Clinical trial • Phase III • Respiratory

ADMILPARANT for Progressive pulmonary fibrosis

Phase III trial of ADMILPARANT for Progressive pulmonary fibrosis.

Overview

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

Key dates

Initial CTIS Submission Date
19-02-2024
First CTIS Authorization Date
10-06-2024

Trial design

Randomised, placebo for bms-986278 (matching placebo); dose/schedule not specified in the ctis product listing.-controlled Phase III trial in Czechia, Austria, Spain and others.

Randomised
Yes
Comparator
Placebo for BMS-986278 (matching placebo); dose/schedule not specified in the CTIS product listing.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
843
Trial Duration For Participant
364

Eligibility

Recruits 843 No vulnerable population selected. Participants are adults (≥21 years) and provide informed consent; no paediatric or special assent provisions are described in the CTIS record..

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. Participants are adults (≥21 years) and provide informed consent; no paediatric or special assent provisions are described in the CTIS record.

Inclusion criteria

  • {"criterion_text":"- Subjects ≥ 21 years at the time of signing the informed consent."}
  • {"criterion_text":"- Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis on screening high-resolution computed tomography (HRCT)."}
  • {"criterion_text":"- If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening"}
  • {"criterion_text":"- If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening."}
  • {"criterion_text":"- Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening."}
  • {"criterion_text":"- Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening."}
  • {"criterion_text":"- Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK) (inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken these medications within 28 days prior to screening."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Men who are sexually active with women of childbearing potential agree to use male barrier contraception"}

Exclusion criteria

  • {"criterion_text":"- Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening."}
  • {"criterion_text":"- History of stroke or transient ischemic attack within 3 months prior to screening."}
  • {"criterion_text":"- Exhibit symptoms of heart failure at rest."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Use of systemic corticosteroids equivalent to prednisone > 15 mg/day is not allowed within 4 weeks prior to screening and during the study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Absolute change in FVC (mL) from baseline at Week 52.","definition_or_measurement_approach":"Measured as absolute change in forced vital capacity (FVC) in millilitres from baseline to 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 composite endpoint measured as time from Day 1 to first disease progression event through the Primary Endpoint Visit."}
  • {"endpoint_text":"- Change in walking distance measured in 6MWT from baseline at Week 52.","definition_or_measurement_approach":"Change from baseline in distance walked during the 6-minute walk test (6MWT) at Week 52."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
843
Recruitment Window Months
25
Consent Approach
Informed consent is obtained from adult participants (participants must be ≥21 years). Subject information sheets and informed consent forms are available in multiple country/language versions (documents present in English, Spanish, French, Dutch, German, Polish, Hungarian, Italian, Portuguese, Greek and other local language versions). Specific consent materials include pregnancy/pregnant partner information and optional future research/sample consent documents; no paediatric assent documents are applicable.

Methods

  • Print advertisements (country- and language-specific print ads) targeting potential study participants with progressive pulmonary fibrosis.
  • Social media advertisements and posts (country/language versions) targeting potential participants.
  • HCP letters and HCP-targeted materials to engage referring clinicians.
  • Brochures and study blurb documents for potential participants.
  • Screener forms and screeners (paper/online) to pre-screen potential participants.
  • Informed consent presentations and Informed Consent Aids to support consent discussions.
  • Study Connect / online screener platforms (Study Connect screener documents present) to facilitate digital pre-screening.

Geography

Total Number Of Sites
115
Total Number Of Participants
249

Czechia

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
14-06-2024
Processing Time Days
30
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
University Hospital Olomouc
Department Name
Department of Pulmonary diseases and Tuberculosis
Contact Person Name
Monika Žurková
Contact Person Email
monika.zurkova@fnol.cz

Austria

Earliest CTIS Part Ii Submission Date
30-05-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
18
Number Of Sites
5
Number Of Participants
4

Sites

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

Spain

Earliest CTIS Part Ii Submission Date
24-05-2024
Latest Decision Or Authorization Date
11-06-2024
Processing Time Days
18
Number Of Sites
17
Number Of Participants
36

