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

NCT07179380 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: INS1009-3112025-521558-40-00
• Study Type: interventional
• Target: 344
• Locations: 22 countries
• Sites: 105

Brief Summary

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.

Conditions

Pulmonary Hypertension; Interstitial Lung Disease

Keywords

pulmonary hypertension; interstitial lung disease

Outcome Measures

Primary Outcomes (1)

• Change in 6MWD Measured at Peak Exposure From Baseline to Week 24

  Baseline, Week 24

Secondary Outcomes (8)

• Time From Randomization to First Clinical Worsening Over the 24-Week Treatment Period

  Up to Week 24

• Time From Randomization to First Major Morbidity or Mortality Event Over the 24-Week Treatment Period

  Up to Week 24

• Change From Baseline in N-Terminal Pro Hormone Brain Natriuretic Peptide (NT-proBNP) Plasma Concentration Over 24 Weeks

  Baseline up to Week 24

• Number of Participants With Greater Than or Equal to (>=) 30% Decrease in NT-proBNP or Who Maintained/Achieved Less Than (<) 300 Nanogram per Liter (ng/L) of NT-proBNP Level at Week 24

  At Week 24

• Change in 6MWD Measured at Trough Exposure From Baseline to Week 22

  Baseline, Week 22

Study Arms (2)

Treprostinil Palmitil Inhalation Powder

EXPERIMENTAL

Participants will receive TPIP, once daily (QD), at a starting dose of 80 micrograms (μg) to maximum tolerated dose up to 1280 μg for 24 weeks.

Drug: Treprostinil Palmitil Inhalation Powder

Placebo

PLACEBO COMPARATOR

Participants will receive a placebo matching TPIP QD for 24 weeks.

Drug: Placebo

Interventions

Treprostinil Palmitil Inhalation Powder DRUG

Oral inhalation using a capsule-based dry powder inhaler device.

Also known as: INS1009

Treprostinil Palmitil Inhalation Powder

Placebo DRUG

Oral inhalation using a capsule-based dry powder inhaler device.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (109)

