Clinical trial • Phase III • Respiratory

ADMILPARANT for Idiopathic pulmonary fibrosis

Phase III trial of ADMILPARANT for Idiopathic pulmonary fibrosis.

Overview

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

Key dates

Initial CTIS Submission Date
06-02-2024
First CTIS Authorization Date
27-05-2024

Trial design

Randomised, placebo for bms-986278 (placebo for bms-986278, oral film-coated tablet) matched to active bms-986278 (admilparant). a 30 mg bid titration step is mentioned in study materials.-controlled Phase III trial in Czechia, Poland, Belgium and others.

Randomised
Yes
Comparator
Placebo for BMS-986278 (Placebo for BMS-986278, oral film-coated tablet) matched to active BMS-986278 (admilparant). A 30 mg BID titration step is mentioned in study materials.
Target Sample Size
962
Trial Duration For Participant
364

Eligibility

Recruits 962 No vulnerable population selected (isVulnerablePopulationSelected: false). Standard informed consent from adult participants is required. Separate information sheets for pregnant partners are provided (documents listed as 'L1_SIS and ICF Pregnant Partner' in multiple versions)..

Pregnancy Exclusion
Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test at screening and predose
Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Standard informed consent from adult participants is required. Separate information sheets for pregnant partners are provided (documents listed as 'L1_SIS and ICF Pregnant Partner' in multiple versions).

Inclusion criteria

  • {"criterion_text":"- Subjects with IPF aged ≥ 40 years at the time of signing the informed consent.\n- Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia.\n- If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.\n- If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.\n- Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test at screening and predose\n- Men who are sexually active with women of childbearing potential agree to use male barrier contraception"}

Exclusion criteria

  • {"criterion_text":"- History of stroke or transient ischemic attack within 3 months prior to screening.\n- Exhibit symptoms of heart failure at rest\n- Participants who have: 1) a current malignancy, 2) a previous malignancy with less than 2 years free of recurrence; 3) a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be ruled out.\n- Interstitial Lung Disease (ILD) associated with known primary causes (eg.hypersensitivity pneumonitis,autoimmune associated ILD,sarcoidosis,etc.)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Absolute change in FVC (mL) from baseline at Week 52.","definition_or_measurement_approach":"Absolute change in Forced Vital Capacity (FVC) measured in mL from baseline to Week 52; primary objective is to evaluate improvement in absolute change in FVC at Week 52."}

Secondary endpoints

  • {"endpoint_text":"- Disease progression 4-component composite endpoint: Time to first disease progression event from Day 1 through the Primary Endpoint Visit.","definition_or_measurement_approach":"Time-to-event analysis: time to first disease progression event from Day 1 through the Primary Endpoint Visit (definition per protocol composite of 4 components)."}
  • {"endpoint_text":"- Change in walking distance measured in 6MWT from baseline at Week 52","definition_or_measurement_approach":"Change in distance walked in the 6-minute walk test (6MWT) from baseline to Week 52, measured in metres."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
962
Recruitment Window Months
26
Consent Approach
Informed consent is obtained from adult participants (subjects are aged ≥ 40 years). Multiple versions of the subject information sheet and informed consent form (L1_SIS and ICF) are provided in multiple languages (examples in the document list: English, French, Dutch, German, Italian, Polish, Portuguese, Spanish, Greek, Hungarian, Danish, Finnish, etc.). Separate information/ICF documents for pregnant partners are provided (documents titled 'L1_SIS and ICF Pregnant Partner'). Consent materials include main ICF, optional future research/sample collection documents and localized translations as listed in the document inventory.

Methods

  • Print ads (K1/K2_Print Ad, Print Ads ENG, Print Ads FRE, Print Ads DUT, Print Ads GER, Print Ad documents) — channel: newspapers/print; target audience: patients with idiopathic pulmonary fibrosis / general public.
  • Social media ads and posts (K2_Recruitment material_Social Media Ads, Social Media Posts in multiple languages) — channel: social media; target audience: patients and caregivers with pulmonary fibrosis.
  • Brochures and study brochures (K2_Brochure, K1_Brochure) — channel: printed brochure/leaflet; target audience: potential participants and HCPs; language-specific versions provided.
  • HCP letters and HCP-targeted materials (K2_HCP Letter, HCP Letter for two studies) — channel: direct contact with healthcare professionals; target audience: clinicians treating pulmonary fibrosis to assist recruitment.
  • Study Connect / e-med screener (Study Connect Pulmonary fibrosis emed screener / Study Connect screener) — channel: digital screener platform; target audience: potential participants self-screening remotely.
  • Study blurb and informed consent presentations (K2_Study Blurb, K2_Informed Consent Presentation) — channel: sites and digital channels; target audience: patients; multiple language versions available.
  • Study visit planner and patient materials (K2_Study Visit Planner, K2_Study Participant Guide) — channel: site-delivered materials to support participant engagement.

