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Active, not recruiting Observational

An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH

NCT06129240 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2023-12-28
Last updated
2026-10-30

Condition(s) studied

Pulmonary HypertensionInterstitial Lung Disease

Investigational drug(s) / intervention(s)

LIQ861

LIQ861: trepostinil inhalation powder in combination with inhaler

Study summary

Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 \& 3 PH.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Cohort A Key Inclusion Criteria: 1. Males or Females between 18 years to 80 years of age. 2. Has a confirmed diagnosis of WHO Group 3 PH-ILD based on CT chest imaging performed, which demonstrates evidence of diffuse parenchymal lung disease and FEV1/FVC (absolute values) ≥ 70% and are required to have evidence of pulmonary hypertension (PH) as demonstrated from right heart catheterization (RHC) with the following hemodynamic parameters. 1. i) Pulmonary vascular resistance (PVR) ≥ 3 Wood Units (WU) and ii) Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and iii) A mean pulmonary arterial pressure (mPAP) of ≥ 30 mmHg. OR 2. An exploratory subset of subjects with ILD: i) Pulmonary vascular resistance (PVR) ≥ 3 Wood Units (WU) and ii) Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and iii) A mean pulmonary arterial pressure (mPAP) of ≥ 21 mmHg. 3. 6-minute walk distance of ≥ 125 meters Cohort A Key Exclusion Criteria: A Subject is not eligible for inclusion in the study if any of the following criteria apply: 1. PH in the Updated WHO Classification Groups 1, 2, 4, or 5. 2. History of hemodynamically significant left-sided heart disease. 3. Exacerbation of underlying lung disease or active pulmonary or upper respiratory infections. 4. Initiation of pulmonary rehabilitation. Cohort B Key Inclusion Criteria 1. Male or Females between 18 years to 75 years of age at Screening. 2. Has a diagnosis of WHO Group 3 PH-ILD confirmed with CT chest imaging performed at the screening visit, which demonstrates evidence of diffuse parenchymal lung disease and FEV1/FVC (absolute values) ≥70%. Subjects are required to have evidence of pulmonary hypertension (PH) as demonstrated from right heart catheterization (RHC) with the following documented parameters: 1. Pulmonary vascular resistance (PVR) ≥3 Wood Units (WU) and 2. Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and 3. A mean pulmonary arterial pressure (mPAP) of ≥ 25 mmHg 3. Subjects must be on protocol specified dose of inhaled treprostinil QID not at treatment goal, and able to transition from their prescribed dose of inhaled Treprostinil therapy to LIQ861. 4. 6-minute walk distance of ≥ 200 meters Cohort B Key Exclusion Criteria 1. PH in the Updated WHO Classification Groups 1, 2, 4, or 5. 2. Inability to titrate inhaled treprostinil above 5 breaths (Tyvaso®) or above 16 mcg Tyvaso DPI®. 3. History of Bronchospasm with Tyvaso or Tyvaso DPI. 4. History of persistent moderate asthma or severe asthma. 5. History of hemodynamically significant left-sided heart disease. 6. Exacerbation of underlying lung disease or active pulmonary or upper respiratory infections.

Primary outcome measure(s)

  • Cohort A: Incident of treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs) — Baseline until the end of the study.
    Treatment-emergent AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration. Device-related AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration.
  • Cohort B: Number of participants with treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs) — 16 weeks
    Treatment-emergent AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration. Device-related AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration.

Trial sites (18)

FacilityCityRegionStatus
Arizona Pulmonary Specialists Phoenix Arizona
The Medical Research Group, Inc. Fresno California
UCLA Westwood Los Angeles California
UC Davis Sacremento California
UCSF San Francisco California
National Jewish Health Denver Colorado
Advent Health Orlando Florida
Tampa General Hospital Center of Research Excellence Tampa Florida
Vincent Medical Group Indianapolis Indiana
University of Michigan Ann Arbor Michigan
University of Minnesota Minneapolis Minnesota
NYU Langone Medical Center New York New York
University of Rochester Rochester New York
University of Cincinnati Health Cincinnati Ohio
Summit Health Bend Oregon
Medical University of South Carolina Charleston South Carolina
Houston Methodist Houston Texas
University of Utah Salt Lake City Utah
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06129240 on ClinicalTrials.gov ↗ ← All trials in the USA