TrialPath
Recruiting

Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

NCT07179380 · Insmed Incorporated
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
About this study
The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.
Eligibility criteria
Inclusion Criteria * Diagnosis of PH World Health Organisation (WHO) Group 3 associated with ILD \[including but not limited to idiopathic interstitial pneumonia (IIP), chronic hypersensitivity pneumonitis (HSP), connective tissue disease-associated interstitial lung disease (CTD-ILD), combined pulmonary fibrosis and emphysema (CPFE)\]. * Confirmation of fibrotic interstitial lung disease by centrally overread computed tomography (CT) scan performed at Screening or within prior 12 months. * PH confirmed by right heart catheterization (RHC) at Screening or within 12 months prior to Screening, with the following hemodynamic findings: * Mean pulmonary arterial pressure (mPAP) \>20 millimetre of mercury (mmHg) and * Pulmonary capillary wedge pressure (PCWP) of ≤15 mmHg and * Pulmonary vascular resistance (PVR) ≥4 wood units (WU). * 6 Minute walking distance (6MWD) ≥100 and ≤500 meters at two 6MWTs at Screening performed at least 4 hours apart, with the difference between the 2 distances ≤15%. * Participants receiving chronic medication for underlying disease (e.g., antifibrotic, immunomodulators, immunosuppressants, etc.) and/or phosphodiesterase 5 (PDE5) inhibitors, should be on this treatment for ≥90 days and on a stable dose for ≥30 days prior to Screening. * Capable of giving signed informed consent as described in Section 10.1.5 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion criteria * Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease. * Primary diagnosis of chronic obstructive pulmonary disease (COPD) and/or forced expiratory volume in 1 second (FEV1)/FVC \<0.7 (based on screening or historical spirometry within the prior 6 months). * Clinically significant left heart disease: * evidence of clinically significant left-sided valvular heart disease, * left ventricular failure with left ventricular ejection fraction (LVEF) \<45%, or diagnosis of heart failure with preserved ejection fraction (HFpEF) * echocardiography findings at Screening suggestive for postcapillary PH * unstable ischemic heart disease * unstable arrhythmia, including uncontrolled atrial fibrillation (rate-controlled arrhythmia or paroxysmal atrial fibrillation is allowed) * Evidence of chronic thromboembolic disease or recent (within 6 months of Screening) acute pulmonary embolism. * Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (e.g., mannitol, leucine). * Current use of cigarettes 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. * 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. Note: Other protocol defined inclusion/exclusion criteria may apply.
Study design
Enrollment target: 344 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-01-07
Estimated completion: 2028-12-30
Last updated: 2026-08-14
Interventions
Drug: Treprostinil Palmitil Inhalation PowderDrug: Placebo
Primary outcomes
  • Change in 6MWD Measured at Peak Exposure From Baseline to Week 24 (Baseline, Week 24)
Sponsor
Insmed Incorporated · industry
Contacts & investigators
ContactInsmed Medical Information · contact · medicalinformation@insmed.com · 18444467633
All locations (145)
USA010Not Yet Recruiting
