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

NCT06129240 · Liquidia Technologies, Inc.
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Official title
An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension
About this study
Open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 \& 3 PH. Cohort A will include approximately 60 subjects who have WHO Group 3 Pulmonary Hypertension associated with interstitial lung disease (PH-ILD) Cohort B will include approximately 20 subjects who have WHO Group 3 PH-ILD, have been on protocol specified dosing of inhaled treprostinil QID, not at treatment goal, and able to transition to LIQ861. The primary objective of this study is to evaluate the safety and tolerability of LIQ861 in subjects with WHO Group 1 \& 3 Pulmonary Hypertension (PH).
Eligibility criteria
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.
Study design
Enrollment target: 80 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-12-28
Estimated completion: 2028-02-08
Last updated: 2026-06-26
Interventions
Drug: LIQ861
Primary outcomes
  • Cohort A: Incident of treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs) (Baseline until the end of the study.)
  • Cohort B: Number of participants with treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs) (16 weeks)
Sponsor
Liquidia Technologies, Inc. · industry
All locations (23)
Arizona Pulmonary SpecialistsRecruiting
Phoenix, Arizona, United States
The Medical Research Group, Inc.Recruiting
Fresno, California, United States
University of California San DiegoWithdrawn
La Jolla, California, United States
UCLA WestwoodActive Not Recruiting
Los Angeles, California, United States
UC DavisActive Not Recruiting
Sacremento, California, United States
UCSFActive Not Recruiting
San Francisco, California, United States
National Jewish HealthRecruiting
Denver, Colorado, United States
Hartford HospitalWithdrawn
Hartford, Connecticut, United States
Advent HealthRecruiting
Orlando, Florida, United States
Tampa General Hospital Center of Research ExcellenceRecruiting
Tampa, Florida, United States
Vincent Medical GroupRecruiting
Indianapolis, Indiana, United States
Norton Pulmonary SpecialistsWithdrawn
Louisville, Kentucky, United States
Tufts Medical CenterWithdrawn
Boston, Massachusetts, United States
University of MichiganActive Not Recruiting
Ann Arbor, Michigan, United States
University of MinnesotaActive Not Recruiting
Minneapolis, Minnesota, United States
NYU Langone Medical CenterActive Not Recruiting
New York, New York, United States
University of RochesterActive Not Recruiting
Rochester, New York, United States
University of North Carolina at Chapel HillWithdrawn
Chapel Hill, North Carolina, United States
University of Cincinnati HealthActive Not Recruiting
Cincinnati, Ohio, United States
Summit HealthRecruiting
Bend, Oregon, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
Houston MethodistActive Not Recruiting
Houston, Texas, United States
University of UtahActive Not Recruiting
Salt Lake City, Utah, United States
An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH · TrialPath