
Klinik für Pneumologie und Allergologie
Contact Person Name
Lars Hagmeyer
Site Name
Velocity Clinical Research Germany GmbH
Department Name
Standort Grosshansdorf, Pneumologisches Forschungsinstitut
Contact Person Name
Sameer Kulkarni
Contact Person Email
skulkarni@velocityclinical.com
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Medizinische Klinik Innere Medizin VIII
Contact Person Name
Werner Spengler
Site Name
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Department Name
Abteilung Pneumologie und Allergologie
Contact Person Name
Francesco Bonella
Site Name
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Department Name
Lungenzentrum Stuttgart
Contact Person Name
Axel Kempa
Contact Person Email
axel.kempa@rbk.de
Site Name
Klinikum Region Hannover GmbH
Department Name
Klinik für Pneumologie, Intensiv- und Schlafmedizin
Contact Person Name
Thomas Fühner
Contact Person Email
Thomas.Fuehner@krh.de

Hungary

Earliest CTIS Part Ii Submission Date
22-02-2024
Latest Decision Or Authorization Date
29-04-2024
Processing Time Days
67
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
University Of Debrecen
Department Name
Pulmonology Clinic
Contact Person Name
Anna Sarkozi
Contact Person Email
sarkozi.anna@med.unideb.hu
Site Name
Koranyi National Institute For Pulmonology
Department Name
IV. Pulmonology Department
Contact Person Name
Reka Gajdocsi
Contact Person Email
gajdocsi@koranyi.hu
Site Name
Semmelweis University
Department Name
Faculty of General Medicine, Clinic of Pulmonology
Contact Person Name
Veronika Muller

Italy

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
23-04-2024
Processing Time Days
99
Number Of Sites
14
Number Of Participants
53

Sites

Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
U.O. di Pneumologia
Contact Person Name
Fabrizio Luppi
Contact Person Email
fabrizio.luppi@unimib.it
Site Name
Azienda Ospedale-Universita Padova
Department Name
U.O. Pneumologia
Contact Person Name
Elisabetta Balestro
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O. di Pneumologia e Fisiopatologia Respiratoria
Contact Person Name
Guido Levi
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Clinica di Malattie dell’Apparato Respiratorio
Contact Person Name
Marialuisa Bocchino
Contact Person Email
Marialuisa.bocchino@gmail.com
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Clinica Malattie Apparato Respiratorio
Contact Person Name
Stefania Cerri
Contact Person Email
stefania.cerri@unimore.it
Site Name
Ospedale Giovan Battista Morgagni-Luigi Pierantoni Di Forlì
Department Name
Dipartimento Toracico - AUSL di Forlì
Contact Person Name
Claudia Ravaglia
Contact Person Email
claudiaravaglia79@gmail.com
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Pneumologia
Contact Person Name
Luca Richeldi
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
Pneumologia 4
Contact Person Name
Donato Lacedonia
Contact Person Email
donato.lacedonia@unifg.it
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
Via Santa Sofia 78
Contact Person Name
Carlo Vancheri
Contact Person Email
vancheri@unict.it
Site Name
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
Department Name
Clinica di Malattie Respiratorie dell’Università degli Studi di Milano
Contact Person Name
Michele Mondoni
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Department Name
U. O. di Pneumologia
Contact Person Name
Martina Bonifazi
Contact Person Email
bonifazimarti@gmail.com
Site Name
Careggi University Hospital
Department Name
Pneumologia Interventistica
Contact Person Name
Federico Lavorini
Contact Person Email
flavorinicareggi@gmail.com
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
U.O.C. Malattie Respiratorie e Trapianto Polmonare
Contact Person Name
Elena Bargagli
Contact Person Email
bargagli2@gmail.com
Site Name
Multimedica S.p.A.
Department Name
U.O. di Pneumologia
Contact Person Name
Sergio Harari
Contact Person Email
sharari@ilpolmone.it

Sponsor

Primary sponsor

Full Name
Boehringer Ingelheim International GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
IQVIA Limited
Responsibilities
Study start-up (as listed in sponsor thirdParty duties)

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Sponsor duties codes: 1, 12, 15 (15: Study start-up); contact email: kelly.powell@iqvia.com","organisation_type":"Pharmaceutical company"}

Co-sponsors

  • Boehringer Ingelheim RCV GmbH & Co. KG
  • Boehringer Ingelheim Espana S.A.

Investigational products

Investigational Product Name
BI 1015550
Active Substance
BI 1015550 (chemical: 1-[[(5R)-2-[4-(5-CHLORO-2-PYRIMIDINYL)-1-PIPERIDINYL]-6,7-DIHYDRO-5-OXIDOTHIENO[3,2-D]PYRIMIDIN-4-YL]AMINO]-CYCLOBUTANEMETHANOL)
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (prodAuthStatus:1)
Maximum Dose
18 mg (one product entry) and 36 mg (other product entry) - maximum daily dose amounts reported in Part I: 18 mg and 36 mg

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