USA010

Los Angeles, California, 900275969, United States

NOT YET RECRUITING

USA001

Santa Barbara, California, 93105-4349, United States

NOT YET RECRUITING

USA006

Naples, Florida, 34102-5412, United States

RECRUITING

USA026

St. Petersburg, Florida, 33707-6129, United States

NOT YET RECRUITING

USA002

Kansas City, Kansas, 66160, United States

NOT YET RECRUITING

USA003

Bend, Oregon, 97701, United States

RECRUITING

USA013

Philadelphia, Pennsylvania, 19140, United States

NOT YET RECRUITING

USA008

Richmond, Virginia, 23230, United States

NOT YET RECRUITING

ARG002

CiudadAutonoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina

NOT YET RECRUITING

ARG003

Río Cuarto, Córdoba Province, X5800AEV, Argentina

NOT YET RECRUITING

ARG008

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

NOT YET RECRUITING

ARG004

Córdoba, X5000KEH, Argentina

NOT YET RECRUITING

ARG001

Córdoba, X5003DCE, Argentina

NOT YET RECRUITING

AUS001

Camperdown, New South Wales, 2050, Australia

NOT YET RECRUITING

AUS006

Kingswood, New South Wales, 2747, Australia

NOT YET RECRUITING

AUS005

New Lambton Heights, New South Wales, 2305, Australia

NOT YET RECRUITING

AUS003

Westmead, New South Wales, 2145, Australia

NOT YET RECRUITING

AUT002

Innsbruck, 6020, Austria

NOT YET RECRUITING

BEL002

Leuven, Vlaams Brabant, 3000, Belgium

NOT YET RECRUITING

BEL001

Anderlecht, 1070, Belgium

NOT YET RECRUITING

CZE001

Prague, 14000, Czechia

RECRUITING

DNK001

Aarhus N, Central Jutland, 8200, Denmark

NOT YET RECRUITING

FRA009

Nice, Alpes-Maritimes, 6001, France

NOT YET RECRUITING

FRA002

Marseille, Bouches-du-Rhône, 13015, France

RECRUITING

FRA004

Angers, Maine-et-Loire, 49100, France

NOT YET RECRUITING

FRA007

Lille, Nord, 59037, France

NOT YET RECRUITING

FRA008

Saint Priest En Jarez, Pays de la Loire Region, 42270, France

NOT YET RECRUITING

FRA003

Le Kremlin-Bicêtre, Val-de-Marne, 94270, France

RECRUITING

FRA001

Poitiers, Vienne, 86000, France

NOT YET RECRUITING

FRA010

Brest, 29200, France

NOT YET RECRUITING

FRA011

Bron, 69500, France

NOT YET RECRUITING

FRA006

Strasbourg, 67091, France

NOT YET RECRUITING

GEO002

Tbilisi, 0144, Georgia

NOT YET RECRUITING

GEO004

Tbilisi, 0159, Georgia

NOT YET RECRUITING

GEO003

Tbilisi, 0180, Georgia

RECRUITING

GEO001

Tbilisi, 0186, Georgia

NOT YET RECRUITING

DEU005

Immenhausen, Baden-Wurttemberg, 34376, Germany

NOT YET RECRUITING

DEU012

Stuttgart, Baden-Wurttemberg, 70376, Germany

NOT YET RECRUITING

DEU003

München, Bavaria, 80335, Germany

NOT YET RECRUITING

DEU006

München, Bavaria, 80639, Germany

RECRUITING

DEU008

Bonn, North Rhine-Westphalia, 53127, Germany

NOT YET RECRUITING

DEU009

Homburg, Saarland, 66424, Germany

NOT YET RECRUITING

DEU011

Lübeck, Schleswig-Holstein, 23562, Germany

NOT YET RECRUITING

DEU010

Gauting, 82131, Germany

RECRUITING

GRC003

Pátrai, Achaia, 26504, Greece

NOT YET RECRUITING

GRC002

Athens, Anatoliki Attiki, 106 76, Greece

NOT YET RECRUITING

ISR003

Petah Tikva, Central District, 4941492, Israel

NOT YET RECRUITING

ISR002

Jerusalem, Jerusalem, 9112001, Israel

NOT YET RECRUITING

ISR005

Haifa, 3109601, Israel

NOT YET RECRUITING

ISR001

Haifa, 3436212, Israel

NOT YET RECRUITING

ISR004

Tel Aviv, 6423906, Israel

NOT YET RECRUITING

ITA011

Bologna, Emilia-Romagna, 40138, Italy

NOT YET RECRUITING

ITA008

Milan, 20123, Italy

NOT YET RECRUITING

ITA001

Pavia, 27100, Italy

NOT YET RECRUITING

ITA003

Roma, 161, Italy

NOT YET RECRUITING

ITA012

Sassari, 07100, Italy

