Clinical trial • Respiratory

1-[[(5R)-2-[4-(5-CHLORO-2-PYRIMIDINYL)-1-PIPERIDINYL]-6,7-DIHYDRO-5-OXIDOTHIENO[3,2-D]PYRIMIDIN-4-YL]AMINO]-CYCLOBUTANEMETHANOL for Systemic autoimmune rheumatic disease-associated interstitial lung disease (SARD-ILD)

Clinical trial of 1-[[(5R)-2-[4-(5-CHLORO-2-PYRIMIDINYL)-1-PIPERIDINYL]-6,7-DIHYDRO-5-OXIDOTHIENO[3,2-D]PYRIMIDIN-4-YL]AMINO]-CYCLOBUTANEMETHANOL for Syst…

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Systemic autoimmune rheumatic disease-associated interstitial lung disease (SARD-ILD)
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
20-11-2024
First CTIS Authorization Date
25-03-2025

Trial design

Randomised, placebo matching nerandomilast (bi 1015550) (dose and schedule not specified in provided data)-controlled trial in Germany, France, Norway and others.

Randomised
Yes
Comparator
Placebo matching nerandomilast (BI 1015550) (dose and schedule not specified in provided data)
Target Sample Size
242
Trial Duration For Participant
182

Eligibility

Recruits 242 Vulnerable population not selected; no specific consent or assent handling mentioned..

Vulnerable Population
Vulnerable population not selected; no specific consent or assent handling mentioned.

Inclusion criteria

  • {"criterion_text":"- \"Participant has SARD-ILD, defined as - Diagnosis by a rheumatologist with at least 1 of the following SARDs: RA, SSc (participants must be anticentromere auto-antibody negative), IIM, Sjögren’s disease, or MCTD - Presence of fibrotic ILD on HRCT, defined as presence of reticular abnormality with traction bronchiectasis with or without honeycombing (HC), with disease extent >10% on HRCT performed within 12 months of Visit 1 or, if historical scan is not available, on baseline HRCT taken prior to Visit 2, as confirmed by central review \""}
  • {"criterion_text":"- \"No lung function improvement and no clinically significant ILD improvement as a treatment response to IS therapy according to both criteria: - No improvement in absolute FVC % predicted >5% within the 15 months prior to Visit 1, as measured by 2 spirometry assessments that must be ≥3 months apart. (Note: Visit 1 spirometry may be used to fulfill the inclusion criterion if there is only 1 spirometry reading in the 15 months prior to Visit 1) - No clinically significant improvement in ILD based on clinician’s judgement (including symptoms, imaging/HRCT, or other assessments as considered relevant and documented by the Investigator) \""}
  • {"criterion_text":"- FVC ≥45% of predicted normal at Visit 1"}
  • {"criterion_text":"- Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for haemoglobin (Hb) within 3 months prior to or at Visit 1"}
  • {"criterion_text":"- \"Participants must be on stable treatment with any IS agent for ≥6 months (or ≥3 months for participants with IIM-ILD) with the following specifications: - If using prednisone, participants must be on stable dose for ≥4 weeks prior to Visit 2 - If using rituximab, participants must have completed their first cycle >6 months prior to Visit 2\""}
  • {"criterion_text":"- If using nintedanib, participants must be on a stable dose for ≥12 weeks prior to Visit 2"}
  • {"criterion_text":"- In the opinion of the Investigator, no change in background SoC treatment with IS, IM, or nintedanib is planned"}
  • {"criterion_text":"- Further inclusion criteria apply"}