Sites

Site Name
Clinica Universidad De Navarra
Department Name
Pulmonology
Contact Person Name
Arantza Campo
Contact Person Email
acampoe@unav.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Pulmonology
Contact Person Name
JUAN SUÁREZ
Contact Person Email
jsuaantelo@yahoo.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Pulmonology
Contact Person Name
Cristhian García
Contact Person Email
christian.garcia@gmail.com
Site Name
Hospital Arnau De Vilanova De Valencia
Department Name
Pulmonology
Contact Person Name
JOSE BELDA
Contact Person Email
belda_josram@gva.es
Site Name
Hospital Universitario De La Princesa
Department Name
Pulmonology
Contact Person Name
Claudia Valenzuela
Contact Person Email
claudiavale@hotmail.com
Site Name
Bellvitge University Hospital
Department Name
Pulmonology
Contact Person Name
MARIA MOLINA-MOLINA
Contact Person Email
mariamolinamolina@hotmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Pulmonology
Contact Person Name
José Luis Velasco Garrido
Contact Person Email
jlvelascogarrido@hotmail.com
Site Name
Hospital Universitario del Henares
Department Name
Pulmonology
Contact Person Name
Álvaro Casanova
Site Name
Hospital Universitari Vall D Hebron
Department Name
Pulmonology
Contact Person Name
Ana Villar
Contact Person Email
ana.villar@vallhebron.cat
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Pulmonology
Contact Person Name
Arantza Campo
Contact Person Email
acampoe@unav.es
Site Name
Hospital Universitario Central De Asturias
Department Name
Pulmonology
Contact Person Name
JOSE BELDA? (contact listed as Miguel Arias-Guillén)
Contact Person Email
miguelariasguillen@gmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Pulmonology
Contact Person Name
Maria Jesús Rodriguez
Contact Person Email
mjrodriguezn@fjd.es
Site Name
Hospital Universitario La Paz
Department Name
Pulmonology
Contact Person Name
Luis Gómez
Contact Person Email
lgomezc@salud.madrid.org
Site Name
Giromed Institute S.L.P.
Department Name
Pulmonology
Contact Person Name
Juan Roldan
Site Name
Hospital Clinico San Carlos
Department Name
Pulmonology
Contact Person Name
Asunción Nieto
Site Name
Hospital Clinic De Barcelona
Department Name
Pulmonology
Contact Person Name
JACOBO SELLARES
Contact Person Email
sellares@clinic.cat
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Pulmonology
Contact Person Name
JOSE MANUEL CIFIRÁN
Contact Person Email
josemanuel.cifrian@scsalud.es

Greece

Earliest CTIS Part Ii Submission Date
05-03-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
104
Number Of Sites
8
Number Of Participants
18

Sites

Site Name
University General Hospital Attikon
Department Name
2nd Pulmonary Clinic
Contact Person Name
Effrosyni Manali
Contact Person Email
fmanali@otenet.gr
Site Name
General University Hospital Of Patras
Department Name
Department of Internal and Respiratory Medicine
Contact Person Name
Argyrios Tzouvelekis
Contact Person Email
atzouvelekis@upatras.gr
Site Name
Athens Medical Center S.A.
Department Name
Pulmonology Department
Contact Person Name
Demosthenes Bouros
Contact Person Email
d.bouros@iatriko.gr
Site Name
General University Hospital Of Larissa
Department Name
Pulmonary Clinic
Contact Person Name
Zoe Daniil
Contact Person Email
zdaniil@med.uth.gr
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Pulmonary Department
Contact Person Name
Aikaterini Manika
Contact Person Email
Ktmn05@yahoo.gr
Site Name
University General Hospital Of Ioannina
Department Name
Respiratory Medicine Department
Contact Person Name
Konstantinos Kostikas
Contact Person Email
ktkostikas@uoi.gr
Site Name
University General Hospital Of Heraklion
Department Name
Pulmonology Clinic
Contact Person Name
Katerina Antoniou
Contact Person Email
kantoniou@med.uoc.gr
Site Name
General Hospital Of Corfu Agia Eirini
Department Name
Pulmonary Department
Contact Person Name
Ilias Papanikolaou
Contact Person Email
icpapanikolaou@hotmail.com

Italy

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
11-06-2024
Processing Time Days
43
Number Of Sites
16
Number Of Participants
40

