Clinical trial • Phase III • Respiratory

TREPROSTINIL for Pulmonary hypertension associated with interstitial lung disease (WHO Group 3)

Phase III trial of TREPROSTINIL for Pulmonary hypertension associated with interstitial lung disease (WHO Group 3).

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Pulmonary hypertension associated with interstitial lung disease (WHO Group 3)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
07-11-2025
First CTIS Authorization Date
11-03-2026

Trial design

Randomised, open-label, l606 placebo inhalation suspension (matching placebo); dose/schedule not specified-controlled Phase III trial in Austria, Belgium, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
L606 Placebo Inhalation Suspension (matching placebo); dose/schedule not specified
Target Sample Size
222
Trial Duration For Participant
168

Eligibility

Recruits 222 adults.

Inclusion criteria

  • {"criterion_text":"- Participant is between 18 years to 80 years old"}
  • {"criterion_text":"- Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging"}
  • {"criterion_text":"- Evidence of PH as demonstrated from Right Heart Catheterization (RHC) with the following hemodynamic parameters: a. Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec/cm5, and b. Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and c. Pulmonary capillary wedge pressure (PCWP) or Left-Ventricular End Diastolic Pressure (LVEDP) of ≤ 15 mmHg"}
  • {"criterion_text":"- FEV1/FVC (ratio) > 0.70"}
  • {"criterion_text":"- 6-minute walk distance ≥ 150 meters"}

Exclusion criteria

  • {"criterion_text":"- PH in the updated WHO Classification Groups 1, 2, 4, or 5"}
  • {"criterion_text":"- Has evidence of clinically significant left-sided heart disease as defined by echocardiography"}
  • {"criterion_text":"- Participants with history of persistent/permanent or uncontrolled atrial fibrillation"}
  • {"criterion_text":"- Participants with severe obstructive sleep apnea"}
  • {"criterion_text":"- Has experienced exacerbation of underlying lung disease or active respiratory infection requiring antibiotics"}
  • {"criterion_text":"- Initiation of pulmonary rehabilitation"}
  • {"criterion_text":"- Severe coronary heart disease or unstable angina or myocardial infarction within 180 days prior to Screening"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from Baseline to Week 16 in 6-minute walk distance (6MWD)","definition_or_measurement_approach":"Change in walk distance as measured by the six-minute walk test (6MWT) from baseline to Week 16"}

Secondary endpoints

  • {"endpoint_text":"- Time to first occurrence of 1 of the following clinical worsening event (CWE) criterion are met: -Death (all causes) -Hospitalization due to a cardio-pulmonary indication related to underlying disease -Lung transplant -Decrease in 6MWD > 15% from Baseline related to disease under study, at 2 consecutive visits and at least 1 week apart","definition_or_measurement_approach":"Defined as time to first occurrence of any listed clinical worsening events (death, cardio-pulmonary hospitalization related to underlying disease, lung transplant, or ≥15% decrease in 6MWD from baseline confirmed at two consecutive visits ≥1 week apart)"}
  • {"endpoint_text":"- Change from Baseline to Week 24 in 6-Minute Walk Distance (6MWD)","definition_or_measurement_approach":"Change in 6MWD measured by the six-minute walk test (6MWT) from baseline to Week 24"}
  • {"endpoint_text":"- Change from Baseline to Week 16 in 6MWD","definition_or_measurement_approach":"Change in 6MWD measured by the six-minute walk test (6MWT) from baseline to Week 16"}

Recruitment

Planned Sample Size
222
Recruitment Window Months
67
Consent Approach
Informed consent is obtained from adult participants (study includes participants aged 18–80). Country-specific subject information sheets and informed consent forms are provided (documents available for Austria, Belgium, Czechia, France, Germany, Italy, Latvia, Portugal, Spain, Poland in their respective languages); a pregnancy-specific ICF is listed. (Detailed consent/assent text not available in the extract.)

