An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Part of paid clinical trials in Naples, Florida.

Sponsor
Insmed Incorporated
Study ID
NCT07234032
Phase
PHASE3
Status
Recruiting
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Conditions

  • Interstitial Lung Disease
  • Pulmonary Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Treprostinil Palmitil Inhalation Powder — DRUG
    Oral inhalation using a capsule-based dry powder.
  • Placebo — DRUG
    Oral inhalation in initial double-dummy titration period.

Study Details

The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).

Key Dates

First listed
Nov 18, 2025
Start date
Jul 20, 2026
Status verified
Aug 2026
Primary completion
Jan 22, 2031
Completion
Jan 22, 2031

Study Design

Enrollment
344 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treprostinil Palmitil Inhalation Powder (TPIP)
    Participants transitioning from study INS1009-311 (NCT07179380) will undergo an initial double-dummy titration with the stable dose from the lead-in study and either TPIP or placebo for 4 weeks. They will then receive open-label TPIP at a stable maintenance dose with optional escalation (80-1280 micrograms once daily) for the remainder of the 104-week treatment period.

Primary Outcome Measure

Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 108 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
USA006NaplesFlorida34102-
USA003BendOregon97701-

Find similar trials in Naples, FL

By research site
USA006· Naples, FLUSA003· Bend, OR

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