Clinical trial • Phase II • Cardiology|Respiratory

MOSLICIGUAT for Pulmonary hypertension associated with interstitial lung disease

Phase II trial of MOSLICIGUAT for Pulmonary hypertension associated with interstitial lung disease.

Overview

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

Key dates

Initial CTIS Submission Date
30-08-2024
First CTIS Authorization Date
11-12-2024

Trial design

Randomised, placebo: colorless, clear, hard capsules for inhalation (placebo) used as comparator; study is described as placebo-controlled. no active comparator drug dose/schedule specified for placebo. Phase II trial in Belgium, Czechia, France and others.

Randomised
Yes
Comparator
Placebo: Colorless, clear, hard capsules for inhalation (placebo) used as comparator; study is described as placebo-controlled. No active comparator drug dose/schedule specified for placebo.
Target Sample Size
96
Trial Duration For Participant
366

Eligibility

Recruits 96 The trial flags vulnerable population selection (isVulnerablePopulationSelected = true). Participation requires that "Participants willing and able to provide informed consent." Adult participant informed consent forms are provided (L1 SIS-ICF Main and related ICFs). Participant-facing materials / ICFs are available in multiple languages for participating countries (examples include French, Dutch, German, Czech, Italian, Spanish, Polish). No assent process for minors is described in the provided documents..

Vulnerable Population
The trial flags vulnerable population selection (isVulnerablePopulationSelected = true). Participation requires that "Participants willing and able to provide informed consent." Adult participant informed consent forms are provided (L1 SIS-ICF Main and related ICFs). Participant-facing materials / ICFs are available in multiple languages for participating countries (examples include French, Dutch, German, Czech, Italian, Spanish, Polish). No assent process for minors is described in the provided documents.

Inclusion criteria

  • {"criterion_text":"- 1. Participants willing and able to provide informed consent.\n- 2. Participants with diagnosis of Interstitial Lung Disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed diseases include one of the following: a.Idiopathic interstitial pneumonia (IIP). b.Chronic hypersensitivity pneumonitis. c.ILD associated with connective tissue disease (CTD) with a forced vital capacity (FVC) <70% of predicted.\n- 3. Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC).\n- 4. Ability to perform 6MWD ≥ 100 meters."}

Exclusion criteria

  • {"criterion_text":"- 1. Diagnosis of WHO PH Group 1 (eg. pulmonary arterial hypertension), Group 2 (related to left-heart dysfunction), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified).\n- 2. Exacerbation of underlying lung disease requiring augmentation of therapy or emergent hospitalization within 28 days prior to randomization.\n- 3. Initiation of pulmonary rehabilitation within 28 days prior to randomization.\n- 4. Receiving >10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.\n- 5. History or intolerance to mosliciguat or sGC stimulators or activators.\n- 6. Receipt of investigational, or experimental therapy within 42 days OR 5 half-lives prior to randomization."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percent change from baseline in PVR assessed at estimated peak exposure at Week 16 (%ΔPVR16) by right heart catheterization (RHC)","definition_or_measurement_approach":"Percent change from baseline in pulmonary vascular resistance (PVR) assessed at estimated peak exposure at Week 16, measured by right heart catheterization (RHC)."}

Secondary endpoints

  • {"endpoint_text":"- 1. Change in 6MWD from baseline measured at estimated peak exposure at Week 16 using the 6-Minute Walk Test (6MWT)","definition_or_measurement_approach":"Change from baseline in 6-minute walk distance (6MWD) measured at estimated peak exposure at Week 16 using the 6-Minute Walk Test (6MWT)."}
  • {"endpoint_text":"- 2. Change from baseline in NT-proBNP at Week 16","definition_or_measurement_approach":"Change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP) measured at Week 16."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
96
Recruitment Window Months
32
Consent Approach
Informed consent is provided by the participant: inclusion requires "Participants willing and able to provide informed consent." Subject information and informed consent forms (L1 SIS-ICF Main and supporting ICFs including pre-screening, PK/optional consents, pregnancy-related ICFs) are available for each participating country in the local language (examples: French, Dutch, German, Czech, Italian, Spanish, Polish). No assent for minors is described.