Geography

Total Number Of Sites
104
Total Number Of Participants
239

Czechia

Earliest CTIS Part Ii Submission Date
06-05-2024
Latest Decision Or Authorization Date
30-05-2024
Processing Time Days
24
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
University Hospital Olomouc
Department Name
Klinika plícních nemocí a tuberkulózy
Principal Investigator Name
Monika Žurková
Principal Investigator Email
monika.zurkova@fnol.cz
Contact Person Name
Monika Žurková
Contact Person Email
monika.zurkova@fnol.cz

Poland

Earliest CTIS Part Ii Submission Date
09-05-2024
Latest Decision Or Authorization Date
31-05-2024
Processing Time Days
22
Number Of Sites
7
Number Of Participants
45

Sites

Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddział Alergologiczno-Pulmonologiczny
Principal Investigator Name
Luiza Grabowska-Skudlarz
Principal Investigator Email
lgrabowska@pulmonologia.olsztyn.pl
Contact Person Name
Luiza Grabowska-Skudlarz
Site Name
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Pneumonologii
Principal Investigator Name
Adam Barczyk
Principal Investigator Email
pneumo@sum.edu.pl
Contact Person Name
Adam Barczyk
Contact Person Email
pneumo@sum.edu.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Principal Investigator Name
Agnieszka Jarzemska
Principal Investigator Email
a.jarzemska@naszlekarz.pl
Contact Person Name
Agnieszka Jarzemska
Contact Person Email
a.jarzemska@naszlekarz.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Pneumatologii
Principal Investigator Name
Amelia Szymanowska-Narloch
Principal Investigator Email
aszymanowska@gumed.edu.pl
Contact Person Name
Amelia Szymanowska-Narloch
Contact Person Email
aszymanowska@gumed.edu.pl
Site Name
Vitamed Galaj I Cichomski Sp. j.
Principal Investigator Name
Iwona Patyk
Principal Investigator Email
i.patyk@vitamed.info
Contact Person Name
Iwona Patyk
Contact Person Email
i.patyk@vitamed.info
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ
Department Name
Oddział Kliniczny Pulmonologii i Alergologii
Principal Investigator Name
Sebastian Majewski
Principal Investigator Email
sebastian.majewski@umed.lodz.pl
Contact Person Name
Sebastian Majewski
Site Name
Centrum Medycyny Oddechowej Mroz Sp. j.
Principal Investigator Name
Robert Mróz
Principal Investigator Email
robmroz@wp.pl
Contact Person Name
Robert Mróz
Contact Person Email
robmroz@wp.pl

Belgium

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
29-05-2024
Processing Time Days
12
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
CHU De Liege
Department Name
Respiratory Medicince
Principal Investigator Name
Julien Guiot
Principal Investigator Email
j.guiot@chuliege.be
Contact Person Name
Julien Guiot
Contact Person Email
j.guiot@chuliege.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Pneumology
Principal Investigator Name
Antoine Froidure
Principal Investigator Email
antoine.froidure@uclouvain.be
Contact Person Name
Antoine Froidure
Contact Person Email
antoine.froidure@uclouvain.be
Site Name
CHU UCL Namur
Department Name
Pneumology
Principal Investigator Name
Caroline Dahlqvist
Principal Investigator Email
caroline.dahlqvist@uclouvain.be
Contact Person Name
Caroline Dahlqvist
Site Name
UZ Leuven
Department Name
Pneumonology
Principal Investigator Name
Wim Wuyts
Principal Investigator Email
wim.wuyts@uzleuven.be
Contact Person Name
Wim Wuyts
Contact Person Email
wim.wuyts@uzleuven.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Pneumology
Principal Investigator Name
Tom Moerman
Principal Investigator Email
tom.moerman@azgroeninge.be
Contact Person Name
Tom Moerman
Contact Person Email
tom.moerman@azgroeninge.be

Finland

Earliest CTIS Part Ii Submission Date
06-05-2024
Latest Decision Or Authorization Date
29-05-2024
Processing Time Days
23
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Turku University Hospital
Department Name
Dept of pulmonary diseases
Principal Investigator Name
Maritta Kilpeläinen
Principal Investigator Email
maritta.kilpelainen@varha.fi
Contact Person Name
Maritta Kilpeläinen
Contact Person Email
maritta.kilpelainen@varha.fi
Site Name
HUS Helsinki University Hospital
Department Name
Heart and Lung Center
Principal Investigator Name
Marjukka Myllärniemi
Principal Investigator Email
marjukka.myllarniemi@hus.fi
Contact Person Name
Marjukka Myllärniemi
Contact Person Email
marjukka.myllarniemi@hus.fi