Sites

Site Name
Ospedale Giovan Battista Morgagni-Luigi Pierantoni Di Forlì
Department Name
Department of specialistic medicine -Pneumology Unit
Contact Person Name
Claudia Ravaglia
Site Name
Azienda Ospedaliera Papa Giovanni XXIII
Department Name
Pneumology Unit
Contact Person Name
Fabiano Di Marco
Contact Person Email
fdimarco@asst-pg23.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Pneumology Unit
Contact Person Name
Angelo Guido Corsico
Contact Person Email
corsico@unipv.it
Site Name
Azienda Ospedaliera Dei Colli-Ospedale Colli Monaldi
Department Name
Division of respiratory disease
Contact Person Name
Marialuisa Bocchino
Contact Person Email
marialuisa.bocchino@unina.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Pneumology Unit
Contact Person Name
Laura Tavanti
Contact Person Email
l.tavanti@ao-pisa.toscana.it
Site Name
Azienda Ospedaliero Universitaria di Sassari
Department Name
Pneumology Unit
Contact Person Name
Alessandro Fois
Contact Person Email
agfois@uniss.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Phase I Research Center
Contact Person Name
Fabrizio Luppi
Contact Person Email
fabrizio.luppi@unimib.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Respiratory Diseases Unit
Contact Person Name
Dario Andrisani
Contact Person Email
dario.andrisani@unimore.it
Site Name
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
Department Name
Pneumology Unit
Contact Person Name
Michele Mondoni
Contact Person Email
michele.mondoni@unimi.it
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
Respiratory Diseases Unit, Department of Medical and Surgery Science and Neuroscience
Contact Person Name
Elena Bargagli
Contact Person Email
bargagli2@unisi.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Respiratory Medicine
Contact Person Name
Martina Bonifazi
Contact Person Email
m.bonifazi@univpm.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Pneumology Unit
Contact Person Name
Luca Richeldi
Site Name
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.L
Department Name
Pulmonology Unit
Contact Person Name
Patrizio Vitulo
Contact Person Email
pvitulo@ismett.edu
Site Name
Careggi University Hospital
Department Name
Interventional Pulmonology Unit
Contact Person Name
Sara Tomassetti
Contact Person Email
sara.tomassetti@unifi.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Respiratory Medicine
Contact Person Name
Francesco Bruno Arturo Blasi
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti-Policlinico di Foggia-Ospedale C. D'Avanzo
Department Name
Respiratory Diseases
Contact Person Name
Donato Lacedonia
Contact Person Email
donato.lacedonia@unifg.it

Belgium

Earliest CTIS Part Ii Submission Date
20-05-2024
Latest Decision Or Authorization Date
10-06-2024
Processing Time Days
21
Number Of Sites
5
Number Of Participants
10

Sites

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

Finland

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
11-06-2024
Processing Time Days
27
Number Of Sites
2
Number Of Participants
5

Sites

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

Hungary

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
31
Number Of Sites
2
Number Of Participants
5

Sites

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

Ireland

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
14-06-2024
Processing Time Days
24
Number Of Sites
4
Number Of Participants
7

Sites

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

Portugal

Earliest CTIS Part Ii Submission Date
29-05-2024
Latest Decision Or Authorization Date
12-06-2024
Processing Time Days
14
Number Of Sites
10
Number Of Participants
14

Sites

Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Pneumologia
Contact Person Name
Maria Alvarenga Santos
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Pneumologia
Contact Person Name
Margarida Serrado
Contact Person Email
margaridaserrado@gmail.com
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Pneumologia
Contact Person Name
António Morais
Contact Person Email
amorais@ulssjoao.min-saude.pt
Site Name
Hospital Cuf Tejo S.A.
Department Name
Pneumologia
Contact Person Name
Nelson Marçal
Contact Person Email
nelson.marcal@cuf.pt
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Pneumologia
Contact Person Name
Sérgio Campainha
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Pneumologia
Contact Person Name
Tiago Oliveira
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Pneumologia
Contact Person Name
Alexandra Borba e Maia
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Pneumologia
Contact Person Name
Rui Rolo
Contact Person Email
rui.rolo@hb.min-saude.pt
Site Name
Unidade Local De Saude De Sao Joao E.P.E. (additional site)
Department Name
Pneumologia
Site Name
Unidade Local De Saude De Loures-Odivelas EPE (additional site)
Department Name
Pneumologia (additional)

Germany

Earliest CTIS Part Ii Submission Date
28-05-2024
Latest Decision Or Authorization Date
13-06-2024
Processing Time Days
16
Number Of Sites
16
Number Of Participants
37

