344 Participants NeededMy employer runs this trial

Treprostinil Palmitil for Pulmonary Hypertension

Recruiting at 14 trial locations
II
Overseen ByInsmed Incorporated
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new inhalation powder, Treprostinil Palmitil, to assess its safety and tolerability for long-term use in individuals with pulmonary hypertension linked to interstitial lung disease (PH-ILD). Participants will use the treatment daily for up to two years to evaluate its effects. It is suitable for those who completed the initial study related to this treatment and are not currently using other specific pulmonary hypertension medications. Participants must have finished the earlier study without experiencing severe side effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Is there any evidence suggesting that Treprostinil Palmitil Inhalation Powder is likely to be safe for humans?

Research has shown that Treprostinil Palmitil Inhalation Powder (TPIP) is generally safe and well-tolerated. In one study, 79.3% of participants used the highest dose tested, indicating that most handled the treatment well. Mild side effects, such as headaches, were common, but no severe or serious side effects occurred.

Another study supported these findings, with 69% of participants experiencing mild side effects and 16.7% having moderate ones. Importantly, no severe side effects were noted. These results suggest that TPIP is safe for treating conditions like pulmonary hypertension.12345

Why do researchers think this study treatment might be promising for pulmonary hypertension?

Treprostinil Palmitil Inhalation Powder (TPIP) is unique because it offers a new delivery method for treating pulmonary hypertension. Unlike standard treatments that are often delivered via intravenous or subcutaneous routes, TPIP is administered as an inhalation powder, potentially making it more convenient and less invasive for patients. Additionally, the once-daily dosing of TPIP may improve patient adherence compared to more frequent dosing schedules of existing therapies. Researchers are excited about TPIP because it could simplify treatment regimens and enhance the quality of life for those with pulmonary hypertension.

What evidence suggests that Treprostinil Palmitil Inhalation Powder might be an effective treatment for pulmonary hypertension?

Research has shown that Treprostinil Palmitil Inhalation Powder (TPIP), which participants in this trial will receive, may help treat pulmonary hypertension linked to interstitial lung disease. Studies have found that TPIP can reduce fatigue during physical activities by improving exercise capacity. In one study, the treatment demonstrated lasting improvement in various effectiveness measures and was well tolerated, causing few side effects. TPIP is designed to release medication slowly in the lungs, reducing the frequency of doses. This feature could simplify daily management of the condition. Overall, evidence suggests TPIP could be a helpful option for those with this type of pulmonary hypertension.678910

Who Is on the Research Team?

SD

Study Director

Principal Investigator

Insmed Incorporated

Are You a Good Fit for This Trial?

This trial is for people with pulmonary hypertension linked to interstitial lung disease who have already finished a previous related study (INS1009-311). Participants must be able to give consent and agree not to join other clinical trials during this study.

Inclusion Criteria

I agree not to join other trials or use experimental treatments while in the INS1009-312 study.
I completed the INS1009-311 study for PH-ILD.
I am able to understand and sign the consent form for this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Titration

Participants undergo an initial double-dummy titration with the stable dose from the lead-in study and either TPIP or placebo

4 weeks

Treatment

Participants receive open-label TPIP at a stable maintenance dose with optional escalation

104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Treprostinil Palmitil Inhalation Powder

Trial Overview

The study is testing the long-term safety of Treprostinil Palmitil Inhalation Powder (TPIP) compared to placebo in people with PH-ILD. All participants previously took part in an earlier TPIP trial.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treprostinil Palmitil Inhalation Powder (TPIP)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Insmed Incorporated

Lead Sponsor

Trials
44
Recruited
7,600+

Citations

Efficacy and Safety Study of Treprostinil Palmitil Inhalation ...

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

An open-label extension study to evaluate the safety, ...

TPIP is expected to provide prolonged release of treprostinil in the lungs with the aim of less frequent and more convenient dosing while ...

A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In ...

The main purpose of this study is to evaluate the safety and tolerability of single dose of treprostinil palmitil inhalation powder (TPIP) ...

Insmed to Present Multiple Abstracts on Treprostinil Palmitil ...

Developed entirely in Insmed's laboratories, TPIP is being evaluated as a once-daily therapy for the treatment of patients with PAH, PH-ILD, and ...

Efficacy and Safety Study of Treprostinil Palmitil Inhalation ...

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

Insmed Announces Topline Results from Phase 1 Study of ...

Data from the study demonstrated that TPIP was generally safe and well tolerated, with a pharmacokinetic profile that supports once-daily dosing ...

NCT05176951 | A Study to Evaluate the Safety and ...

The primary objective of this study is to evaluate the safety and tolerability of treprostinil palmitil inhalation powder (TPIP) compared with placebo

B106-14 Population Pharmacokinetics Analysis of Treprostinil ...

Phase 2 trials demonstrated safety, tolerability, and efficacy of TPIP in pulmonary arterial hypertension (PAH) and pulmonary hypertension

Insmed Presents Data on TPIP Inhalation Drug for PAH | RT

Insmed will present 4 abstracts on treprostinil palmitil inhalation powder (TPIP) evaluated for PAH, PH-ILD, and rare pulmonary disorders.