Ireland

Earliest CTIS Part Ii Submission Date
16-05-2024
Latest Decision Or Authorization Date
31-05-2024
Processing Time Days
15
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
St Vincent's University Hospital
Department Name
Respiratory
Principal Investigator Name
Cormac McCarthy
Principal Investigator Email
cormac.mccarthy@ucd.ie
Contact Person Name
Cormac McCarthy
Contact Person Email
cormac.mccarthy@ucd.ie
Site Name
Connolly Hospital
Department Name
Respiratory
Principal Investigator Name
Eoin Judge
Principal Investigator Email
eoinjudge@rcsi.ie
Contact Person Name
Eoin Judge
Contact Person Email
eoinjudge@rcsi.ie
Site Name
Our Lady Of Lourdes Hospital
Department Name
Respiratory
Principal Investigator Name
Tidi Hassan
Principal Investigator Email
thassan@crp.healthcare
Contact Person Name
Tidi Hassan
Contact Person Email
thassan@crp.healthcare

Spain

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
27-05-2024
Processing Time Days
10
Number Of Sites
15
Number Of Participants
12

Sites

Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
NEUMOLOGÍA
Principal Investigator Name
Arantza Campo
Principal Investigator Email
acampoe@unav.es
Contact Person Name
Arantza Campo
Contact Person Email
acampoe@unav.es
Site Name
Hospital Universitario Central De Asturias
Department Name
NEUMOLOGÍA
Principal Investigator Name
Miguel Arias-Guillén
Principal Investigator Email
miguelariasguillen@gmail.com
Contact Person Name
Miguel Arias-Guillén
Contact Person Email
miguelariasguillen@gmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
NEUMOLOGIA
Principal Investigator Name
JUAN SUÁREZ
Principal Investigator Email
jsuaantelo@yahoo.es
Contact Person Name
JUAN SUÁREZ
Contact Person Email
jsuaantelo@yahoo.es
Site Name
Giromed Institute S.L.P.
Principal Investigator Name
JUAN ROLDAN
Principal Investigator Email
juan.roldan@giromedinstitute.com
Contact Person Name
JUAN ROLDAN
Site Name
Hospital Universitario La Paz
Department Name
NEUMOLOGÍA
Principal Investigator Name
Luis Gómez
Principal Investigator Email
lgomezc@salud.madrid.org
Contact Person Name
Luis Gómez
Contact Person Email
lgomezc@salud.madrid.org
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
NEUMOLOGÍA
Principal Investigator Name
Maria Jesús Rodriguez
Principal Investigator Email
mjrodriguezn@fjd.es
Contact Person Name
Maria Jesús Rodriguez
Contact Person Email
mjrodriguezn@fjd.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
NEUMOLOGÍA
Principal Investigator Name
JOSE MANUEL CIFIRÁN
Principal Investigator Email
josemanuel.cifrian@scsalud.es
Contact Person Name
JOSE MANUEL CIFIRÁN
Contact Person Email
josemanuel.cifrian@scsalud.es
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
NEUMOLOGÍA
Principal Investigator Name
Arantza Campo
Principal Investigator Email
acampoe@unav.es
Contact Person Name
Arantza Campo
Contact Person Email
acampoe@unav.es
Site Name
Hospital Universitario De La Princesa
Department Name
NEUMOLOGÍA
Principal Investigator Name
Claudia Valenzuela
Principal Investigator Email
claudiavale@hotmail.com
Contact Person Name
Claudia Valenzuela
Contact Person Email
claudiavale@hotmail.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
NEUMOLOGÍA
Principal Investigator Name
Cristhian García
Principal Investigator Email
christian.garcia@gmail.com
Contact Person Name
Cristhian García
Contact Person Email
christian.garcia@gmail.com
Site Name
Hospital Universitario del Henares
Department Name
NEUMOLOGIA
Principal Investigator Name
ALVARO CASANOVA ESPINOSA
Principal Investigator Email
fundacion.huis.hhen@salud.madrid.org
Contact Person Name
ALVARO CASANOVA ESPINOSA
Site Name
Hospital Clinico San Carlos
Department Name
NEUMOLOGÍA
Principal Investigator Name
Asunción Nieto
Principal Investigator Email
mariaasuncion.nieto@salud.madrid.org
Contact Person Name
Asunción Nieto
Site Name
Bellvitge University Hospital
Department Name
NEUMOLOGIA
Principal Investigator Name
MARIA MOLINA-MOLINA
Principal Investigator Email
mariamolinamolina@hotmail.com
Contact Person Name
MARIA MOLINA-MOLINA
Contact Person Email
mariamolinamolina@hotmail.com
Site Name
Hospital Arnau De Vilanova De Valencia
Department Name
NEUMOLOGÍA
Principal Investigator Name
JOSE BELDA
Principal Investigator Email
belda_josram@gva.es
Contact Person Name
JOSE BELDA
Contact Person Email
belda_josram@gva.es
Site Name
Hospital Clinic De Barcelona
Department Name
NEUMOLOGÍA
Principal Investigator Name
JACOBO SELLARES
Principal Investigator Email
sellares@clinic.cat
Contact Person Name
JACOBO SELLARES
Contact Person Email
sellares@clinic.cat

