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Not yet recruiting NCT07234032

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

Phase III Interventional Pulmonary Hypertension Interstitial Lung Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Treprostinil Palmitil Inhalation Powder, Placebo.
Who it may be relevant to
Registry conditions: Pulmonary Hypertension, Interstitial Lung Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease

Overview

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).

Interventions

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

Primary outcome measures

  • Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to 108 weeks]
Secondary outcome measures (12)
  • Change From Baseline in 6-Minute Walk Distance (6MWD) Measured Post-Dose [Time frame: Up to 104 weeks]
  • Absolute Change From Baseline in Forced Vital Capacity (FVC) [Time frame: Up to 104 weeks]
  • Percent Change From Baseline in Forced Vital Capacity (FVC) [Time frame: Up to 104 weeks]
  • Absolute Change From Baseline in Percent Predicted FVC (FVC% pred) [Time frame: Up to 104 weeks]
  • Percent Change From Baseline in Percent Predicted FVC (FVC% pred) [Time frame: Up to 104 weeks]
  • Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) [Time frame: Up to 104 weeks]
  • Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) [Time frame: Up to 104 weeks]
  • Absolute Change From Baseline in Percent Predicted FEV1 (FEV1%) [Time frame: Up to 104 weeks]
  • Percent Change From Baseline in Percent Predicted FEV1 (FEV1%) [Time frame: Up to 104 weeks]
  • Change From Baseline in the Plasma Concentration of N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) [Time frame: Up to 104 weeks]
  • Annualized Rate of Occurrence of Exacerbations of Interstitial Lung Disease (ILD) [Time frame: Up to 104 weeks]
  • Percentage of Participants With a Clinical Worsening Events [Time frame: Up to 104 weeks]

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).

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07234032 · INS1009-312 · 2025-521769-29-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