Exclusion criteria

  • {"criterion_text":"- Organising pneumonia as predominant pattern in the HRCT"}
  • {"criterion_text":"- Prebronchodilator FEV1/FVC <0.7 at Visit 1"}
  • {"criterion_text":"- Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period, based on Investigator judgement"}
  • {"criterion_text":"- Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period"}
  • {"criterion_text":"- Any suicidal behaviour in the past 2 years"}
  • {"criterion_text":"- Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 3 months or at Visit 1, and/or at Visit 2"}
  • {"criterion_text":"- Use of any of the following medications: cyclophosphamide within 6 months of Visit 1, pirfenidone within 8 weeks of Visit 1"}
  • {"criterion_text":"- Further exclusion criteria apply"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Absolute change from baseline in QILD score [%] on HRCT at Week 26","definition_or_measurement_approach":"Change in quantitative interstitial lung disease (QILD) score on quantitative high-resolution CT (qHRCT) from baseline to Week 26; primary treatment comparison is as randomised including all data collected until Week 26 regardless of treatment discontinuation or changes in background therapies."}

Secondary endpoints

  • {"endpoint_text":"- Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26","definition_or_measurement_approach":"Change in QLF score on HRCT from baseline to Week 26 (quantitative HRCT parameter)."}
  • {"endpoint_text":"- Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] on HRCT at Week 26","definition_or_measurement_approach":"Change in QGGO score on HRCT from baseline to Week 26 (quantitative HRCT parameter)."}
  • {"endpoint_text":"- Absolute change from baseline in vascular volume [%] on HRCT at Week 26","definition_or_measurement_approach":"Change in vascular volume measured on HRCT from baseline to Week 26."}
  • {"endpoint_text":"- Absolute change from baseline in FVC [mL] at Week 26","definition_or_measurement_approach":"Change in forced vital capacity (FVC) in mL from baseline to Week 26 measured by spirometry."}
  • {"endpoint_text":"- Absolute change from baseline in supplemental oxygen use over the whole trial for oxygen users at Week 26 at baseline","definition_or_measurement_approach":"Change in supplemental oxygen use over the trial period for participants who were using oxygen at baseline, measured up to Week 26."}
  • {"endpoint_text":"- \"Time to first supplemental oxygen use during the trial for oxygen non-users at baseline\"","definition_or_measurement_approach":"Time-to-event analysis measuring time from baseline to first use of supplemental oxygen during the trial for participants not using oxygen at baseline."}
  • {"endpoint_text":"- Occurrence of infection-related AEs from baseline over the duration of the trial","definition_or_measurement_approach":"Safety endpoint capturing occurrence of infection-related adverse events (AEs) from baseline throughout trial duration."}

Recruitment

Planned Sample Size
242
Recruitment Window Months
23
Consent Approach
Informed consent obtained from participants. Country-specific subject information and informed consent forms (L1 ICF main documents) are available in multiple languages (examples in the file list: DE, FR, NO, IT, ES, NL, AT). Additional country/language specific ICFs include parent/newborn and pregnant-partner versions in some countries (e.g., 'L1_ ICF-parents-FR', 'L1_ ICF-newborn-DE-public', 'L1_ ICF-pregnant-partner-DE'). Contact/functional consent point: 'CT Disclosure & Data Transparency' (clintriage.rdg@boehringer-ingelheim.com).

Geography

Total Number Of Sites
58
Total Number Of Participants
158

Germany

Earliest CTIS Part Ii Submission Date
14-03-2025
Latest Decision Or Authorization Date
27-03-2025
Processing Time Days
13
Number Of Sites
20
Number Of Participants
59