France

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
28-05-2024
Processing Time Days
6
Number Of Sites
12
Number Of Participants
18

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service de Pneumologie
Principal Investigator Name
Stephanie Dirou
Principal Investigator Email
stephanie.dirou@chu-nantes.fr
Contact Person Name
Stephanie Dirou
Contact Person Email
stephanie.dirou@chu-nantes.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Service de Pneumologie
Principal Investigator Name
Sylvain Marchand-Adam
Principal Investigator Email
s.marchandadam@univ-tours.fr
Contact Person Name
Sylvain Marchand-Adam
Contact Person Email
s.marchandadam@univ-tours.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service de Pneumologie
Principal Investigator Name
Elodie Blanchard
Principal Investigator Email
elodie.blanchard@chu-bordeaux.fr
Contact Person Name
Elodie Blanchard
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Service de Pneumologie
Principal Investigator Name
Philippe Bonniaud
Principal Investigator Email
philippe.bonniaud@chu-dijon.fr
Contact Person Name
Philippe Bonniaud
Contact Person Email
philippe.bonniaud@chu-dijon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Pneumologie
Principal Investigator Name
Bruno Crestani
Principal Investigator Email
bruno.crestani@aphp.fr
Contact Person Name
Bruno Crestani
Contact Person Email
bruno.crestani@aphp.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service hospitalo-universitaire de pneumologie et physiologie Pôle thorax et Vaisseaux
Principal Investigator Name
Sebastien Quetant
Principal Investigator Email
squetant@chu-grenoble.fr
Contact Person Name
Sebastien Quetant
Contact Person Email
squetant@chu-grenoble.fr
Site Name
Assistance Publique Hopitaux De Marseille
Department Name
Service de pneumologie et maladies rares
Principal Investigator Name
Martine Reynaud-Gaubert
Principal Investigator Email
martinelouise.reynaud@ap-hm.fr
Contact Person Name
Martine Reynaud-Gaubert
Contact Person Email
martinelouise.reynaud@ap-hm.fr
Site Name
Hopital Avicenne
Department Name
Service de Pneumologie
Principal Investigator Name
Hilario Nunes
Principal Investigator Email
hilario.nunes@aphp.fr
Contact Person Name
Hilario Nunes
Contact Person Email
hilario.nunes@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service de Pneumologie
Principal Investigator Name
Gregoire Prevot
Principal Investigator Email
prevot.g@chu-toulouse.fr
Contact Person Name
Gregoire Prevot
Contact Person Email
prevot.g@chu-toulouse.fr
Site Name
Hospices Civils De Lyon
Department Name
Service de Pneumologie
Principal Investigator Name
Vincent Cottin
Principal Investigator Email
vincent.cottin@chu-lyon.fr
Contact Person Name
Vincent Cottin
Contact Person Email
vincent.cottin@chu-lyon.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Service de Pneumologie
Principal Investigator Name
Aude Barnier
Principal Investigator Email
aude.barnier@chu-brest.fr
Contact Person Name
Aude Barnier
Contact Person Email
aude.barnier@chu-brest.fr
Site Name
Centre Hospitalier Universitaire D Angers
Department Name
Service de Pneumologie
Principal Investigator Name
Frederic Gagnadoux
Principal Investigator Email
frgagnadoux@chu-angers.fr
Contact Person Name
Frederic Gagnadoux
Contact Person Email
frgagnadoux@chu-angers.fr

Greece

Earliest CTIS Part Ii Submission Date
29-05-2024
Latest Decision Or Authorization Date
03-06-2024
Processing Time Days
5
Number Of Sites
7
Number Of Participants
12

