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Prostacyclin Analogue

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 pre-ole baseline (baseline of the lead-in tpip study), months 6, 12, 18, and 24
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~pre-ole baseline (baseline of the lead-in tpip study), months 6, 12, 18, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-ole baseline (baseline of the lead-in tpip study), months 6, 12, 18, and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Experience at Least one Treatment Emergent Adverse Event (TEAE) and TEAEs by Severity
Secondary outcome measures
Absolute Change From Pre-Open Label Extension (OLE) Baseline in 6-Minute Walk Distance (6MWD)
Annualized Clinical Worsening Event Rate
Change From Pre-OLE Baseline in New York Heart Association/ World Health Organization (NYHA/WHO) Functional Capacity Class
+4 more

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: 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. 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

Find a Location

Who is running the clinical trial?

Insmed IncorporatedLead Sponsor
42 Previous Clinical Trials
7,102 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
100 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

Treprostinil Palmitil Inhalation Powder (TPIP) (Prostacyclin Analogue) Clinical Trial Eligibility Overview. Trial Name: NCT05649748 — Phase 2 & 3
Pulmonary Arterial Hypertension Research Study Groups: Treprostinil Palmitil Inhalation Powder (TPIP)
Pulmonary Arterial Hypertension Clinical Trial 2023: Treprostinil Palmitil Inhalation Powder (TPIP) Highlights & Side Effects. Trial Name: NCT05649748 — Phase 2 & 3
Treprostinil Palmitil Inhalation Powder (TPIP) (Prostacyclin Analogue) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05649748 — Phase 2 & 3
~67 spots leftby Dec 2026
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