A Study to Assess the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Progressive Pulmonary Fibrosis (PPF) (PALM-PPF)

September 1, 2026 updated by: Insmed Incorporated

A Phase 3, Randomized, Double-Blind, Placebo-controlled, Multicenter, Parallel Group Study of Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants With Progressive Pulmonary Fibrosis (PPF)-PALM-PPF

The primary objective of this study is to evaluate the effect of 52 weeks of once daily treatment with TPIP compared with placebo on lung function in adults with PPF.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Radiologic evidence of pulmonary fibrosis of >10% extent on high-resolution computed tomography (HRCT) in the previous 12 months.

  • Diagnosis of interstitial lung disease (ILD) (other than idiopathic pulmonary fibrosis [IPF]) that fulfills at least 1 of the following criteria for progression within 24 months of screening despite standard treatment of ILD, as assessed by the Investigator:

    • Clinically significant decline in % predicted Forced Vital Capacity (FVC) based on ≥10% relative decline
    • Decline in % predicted FVC based on ≥5% to <10% relative decline combined with worsening of respiratory symptoms
    • Decline in % predicted FVC based on ≥5% to <10% relative decline combined with an increasing extent of fibrotic changes on chest imaging
    • Worsening of respiratory symptoms and increasing extent of fibrotic changes on chest imaging
  • Forced Vital Capacity ≥45% predicted at Screening.
  • Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin at Screening.

  • Participants may be either:

    • On stable therapy (defined as no dose changes in the prior 12 weeks) with an approved antifibrotic agent (eg, nintedanib or nerandomilast) for at least 12 weeks prior to Screening and during the screening period and are planning to stay on this background treatment throughout the study. Combination therapy with more than 1 approved antifibrotic agent is not allowed. Or
    • Not on treatment with an approved antifibrotic agent (eg, nintedanib or nerandomilast) for at least 8 weeks prior to Screening and during the screening period (ie, either antifibrotic-treatment-naïve or previously discontinued) and do not plan to start or restart antifibrotic treatment during the study.
  • If treated with rituximab, must be on it for at least 6 months before Screening and in the Investigator's clinical opinion must be refractory to the current regimen. If treated with other immunosuppressive agents (eg, mycophenolate, methotrexate, azathioprine, oral corticosteroids), need to be on treatment for at least 12 weeks before Screening and in the investigator's clinical opinion must be refractory to the current regimen.

Exclusion Criteria:

  • Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) <0.7 and less than the age-adjusted lower limit of normal at Screening.
  • Diagnosis of idiopathic pulmonary fibrosis (IPF).
  • Diagnosis of combined pulmonary fibrosis and emphysema.
  • Extent of emphysema greater than fibrosis on HRCT within 1 year prior to Screening or during the screening period confirmed by central overread.
  • Acute ILD exacerbation within 90 days prior to Screening or during the screening period (investigator-determined). If hospitalized for a respiratory indication, participants must have been discharged more than 90 days prior to Screening to be eligible.
  • Acute respiratory infection (eg, COVID-19, influenza, pneumonia) within 30 days prior to Screening or during the Screening period.
  • Acute pulmonary embolism within 90 days prior to Screening.
  • Prior TPIP exposure or participation in other clinical trials involving the study drug, TPIP.
  • Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine).
  • History of clinically significant pulmonary hypertension (PH) (ie, pulmonary hypertension requiring medical treatment) or the participant has received any PH-approved therapy, including prostacyclin analogs (eg, beraprost, epoprostenol, iloprost, or treprostinil; except for acute vasoreactivity testing), prostacyclin receptor (IP receptor) agonists (eg, selexipag), endothelin receptor antagonists (eg, ambrisentan, bosentan, or macitentan), activin signaling inhibitors (eg, sotatercept), phosphodiesterase type 5 inhibitors (PDE5-Is; eg, sildenafil, tadalafil), or soluble guanylate cyclase stimulators (eg, riociguat) within 60 days prior to Screening or during the screening period. As needed use of a PDE5-I for erectile dysfunction is permitted, provided that no doses are taken within 48 hours prior to any study-related efficacy assessments.
  • Any physical limitation that would impair the participant's use of the inhaler device or ability to participate in spirometry and/or DLCO assessment.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treprostinil Palmitil Inhalation Powder (TPIP)
Participants will receive TPIP, once daily (QD), at a starting dose of 80 micrograms (μg) to the maximum tolerated dose (up to 1280 μg) for up to 104 weeks.
Drug: Treprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder inhaler device.
Other Names:
  • INS1009
Placebo Comparator: Placebo
Participants will receive a TPIP-matching placebo, QD for up to 104 weeks.
Drug: Placebo
Oral inhalation using a capsule-based dry powder inhaler device.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to First Clinical Worsening Event
Time Frame: Up to 104 weeks
Up to 104 weeks
Time to First Acute Exacerbation of Interstitial Lung Disease (ILD)
Time Frame: Up to 104 weeks
Up to 104 weeks
Absolute Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % Predicted Corrected for Hemoglobin at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Time to Death
Time Frame: Up to 104 weeks
Up to 104 weeks
Change in Living With Pulmonary Fibrosis (L-PF) Total Symptom Domain Score From Baseline at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Plasma Concentrations of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Time Frame: Pre-dose and post-dose at multiple timepoints up to Week 52
Pre-dose and post-dose at multiple timepoints up to Week 52
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 104 weeks
Up to 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insmed Incorporated

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Insmed Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INS1009-331
  • 2026-525924-37-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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