Sites

Site Name
General Hospital Of Corfu Agia Eirini
Department Name
Pulmonary Department
Principal Investigator Name
Ilias Papanikolaou
Principal Investigator Email
icpapanikolaou@hotmail.com
Contact Person Name
Ilias Papanikolaou
Contact Person Email
icpapanikolaou@hotmail.com
Site Name
General University Hospital Of Larissa
Department Name
Pulmonary Clinic
Principal Investigator Name
Zoe Daniil
Principal Investigator Email
zdaniil@med.uth.gr
Contact Person Name
Zoe Daniil
Contact Person Email
zdaniil@med.uth.gr
Site Name
Athens Medical Center S.A.
Department Name
Pulmonology Department
Principal Investigator Name
Demosthenes Bouros
Principal Investigator Email
debouros@gmail.com
Contact Person Name
Demosthenes Bouros
Contact Person Email
debouros@gmail.com
Site Name
General University Hospital Of Patras
Department Name
Department of Internal and Respiratory Medicine
Principal Investigator Name
Argyrios Tzouvelekis
Principal Investigator Email
argyris.tzouvelekis@gmail.com
Contact Person Name
Argyrios Tzouvelekis
Contact Person Email
argyris.tzouvelekis@gmail.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Pulmonary Department - Aristotle University of Thessaloniki
Principal Investigator Name
Aikaterini Manika
Principal Investigator Email
katman@auth.gr
Contact Person Name
Aikaterini Manika
Contact Person Email
katman@auth.gr
Site Name
University General Hospital Of Ioannina
Department Name
Respiratory Medicine Department
Principal Investigator Name
Konstantinos Kostikas
Principal Investigator Email
ktkostikas@gmail.com
Contact Person Name
Konstantinos Kostikas
Contact Person Email
ktkostikas@gmail.com
Site Name
University General Hospital Attikon
Department Name
2nd Pulmonary Clinic
Principal Investigator Name
Effrosyni Manali
Principal Investigator Email
fmanali@otenet.gr
Contact Person Name
Effrosyni Manali
Contact Person Email
fmanali@otenet.gr

Hungary

Earliest CTIS Part Ii Submission Date
16-05-2024
Latest Decision Or Authorization Date
03-06-2024
Processing Time Days
18
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Pulmonology
Principal Investigator Name
Zsuzsanna Szalai
Principal Investigator Email
clinstudy@gmail.com
Contact Person Name
Zsuzsanna Szalai
Contact Person Email
clinstudy@gmail.com
Site Name
Clinic Of Pulmonology Semmelweis University
Department Name
Pulmonology
Principal Investigator Name
Veronika Müller
Principal Investigator Email
muller.veronika@semmelweis.hu
Contact Person Name
Veronika Müller
Contact Person Email
muller.veronika@semmelweis.hu

Italy

Earliest CTIS Part Ii Submission Date
30-04-2024
Latest Decision Or Authorization Date
29-05-2024
Processing Time Days
29
Number Of Sites
16
Number Of Participants
24

Sites

Site Name
Azienda Ospedaliero Universitaria di Sassari
Department Name
Pneumology Unit
Principal Investigator Name
Alessandro Fois
Principal Investigator Email
agfois@uniss.it
Contact Person Name
Alessandro Fois
Contact Person Email
agfois@uniss.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Respiratory Medicine
Principal Investigator Name
Francesco Bruno Arturo Blasi
Principal Investigator Email
francesco.blasi@policlinico.mi.it
Contact Person Name
Francesco Bruno Arturo Blasi
Site Name
Azienda Ospedaliera Dei Colli-Ospedale Colli Monaldi
Department Name
Division of respiratory disease
Principal Investigator Name
Marialuisa Bocchino
Principal Investigator Email
marialuisa.bocchino@unina.it
Contact Person Name
Marialuisa Bocchino
Contact Person Email
marialuisa.bocchino@unina.it
Site Name
Azienda Ospedaliera Papa Giovanni XXIII
Department Name
Pneumology Unit
Principal Investigator Name
Fabiano Di Marco
Principal Investigator Email
fdimarco@asst-pg23.it
Contact Person Name
Fabiano Di Marco
Contact Person Email
fdimarco@asst-pg23.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Phase I Research Center and Pneumology Unit
Principal Investigator Name
Fabrizio Luppi
Principal Investigator Email
fabrizio.luppi@unimib.it
Contact Person Name
Fabrizio Luppi
Contact Person Email
fabrizio.luppi@unimib.it
Site Name
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l.
Department Name
Pulmonology Unit
Principal Investigator Name
Patrizio Vitulo
Principal Investigator Email
pvitulo@ismett.edu
Contact Person Name
Patrizio Vitulo
Contact Person Email
pvitulo@ismett.edu
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Respiratory and Critical Care Unit
Principal Investigator Name
Stefano Nava
Principal Investigator Email
stefano.nava@aosp.bo.it
Contact Person Name
Stefano Nava
Contact Person Email
stefano.nava@aosp.bo.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Pneumology Unit
Principal Investigator Name
Laura Tavanti
Principal Investigator Email
l.tavanti@ao-pisa.toscana.it
Contact Person Name
Laura Tavanti
Contact Person Email
l.tavanti@ao-pisa.toscana.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Pneumology Unit
Principal Investigator Name
Luca Richeldi
Principal Investigator Email
luca.richeldi@policlinicogemelli.it
Contact Person Name
Luca Richeldi
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
Respiratory Diseases Unit, Department of Medical and Surgery Science and Neuroscience
Principal Investigator Name
Elena Bargagli
Principal Investigator Email
bargagli2@unisi.it
Contact Person Name
Elena Bargagli
Contact Person Email
bargagli2@unisi.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Pneumology Unit
Principal Investigator Name
Angelo Guido Corsico
Principal Investigator Email
corsico@unipv.it
Contact Person Name
Angelo Guido Corsico
Contact Person Email
corsico@unipv.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
SOSD Diagnosi Terapia delle Pat. polmonari infiltrative diffuse pleuriche,bronchiectasie dell’adulto
Principal Investigator Name
Martina Bonifazi
Principal Investigator Email
m.bonifazi@univpm.it
Contact Person Name
Martina Bonifazi
Contact Person Email
m.bonifazi@univpm.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Respiratory Diseases Unit
Principal Investigator Name
Dario Andrisani
Principal Investigator Email
dario.andrisani@unimore.it
Contact Person Name
Dario Andrisani
Contact Person Email
dario.andrisani@unimore.it
Site Name
Ospedale Giovan Battista Morgagni-Luigi Pierantoni Di Forlì
Department Name
Department of specialistic medicine -Pneumology Unit
Principal Investigator Name
Claudia Ravaglia
Principal Investigator Email
claudia.ravaglia2@auslromagna.it
Contact Person Name
Claudia Ravaglia
Site Name
Azienda Ospedaliero-Universitaria Ospedali Riuniti-Policlinico di Foggia-Ospedale C. D'Avanzo
Department Name
Respiratory Diseases Unit
Principal Investigator Name
Donato Lacedonia
Principal Investigator Email
donato.lacedonia@unifg.it
Contact Person Name
Donato Lacedonia
Contact Person Email
donato.lacedonia@unifg.it
Site Name
Careggi University Hospital
Department Name
Interventional Pulmonology Unit
Principal Investigator Name
Sara Tomassetti
Principal Investigator Email
sara.tomassetti@unifi.it
Contact Person Name
Sara Tomassetti
Contact Person Email
sara.tomassetti@unifi.it