Sites

Site Name
Helios Hanseklinikum Stralsund GmbH
Department Name
Department of Respiratory Medicine and Infectious Diseases
Contact Person Name
Tom Bollmann
Site Name
Medical Center - University Of Freiburg
Department Name
Department of Pneumology
Contact Person Name
Daiana Stolz
Site Name
Lungenfachklinik Immenhausen
Contact Person Name
Peter Hammerl
Site Name
GWT-Tud GmbH
Contact Person Name
Dirk Koschel
Site Name
Thoraxzentrum Bezirk Unterfranken
Department Name
Department of Pneumology
Contact Person Name
Bernd Seese
Contact Person Email
b.seese@tzbu.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Department of Pneumology
Contact Person Name
Tim Oqueka
Contact Person Email
t.oqueka@uke.de
Site Name
Augustinerinnen Krankenhaeuser gGmbH
Department Name
Department of Pneumology, Allergology, Sleep and Ventilation Medicine
Contact Person Name
Urte Sommerwerck
Site Name
Velocity Clinical Research Germany GmbH
Contact Person Name
Anne-Marie Kirsten
Contact Person Email
AKirsten@velocityclinical.com
Site Name
Helios Klinikum Emil Von Behring GmbH
Department Name
Clinic for Pneumology
Contact Person Name
Torsten-Gerriet Blum
Site Name
Klinikum der Universitaet Muenchen AöR
Contact Person Name
Jürgen Behr
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Internal Medicine - Pulmonary Medicine and Infectious Diseases
Contact Person Name
Sven Glaeser
Site Name
Universitaet Leipzig
Department Name
Department of Pneumology
Contact Person Name
Hubert Wirtz
Site Name
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Department Name
Interstitial and Rare Lung Disease Centre
Contact Person Name
Francesco Bonella
Site Name
Thoraxklinik At University Of Heidelberg
Department Name
Department of Pneumology and Respiratory Medicine
Contact Person Name
Felix Herth
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Pneumologie
Contact Person Name
Michael Kreuter
Contact Person Email
kreuterm@uni-mainz.de
Site Name
Klinikum Konstanz GmbH
Department Name
II. Medizinische Klinik
Contact Person Name
Stephan Walterspacher
Contact Person Email
Stephan.walterspacher@glkn.de

France

Earliest CTIS Part Ii Submission Date
09-05-2024
Latest Decision Or Authorization Date
12-06-2024
Processing Time Days
34
Number Of Sites
13
Number Of Participants
31

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Department of Pulmonology
Contact Person Name
Bruno Crestani
Contact Person Email
bruno.crestani@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Department of Pulmonology
Contact Person Name
Gregoire Prevot
Contact Person Email
prevot.g@chu-toulouse.fr
Site Name
Hopital Avicenne
Department Name
Department of Pulmonology
Contact Person Name
Hilario Nunes
Contact Person Email
hilario.nunes@aphp.fr
Site Name
Centre Hospitalier Universitaire De Brest
Department Name
Department of Pulmonology
Contact Person Name
Aude Barnier
Contact Person Email
aude.barnier@chu-brest.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Department of Pulmonology
Contact Person Name
Elodie Blanchard
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Service de Pneumologie
Contact Person Name
Frederic Gagnadoux
Contact Person Email
frgagnadoux@chu-angers.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Department of Pulmonology
Contact Person Name
Sylvain Marchand-Adam
Contact Person Email
s.marchandadam@univ-tours.fr
Site Name
Assistance Publique Hopitaux De Marseille
Department Name
Department of Pulmonology and Rare Diseases
Contact Person Name
Martine Reynaud-Gaubert
Contact Person Email
martinelouise.reynaud@ap-hm.fr
Site Name
Hospices Civils De Lyon
Department Name
Department of Pulmonology
Contact Person Name
Vincent Cottin
Contact Person Email
vincent.cottin@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Department of Pulmonology
Contact Person Name
Stephanie Dirou
Contact Person Email
stephanie.dirou@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Pulmonology, thoracic oncology and critical care department
Contact Person Name
Charles-Hugo Marquette
Contact Person Email
marquette.c@chu-nice.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Pulmonology and Physiology University Hospital Department Chest and Vessels Unit
Contact Person Name
Sebastien Quetant
Contact Person Email
squetant@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Department of Pulmonology
Contact Person Name
Philippe Bonniaud
Contact Person Email
philippe.bonniaud@chu-dijon.fr

Poland

Earliest CTIS Part Ii Submission Date
20-05-2024
Latest Decision Or Authorization Date
14-06-2024
Processing Time Days
25
Number Of Sites
8
Number Of Participants
19