Geography

Total Number Of Sites
43
Total Number Of Participants
121

Austria

Earliest CTIS Part Ii Submission Date
05-03-2026
Latest Decision Or Authorization Date
22-03-2026
Processing Time Days
17
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Medical University Of Graz
Department Name
Internal Medicine
Contact Person Name
Gabor Kovacs
Site Name
Ordensklinikum Linz GmbH
Department Name
Internal Medicine
Contact Person Name
Regina Steringer-Mascherbauer
Contact Person Email
StudienDermaKardio@bhs.at

Belgium

Earliest CTIS Part Ii Submission Date
18-02-2026
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
21
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Department of Internal medicine
Contact Person Name
Geert Van Pottelberge
Contact Person Email
pneumostudies@uzgent.be
Site Name
Hopital Erasme
Department Name
Department of Cardiology
Contact Person Name
Jean-Luc Vachiéry
Site Name
UZ Leuven
Department Name
Department of Pneumonology
Contact Person Name
Laurent Godinas

Czechia

Earliest CTIS Part Ii Submission Date
13-02-2026
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
28
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Pulmonary Hypertension Centre
Contact Person Name
Jansa Pavel
Contact Person Email
plicnihypertenze@vfn.cz

France

Earliest CTIS Part Ii Submission Date
23-02-2026
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
22
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
CHRU De Nancy
Department Name
Pneumologie
Contact Person Name
Ari Chaouat
Contact Person Email
a.chaouat@chru-nancy.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Pneumologie
Contact Person Name
Marianne Riou
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Maladies pulmonaires
Contact Person Name
Martine Reynaud-Gaubert
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pneumologie et réanimation respiratoire
Contact Person Name
Olivier Sitbon
Contact Person Email
olivier.sitbon@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Pneumologie
Contact Person Name
Vincent Cottin
Contact Person Email
vincent.cottin@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Médecine interne
Contact Person Name
Eric Hachulla
Contact Person Email
eric.hachulla@chu-lille.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Pneumologie
Contact Person Name
Grégoire Prévot

Germany

Earliest CTIS Part Ii Submission Date
10-03-2026
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
8
Number Of Sites
10
Number Of Participants
26

Sites

Site Name
Universitaetsklinikum Koeln AöR
Department Name
Innere Medizin
Contact Person Name
Stephan Rosenkranz
Contact Person Email
stephan.rosenkranz@uk-koeln.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Pneumologie
Contact Person Name
Hans Klose
Contact Person Email
pneumo-studienzentrale@uke.de
Site Name
Krankenhaus Neuwittelsbach
Department Name
Internal Medicine II
Contact Person Name
Hanno Leuchte
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Medicine II
Contact Person Name
Khodr Tello
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Internal Medicine, Respiratory Medicine and Infectious Diseases
Contact Person Name
Beate Stubbe
Contact Person Email
innereb@med.uni-greifswald.de
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Centre for pulmonary hypertension
Contact Person Name
Ekkehard Gruenig
Site Name
LMU Klinikum Muenchen AöR
Department Name
Internal Medicine V
Contact Person Name
Juergen Behr
Site Name
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Department Name
Pneumologie
Contact Person Name
Francesco Bonella
Site Name
Technische Universitaet Dresden
Department Name
Pneumologie
Contact Person Name
Michael Halank
Contact Person Email
pulmo.studien@ukdd.de
Site Name
Medizinische Hochschule Hannover
Department Name
Respiratory and Infectious Medicine
Contact Person Name
Marius Hoeper
Contact Person Email
pneumo-trials@mh-hannover.de

Italy

Earliest CTIS Part Ii Submission Date
23-02-2026
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
25
Number Of Sites
6
Number Of Participants
17

Sites

Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Cardiovascular Diseases Unit
Contact Person Name
Pietro Ameri
Contact Person Email
pietro.ameri@unige.it
Site Name
Azienda Ospedaliera Dei Colli
Department Name
UOC Pneumotisiologia
Contact Person Name
Marialuisa Bocchino
Contact Person Email
marialuisa.bocchino@unina.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
U.O. Cardiologia
Contact Person Name
Stefano Ghio
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
UOC Malattie Cardiovascolari
Contact Person Name
Silvia Papa
Contact Person Email
silvia.papa@uniroma.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
UOC Pneumologia
Contact Person Name
Giuseppe Paciocco
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
Unità Pneumologia
Contact Person Name
Patrizio Vitulo
Contact Person Email
pvitulo@ismett.edu