Portugal

Earliest CTIS Part Ii Submission Date
25-04-2024
Latest Decision Or Authorization Date
28-05-2024
Processing Time Days
33
Number Of Sites
8
Number Of Participants
33

Sites

Site Name
Hospital Cuf Tejo S.A.
Department Name
Pneumologia
Principal Investigator Name
Nelson Marçal
Principal Investigator Email
nelson.marcal@cuf.pt
Contact Person Name
Nelson Marçal
Contact Person Email
nelson.marcal@cuf.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Pneumologia
Principal Investigator Name
Margarida Serrado
Principal Investigator Email
margaridaserrado@gmail.com
Contact Person Name
Margarida Serrado
Contact Person Email
margaridaserrado@gmail.com
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Pneumologia
Principal Investigator Name
Sérgio Campainha
Principal Investigator Email
sergio.fernandes@chvng.min-saude.pt
Contact Person Name
Sérgio Campainha
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Pneumologia
Principal Investigator Name
Alexandra Maia
Principal Investigator Email
alexandra.maia@chlc.min-saude.pt
Contact Person Name
Alexandra Maia
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Pneumologia
Principal Investigator Name
Maria Alvarenga Santos
Principal Investigator Email
maria.cmsantos@ulslod.min-saude.pt
Contact Person Name
Maria Alvarenga Santos
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Pneumologia
Principal Investigator Name
António Morais
Principal Investigator Email
amorais@ulssjoao.min-saude.pt
Contact Person Name
António Morais
Contact Person Email
amorais@ulssjoao.min-saude.pt
Site Name
Unidade Local de Saude do Algarve E.P.E.
Department Name
Pneumologia
Principal Investigator Name
Vanda Areias
Principal Investigator Email
vareias@ulsalg.min-saude.pt
Contact Person Name
Vanda Areias
Contact Person Email
vareias@ulsalg.min-saude.pt
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Oliveira
Principal Investigator Name
Tiago Oliveira
Contact Person Name
Tiago Oliveira