Sites

Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Pneumologie und Infektiologie, Klinisches Studienzentrum
Principal Investigator Name
Benjamin Seeliger
Principal Investigator Email
seeliger.benjamin@mh-hannover.de
Contact Person Name
Benjamin Seeliger
Site Name
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Department Name
am Universitätsklinikum Essen gGmbH, Abteilung Pneumologie und Allergologie
Principal Investigator Name
Francesco Bonella
Principal Investigator Email
francesco.bonella@rlk.uk-essen.de
Contact Person Name
Francesco Bonella
Site Name
medius KLINIKEN gGmbH
Department Name
Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie
Principal Investigator Name
Bastian Walz
Principal Investigator Email
b.walz@medius-kliniken.de
Contact Person Name
Bastian Walz
Contact Person Email
b.walz@medius-kliniken.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Medizinische Klinik 3 – Rheumatologie und Immunologie
Principal Investigator Name
Christina Bergmann
Principal Investigator Email
Christina.Bergmann@uk-erlangen.de
Contact Person Name
Christina Bergmann
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik IV - Rheumaeinheit
Principal Investigator Name
Hendrik Schulze-Koops
Principal Investigator Email
hendrik.schulze-koops@med.uni-muenchen.de
Contact Person Name
Hendrik Schulze-Koops
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Poliklinik und Funktionsbereich für Rheumatologie
Principal Investigator Name
Jörg Distler
Principal Investigator Email
joerg.distler@med.uni-duesseldorf.de
Contact Person Name
Francesco Bonella
Site Name
HELIOS Fachklinik Vogelsang-Gommern GmbH
Department Name
Rheumatologie
Principal Investigator Name
Eugen Feist
Principal Investigator Email
eugen.feist@helios-gesundheit.de
Contact Person Name
Eugen Feist
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Rheumatologie und klinische Immunologie
Principal Investigator Name
Gabriela Riemekasten
Principal Investigator Email
gabriela.riemekasten@uksh.de
Contact Person Name
Gabriela Riemekasten
Contact Person Email
gabriela.riemekasten@uksh.de
Site Name
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
Department Name
Abteilung Rheumatologie
Principal Investigator Name
Georg Pongratz
Principal Investigator Email
Georg.Pongratz@barmherzige-regensburg.de
Contact Person Name
Georg Pongratz
Site Name
Johannes Wesling Klinikum Minden
Department Name
Klinik für Rheumatologie und klinische Immunologie
Principal Investigator Name
Gunter Assmann
Principal Investigator Email
Gunter.Assmann@muehlenkreiskliniken.de
Contact Person Name
Gunter Assmann
Site Name
Krankenhaus Porz Am Rhein gGmbH
Department Name
Rheumatologie
Principal Investigator Name
Johannes Strunk
Principal Investigator Email
j.strunk@khporz.de
Contact Person Name
Johannes Strunk
Contact Person Email
j.strunk@khporz.de
Site Name
Technische Universitaet Dresden
Department Name
Universitätsklinikum Carl Gustav Carus Dresden an der TU Dresden - Med. Klinik und Poliklinik III
Principal Investigator Name
Anne-Kathrin Tausche-Wunderlich
Principal Investigator Email
anne-kathrin.tausche@ukdd.de
Contact Person Name
Anne-Kathrin Tausche-Wunderlich
Contact Person Email
anne-kathrin.tausche@ukdd.de
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie
Principal Investigator Name
Ioana Andreica
Principal Investigator Email
ioana.andreica@elisabethgruppe.de
Contact Person Name
Ioana Andreica
Site Name
Medical Center - University Of Freiburg
Department Name
Innere Medizin
Principal Investigator Name
Stephanie Finzel
Principal Investigator Email
stephanie.finzel@uniklinik-freiburg.de
Contact Person Name
Stephanie Finzel
Site Name
Immanuel-Krankenhaus GmbH
Department Name
Innere Medizin - Rheumatologie, Klinische Immunologie und Osteologie Standort Berlin-Buch
Principal Investigator Name
Hans Bastian
Principal Investigator Email
hans.bastian@immanuelalbertinen.de
Contact Person Name
Hans Bastian
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Rheumatologie und Klinische Immunologie
Principal Investigator Name
Fredrik Albach
Principal Investigator Email
fredrik.albach@charite.de
Contact Person Name
Fredrik Albach
Contact Person Email
fredrik.albach@charite.de
Site Name
Klinikum Konstanz GmbH
Department Name
Medizinische Klinik, Studienzentrum
Principal Investigator Name
Stephan Walterspacher
Principal Investigator Email
stephan.walterspacher@glkn.de
Contact Person Name
Stephan Walterspacher
Contact Person Email
stephan.walterspacher@glkn.de
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Leitung Pneumologie und Beatmungsmedizin
Principal Investigator Name
Steven Demedts
Principal Investigator Email
steven.demedts@gesundheitnord.de
Contact Person Name
Steven Demedts
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Fachbereich Rheumatologie
Principal Investigator Name
Katja Schmitt-Bieda
Principal Investigator Email
k.schmitt-bieda@skbs.de
Contact Person Name
Katja Schmitt-Bieda
Contact Person Email
k.schmitt-bieda@skbs.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik und Poliklinik III - Sektion Rheumatologie
Principal Investigator Name
Valentin Schäfer
Principal Investigator Email
valentin.schaefer@ukbonn.de
Contact Person Name
Valentin Schäfer
Contact Person Email
valentin.schaefer@ukbonn.de

