Progressive Pulmonary FibrosisPhase 3PALM-PPFNCT07805785
A Study to Assess the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Progressive Pulmonary Fibrosis (PPF)
A Phase 3 study testing Treprostinil Palmitil Inhalation Powder in people with Progressive Pulmonary Fibrosis and Interstitial Lung Disease, run by Insmed Incorporated.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Progressive Pulmonary Fibrosis, Interstitial Lung Disease
- What is being tested?
- Treprostinil Palmitil Inhalation Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 31 Aug 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Treprostinil Palmitil Inhalation Powder, Placebo
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treprostinil Palmitil Inhalation PowderDrug
Also called INS1009
Oral inhalation using a capsule-based dry powder inhaler device.
PlaceboDrug
Oral inhalation using a capsule-based dry powder inhaler device.
| Study group | Role | What they receive |
|---|---|---|
| Treprostinil Palmitil Inhalation Powder (TPIP) | Experimental | 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. Receives: Drug: Treprostinil Palmitil Inhalation Powder |
| Placebo | Placebo comparator | Participants will receive a TPIP-matching placebo, QD for up to 104 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52
Measured: Baseline, Week 52
Secondary outcomes (7)
Time to First Clinical Worsening Event
Measured: Up to 104 weeks
Time to First Acute Exacerbation of Interstitial Lung Disease (ILD)
Measured: 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
Measured: Baseline, Week 52
Time to Death
Measured: Up to 104 weeks
Change in Living With Pulmonary Fibrosis (L-PF) Total Symptom Domain Score From Baseline at Week 52
Measured: Baseline, Week 52
Plasma Concentrations of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Measured: 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)
Measured: Up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Insmed Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805785
- Sponsor's protocol ID
- INS1009-331
- Other IDs
- 2026-525924-37-00
- Acronym
- PALM-PPF
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07805785
- Acronym / sponsor ID
- PALM-PPF / INS1009-331
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treprostinil Palmitil Inhalation Powder (TPIP) | Experimental | Drug: Treprostinil Palmitil Inhalation PowderParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a TPIP-matching placebo, QD for up to 104 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treprostinil Palmitil Inhalation PowderAlso: INS1009Oral inhalation using a capsule-based dry powder inhaler device. | Drug | Treprostinil Palmitil Inhalation Powder (TPIP) |
| PlaceboOral inhalation using a capsule-based dry powder inhaler device. | Drug | Placebo |
Primary outcome
Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52
Time frame: Baseline, Week 52
7 secondary outcomes
Time to First Clinical Worsening Event
Time frame: Up to 104 weeks
Time to First Acute Exacerbation of Interstitial Lung Disease (ILD)
Time frame: 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
Time to Death
Time frame: 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
Plasma Concentrations of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Progressive Pulmonary Fibrosis
Active, not recruiting
Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial
Interstitial Lung Disease (ILD), Fibrotic Interstitial Lung Disease
Not yet recruitingPhase 2
Autoantibody Reduction Therapy for Progressive Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Enrolling by invitationPhase 3
Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Active, not recruitingPhase 3
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast
Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Insmed Incorporated
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treprostinil Palmitil Inhalation Powder in people with Progressive Pulmonary Fibrosis and Interstitial Lung Disease, run by Insmed Incorporated.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Insmed Medical Information (18444467633, medicalinformation@insmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52 (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.