Methods

  • Study-specific recruitment procedures (K1) at site level (country-specific K1 documents listed for Belgium, Czechia, France, Germany, Italy, Latvia, Netherlands, Poland, Spain).
  • Informational website / trial webpages (K2 recruitment material: Informational Website) targeted to potential participants in the participating countries.
  • Patient brochures, flyers and posters (K2 recruitment material: Patient Brochure / Patient Flyer / Patient Poster) distributed per country (languages per country).
  • Dear Patient letters (K2 recruitment material_Dear Patient Letter) for distribution to identified patients.
  • Clinical Trial Overview video scripts (K2 recruitment material_Clinical Trial Overview video Script) for communicating trial overview to patients.
  • Social media advertisements (K2 recruitment material_Social Media Ads) used as recruitment channel (country-specific social media ads PDFs present).
  • Site-level outreach via participating hospitals/clinics (trial sites listed with contact emails).

Geography

Total Number Of Sites
29
Total Number Of Participants
96

Belgium

Earliest CTIS Part Ii Submission Date
19-09-2024
Latest Decision Or Authorization Date
14-11-2025
Processing Time Days
421
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
UZ Leuven
Department Name
Pneumology
Contact Person Name
Laurent Godinas
Contact Person Email
pneumologie@uzleuven.be
Site Name
Hopital Erasme
Department Name
Cardiology
Contact Person Name
Jean-Luc Vachiery
Contact Person Email
contact@erasme.ulb.ac.be

Czechia

Earliest CTIS Part Ii Submission Date
04-12-2024
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
355
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Fakultni Thomayerova nemocnice
Contact Person Name
Ladislav Lacina
Contact Person Email
ladislav.lacina@ftn.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Contact Person Name
Pavel Jansa
Contact Person Email
pavel.jansa@vfn.cz

France

Earliest CTIS Part Ii Submission Date
20-11-2024
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
363
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Pulmonology and Physiology Unit
Contact Person Name
Marianne Riou
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Vascular and therapeutic medicine service
Contact Person Name
Laurent Bertoletti
Site Name
Hospices Civils De Lyon
Department Name
Pulmonology Department
Contact Person Name
Vincent Cottin
Contact Person Email
Vincent.cottin@chu-lyon.fr
Site Name
Bicetre Hospital
Department Name
Pulmonary department
Contact Person Name
David Montani
Contact Person Email
contact@erasme.ulb.ac.be

Germany

Earliest CTIS Part Ii Submission Date
09-12-2024
Latest Decision Or Authorization Date
19-11-2025
Processing Time Days
345
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik I Pneumological Department
Contact Person Name
Michael Halank
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Medizinische Klinik II, Ambulanz für pulmonale Hypertonie
Contact Person Name
Khodr Tello
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Centre for pulmonary hypertension
Contact Person Name
Ekkehard Grünig
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Clinic of University Munich LMU Klinikum
Contact Person Name
Jürgen Behr
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Universitätsklinik und Poliklinik für Innere Medizin I
Contact Person Name
Stephan Eisenmann
Contact Person Email
Stephan.eisenmann@ukhalle.de

Italy

Earliest CTIS Part Ii Submission Date
19-09-2024
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
424
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
Azienda Ospedaliera Dei Colli
Department Name
U.O.C. Pneumotisiologia
Contact Person Name
Marialuisa Bocchino
Contact Person Email
Marialuisa.bocchino@unina.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
U.O. Pneumologia
Contact Person Name
Fulvio Braido
Contact Person Email
Fulvio.Braido@unige.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
U.O. Cardiologia
Contact Person Name
Laura Scelsi
Contact Person Email
l.scelsi@smatteo.pv.it
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
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
UOC Malattie Cardiovascolari
Contact Person Name
Giovanna Manzi
Contact Person Email
g.manzi@policlinicoumberto1.it