Los Angeles, California, United States
USA001Recruiting
Santa Barbara, California, United States
USA017Not Yet Recruiting
Gainesville, Florida, United States
USA006Recruiting
Naples, Florida, United States
USA026Recruiting
St. Petersburg, Florida, United States
USA002Not Yet Recruiting
Kansas City, Kansas, United States
USA005Not Yet Recruiting
New York, New York, United States
USA015Not Yet Recruiting
Cincinnati, Ohio, United States
USA003Recruiting
Bend, Oregon, United States
USA013Recruiting
Philadelphia, Pennsylvania, United States
USA008Recruiting
Richmond, Virginia, United States
ARG005Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
ARG002Recruiting
CiudadAutonoma de Buenos Aires, Buenos Aires, Argentina
ARG003Recruiting
Río Cuarto, Córdoba Province, Argentina
ARG008Recruiting
San Miguel de Tucumán, Tucumán Province, Argentina
ARG004Not Yet Recruiting
Córdoba, Argentina
ARG001Not Yet Recruiting
Córdoba, Argentina
AUS001Recruiting
Camperdown, New South Wales, Australia
AUS006Recruiting
Kingswood, New South Wales, Australia
AUS005Recruiting
New Lambton Heights, New South Wales, Australia
AUS003Not Yet Recruiting
Westmead, New South Wales, Australia
AUS002Not Yet Recruiting
South Brisbane, Queensland, Australia
AUT002Not Yet Recruiting
Innsbruck, Austria
BEL002Recruiting
Leuven, Vlaams Brabant, Belgium
BEL001Recruiting
Anderlecht, Belgium
BRA012Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
BRA007Not Yet Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
BRA003Not Yet Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
CZE001Recruiting
Prague, Czechia
DNK001Recruiting
Aarhus N, Central Jutland, Denmark
FRA009Recruiting
Nice, Alpes-Maritimes, France
FRA002Recruiting
Marseille, Bouches-du-Rhône, France
FRA004Recruiting
Angers, Maine-et-Loire, France
FRA007Not Yet Recruiting
Lille, Nord, France
FRA008Not Yet Recruiting
Saint Priest En Jarez, Pays de la Loire Region, France
FRA003Recruiting
Le Kremlin-Bicêtre, Val-de-Marne, France
FRA001Recruiting
Poitiers, Vienne, France
FRA010Not Yet Recruiting
Brest, France
FRA011Not Yet Recruiting
Bron, France
FRA005Recruiting
Pessac, France
FRA006Recruiting
Strasbourg, France
GEO002Recruiting
Tbilisi, Georgia
GEO004Recruiting
Tbilisi, Georgia
GEO003Recruiting
Tbilisi, Georgia
GEO001Recruiting
Tbilisi, Georgia
DEU001Recruiting
Heidelberg, Baden-Wurttemberg, Germany
DEU005Recruiting
Immenhausen, Baden-Wurttemberg, Germany
DEU012Not Yet Recruiting
Stuttgart, Baden-Wurttemberg, Germany
DEU003Not Yet Recruiting
München, Bavaria, Germany
DEU006Recruiting
München, Bavaria, Germany
DEU008Not Yet Recruiting
Bonn, North Rhine-Westphalia, Germany
DEU002Not Yet Recruiting
Essen, North Rhine-Westphalia, Germany
DEU009Not Yet Recruiting
Homburg, Saarland, Germany
DEU004Not Yet Recruiting
Dresden, Saxony, Germany
DEU011Not Yet Recruiting
Lübeck, Schleswig-Holstein, Germany
DEU010Recruiting
Gauting, Germany
GRC003Not Yet Recruiting
Pátrai, Achaia, Greece
GRC002Recruiting
Athens, Anatoliki Attiki, Greece
GRC004Not Yet Recruiting
Heraklion, Crete, Greece
GRC001Recruiting
Thessaloniki, Greece
ISR003Not Yet Recruiting
Petah Tikva, Central District, Israel
ISR002Not Yet Recruiting
Jerusalem, Jerusalem, Israel
ISR005Recruiting
Haifa, Israel
ISR001Recruiting
Haifa, Israel
ISR004Not Yet Recruiting
Tel Aviv, Israel
ITA011Recruiting
Bologna, Emilia-Romagna, Italy
ITA008Not Yet Recruiting
Milan, Italy
ITA005Recruiting
