Treprostinil Palmitil for PAH

Phase 2 & 3

Recruiting

Research Sponsored by Insmed Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female participants who completed end of treatment study visit in Study INS1009-201, INS1009-202, or any other lead-in PAH TPIP study

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ole baseline (day 1) up to month 24 or early discontinuation

Summary

This trial tests if a drug is safe and tolerable for long-term use to treat Pulmonary Arterial Hypertension.

Who is the study for?

This trial is for men and women who have completed previous TPIP studies for PAH within the last year. They must not have started parenteral prostacyclin analogues since their last study but can join if they've stopped certain inhaled or oral treatments at least a day before starting this trial.

What is being tested?

The study tests the long-term safety of Treprostinil Palmitil Inhalation Powder (TPIP) in people with Pulmonary Arterial Hypertension. Participants from earlier TPIP trials will either continue with TPIP or receive a placebo to compare effects over time.

What are the potential side effects?

While specific side effects are not listed, participants will be monitored for any adverse reactions due to long-term use of TPIP, which could include issues related to lung function, blood pressure changes, or other drug-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I completed a previous PAH study with INS1009.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ole baseline (day 1) up to month 24 or early discontinuation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ole baseline (day 1) up to month 24 or early discontinuation

This trial's timeline: 3 weeks for screening, Varies for treatment, and ole baseline (day 1) up to month 24 or early discontinuation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Annualized Clinical Worsening Event Rate

Trial Design

1Treatment groups

Experimental Treatment

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

Participants who are not transitioning immediately from other TPIP studies:INS1009-201(NCT04791514), INS1009-202(NCT05147805) and other lead-in studies, will be given TPIP, once daily (QD), starting with 80 micrograms (μg), up-titrated to highest tolerated dose between 80 μg and 640 μg during 3-week titration period that maybe increased upto maximum dose of 1280 μg QD post initial titration, per investigator's assessment. Overall treatment period=24 months. Participants transitioning immediately from randomized blinded lead-in TPIP study and who previously received: 1. TPIP- will be given placebo QD(80 μg upto achieved TPIP dose from previous study)along with achieved TPIP dose from previous study in blinded manner during 3-week titration period. 2. Placebo- will be given TPIP QD (80 μg up to achieved placebo dose from previous study)along with achieved placebo dose from previous study in blinded manner during 3-week titration period.Overall treatment period=24 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Treprostinil Palmitil

2022

Completed Phase 2

~40

Placebo

1995

Completed Phase 3

~2670