Sites

Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Contact Person Name
Agnieszka Jarzemska
Contact Person Email
a.jarzemska@naszlekarz.pl
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddział Alergologiczno-Pulmonologiczny
Contact Person Name
Luiza Grabowska-Skudlarz
Site Name
Centrum Medycyny Oddechowej Mroz Sp. j.
Contact Person Name
Robert Mroz
Contact Person Email
robmroz@wp.pl
Site Name
Vitamed Galaj I Cichomski Sp. j.
Contact Person Name
Iwona Patyk
Contact Person Email
i.patyk@vitamed.info
Site Name
Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego W Lodzi Centralny Szpital Weteranow SPZOZ
Department Name
Oddzial Kliniczny Pulmonologii Ogolnej i Onkologicznej, Onkologii Klinicznej z Pododdzialem Endoskop
Contact Person Name
Adam Antczak
Contact Person Email
adam.antczak1@wp.pl
Site Name
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Pneumonologii
Contact Person Name
Adam Barczyk
Contact Person Email
pneumo@sum.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ
Department Name
Oddział Kliniczny Pulmonologii i Alergologii
Contact Person Name
Sebastian Majewski
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Pneumonologii
Contact Person Name
Amelia Szymanowska-Narloch
Contact Person Email
aszymanowska@gumed.edu.pl

Denmark

Earliest CTIS Part Ii Submission Date
28-05-2024
Latest Decision Or Authorization Date
10-06-2024
Processing Time Days
13
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Gentofte Hospital
Department Name
Department of Respiratory Medicine
Contact Person Name
Saher B. Shaker
Contact Person Email
saher.burhan.shaker@regionh.dk
Site Name
Odense University Hospital
Department Name
Department of Respiratory Medicine
Contact Person Name
Ingrid Titlestad
Contact Person Email
ingrid.titlestad@rsyd.dk
Site Name
Rigshospitalet
Department Name
Lung transplantation
Contact Person Name
Thomas K. Lund
Contact Person Email
thomas.kromann.lund@regionh.dk

Netherlands

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
10-06-2024
Processing Time Days
10
Number Of Sites
5
Number Of Participants
11

Sites

Site Name
Academisch Ziekenhuis Leiden
Department Name
Pulmonology
Contact Person Name
Emiel Marges
Contact Person Email
e.r.marges@lumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Pulmonary Medicine
Contact Person Name
Marlies Wijsenbeek
Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
Pulmonology
Contact Person Name
Marcel Veltkamp
Site Name
Zuyderland Medisch Centrum Stichting
Department Name
Lung disease
Contact Person Name
Remy Mostard
Contact Person Email
r.mostard@zuyderland.nl
Site Name
Amsterdam UMC
Department Name
Pulmonology
Contact Person Name
Esther Jeritza Nossent
Contact Person Email
e.nossent@amsterdamumc.nl

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
CRO
Name
Fortrea Development Ltd. Branch of Foreign Company
Responsibilities
CRO

Third parties

  • {"country":"Israel","full_name":"Trialog Clinical Trials Ltd.","duties_or_roles":"Depot; Importation, storage and distribution of Investigational Medicinal Products.","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Empatica Inc.","duties_or_roles":"Digital Specimen Services - digital biomarkers data, SpO2, pulse rate, respiration rate (RR), physical activity (such as steps, activity intensity, etc.), and skin conductance level (SCL).","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"CRO and other duties (multiple codes listed including CRO).","organisation_type":"Pharmaceutical company"}
  • {"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":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"Specialty Biomarker Laboratory, Exploratory Serum Biomarkers analysis","organisation_type":"Laboratory/Research/Testing facility"}
  • {"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":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations; other operational duties (multiple entries listed).","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":"India","full_name":"Accenture Solutions Private Limited (additional address)","duties_or_roles":"Pharmacovigilance, Medical Review & Cases Data Entry","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Plasma LPA Quantification; Plasma LPA LC/MS","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Accenture Solutions Private Limited (other entry)","duties_or_roles":"Operational support (code 6 indicated)","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Fortrea Development Ltd. Branch of Foreign Company","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
LPA1 antagonist
Active Substance
ADMILPARANT
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Marketing authorisation number PRD10258659 (prodAuthStatus:1) shown in product listing
Frequency
BID (twice daily)
Investigational Product Name
Placebo for BMS-986278
Modality
Other

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