Once-daily inhaled treprostinil palmitil for pulmonary hypertension linked to interstitial lung disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares once-daily treprostinil palmitil inhalation powder (TPIP) with placebo over 24 weeks in adults who have pulmonary hypertension associated with fibrotic interstitial lung disease. Fibrotic ILD must be confirmed by a centrally read CT and pulmonary hypertension must be confirmed by right heart catheterization with mPAP >20 mmHg, PCWP ≤15 mmHg, and PVR ≥4 WU. Eligible participants must have a 6-minute walk distance between 100 and 500 meters confirmed by two tests at screening performed at least four hours apart. The primary outcome is change in exercise capacity (6MWD) after 24 weeks of once-daily inhaled therapy.

Why it matters

Who can join: the full rules

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 6 minute walking test (6MWT)s 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 (including sarcoidosis), 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)/ forced vital capacity (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%
  * echocardiography findings at Screening suggestive for postcapillary (or combined pre and postcapillary) PH, heart failure with preserved ejection fraction (HFpEF), or heart failure with mildly reduced ejection fraction (HFmrEF), including left atrial volume index (LAVI) \>34 millilitres per metre square (mL/m\^2)
  * 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.

Where it's running

• Usa010
  Los Angeles, California, United States Recruiting
• Usa023
  Los Angeles, California, United States Recruiting
• Usa020
  San Francisco, California, United States Recruiting
• Usa001
  Santa Barbara, California, United States Recruiting
• Usa017
  Gainesville, Florida, United States Recruiting
• Usa006
  Naples, Florida, United States Recruiting

+136 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Insmed Medical Information
• Email: medicalinformation@insmed.com
• Phone: 18444467633

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Inhaled mosliciguat for pulmonary hypertension in interstitial lung disease (PH-ILD) patients

  This study tests inhaled mosliciguat versus placebo in people with PH-ILD to see if it helps with their condition.

  Recruiting at 3 sites Phase 3 Pulmovant, Inc. · Kissimmee, Florida and 2 other locations · NCT07816185

• Home exercise for people with pulmonary hypertension and ILD

  A home-based exercise program is tested to see if people with pulmonary hypertension related to interstitial lung disease can improve walking ability and daily function over 16 weeks.

  Recruiting University of Rochester · Rochester, New York · NCT07561034

• Long-Term TPIP Extension for PH-ILD (open-label)

  This study tests whether long-term use of Treprostinil Palmitil Inhalation Powder helps people with pulmonary hypertension due to interstitial lung disease who completed a prior trial.

  Recruiting at 12 sites Phase 3 Insmed Incorporated · Naples, Florida and 11 other locations · NCT07234032

• Registry for patients with pulmonary hypertension linked to interstitial lung disease

  This study is collecting information from patients with pulmonary hypertension linked to interstitial lung disease to see how different treatments affect their health over time.

  Recruiting at 71 sites United Therapeutics · Birmingham, Alabama and 70 other locations · NCT06388421

• Using semaglutide to treat advanced lung disease

  This study is testing if a diabetes and weight loss medication called semaglutide can be safely used by adults with advanced lung diseases to see if it helps them manage their weight better.

  Recruiting Phase 1/2 University of Pennsylvania · Philadelphia, Pennsylvania · NCT05746039

• Using hyperpolarized 129Xe MRI to assess lung function in healthy individuals and those with lung diseases

  This study is testing a special type of MRI using hyperpolarized gas to see how well it can check lung function in both healthy people and those with lung diseases like asthma and COPD.

  Recruiting Phase 1 University of Kansas Medical Center · Kansas City, Kansas · NCT04624490

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.