Clinical trial • Phase III • Respiratory|Rare Disease

TREPROSTINIL PALMITIL for Pulmonary hypertension associated with interstitial lung disease

Phase III trial of TREPROSTINIL PALMITIL for Pulmonary hypertension associated with interstitial lung disease.

Overview

Trial Therapeutic Area
Respiratory|Rare Disease
Trial Disease
Pulmonary hypertension associated with interstitial lung disease
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
19-09-2025
First CTIS Authorization Date
26-01-2026

Trial design

Randomised, placebo matching tpip qd (placebo inhalation powder capsules containing one of 4 dosage strengths of tpip: 80 μg, 160 μg, 320 μg or 640 μg). active arm: treprostinil palmitil inhalation powder by oral inhalation using a capsule-based dry powder inhaler device, 80 µg up to 1280 µg for 24 weeks.-controlled Phase III trial in Austria, Belgium, Czechia and others.

Randomised
Yes
Comparator
Placebo matching TPIP QD (Placebo inhalation powder capsules containing one of 4 dosage strengths of TPIP: 80 μg, 160 μg, 320 μg or 640 μg). Active arm: TREPROSTINIL PALMITIL INHALATION POWDER by oral inhalation using a capsule-based dry powder inhaler device, 80 µg up to 1280 µg for 24 weeks.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
110
Trial Duration For Participant
226

Eligibility

Recruits 110 The trial selects vulnerable population flag true in the registry but only enrolls adults (≥18) who are "Capable of giving signed informed consent as described in Section 10.1.5". Separate informed consent forms are provided (country-specific Main ICFs), with supplemental/optional ICFs for procedures (eg, Optional RHC ICF) and specific ICFs for pregnant participants and pregnant partners. No paediatric/assent procedures are described..

Pregnancy Exclusion
Pregnant or breastfeeding.
Vulnerable Population
The trial selects vulnerable population flag true in the registry but only enrolls adults (≥18) who are "Capable of giving signed informed consent as described in Section 10.1.5". Separate informed consent forms are provided (country-specific Main ICFs), with supplemental/optional ICFs for procedures (eg, Optional RHC ICF) and specific ICFs for pregnant participants and pregnant partners. No paediatric/assent procedures are described.

Inclusion criteria

  • {"criterion_text":"- 1. Males and females ≥18 years of age at the time of signing the ICF.\n- 2. Diagnosis of PH WHO Group 3 associated with ILD (including but not limited to IIP, chronic HSP, CTD-ILD, CPFE)\n- 3. Confirmation of fibrotic ILD by centrally overread CT scan performed at Screening or within prior 12 months.\n- 4. PH confirmed by RHC at Screening or within 12 months prior to Screening, with the following hemodynamic findings: a. mPAP >20 mmHg and b. PCWP of ≤15 mmHg and c. PVR ≥4 Wood Units\n- 5 6MWD ≥100 and ≤500 meters at two 6MWTs at S two distances at Screening perfored at least 4 hours apart, with the difference between the 2 distances ≤15%\n- 7. Participants receiving chronic medication for underlying disease (eg, antifibrotic, immunomodulators, immunosuppressants, etc) and/or PDE5 inhibitors, should be on this treatment for ≥90 days and on a stable dose for ≥30 days prior to Screening.\n- 8. Male and female (WOCBP) participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n- 9. Capable of giving signed informed consent as described in Section 10.1.5 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol."}