NOT YET RECRUITING

JPN006

Nagakute, Aichi-ken, 480-1195, Japan

NOT YET RECRUITING

JPN011

Hirosaki, Aomori, 036-8563, Japan

NOT YET RECRUITING

JPN002

Narashino-shi, Chiba, 275-0006, Japan

NOT YET RECRUITING

JPN004

Narita-shi, Chiba, 286-8520, Japan

RECRUITING

JPN001

Sapporo, Hokkaido, 060-8648, Japan

NOT YET RECRUITING

JPN007

Yokohama, Kanagawa, 236-0051, Japan

RECRUITING

JPN010

Kyotoshi, Kyoto, 606-8507, Japan

NOT YET RECRUITING

JPN005

Nagano, Nagano, 380-0928, Japan

RECRUITING

JPN015

Sakai, Osaka, 590-0197, Japan

NOT YET RECRUITING

JPN013

Bunkyo-Ku, Tokyo, 113-8431, Japan

NOT YET RECRUITING

JPN008

Kiyose, Tokyo, 204-0023, Japan

NOT YET RECRUITING

JPN003

Shibuya City, Tokyo, 151-8528, Japan

NOT YET RECRUITING

JPN014

Chiba, 260-8677, Japan

NOT YET RECRUITING

JPN016

Tsukuba, 305-8576, Japan

NOT YET RECRUITING

MYS004

Alor Star, Kedah, 5460, Malaysia

NOT YET RECRUITING

MYS001

Kota Bharu, Kelantan, 15586, Malaysia

NOT YET RECRUITING

MYS003

Kuantan, Pahang, 25200, Malaysia

NOT YET RECRUITING

MYS002

Kuching, Sarawak, 93586, Malaysia

NOT YET RECRUITING

MYS005

Kajang, Selangor, 43000, Malaysia

NOT YET RECRUITING

NZL001

Christchurch, Canterbury, 8011, New Zealand

NOT YET RECRUITING

NZL002

Dunedin, Otago, 9010, New Zealand

NOT YET RECRUITING

PRT002

Almada, Setúbal District, 2805-267, Portugal

NOT YET RECRUITING

PRT001

Lisbon, 1769-001, Portugal

NOT YET RECRUITING

ROU002

Târgu Mureş, Mureș County, 540136, Romania

NOT YET RECRUITING

ROU001

Timișoara, Timiș County, 300310, Romania

NOT YET RECRUITING

KOR002

Incheon, 21565, South Korea

NOT YET RECRUITING

KOR001

Seoul, 03080, South Korea

NOT YET RECRUITING

KOR004

Seoul, 3722, South Korea

NOT YET RECRUITING

KOR006

Seoul, 6351, South Korea

NOT YET RECRUITING

KOR003

Seoul, 6591, South Korea

NOT YET RECRUITING

KOR005

Wŏnju, 26426, South Korea

NOT YET RECRUITING

ESP002

Palma de Mallorca, Balearic Islands, 7120, Spain

NOT YET RECRUITING

ESP005

L'Hospitalet de Llobregat, Barcelona, 8907, Spain

NOT YET RECRUITING

ESP010

Majadahonda, Madrid, 28222, Spain

NOT YET RECRUITING

ESP012

Barcelona, 8035, Spain

RECRUITING

ESP004

Barcelona, 8036, Spain

NOT YET RECRUITING

ESP006

Madrid, 28041, Spain

RECRUITING

ESP003

Madrid, 28046, Spain

NOT YET RECRUITING

ESP009

Madrid, 28304, Spain

NOT YET RECRUITING

ESP011

Santiago de Compostela, 15706, Spain

NOT YET RECRUITING

ESP001

Seville, 41009, Spain

NOT YET RECRUITING

ESP007

Toledo, 45007, Spain

NOT YET RECRUITING

CHE001

Basel, 4031, Switzerland

NOT YET RECRUITING

CHE002

Zurich, 8091, Switzerland

NOT YET RECRUITING

TWN003

Hsinchu, 300, Taiwan

NOT YET RECRUITING

TWN001

Kaohsiung City, 80756, Taiwan

NOT YET RECRUITING

TWN005

Taichung, 40447, Taiwan

NOT YET RECRUITING

TWN002

Taipei, 10002, Taiwan

NOT YET RECRUITING

TWN006

Taipei, 104, Taiwan

NOT YET RECRUITING

GBR009

London, Greater London, W12 0HS, United Kingdom

NOT YET RECRUITING

GBR004

Sheffield, Yorkshire, S10 2JF, United Kingdom

NOT YET RECRUITING

GBR002

London, NW3 2QG, United Kingdom

NOT YET RECRUITING

GBR005

Southampton, SO16 6YD, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Insmed Medical Information

CONTACT

18444467633; medicalinformation@insmed.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: January 7, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

RO (2); GR (2); DK (1); MY (5); GB (4); DE (8); KR (6); PT (2); NZ (2); US (8); TW (5); FR (10); IL (5); BE (2); ES (11); CZ (1); IT (5); CH (2); GE (4); AU (1); AR (5); JP (14)