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

NCT ID: NCT07234032

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 344 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-01
• Study Completion Date: 2031-01-22

Brief Summary

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).

Conditions

Pulmonary Hypertension; Interstitial Lung Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Treprostinil Palmitil Inhalation Powder

Intervention Type: DRUG

Oral inhalation using a capsule-based dry powder.

Placebo

Intervention Type: DRUG

Oral inhalation in initial double-dummy titration period.

Interventions

Treprostinil Palmitil Inhalation Powder

Oral inhalation using a capsule-based dry powder.

Intervention Type: DRUG

Placebo

Oral inhalation in initial double-dummy titration period.

Intervention Type: DRUG

Other Intervention Names

INS1009

Eligibility Criteria

Inclusion Criteria

• Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07179380).
• Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Agree not to participate in any other interventional trials or use investigational drugs or devices while participating in the INS1009-312 study.

Exclusion Criteria

• Participants who experienced any adverse events (AEs) evaluated as causally related to TPIP by the Investigator in a lead-in study, which in the opinion of the Investigator, could pose an unreasonable risk of continued treatments for the participant.
• Current use or expected need for pulmonary arterial hypertension (PAH)-approved therapy, including prostacyclin, prostacyclin analogues or other prostacyclin receptor agonists, endothelin receptor antagonists, and/or soluble guanylate cyclase stimulator, or any PH-ILD approved treprostinil therapy. Use of phosphodiesterase 5 inhibitors in line with applicable guidelines is allowed.
• Diagnosis of Pulmonary Hypertension World Health Organisation (WHO) Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease (including combined pulmonary fibrosis and emphysema).
• Evidence of left ventricular failure, heart failure with preserved ejection fraction (HFpEF) or postcapillary PH.
• Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insmed Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Insmed Incorporated

Role: CONTACT

medicalinformation@insmed.com

18444467633

Other Identifiers

2025-521769-29-00

Identifier Type: OTHER

Identifier Source: secondary_id

INS1009-312

Identifier Type: -

Identifier Source: org_study_id