Exclusion criteria

  • {"criterion_text":"- • Diagnosis of PH WHO Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than Interstitial lung disease as described in Inclusion criterion 2 • Primary diagnosis of COPD and/or FEV1/FVC <0.7 (based on screening or historical spirometry within the prior 6 months)\n- •\tClinically significant left heart disease: •\tevidence of clinically significant left-sided valvular heart disease, •\tleft ventricular failure with LVEF <45%, or diagnosis of HFpEF •\techocardiography findings at Screening suggestive for postcapillary PH •\tunstable ischemic heart disease •\tunstable arrhythmia, including uncontrolled atrial fibrillation (rate-controlled arrhythmia or paroxysmal atrial fibrillation is allowed). •\tAcutely decompensated heart failure within 30 days of Screening or during Screening. •\tQTcF interval >500 ms at Screening or Baseline, or known medical history of long QT syndrome. •\tEvidence of chronic thromboembolic disease or recent (within 6 months of Screening) acute pulmonary embolism.\n- •Platelet count <50.0 x 103/μL at Screening, and/or unexplained coagulation abnormalities in repeated laboratory tests during the screening. •Systolic BP <90 mmHg at Screening and Baseline. •Supplemental oxygen requirement at rest >10 L/min at Screening (otherwise use of supplemental oxygen is allowed). •Active cardiopulmonary rehabilitation program started within 30 days of Screening and planned to continue or be initiated during the study. •Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine). •Exacerbation of underlying lung disease or active respiratory tract infection within 30 days of Screening or during Screening (based on the last dose of therapy or hospitalization, whichever is later).\n- •Any acute or chronic musculoskeletal disease, injury, or other condition (eg, arthritis affecting the lower limbs, recent hip or knee joint replacement), other than the disease under study that, in the opinion of the Investigator, might affect the participant’s ability to perform the 6MWT and/or the 6MWT accuracy. •Active liver disease or hepatic dysfunction: •\tElevated serum ALT or AST levels >3 × ULN or total bilirubin >1.5 × ULN (except when explained by Gilbert's syndrome) at Screening •\tModerate to severe chronic hepatic impairment (Child-Pugh Class B-C) •\t Hepatitis B and/or hepatitis C with evidence of recent infection and/or active virus replication (participant with undetectable hepatitis B virus DNA and negative hepatitis C virus RNA are acceptable)\n- •History of HIV infection or positive serology for HIV-1 or HIV-2. •Severe concomitant illness (other than the disease under study) limiting life expectancy (<6 months). •History of solid organ transplantation, or expected transplant within 24 weeks after randomization(otherwise participant on lung transplant list are accepted). •Any physical limitation that would impair the participant's use of the inhaler device. •Use of any investigational drug/device, or participation in any investigational study within 30 days prior to Screening. •History of alcohol or drug abuse, as judged by the Investigator, within 6 months prior to Screening. •Current use of cigarettes (as defined by CDC) or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime and who currently smokes either every day or some days (Glossary, CDC Tobacco Glossary, 2017).\n- •Current use of inhaled marijuana, recreational or medical (current use defined as used at least one or more times during the past 30 days prior to Screening), or expected use during the study. •Any other medical or psychological condition including relevant laboratory abnormalities at Screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease and/or may present an unreasonable risk to the study participant as a result of his/her participation in this clinical trial, may impede their ability complete the study or the study assessments or confound the outcomes of the trial. •History of malignancy within 5 years prior to Screening Visit, with exception of completely treated in situ carcinoma of the cervix, in situ melanoma, and completely treated non-metastatic squamous or basal cell carcinoma of the skin. •Pregnant or breastfeeding."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change in 6MWD measured at peak exposure from Baseline to Week 24","definition_or_measurement_approach":"6-minute walk distance (6MWD) measured at peak exposure; change from baseline to Week 24 (as stated in endpoint description)."}

Secondary endpoints

  • {"endpoint_text":"- Time from randomization to first clinical worsening over 24 weeks","definition_or_measurement_approach":"Time-to-event (from randomization to first clinical worsening) over a 24-week period."}
  • {"endpoint_text":"- Time from randomization to first major morbidity or mortality event over 24 weeks","definition_or_measurement_approach":"Time-to-event (from randomization to first major morbidity or mortality) over 24 weeks."}
  • {"endpoint_text":"- Change in NT proBNP plasma concentration from Baseline over 24 weeks","definition_or_measurement_approach":"Change from baseline in plasma NT‑proBNP concentration measured over 24 weeks."}
  • {"endpoint_text":"- Proportion of participants with improvement in NT proBNP levels over 24 weeks","definition_or_measurement_approach":"Proportion of participants showing improvement in NT‑proBNP levels during 24 weeks."}
  • {"endpoint_text":"- Change in 6MWD measured at trough exposure from Baseline to Week 22","definition_or_measurement_approach":"Change in 6MWD measured at trough exposure from baseline to Week 22."}
  • {"endpoint_text":"- Change in 6MWD measured at peak exposure from Baseline over 20 weeks","definition_or_measurement_approach":"Change from baseline in 6MWD measured at peak exposure over 20 weeks."}
  • {"endpoint_text":"- Change in L-PF total symptom domain score from Baseline over 24 weeks","definition_or_measurement_approach":"Change from baseline in Living With Pulmonary Fibrosis (L-PF) total symptom domain score over 24 weeks."}
  • {"endpoint_text":"- Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Total Symptom Domain Score Over 24 Week","definition_or_measurement_approach":"Mean change from baseline in L-PF total symptom domain score over 24 weeks."}
  • {"endpoint_text":"- Plasma Concentrations of Treprostinil Palmitil (TP) and Treprostinil (TRE)","definition_or_measurement_approach":"Pharmacokinetic measurement of plasma concentrations of TP and TRE."}

