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NCT06129240Recruiting

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

Liquidia Technologies, Inc.

Start Date

12/28/2023

Completion Date

2/8/2028

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.

Detailed Description

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

Age Range: 18 years to 80 years

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.

Interventions

DRUG

LIQ861

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Conditions

Pulmonary HypertensionInterstitial Lung Disease

Locations

Arizona Pulmonary Specialists

Phoenix, Arizona 85012

United States

The Medical Research Group, Inc.

Fresno, California 93720

United States

University of California San Diego

La Jolla, California 92093

United States

UCLA Westwood

Los Angeles, California 90095

United States

UC Davis

Sacremento, California 95817

United States

UCSF

San Francisco, California 94143

United States

National Jewish Health

Denver, Colorado 80206

United States

Hartford Hospital

Hartford, Connecticut 06102

United States

Advent Health

Orlando, Florida 32803

United States

Tampa General Hospital Center of Research Excellence

Tampa, Florida 33606

United States

Vincent Medical Group

Indianapolis, Indiana 46260

United States

Norton Pulmonary Specialists

Louisville, Kentucky 40241

United States

Tufts Medical Center

Boston, Massachusetts 02111

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

NYU Langone Medical Center

New York, New York 10016

United States

University of Rochester

Rochester, New York 14627

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27514

United States

University of Cincinnati Health

Cincinnati, Ohio 45219

United States

Summit Health

Bend, Oregon 97701

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Houston Methodist

Houston, Texas 77030

United States

University of Utah

Salt Lake City, Utah 84112

United States