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

NCT07234032 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: INS1009-3122025-521769-29-00
• Study Type: interventional
• Target: 344
• Locations: 0 countries
• Sites: N/A

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

Keywords

pulmonary hypertension, interstitial lung disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)

  Up to 108 weeks

Secondary Outcomes (19)

• Change From Baseline in 6-Minute Walk Distance (6MWD) Measured Post-Dose

  Up to 104 weeks

• Absolute Change From Baseline in Forced Vital Capacity (FVC)

  Up to 104 weeks

• Percent Change From Baseline in Forced Vital Capacity (FVC)

  Up to 104 weeks

• Absolute Change From Baseline in Percent Predicted FVC (FVC% pred)

  Up to 104 weeks

• Percent Change From Baseline in Percent Predicted FVC (FVC% pred)

  Up to 104 weeks

Study Arms (1)

Treprostinil Palmitil Inhalation Powder (TPIP)

EXPERIMENTAL

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.

Drug: Treprostinil Palmitil Inhalation Powder; Drug: Placebo

Interventions

Treprostinil Palmitil Inhalation Powder DRUG

Oral inhalation using a capsule-based dry powder.

Also known as: INS1009

Treprostinil Palmitil Inhalation Powder (TPIP)

Placebo DRUG

Oral inhalation in initial double-dummy titration period.

Treprostinil Palmitil Inhalation Powder (TPIP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Insmed Incorporated: lead

MeSH Terms

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Insmed Incorporated

CONTACT

18444467633; medicalinformation@insmed.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 22, 2031
• Study Completion (Estimated): January 22, 2031
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share