Recruitment

Planned Sample Size
110
Recruitment Window Months
34
Consent Approach
Informed consent is obtained from adult participants (≥18 years) who must be capable of giving signed informed consent as described in Section 10.1.5. Country-specific Main ICFs are provided (multiple languages), plus supplemental/optional ICFs (eg, Optional RHC ICF), pregnancy participant and pregnancy partner ICFs, and site/patient advocacy contact lists. Consent is signed by the participant; separate documentation exists for special situations (pregnancy, optional procedures).

Geography

Total Number Of Sites
73
Total Number Of Participants
251

Austria

Earliest CTIS Part Ii Submission Date
09-01-2026
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
17
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Medical University Of Vienna
Department Name
Universitätsklinik für Innere Medizin Il Klinische Abteilung fur 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
Medizinische Universitaet Innsbruck
Department Name
Universitätsklinik für Innere Medizin II A.ö. Landeskrankenhaus/
Principal Investigator Name
Thomas Sonnweber
Principal Investigator Email
thomas.sonnweber@i-med.ac.at
Contact Person Name
Thomas Sonnweber
Contact Person Email
thomas.sonnweber@i-med.ac.at
Site Name
Johannes Kepler University Linz
Department Name
Universitätsklinik für Innere Medizin 4 - Pneumologie
Principal Investigator Name
David Lang
Principal Investigator Email
davidlang@kepleruniklinikum.at
Contact Person Name
David Lang
Contact Person Email
davidlang@kepleruniklinikum.at

Belgium

Earliest CTIS Part Ii Submission Date
08-01-2026
Latest Decision Or Authorization Date
29-01-2026
Processing Time Days
21
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Hopital Erasme
Department Name
Cardiology
Principal Investigator Name
Jean-Luc Vachiéry
Principal Investigator Email
jean.luc.vachiery@hubruxelles.be
Contact Person Name
Jean-Luc Vachiéry
Site Name
UZ Leuven
Department Name
Pneumology
Principal Investigator Name
Laurent Godinas
Principal Investigator Email
Laurent.Godinas@uzleuven.be
Contact Person Name
Laurent Godinas
Contact Person Email
Laurent.Godinas@uzleuven.be

Czechia

Earliest CTIS Part Ii Submission Date
13-01-2026
Latest Decision Or Authorization Date
29-01-2026
Processing Time Days
16
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Fakultni Thomayerova nemocnice
Department Name
Pneumologická klinika 1. LF UK a FTN
Principal Investigator Name
Martina Šterclová
Principal Investigator Email
Martina.sterclova@ftn.cz
Contact Person Name
Martina Šterclová
Contact Person Email
Martina.sterclova@ftn.cz

Denmark

Earliest CTIS Part Ii Submission Date
12-01-2026
Latest Decision Or Authorization Date
27-01-2026
Processing Time Days
15
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Region Midtjylland
Department Name
Aarhus Universitetshospital, Afdeling for Hjertesygdomme
Principal Investigator Name
Soeren Mellemkjaer
Principal Investigator Email
soren.mellemkjaer@rm.dk
Contact Person Name
Soeren Mellemkjaer
Contact Person Email
soren.mellemkjaer@rm.dk

France

Earliest CTIS Part Ii Submission Date
06-01-2026
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
20
Number Of Sites
11
Number Of Participants
40