France

Earliest CTIS Part Ii Submission Date
07-03-2025
Latest Decision Or Authorization Date
31-03-2025
Processing Time Days
24
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Entrée E1, ascenseur (1ère étage)
Principal Investigator Name
Christian Lavigne
Principal Investigator Email
chlavigne@chu-angers.fr
Contact Person Name
Christian Lavigne
Contact Person Email
chlavigne@chu-angers.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service de Médecine Interne et Immunologie clinique
Principal Investigator Name
Eric Mensi
Principal Investigator Email
eric.mensi@chu-rennes.fr
Contact Person Name
Eric Mensi
Contact Person Email
eric.mensi@chu-rennes.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Centre d'Investigation Clinique
Principal Investigator Name
Alain Meyer
Principal Investigator Email
alain.meyer1@chru-strasbourg.fr
Contact Person Name
Alain Meyer
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service de Médecine interne
Principal Investigator Name
Grégory Pugnet
Principal Investigator Email
pugnet.g@chu-toulouse.fr
Contact Person Name
Grégory Pugnet
Contact Person Email
pugnet.g@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service de Médecine Interne et Immunologie Clinique
Principal Investigator Name
Eric Hachulla
Principal Investigator Email
eric.hachulla@chru-lille.fr
Contact Person Name
Eric Hachulla
Contact Person Email
eric.hachulla@chru-lille.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
rheumatology department
Principal Investigator Name
Marie Elise Truchetet
Principal Investigator Email
marie-elise.truchetet@chu-bordeaux.fr
Contact Person Name
Marie Elise Truchetet
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Rhumatologie
Principal Investigator Name
Yannick Allanore
Principal Investigator Email
yannick.allanore@aphp.fr
Contact Person Name
Yannick Allanore
Contact Person Email
yannick.allanore@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Rhumatologie
Principal Investigator Name
Philippe Dieudé
Principal Investigator Email
philippe.dieude@aphp.fr
Contact Person Name
Philippe Dieudé
Contact Person Email
philippe.dieude@aphp.fr

Norway

Earliest CTIS Part Ii Submission Date
06-03-2025
Latest Decision Or Authorization Date
25-03-2025
Processing Time Days
19
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Sykehuset Telemark HF
Department Name
Forskningsavdelingen
Principal Investigator Name
Silje Heitmann
Principal Investigator Email
siheit@sthf.no
Contact Person Name
Silje Heitmann
Contact Person Email
siheit@sthf.no
Site Name
Akershus University Hospital
Department Name
Lungepoliklinikken B105
Principal Investigator Name
Ragnhild Gagama
Principal Investigator Email
Ragnhild.Gagama@ahus.no
Contact Person Name
Ragnhild Gagama
Contact Person Email
Ragnhild.Gagama@ahus.no

Italy

Earliest CTIS Part Ii Submission Date
17-03-2025
Latest Decision Or Authorization Date
27-03-2025
Processing Time Days
10
Number Of Sites
8
Number Of Participants
21