Monza, Italy
ITA001Recruiting
Pavia, Italy
ITA003Not Yet Recruiting
Roma, Italy
ITA004Not Yet Recruiting
Rozzano, Italy
ITA012Not Yet Recruiting
Sassari, Italy
JPN006Recruiting
Nagakute, Aichi-ken, Japan
JPN012Not Yet Recruiting
Seto, Aichi-ken, Japan
JPN011Recruiting
Hirosaki, Aomori, Japan
JPN002Recruiting
Narashino-shi, Chiba, Japan
JPN004Recruiting
Narita-shi, Chiba, Japan
JPN001Not Yet Recruiting
Sapporo, Hokkaido, Japan
JPN007Recruiting
Yokohama, Kanagawa, Japan
JPN010Recruiting
Kyotoshi, Kyoto, Japan
JPN009Not Yet Recruiting
Matsumoto, Nagano, Japan
JPN005Recruiting
Nagano, Nagano, Japan
JPN015Recruiting
Sakai, Osaka, Japan
JPN017Recruiting
Suita, Osaka, Japan
JPN013Not Yet Recruiting
Bunkyo-Ku, Tokyo, Japan
JPN008Not Yet Recruiting
Kiyose, Tokyo, Japan
JPN003Recruiting
Shibuya City, Tokyo, Japan
JPN014Not Yet Recruiting
Chiba, Japan
JPN016Not Yet Recruiting
Tsukuba, Japan
MYS004Recruiting
Alor Star, Kedah, Malaysia
MYS001Not Yet Recruiting
Kota Bharu, Kelantan, Malaysia
MYS003Recruiting
Kuantan, Pahang, Malaysia
MYS002Not Yet Recruiting
Kuching, Sarawak, Malaysia
MYS005Recruiting
Kajang, Selangor, Malaysia
NZL001Recruiting
Christchurch, Canterbury, New Zealand
NZL002Recruiting
Dunedin, Otago, New Zealand
PHL002Not Yet Recruiting
Iloilo City, Philippines
PHL001Not Yet Recruiting
Makati City, Philippines
PRT002Recruiting
Almada, Setúbal District, Portugal
PRT001Not Yet Recruiting
Lisbon, Portugal
ROU004Not Yet Recruiting
Cluj-Napoca, Cluj, Romania
ROU002Recruiting
Târgu Mureş, Mureș County, Romania
ROU001Recruiting
Timișoara, Timiș County, Romania
ROU003Not Yet Recruiting
Bucharest, Romania
SRB001Recruiting
Belgrade, Serbia
SRB002Not Yet Recruiting
Kamenitz, Serbia
SRB003Not Yet Recruiting
Kragujevac, Serbia
KOR002Recruiting
Incheon, South Korea
KOR001Recruiting
Seoul, South Korea
KOR004Recruiting
Seoul, South Korea
KOR006Recruiting
Seoul, South Korea
KOR003Not Yet Recruiting
Seoul, South Korea
KOR005Not Yet Recruiting
Wŏnju, South Korea
ESP002Recruiting
Palma de Mallorca, Balearic Islands, Spain
ESP005Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
ESP010Not Yet Recruiting
Majadahonda, Madrid, Spain
ESP012Recruiting
Barcelona, Spain
ESP004Recruiting
Barcelona, Spain
ESP006Recruiting
Madrid, Spain
ESP003Recruiting
Madrid, Spain
ESP009Recruiting
Madrid, Spain
ESP011Not Yet Recruiting
Santiago de Compostela, Spain
ESP001Recruiting
Seville, Spain
ESP007Recruiting
Toledo, Spain
CHE001Recruiting
Basel, Switzerland
CHE002Recruiting
Zurich, Switzerland
TWN004Not Yet Recruiting
Douliu City Yunlin County, Taiwan
TWN003Recruiting
Hsinchu, Taiwan
TWN001Recruiting
Kaohsiung City, Taiwan
TWN005Not Yet Recruiting
Taichung, Taiwan
TWN002Not Yet Recruiting
Taipei, Taiwan
TWN006Not Yet Recruiting
Taipei, Taiwan
TUR003Not Yet Recruiting
Adana, Turkey (Türkiye)
TUR004Not Yet Recruiting
Ankara, Turkey (Türkiye)
TUR001Not Yet Recruiting
Bursa, Turkey (Türkiye)
TUR012Not Yet Recruiting
Eskişehir, Turkey (Türkiye)
TUR005Recruiting
Kayseri, Turkey (Türkiye)
TUR009Recruiting
Kocaeli, Turkey (Türkiye)
TUR011Not Yet Recruiting
Trabzon, Turkey (Türkiye)
GBR009Not Yet Recruiting
London, Greater London, United Kingdom
GBR004Recruiting
Sheffield, Yorkshire, United Kingdom
GBR001Not Yet Recruiting
Bath, United Kingdom
GBR007Not Yet Recruiting
Glasgow, United Kingdom
GBR002Not Yet Recruiting
London, United Kingdom
GBR005Not Yet Recruiting
Southampton, United Kingdom