Latvia

Earliest CTIS Part Ii Submission Date
20-02-2026
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
26
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Pauls Stradins Clinical University Hospital
Department Name
Department of Cardiology
Contact Person Name
Andris Skride
Contact Person Email
info@stradini.lv

Portugal

Earliest CTIS Part Ii Submission Date
30-12-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
73
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Pulmonary Vascular Disease Unit
Contact Person Name
Mário Santos
Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Department of Pneumology
Contact Person Name
Ana Cláudia Vieira
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Department of Cardiology
Contact Person Name
Graça Castro
Contact Person Email
uicc@ulscoimbra.min-saude.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Department of Cardiology
Contact Person Name
Rui Plácido
Contact Person Email
gaic@medicina.ulisboa.pt

Spain

Earliest CTIS Part Ii Submission Date
16-02-2026
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
30
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Pulmonology
Contact Person Name
Raquel López
Contact Person Email
neumologia_ds07@gva.es
Site Name
Hospital Del Mar
Department Name
Pulmonology
Contact Person Name
Diego Rodríguez
Contact Person Email
info@researchmar.net
Site Name
Hospital Universitari Vall D Hebron
Department Name
Pulmonology
Contact Person Name
Berta Saez
Site Name
Hospital Clinic De Barcelona
Department Name
Pulmonology
Contact Person Name
Isabel Blanco
Contact Person Email
htpulm@clinic.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Cardiology
Contact Person Name
Alejandro Cruz Utrilla
Contact Person Email
cardioinvestigacion@h12o.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Pulmonology
Contact Person Name
José Manuel Cifrián Martínez
Contact Person Email
neumologiavaldecilla@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
10-02-2026
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
41
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Department Name
Department of Cardiac and Vascular Diseases
Contact Person Name
Grzegorz Kopec
Contact Person Email
sekr_kard@szpitaljp2.krakow.pl
Site Name
Wojewodzki Szpital Specjalistyczny Im. Stefana Kardynala Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lublinie
Department Name
Department of Cardiology and Intensive Care Unit
Contact Person Name
Piotr Blaszczak​
Contact Person Email
lubkard@szpital.lublin.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Department of Cardiology
Contact Person Name
Tatiana Mularek-Kubzdela
Contact Person Email
ucwbk@ump.edu.pl

Sponsor

Primary sponsor

Full Name
Liquidia Technologies Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Longboat Clinical Limited
Responsibilities
Central Integrative platform, sponsor - site - patient facing
Name
Ppd Inc.
Responsibilities
code 4
Name
CTI Clinical Trial and Consulting Services Europe GmbH
Responsibilities
codes 1,12,5
Name
Cti Clinical Trial Services Inc.
Responsibilities
codes 1,11,12,13,4,5,8
Name
CTI Laboratory Services Spain S.L.
Responsibilities
code 4
Name
4g Clinical LLC
Responsibilities
code 3

Third parties

  • {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"code 15: Central Integrative platform, sponsor - site - patient facing","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"CTI Laboratory Services Spain S.L.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"code 15: Travel vendor","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"code 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Tcm Groups Inc.","duties_or_roles":"code 10","organisation_type":"Industry"}
  • {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"code 15: Risk-Based Study Execution (RBx) & Data Quality Oversight","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"CTI Clinical Trial and Consulting Services Europe GmbH","duties_or_roles":"codes 1,12,5","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 6","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Cti Clinical Trial Services Inc.","duties_or_roles":"codes 1,11,12,13,4,5,8","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Treprostinil Liposome
Active Substance
TREPROSTINIL
Modality
Small molecule
Routes Of Administration
INHALATION
Route
INHALATION
Maximum Dose
950 µg (max daily dose)
Investigational Product Name
L606 Placebo Inhalation Suspension
Modality
Other

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