Austria

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
31-05-2024
Processing Time Days
8
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Klinik Hietzing
Department Name
Department of Respiratory and Pulmonary Diseases
Principal Investigator Name
Robab Breyer-Kohansal
Contact Person Name
Robab Breyer-Kohansal
Site Name
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Department Name
University Clinic for Pneumology/ Pulmonology
Principal Investigator Name
Michael Studnicka
Principal Investigator Email
m.studnicka@salk.at
Contact Person Name
Michael Studnicka
Contact Person Email
m.studnicka@salk.at
Site Name
Krankenhaus Nord Klinik Floridsdorf
Department Name
Department of Internal Medicine and Pulmonology
Principal Investigator Name
Arschang Valipour
Principal Investigator Email
arschang.valipour@gesundheitsverbund.at
Contact Person Name
Arschang Valipour
Site Name
Kepler Universitaetsklinikum GmbH
Department Name
Department of Internal Medicine 4- Pulmonology
Principal Investigator Name
David Lang
Principal Investigator Email
lunge@kepleruniklinikum.at
Contact Person Name
David Lang
Contact Person Email
lunge@kepleruniklinikum.at

Germany

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
29-05-2024
Processing Time Days
7
Number Of Sites
15
Number Of Participants
28

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Zentrum für Onkologie II. Medizinische Klinik und Poliklinik
Principal Investigator Name
Tim Oqueka
Principal Investigator Email
t.oqueka@uke.de
Contact Person Name
Tim Oqueka
Contact Person Email
t.oqueka@uke.de
Site Name
Helios Klinikum Emil Von Behring GmbH
Department Name
Klinik für Pneumologie Lungenklinik Heckeshorn
Principal Investigator Name
Torsten-Gerriet Blum
Principal Investigator Email
torsten-gerriet.blum@helios-gesundheit.de
Contact Person Name
Torsten-Gerriet Blum
Site Name
Medical Center - University Of Freiburg
Department Name
Department of Pneumology
Principal Investigator Name
Daiana Stolz
Principal Investigator Email
Daiana.Stolz@uniklinik-freiburg.de
Contact Person Name
Daiana Stolz
Site Name
Lungenfachklinik Immenhausen
Principal Investigator Name
Peter Hammerl
Principal Investigator Email
hammerl@lungenfachklinik-immenhausen.de
Contact Person Name
Peter Hammerl
Site Name
Thoraxklinik At University Of Heidelberg
Department Name
Abteilung Pneumologie und Beatmungsmedizin
Principal Investigator Name
Felix Herth
Principal Investigator Email
felix.herth@med.uni-heidelberg.de
Contact Person Name
Felix Herth
Site Name
Velocity Clinical Research Germany GmbH
Principal Investigator Name
Anne-Marie Kirsten
Principal Investigator Email
a.kirsten@pulmoresearch.de
Contact Person Name
Anne-Marie Kirsten
Contact Person Email
a.kirsten@pulmoresearch.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik V
Principal Investigator Name
Jürgen Behr
Principal Investigator Email
juergen.behr@med.uni-muenchen.de
Contact Person Name
Jürgen Behr
Site Name
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Department Name
Interstitial and Rare Lung Disease Centre
Principal Investigator Name
Francesco Bonella
Principal Investigator Email
francesco.bonella@rlk.uk-essen.de
Contact Person Name
Francesco Bonella
Site Name
Universitaet Leipzig
Department Name
Medizinische Klinik II Bereich Pneumologie
Principal Investigator Name
Hubert Wirtz
Principal Investigator Email
hubert.wirtz@medizin.uni-leipzig.de
Contact Person Name
Hubert Wirtz
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Internal Medicine - Pulmonary Medicine and Infectious Diseases
Principal Investigator Name
Sven Glaeser
Principal Investigator Email
Sven.glaeser@vivantes.de
Contact Person Name
Sven Glaeser
Contact Person Email
Sven.glaeser@vivantes.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Forschungsschwerpunkt Pneumologie, Gebäude A7
Principal Investigator Name
Rainer Wiewrodt
Principal Investigator Email
Rainer.Wiewrodt@ukmuenster.de
Contact Person Name
Rainer Wiewrodt
Contact Person Email
Rainer.Wiewrodt@ukmuenster.de
Site Name
GWT-Tud GmbH
Department Name
lnnere Abteilung / Pneumologie
Principal Investigator Name
Dirk Koschel
Principal Investigator Email
koschel@fachkrankenhaus-coswig.de
Contact Person Name
Dirk Koschel
Site Name
Robert-Bosch-Krankenhaus GmbH
Department Name
Dpt. of Pneumology and Critical Care Medicine
Principal Investigator Name
Claus Neurohr
Principal Investigator Email
claus.neurohr@rbk.de
Contact Person Name
Claus Neurohr
Contact Person Email
claus.neurohr@rbk.de
Site Name
Augustinerinnen Krankenhaeuser gGmbH
Department Name
Department of Pneumology, Allergology, Sleep and Ventilation Medicine
Principal Investigator Name
Urte Sommerwerck
Principal Investigator Email
usommerwerck@severinskloesterchen.de
Contact Person Name
Urte Sommerwerck
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Klinik für Pneumologie Zentrum für Thoraxerkrankungen
Principal Investigator Name
Michael Kreuter
Principal Investigator Email
kreuterm@uni-mainz.de
Contact Person Name
Michael Kreuter
Contact Person Email
kreuterm@uni-mainz.de
Site Name
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR
Principal Investigator Name
Lukas Jerrentrup
Principal Investigator Email
jerrentrup@studienzentrum-marburg.de
Contact Person Name
Lukas Jerrentrup