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Unité de pneumologie allergologie et pathologie respiratoire de l’environnement
Principal Investigator Name
Marianne RIOU
Principal Investigator Email
marianne.riou@chru-strasbourg.fr
Contact Person Name
Marianne RIOU
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Pneumologie
Principal Investigator Name
Etienne-Marie JUTANT
Principal Investigator Email
etienne-marie.jutant@chu-poitiers.fr
Contact Person Name
Etienne-Marie JUTANT
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Department of Respiratory and Sleep Medicine
Principal Investigator Name
Frédéric GAGNADOUX
Principal Investigator Email
frgagnadoux@chu-angers.fr
Contact Person Name
Frédéric GAGNADOUX
Contact Person Email
frgagnadoux@chu-angers.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
CRCM- UMA Pneumologie
Principal Investigator Name
Cécilia ICHIM NOGHI
Principal Investigator Email
ichim-noghi.c@chu-nice.fr
Contact Person Name
Cécilia ICHIM NOGHI
Contact Person Email
ichim-noghi.c@chu-nice.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service des maladies pulmonaires (hôpital Nord)
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
Assistance Publique Hopitaux De Paris
Department Name
Service de pneumologie et réanimation respiratoire
Principal Investigator Name
David MONTANI
Principal Investigator Email
david.montani@bct.aphp.fr
Contact Person Name
David MONTANI
Contact Person Email
david.montani@bct.aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Département de pneumologie
Principal Investigator Name
Arnaud MAURAC
Principal Investigator Email
arnaud.maurac@chu-bordeaux.fr
Contact Person Name
Arnaud MAURAC
Contact Person Email
arnaud.maurac@chu-bordeaux.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Pneumologie
Principal Investigator Name
Cécile TROMEUR
Principal Investigator Email
cecile.tromeur@chu-brest.fr
Contact Person Name
Cécile TROMEUR
Contact Person Email
cecile.tromeur@chu-brest.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Service de Médecine Vasculaire et Thérapeutique
Principal Investigator Name
Laurent BERTOLETTI
Principal Investigator Email
laurent.bertoletti@chu-st-etienne.fr
Contact Person Name
Laurent BERTOLETTI
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 Universitaire De Lille
Department Name
Service de cardiologie
Principal Investigator Name
Nicolas LAMBLIN
Principal Investigator Email
nicolas.lamblin@chu-lille.fr
Contact Person Name
Nicolas LAMBLIN
Contact Person Email
nicolas.lamblin@chu-lille.fr

Italy

Earliest CTIS Part Ii Submission Date
08-01-2026
Latest Decision Or Authorization Date
28-01-2026
Processing Time Days
20
Number Of Sites
14
Number Of Participants
22

Sites

Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
UOC Centro Ricerca Fase I
Principal Investigator Name
Giuseppe Paciocco
Principal Investigator Email
giuseppe.paciocco@unimib.it
Contact Person Name
Giuseppe Paciocco
Contact Person Email
giuseppe.paciocco@unimib.it
Site Name
Azienda Ospedaliero Universitaria Di Sassari
Department Name
SC Cardiologia Clinica ed Interventistica
Principal Investigator Name
Gavino Casu
Principal Investigator Email
gavino.casu@aouss.it
Contact Person Name
Gavino Casu
Contact Person Email
gavino.casu@aouss.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Struttura Complessa di Malattie dell’Apparato Respiratorio
Principal Investigator Name
STEFANIA CERRI
Principal Investigator Email
stefania.cerri@unimore.it
Contact Person Name
STEFANIA CERRI
Contact Person Email
stefania.cerri@unimore.it
Site Name
Azienda Ospedaliera Dei Colli
Department Name
U.O.C. Pneumotisiologia (Università Federico II)
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
Multimedica S.p.A.
Department Name
U. O. di Pneumologia
Principal Investigator Name
Sergio Harari
Principal Investigator Email
sergio@sergioharari.it
Contact Person Name
Sergio Harari
Contact Person Email
sergio@sergioharari.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
U.O. di Cardiologia
Principal Investigator Name
Stefano Ghio
Principal Investigator Email
s.ghio@smatteo.pv.it
Contact Person Name
Stefano Ghio
Contact Person Email
s.ghio@smatteo.pv.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
U.O.C. di Pneumologia
Principal Investigator Name
Carlo Vancheri
Principal Investigator Email
vancheri@unict.it
Contact Person Name
Carlo Vancheri
Contact Person Email
vancheri@unict.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
UOC Cardiologia
Principal Investigator Name
Fabio Dardi
Principal Investigator Email
fabio.dardi@aosp.bo.it
Contact Person Name
Fabio Dardi
Contact Person Email
fabio.dardi@aosp.bo.it
Site Name
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
SC Pneumologia U
Principal Investigator Name
Rocco Francesco Rinaldo
Principal Investigator Email
rocco.rinaldo@gmx.com
Contact Person Name
Rocco Francesco Rinaldo
Contact Person Email
rocco.rinaldo@gmx.com
Site Name
Humanitas Mirasole S.p.A.
Department Name
UOC Pneumologia 1
Principal Investigator Name
Anna Stainer
Principal Investigator Email
anna.stainer@hunimed.eu
Contact Person Name
Anna Stainer
Contact Person Email
anna.stainer@hunimed.eu
Site Name
Azienda Ospedaliera di Padova
Department Name
Unità Operativa Complessa di Pneumologia
Principal Investigator Name
Elisabetta Balestro
Principal Investigator Email
Elisabetta.balestro@aopd.veneto.it
Contact Person Name
Elisabetta Balestro
Site Name
Azienda Ospedaliera di Careggi
Department Name
SOD Pneumologia interventistica
Principal Investigator Name
Sara Tomassetti
Principal Investigator Email
sara.tomassetti@unifi.it
Contact Person Name
Sara Tomassetti
Contact Person Email
sara.tomassetti@unifi.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
UOC Malattie Cardiovascolari
Principal Investigator Name
Roberto Badagliacca
Principal Investigator Email
roberto.badagliacca@uniroma1.it
Contact Person Name
Roberto Badagliacca
Site Name
Azienda Ospedaliero-Universitaria Senese
Department Name
UOC Malattie dell'Apparato Respiratorio
Principal Investigator Name
Elena Bargagli
Principal Investigator Email
bargagli2@gmail.com
Contact Person Name
Elena Bargagli
Contact Person Email
bargagli2@gmail.com