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Malattie Autoimmuni Sistemiche
Principal Investigator Name
Lorenzo Beretta
Principal Investigator Email
lorenzo.beretta@policlinico.mi.it
Contact Person Name
Lorenzo Beretta
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Unità U.O.C. di Reumatologia, Scleroderma Unit
Principal Investigator Name
Dilia Giuggioli
Principal Investigator Email
dilia.giuggioli@unimore.it
Contact Person Name
Dilia Giuggioli
Contact Person Email
dilia.giuggioli@unimore.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Struttura complessa di Reumatologia
Principal Investigator Name
Veronica Codullo
Principal Investigator Email
V.Codullo@smatteo.pv.it
Contact Person Name
Veronica Codullo
Contact Person Email
V.Codullo@smatteo.pv.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Dipartimento Medicina Sperimentale e Clinica
Principal Investigator Name
SERENA GUIDUCCI
Principal Investigator Email
serena.guiducci@unifi.it
Contact Person Name
SERENA GUIDUCCI
Contact Person Email
serena.guiducci@unifi.it
Site Name
Universita Degli Studi Di Padova
Department Name
U.O.C. Reumatologia
Principal Investigator Name
Elisabetta Zanatta
Principal Investigator Email
elisabetta.zanatta@yahoo.it
Contact Person Name
Elisabetta Zanatta
Contact Person Email
elisabetta.zanatta@yahoo.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Immunologia, Reumatologia, Allergologia e Malattie Rare
Principal Investigator Name
Veronica Codullo
Principal Investigator Email
V.Codullo@smatteo.pv.it
Contact Person Name
Veronica Codullo
Contact Person Email
V.Codullo@smatteo.pv.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Dip. Scienze Cliniche Int. Anestesiologiche e Cardiovascolari
Principal Investigator Name
Fabrizio Conti
Principal Investigator Email
fabrizio.conti@uniroma1.it
Contact Person Name
Fabrizio Conti
Contact Person Email
fabrizio.conti@uniroma1.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
DSCS-c/o U.O. Reumatologia e Immunologia Clinica
Principal Investigator Name
Ilaria Cavazzana
Principal Investigator Email
ilariacava@virgilio.it
Contact Person Name
Ilaria Cavazzana
Contact Person Email
ilariacava@virgilio.it

Austria

Earliest CTIS Part Ii Submission Date
28-02-2025
Latest Decision Or Authorization Date
31-03-2025
Processing Time Days
31
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Medical University of Vienna
Department Name
Klinische Abteilung für Pulmologie
Principal Investigator Name
Marco Idzko
Principal Investigator Email
marco.idzko@meduniwien.ac.at
Contact Person Name
Marco Idzko
Contact Person Email
marco.idzko@meduniwien.ac.at
Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
Pneumol.
Principal Investigator Name
Monika Steinmaurer
Principal Investigator Email
monika.steinmaurer@klinikum-wegr.at
Contact Person Name
Monika Steinmaurer
Site Name
Universitaetsklinikum Krems
Department Name
Department for Pneumology
Principal Investigator Name
Sabin Handzhiev
Principal Investigator Email
sabin.handzhiev@krems.lknoe.at
Contact Person Name
Sabin Handzhiev
Contact Person Email
sabin.handzhiev@krems.lknoe.at

Spain

Earliest CTIS Part Ii Submission Date
17-03-2025
Latest Decision Or Authorization Date
26-03-2025
Processing Time Days
9
Number Of Sites
14
Number Of Participants
45