Latvia

Earliest CTIS Part Ii Submission Date
13-12-2024
Latest Decision Or Authorization Date
14-11-2025
Processing Time Days
336
Number Of Sites
1
Number Of Participants
4

Sites

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

Spain

Earliest CTIS Part Ii Submission Date
19-09-2024
Latest Decision Or Authorization Date
19-11-2025
Processing Time Days
426
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Cardiology
Contact Person Name
Alejandro Cruz Utrilla
Contact Person Email
acruzutrilla@gmail.com
Site Name
Hospital Costa Del Sol
Department Name
Cardiology
Contact Person Name
Rafael Bravo Marqués
Contact Person Email
rafabravomarques@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Neumology
Contact Person Name
José Manuel Cifrian Martínez
Contact Person Email
jmcifrian@humv.es
Site Name
Hospital Universitario De Toledo
Department Name
Cardiology
Contact Person Name
Maria Lazaro Salvador
Contact Person Email
pbeneyto@sescam.jccm.es

Netherlands

Earliest CTIS Part Ii Submission Date
15-11-2024
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
367
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
VUMC Stichting
Department Name
Pulmonary department
Contact Person Name
Esther Nossent
Contact Person Email
e.nossent@amsterdamumc.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Rheumatology
Contact Person Name
Madelon Vonk
Contact Person Email
Madelon.vonk@radboudumc.nl

Poland

Earliest CTIS Part Ii Submission Date
05-12-2024
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
348
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Kardiologii
Contact Person Name
Tatiana MULAREK-KUBZDELA
Contact Person Email
tatianamularek@wp.pl
Site Name
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Department Name
Oddział Kliniczny Chorób Serca i Naczyń
Contact Person Name
Grzegorz KOPEĆ
Contact Person Email
grzegorzkrakow1@gmail.com
Site Name
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
Department Name
Oddział Kardiologiczny
Contact Person Name
Radosław KRĘCKI
Contact Person Email
rkrecki@gmail.com
Site Name
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Department Name
Oddział Kardiologii
Contact Person Name
Marcin KURZYNA
Contact Person Email
marcin.kurzyna@ecz-otwock.pl

Sponsor

Primary sponsor

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

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Multiple operational roles (sponsorDuties codes: 1,2,5,9,11,12,13,15). Includes Central Imaging (15). Contact: CTIS-Biotech@iconplc.com
Name
Pharmaceutical Product Development LLC (PPD)
Responsibilities
Central lab / study support (code: 4) and PPD Global Central Labs (lab support). Contact: Jonelle.McCreary@ppd.com
Name
Rho Inc.
Responsibilities
Study operational support (code: 13). Contact: nathan_kohn@rhoworld.com
Name
Primevigilance USA Inc.
Responsibilities
Pharmacovigilance (code: 8). Contact: PulmovantPV@primevigilance.com

Third parties

  • {"country":"United States","full_name":"Aliri USA Inc.","duties_or_roles":"PK Analysis","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Codes: 1,11,12,13,15 (Central Imaging),2,5,9","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"FluidDa","duties_or_roles":"High Resolution CT Scan","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Code: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Cardiac Safety, Spirometry (codes: 15,7)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Netherlands","full_name":"Xerimis B.V.","duties_or_roles":"Code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Rho Inc.","duties_or_roles":"Code: 13","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Primevigilance USA Inc.","duties_or_roles":"Code: 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Atreo Inc.","duties_or_roles":"Code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Scarritt Group Inc.","duties_or_roles":"Patient Travel Concierge (code: 15)","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
MOSLICIGUAT
Active Substance
MOSLICIGUAT
Modality
Small molecule
Routes Of Administration
INHALATION USE
Route
Inhalation
Authorisation Status
prodAuthStatus: 1
Dose Levels
Maximum daily dose 4.00 mg; max total dose amount 1429.00 mg
Maximum Dose
4.00 mg per day
Investigational Product Name
Placebo (Colorless, clear, hard capsules for inhalation)
Modality
Other

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