Netherlands

Earliest CTIS Part Ii Submission Date
20-05-2024
Latest Decision Or Authorization Date
03-06-2024
Processing Time Days
14
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Pulmonary Medicine
Principal Investigator Name
Marlies Wijsenbeek
Principal Investigator Email
m.wijsenbeek-lourens@erasmusmc.nl
Contact Person Name
Marlies Wijsenbeek
Site Name
Zuyderland Medisch Centrum Stichting
Department Name
Lung disease
Principal Investigator Name
Remy Mostard
Principal Investigator Email
r.mostard@zuyderland.nl
Contact Person Name
Remy Mostard
Contact Person Email
r.mostard@zuyderland.nl
Site Name
Amsterdam UMC
Department Name
Pulmonology
Principal Investigator Name
Esther Jeritza Nossent
Principal Investigator Email
e.nossent@amsterdamumc.nl
Contact Person Name
Esther Jeritza Nossent
Contact Person Email
e.nossent@amsterdamumc.nl
Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
Pulmonology
Principal Investigator Name
Marcel Veltkamp
Principal Investigator Email
m.veltkamp@antoniusziekenhuis.nl
Contact Person Name
Marcel Veltkamp

Denmark

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
28-05-2024
Processing Time Days
7
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Odense University Hospital
Department Name
Department of Respiratory Medicine
Principal Investigator Name
Ingrid Titlestad
Principal Investigator Email
ingrid.titlestad@rsyd.dk
Contact Person Name
Ingrid Titlestad
Contact Person Email
ingrid.titlestad@rsyd.dk
Site Name
Gentofte Hospital
Department Name
Department of Respiratory Medicine
Principal Investigator Name
Saher Shaker
Principal Investigator Email
Saher.burhan.shaker@regionh.dk
Contact Person Name
Saher Shaker
Contact Person Email
Saher.burhan.shaker@regionh.dk
Site Name
Aarhus Universitetshospital
Department Name
Department of Respiratory Diseases and Allergy
Principal Investigator Name
Karen Elisabeth Martha Bendstrup
Principal Investigator Email
karbends@rm.dk
Contact Person Name
Karen Elisabeth Martha Bendstrup
Contact Person Email
karbends@rm.dk

Sponsor

Primary sponsor

Full Name
Bristol-Myers Squibb Services Unlimited Company
Organisation Type
Pharmaceutical company
Country Of Registered Address
Ireland

Contract research organisations

Name
Fortrea Inc.
Responsibilities
Listed as CRO in sponsor duties (CRO)

Third parties

  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Biorepository Services supporting: Management, Storage, Supply Chain, Logistics, Sample Management Consulting & Continuous Project Management oversight","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"Serum Exploratory Biomarkers: ECM Biomarkers","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Subject Number assignment, Treatment/Arm assignment, Drug (re)supplies assignment, PRO/COA","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Vitalograph Limited","duties_or_roles":"Spirometry Central Reading and Blood Pressure Reading, Equipment Rental Services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Various operational duties; contains entry labelled 'CRO' in duties","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q2 Solutions","duties_or_roles":"Flow cytometry, Sample mgmt, Kit building, Storage and distribution of samples to other vendors for analysis","organisation_type":"Industry"}
  • {"country":"United Kingdom","full_name":"Q2 Solutions","duties_or_roles":"Flow cytometry, Sample mgmt, Kit building, Storage and distribution of samples to other vendors for analysis","organisation_type":"SME"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Plasma LPA Quantification; Plasma LPA LC/MS","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"Core Technology Services; IRT","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Empatica Inc.","duties_or_roles":"Digital Specimen Services - digital biomarkers data, SpO2, pulse rate, respiration rate (RR), physical activity, and skin conductance level (SCL)","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"Clinical Adjudication Services - standalone","organisation_type":"Industry"}
  • {"country":"Israel","full_name":"Trialog Clinical Trials Ltd.","duties_or_roles":"Depot; Importation, storage, and distribution of Investigational Medicinal Products.","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"GWT-Tud GmbH","duties_or_roles":"Local site / vendor responsibilities (listed as organisation in sponsors list)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
LPA1 antagonist
Active Substance
ADMILPARANT
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Investigational Product Name
LPA1 antagonist
Active Substance
ADMILPARANT
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Investigational Product Name
Placebo for BMS-986278
Modality
Other

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