Trial studying safety and effects for Progressive Pulmonary Fibrosis
Official title A Study to Assess the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Progressive Pulmonary Fibrosis (PPF)
ClinicalTrials.gov ID: NCT07805785
What this study is testing
What is Treprostinil Palmitil Inhalation Powder?
Treprostinil Palmitil Inhalation Powder is an investigational medicine, being studied as a potential treatment for progressive pulmonary fibrosis.
Also referred to as INS1009.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a new inhaled powder helps keep lung function stable. It also checks how safe the medicine is.
- Who it's for
- You may be able to join if you are an adult with progressive lung scarring.
- What's involved
- You would breathe in a powder once a day for 52 weeks. Some people get the real medicine, others get a pretend one.
- Time commitment
- The study lasts 52 weeks and includes regular check-ins.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Radiologic evidence of pulmonary fibrosis of \>10% extent on high-resolution computed tomography (HRCT) in the previous 12 months.
- 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
You likely can't join if
- Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) \<0.7 and less than the age-adjusted lower limit of normal...
- 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).
- Acute respiratory infection (eg, COVID-19, influenza, pneumonia) within 30 days prior to Screening or during the Screening period.
See the full eligibility criteria
- Radiologic evidence of pulmonary fibrosis of \>10% extent on high-resolution computed tomography (HRCT) in the previous 12 months.
- 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.
- 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...
- 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...
- 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.
- 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).
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- DuBois, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at DuBois, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.