Portugal

Earliest CTIS Part Ii Submission Date
06-01-2026
Latest Decision Or Authorization Date
28-01-2026
Processing Time Days
22
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Hospital De Santa Maria E.P.E.
Department Name
Cardiology
Principal Investigator Name
Rui Placido
Principal Investigator Email
rui.placido@chln.min-saude.pt
Contact Person Name
Rui Placido
Contact Person Email
rui.placido@chln.min-saude.pt
Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Pneumunology
Principal Investigator Name
Ana Claudia Vieira
Principal Investigator Email
ana.claudia.vieira@ulsas.minsaude.pt
Contact Person Name
Ana Claudia Vieira

Romania

Earliest CTIS Part Ii Submission Date
13-01-2026
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
20
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara
Department Name
Sectia Clinica Pneumologie II
Principal Investigator Name
Ovidiu Fira-Mladinescu
Principal Investigator Email
mladinescu@umft.ro
Contact Person Name
Ovidiu Fira-Mladinescu
Contact Person Email
mladinescu@umft.ro
Site Name
Spitalul Clinic Judetean De Urgenta Targu Mures
Department Name
Sectia Clinica Cardiologie
Principal Investigator Name
Theodora-Mariana-Nicoleta Benedek
Principal Investigator Email
theodora.benedek@gmail.com
Contact Person Name
Theodora-Mariana-Nicoleta Benedek
Contact Person Email
theodora.benedek@gmail.com
Site Name
Elias University Emergency Hospital
Department Name
Sectia Clinica Pneumologie
Principal Investigator Name
Dragos Bumbacea
Principal Investigator Email
d.bumbacea@gmail.com
Contact Person Name
Dragos Bumbacea
Contact Person Email
d.bumbacea@gmail.com
Site Name
Spitalul Clinic De Pneumoftiziologie Leon Daniello
Department Name
Sectia Clinica Pneumologie I
Principal Investigator Name
Milena-Adina Man
Principal Investigator Email
manmilena50@yahoo.com
Contact Person Name
Milena-Adina Man
Contact Person Email
manmilena50@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
13-01-2026
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
20
Number Of Sites
12
Number Of Participants
50