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Servicio de reumatología
Principal Investigator Name
Jesús Loarce
Principal Investigator Email
jesus.loarce@gmail.com
Contact Person Name
Jesús Loarce
Contact Person Email
jesus.loarce@gmail.com
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Servicio de reumatología
Principal Investigator Name
Juan Alegre Sancho
Principal Investigator Email
txantxo@gmail.com
Contact Person Name
Juan Alegre Sancho
Contact Person Email
txantxo@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Servicio de Reumatología
Principal Investigator Name
Virginia Moreira Navarrete
Principal Investigator Email
virgimn@hotmail.com
Contact Person Name
Virginia Moreira Navarrete
Contact Person Email
virgimn@hotmail.com
Site Name
Bellvitge University Hospital
Department Name
Servicio de Reumatología
Principal Investigator Name
Francisco Narváez García
Principal Investigator Email
fjnarvaez@bellvitgehospital.cat
Contact Person Name
Francisco Narváez García
Site Name
Hospital Universitario Basurto
Department Name
Servicio de Reumatología
Principal Investigator Name
Esther Ruiz
Principal Investigator Email
erlucea@hotmail.com
Contact Person Name
Esther Ruiz
Contact Person Email
erlucea@hotmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de reumatología
Principal Investigator Name
Patricia Carreira Delgado
Principal Investigator Email
carreira@h12o.es
Contact Person Name
Patricia Carreira Delgado
Contact Person Email
carreira@h12o.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Medicina Interna
Principal Investigator Name
Alfredo Guillén
Principal Investigator Email
alfredo.guillen@vallhebron.cat
Contact Person Name
Alfredo Guillén
Contact Person Email
alfredo.guillen@vallhebron.cat
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Servicio de Reumatología
Principal Investigator Name
Fredeswinda Romero
Principal Investigator Email
fromero@fjd.es
Contact Person Name
Fredeswinda Romero
Contact Person Email
fromero@fjd.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Servicio de Reumatología
Principal Investigator Name
Iván Castellví Barranco
Principal Investigator Email
ICastellvi@santpau.cat
Contact Person Name
Iván Castellví Barranco
Contact Person Email
ICastellvi@santpau.cat
Site Name
Hospital Universitario Reina Sofia
Department Name
Servicio de Reumatología
Principal Investigator Name
Alejandro Escudero
Principal Investigator Email
alexcudero2@gmail.com
Contact Person Name
Alejandro Escudero
Contact Person Email
alexcudero2@gmail.com
Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
Servicio de Reumatología
Principal Investigator Name
Nair Perez
Principal Investigator Email
nair.perez.gomez@sergas.es
Contact Person Name
Nair Perez
Contact Person Email
nair.perez.gomez@sergas.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Medicina Interna
Principal Investigator Name
María Freire Dapena
Principal Investigator Email
mayka.freire@gmail.com
Contact Person Name
María Freire Dapena
Contact Person Email
mayka.freire@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio de Reumatología
Principal Investigator Name
Clara Aguilera Cross
Principal Investigator Email
clara.aguileracros@gmail.com
Contact Person Name
Clara Aguilera Cross
Contact Person Email
clara.aguileracros@gmail.com
Site Name
Hospital Universitario Juan Ramon Jimenez
Department Name
Servicio de Reumatología
Principal Investigator Name
Alberto Ruiz Román
Principal Investigator Email
albertoruroman@gmail.com
Contact Person Name
Alberto Ruiz Román
Contact Person Email
albertoruroman@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
12-03-2025
Latest Decision Or Authorization Date
25-03-2025
Processing Time Days
13
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
Longcentrum
Principal Investigator Name
Marcel Veltkamp
Principal Investigator Email
m.veltkamp@antoniusziekenhuis.nl
Contact Person Name
Marcel Veltkamp
Site Name
Zuyderland Medisch Centrum Stichting
Department Name
R&D longziekten
Principal Investigator Name
R.L.M. Mostard
Principal Investigator Email
r.mostard@zuyderland.nl
Contact Person Name
R.L.M. Mostard
Contact Person Email
r.mostard@zuyderland.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Longgeneeskunde
Principal Investigator Name
Thomas Koudstaal
Principal Investigator Email
t.koudstaal.1@erasmusmc.nl
Contact Person Name
Thomas Koudstaal
Contact Person Email
t.koudstaal.1@erasmusmc.nl

Sponsor

Primary sponsor

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

Co-sponsors

  • Boehringer Ingelheim Espana S.A.

Investigational products

Investigational Product Name
BI 1015550
Active Substance
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 USE
Route
ORAL USE
Investigational Product Name
Placebo matching nerandomilast (BI 1015550)
Modality
Other
Combination Treatment
Yes

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