A Phase 3 Study to Evaluate the Safety and Tolerability of L606 in Subjects With PAH or PH-ILD

Last updated: March 30, 2026
Sponsor: Liquidia Technologies, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Pulmonary Arterial Hypertension

Circulation Disorders

Williams Syndrome

Treatment

L606 inhalation suspension

Clinical Study ID

NCT04691154
PBI L606p3
  • Ages 18-80
  • All Genders

Study Summary

This Phase 3, 2-part, open-label, multicenter study aims to demonstrate the safety and tolerability of L606 in patients with PAH or PH-ILD. The study will determine the short-term and long-term safety and tolerability of L606 in this patient population.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Males and females ≥18 and ≤80 years of age.

  2. Diagnosed with

  3. PAH belonging to at least 1 of the following subgroups of Group 1 pulmonaryhypertension (PH) per European Society of Cardiology/European RespiratorySociety Guidelines for the diagnosis and treatment of PH at least 1 year priorto screening. or

  4. PH-ILD Group 3 European Society of Cardiology/European Respiratory SocietyGuidelines for the diagnosis and treatment of PH. Subjects with Group 3 PH thatis not related to underlying ILD are not eligible.

  5. Subjects with PAH: Documentation of having PAH as confirmed by RHC meeting thefollowing criteria: i. Mean PAP >20 mmHg. ii. Pulmonary arterial wedge pressure ≤15 mmHg. iii. Pulmonaryvascular resistance >3 Wood units. Subjects with PH-ILD: Confirmation of theunderlying ILD must be based on HRCT imaging with demonstration of diffuseparenchymal lung disease and documented by the Investigator or radiology report.Subjects may have any form of ILD or CPFE.

  6. NYHA functional class II, III, or IV at the screening visit.

  7. Can complete a screening 6MWD of ≥150 meters

  8. For subjects with PAH: >65% of predicted and FEV1/FVC ratio >65% at screening. Forsubjects with PH-ILD: >40% of predicted and FEV1/FVC ratio >70% at screening.

Exclusion

Key Exclusion Criteria:

  1. LVEF of ≤45% on a historical echocardiogram.

  2. History of sleep apnea, or left-sided heart disease (including but not limited toaortic or mitral valve disease, pericardial constriction, restrictive or congestivecardiomyopathy, or coronary artery disease) per investigator's discretion.

  3. Experienced an acute exacerbation of disease or hospitalization for any reasonwithin 30 days of signing the ICF or prior to baseline.

  4. Musculoskeletal disorder (eg, arthritis affecting the lower limbs, recent hip orknee joint replacement) or any disease that would likely be the primary limit toambulation or subject is connected to a machine that is not portable enough to allowfor a 6MWT.

Study Design

Total Participants: 28
Treatment Group(s): 1
Primary Treatment: L606 inhalation suspension
Phase: 3
Study Start date:
August 01, 2021
Estimated Completion Date:
March 31, 2031

Study Description

This Phase 3, 2-part, open-label, multicenter study aims to demonstrate the safety and tolerability of repeated doses of L606 in patients with PAH or PH-ILD.

Cohort A: Subjects with PAH or PH-ILD receiving prior stable doses of Tyvaso and willing to switch to L606.

Cohort B: Subjects with PAH (not initially on prostacyclin therapy) who are likely to receive clinical benefit from inhaled treprostinil based on the opinion of the investigator.

Cohort A subjects will sequentially participate in the Main Study Period (MSP) for 2 weeks and the Open Extension Period (OEP) for 46 weeks. Cohort B subjects will sequentially participate in the MSP for 12 weeks and the OEP for 36 weeks.

Connect with a study center

  • Arizona Pulmonary Specialists

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Arizona Pulmonary Specialists

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Arizona Pulmonary Specialists

    Scottsdale 5313457, Arizona 5551752 85258
    United States

    Site Not Available

  • VA Greater Los Angeles Healthcare

    Los Angeles, California 90073
    United States

    Site Not Available

  • VA Greater Los Angeles Healthcare

    Los Angeles 5368361, California 5332921 90073
    United States

    Site Not Available

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • Mayo Clinic Jacksonville

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Site Not Available

  • University of South Florida

    Tampa 4174757, Florida 4155751 33606
    United States

    Site Not Available

  • Brigham and Womens Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029-6504
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029-6504
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati 4508722, Ohio 5165418 45267
    United States

    Site Not Available

  • Summit Health Eastside Clinic

    Bend, Oregon 97701
    United States

    Site Not Available

  • Summit Health Eastside Clinic

    Bend 5713587, Oregon 5744337 97701
    United States

    Site Not Available

  • UPMC Montefiore

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Baylor Scott and White Research Institute

    Temple, Texas 76508
    United States

    Site Not Available

  • Baylor Scott and White Research Institute

    Temple 4735966, Texas 4736286 76508
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.