Sites

Site Name
Hospital Universitario De Toledo
Department Name
Cardiology
Principal Investigator Name
Maria Lazaro Salvador
Principal Investigator Email
maria.lasal@gmail.com
Contact Person Name
Maria Lazaro Salvador
Contact Person Email
maria.lasal@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Pneumonology
Principal Investigator Name
Isabel Blanco
Principal Investigator Email
iblanco2@clinic.cat
Contact Person Name
Isabel Blanco
Contact Person Email
iblanco2@clinic.cat
Site Name
Hospital Universitario La Paz
Department Name
Pneumonology
Principal Investigator Name
Sergio Alcolea Batres
Principal Investigator Email
alcobatres@yahoo.es
Contact Person Name
Sergio Alcolea Batres
Contact Person Email
alcobatres@yahoo.es
Site Name
Bellvitge University Hospital
Department Name
Pneumonology
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 Universitario 12 De Octubre
Department Name
Cardiology
Principal Investigator Name
Alejandro Cruz Utrilla
Principal Investigator Email
cardioinvestigacion@h12o.es
Contact Person Name
Alejandro Cruz Utrilla
Contact Person Email
cardioinvestigacion@h12o.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Cardiology
Principal Investigator Name
Manuel Francisco Gomez Bueno
Principal Investigator Email
mgomezbuenoc@secardiologia.es
Contact Person Name
Manuel Francisco Gomez Bueno
Contact Person Email
mgomezbuenoc@secardiologia.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Pneumonology
Principal Investigator Name
Manuel Lopez Meseguer
Principal Investigator Email
respiratoryclinicaltrials@vallhebron.cat
Contact Person Name
Manuel Lopez Meseguer
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Pneumonology
Principal Investigator Name
Juan Suarez Antelo
Principal Investigator Email
jsuaantelo@yahoo.es
Contact Person Name
Juan Suarez Antelo
Contact Person Email
jsuaantelo@yahoo.es
Site Name
Hospital Universitario De La Princesa
Department Name
Pneumonology
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 Virgen De La Macarena
Department Name
Cardiology
Principal Investigator Name
Alejandro Recio Mayoral
Principal Investigator Email
jandrorm@hotmail.com
Contact Person Name
Alejandro Recio Mayoral
Contact Person Email
jandrorm@hotmail.com
Site Name
University Hospital Son Espases
Department Name
Pneumonology
Principal Investigator Name
Ernest Sala Llinas
Principal Investigator Email
ernest.sala@ssib.es
Contact Person Name
Ernest Sala Llinas
Contact Person Email
ernest.sala@ssib.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Pneumonology
Principal Investigator Name
Jose Andres Tenes Mayen
Principal Investigator Email
joseandrestenes@gmail.com
Contact Person Name
Jose Andres Tenes Mayen
Contact Person Email
joseandrestenes@gmail.com

Greece

Earliest CTIS Part Ii Submission Date
07-10-2025
Latest Decision Or Authorization Date
27-01-2026
Processing Time Days
112
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
1st Cardiology Clinic
Principal Investigator Name
Georgios Giannakoulas
Principal Investigator Email
g.giannakoulas@gmail.com
Contact Person Name
Georgios Giannakoulas
Contact Person Email
g.giannakoulas@gmail.com
Site Name
General University Hospital Of Patras
Department Name
Department of Respiratory Medicine
Principal Investigator Name
Argyrios Tzouvelekis
Principal Investigator Email
atzouvelekis@upatras.gr
Contact Person Name
Argyrios Tzouvelekis
Contact Person Email
atzouvelekis@upatras.gr
Site Name
Onassis Cardiac Surgery Center
Department Name
Non Invasive Cardiology Department
Principal Investigator Name
Dimitrios Tsiapras
Principal Investigator Email
dtsiapras@hotmail.com
Contact Person Name
Dimitrios Tsiapras
Contact Person Email
dtsiapras@hotmail.com
Site Name
Evangelismos S.A.
Department Name
1st Department of Critical Care and Pulmonary Hypertension Clinic
Principal Investigator Name
Anastasia Anthi
Principal Investigator Email
anastasia.anthi1@gmail.com
Contact Person Name
Anastasia Anthi
Contact Person Email
anastasia.anthi1@gmail.com
Site Name
University General Hospital Of Heraklion
Department Name
Pulmonary Clinic
Principal Investigator Name
Katerina Antoniou
Principal Investigator Email
kantoniou@med.uoc.gr
Contact Person Name
Katerina Antoniou
Contact Person Email
kantoniou@med.uoc.gr

Poland

Earliest CTIS Part Ii Submission Date
07-01-2026
Latest Decision Or Authorization Date
30-01-2026
Processing Time Days
23
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Klinika Kardiologii i Chorób Wewnętrznych z OINK
Principal Investigator Name
Remigiusz Kazimierczyk
Principal Investigator Email
remigiusz.kazimierczyk@umb.edu.pl
Contact Person Name
Remigiusz Kazimierczyk
Site Name
Wojewodzki Szpital Specjalistyczny Im. Stefana Kardynala Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lublinie
Department Name
Oddział Kardiolog.-Pododdział Intens. Nadz. Kardiolog.-Pododdział Rehab. Kardiolog.
Principal Investigator Name
Piotr Błaszczak
Principal Investigator Email
blaszcz12345@interia.pl
Contact Person Name
Piotr Błaszczak
Contact Person Email
blaszcz12345@interia.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
Department Name
Klinika Kardiologii z Intensywnym Nadzorem Kardiologicznym
Principal Investigator Name
Małgorzata Peregud-Pogorzelska
Principal Investigator Email
m1peregud@gmail.com
Contact Person Name
Małgorzata Peregud-Pogorzelska
Contact Person Email
m1peregud@gmail.com
Site Name
Szpital Kliniczny Dzieciątka Jezus
Department Name
Klinika Chorób Wewn. i Kardiologii z CD i Leczenia Żylnej Choroby Zakrzepowo Zatorowej WUM
Principal Investigator Name
Michał Ciurzyński
Principal Investigator Email
michal.ciurzynski@wum.edu.pl
Contact Person Name
Michał Ciurzyński
Contact Person Email
michal.ciurzynski@wum.edu.pl
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Klinika Pulmonologii, Chorób Wewnętrznych, Pulmonologii Onkologicznej i Transplantologicznej
Principal Investigator Name
Piotr Korczyński
Principal Investigator Email
piotr.korczynski@pimmswia.gov.pl
Contact Person Name
Piotr Korczyński
Site Name
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Department Name
Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego
Principal Investigator Name
Grzegorz Kopeć
Principal Investigator Email
grzegorzkrakow1@gmail.com
Contact Person Name
Grzegorz Kopeć
Contact Person Email
grzegorzkrakow1@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
07-01-2026
Latest Decision Or Authorization Date
28-01-2026
Processing Time Days
21
Number Of Sites
12
Number Of Participants
50

Sites

Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Zentrum für pulmonale Hypertonie
Principal Investigator Name
Ekkehard Grünig
Principal Investigator Email
ekkehard.gruenig@med.uni-heidelberg.de
Contact Person Name
Ekkehard Grünig
Site Name
Robert Bosch Krankenhaus GmbH
Department Name
Abteilung für Pneumologie und Beatmungsmedizin RBK Lungenzentrum Stuttgart
Principal Investigator Name
Alessandro Ghiani
Principal Investigator Email
alessandro.ghiani@rbk.de
Contact Person Name
Alessandro Ghiani
Contact Person Email
alessandro.ghiani@rbk.de
Site Name
Lungenfachklinik Immenhausen
Department Name
Lungenfachklinik Immenhausen
Principal Investigator Name
Peter Hammerl
Principal Investigator Email
p.hammerl@lungenfachklinik-immenhausen.de
Contact Person Name
Peter Hammerl
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Innere Medizin V IMED Gebäude
Principal Investigator Name
Albert Omlor
Principal Investigator Email
albert.omlor@uks.eu
Contact Person Name
Albert Omlor
Contact Person Email
albert.omlor@uks.eu
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medizinische Klinik III
Principal Investigator Name
Daniel Drömann
Principal Investigator Email
daniel.droemann@uksh.de
Contact Person Name
Daniel Drömann
Contact Person Email
daniel.droemann@uksh.de
Site Name
LMU Klinikum Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik V, Campus Großhadern
Principal Investigator Name
Michaela Barnikel
Principal Investigator Email
Michaela.Barnikel@med.uni-muenchen.de
Contact Person Name
Michaela Barnikel
Site Name
Technische Universitaet Dresden
Department Name
Universitätsklinikum Carl Gustav Carus Dresden
Principal Investigator Name
Michael Halank
Principal Investigator Email
pulmo.studien@ukdd.de
Contact Person Name
Michael Halank
Contact Person Email
pulmo.studien@ukdd.de
Site Name
Lungenärzte am Rundfunkplatz
Department Name
Lungenärzte am Rundfunkplatz
Principal Investigator Name
Korkut Avsar
Principal Investigator Email
dravsar@lungenaerzte-am-rundfunkplatz.de
Contact Person Name
Korkut Avsar
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Pneumologie
Principal Investigator Name
Francesco Bonella
Principal Investigator Email
francesco.bonella@rlk.uk-essen.de
Contact Person Name
Francesco Bonella
Site Name
Krankenhaus Neuwittelsbach
Department Name
Krankenhaus Neuwittelsbach
Principal Investigator Name
Hanno Leuchte
Principal Investigator Email
prof.leuchte@krankenhaus-neuwittelsbach.de
Contact Person Name
Hanno Leuchte
Site Name
Asklepios Klinik Gauting GmbH
Department Name
Asklepios Klinik Gauting GmbH
Principal Investigator Name
Claus-Peter Kreutz
Principal Investigator Email
c.kreutz@asklepios.com
Contact Person Name
Claus-Peter Kreutz
Contact Person Email
c.kreutz@asklepios.com
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Herzzentrum des Universitätsklinikums Bonn
Principal Investigator Name
Dirk Skowasch
Principal Investigator Email
dirk.skowasch@ukbonn.de
Contact Person Name
Dirk Skowasch
Contact Person Email
dirk.skowasch@ukbonn.de

Sponsor

Primary sponsor

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

Contract research organisations

Name
PPD Development LP
Responsibilities
CYSIS portal/ PVG, Patient ID cards, IoR for IP when required, IoR for eCOA-TBC, In-check Dial, Comfort items; other sponsor duties (codes:1,11,12,13,15,2,5)
Name
PPD Global Ltd.
Responsibilities
Operational/site support duties (codes:1,12,5)
Name
Pharmaceutical Product Development LLC
Responsibilities
Central Laboratory; other central lab responsibilities (code:15; code:4)
Name
Parexel International Corp.
Responsibilities
Programming
Name
ICON Clinical Research Limited
Responsibilities
L-PF questionnaire linguistic validation
Name
Suvoda LLC
Responsibilities
eCOA and related responsibilities

Third parties

  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes:1,11,12,13,15,2,5; CYSIS portal/ PVG, Patient ID cards, IoR for IP when required, IoR for eCOA-TBC, In-check Dial, Comfort items","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"code:15; Service reimbursement (Travel, Meals, Lodge & Stipend)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Alliance Pharma Inc.","duties_or_roles":"code:15; PK","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"codes:1,12,5","organisation_type":"Pharmaceutical company"}
  • {"country":"Singapore","full_name":"PPD Global Central Labs (S) Pte Ltd","duties_or_roles":"code:15; Central Labaratory; code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"code:15; Patient Brochure, recruitment materials","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"code:15; Central Labaratory; code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"FluidDa","duties_or_roles":"code:15; CT Scan FRI","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"code:15; ECG, 6MWT training of SCs","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Stichting EuroQol Research Foundation","duties_or_roles":"code:15; EQ-5d-5L questionnaire license","organisation_type":"Patient organisation/association"}
  • {"country":"Sweden","full_name":"BorgPerception AB","duties_or_roles":"code:15; Borg scale for 6MWT","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"code:15; Programming","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cisys Inc.","duties_or_roles":"code:15; Adjudication of Events","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code:15; eCOA; code:3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"code:15; Clinical Chemistry/Clinical Haematology; code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Mapi Research Trust","duties_or_roles":"code:15; L-PF questionnaire license","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"code:15; Platform for global training","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"code:8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP (duplicate entry)","duties_or_roles":"code:15; Patient ID cards, IoR for IP when required, IoR for eCOA-TBC, In-check Dial, Comfort items","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code:15; L-PF questionnaire linguistic validation","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
TREPROSTINIL PALMITIL INHALATION POWDER
Active Substance
TREPROSTINIL PALMITIL
Modality
Small molecule
Routes Of Administration
INHALATION USE
Route
Inhalation
Authorisation Status
MIA (IMP) 20377
Starting Dose
80 µg
Dose Levels
Dosing strengths include 80 µg, 160 µg, 320 µg, 640 µg; up-titration up to max daily 1280 µg
Frequency
Once daily (QD)
Maximum Dose
1280 µg
Dose Escalation Increase
Initial 80 µg with escalation up to 1280 µg
Investigational Product Name
Placebo (inhalation powder capsules) containing 1 of 4 dosage strengths of TPIP (80 μg, 160 μg, or 320 μg or 640 µg )
Modality
Other
Authorisation Status
MIA (IMP) 20377
Starting Dose
Placebo matching active starting strength (80 µg equivalent)
Dose Levels
Placebo supplied matching strengths 80 µg, 160 µg, 320 µg, 640 µg (to match active dosing); overall blinding allows up to active max
Frequency
Once daily (QD)
Dose Escalation Increase
Placebo matches active titration schedule (initial match to 80 µg with subsequent matches)

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