L606 in people with PH-ILD: safe and effective test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial randomizes adults with ILD-related pulmonary hypertension to receive either L606 or placebo, and monitors safety and efficacy. The primary endpoint includes a six-minute walk distance to assess functional capacity, with secondary measures tracking time to disease progression and other dose-related effects. Patients undergo right heart catheterization to confirm PH and meet inclusion criteria, including preserved left-sided pressures and adequate lung function. The study uses a blinded period followed by dose comparisons to determine if L606 improves outcomes without unacceptable safety risks. Locations include sites in Arizona and California under Liquidia Technologies as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant is between 18 years to 80 years old.
* Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging.
* Evidence of PH as demonstrated from Right Heart Catheterization (RHC) with the following hemodynamic parameters:
* Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec/cm5 (i.e. 4 Woods Units (WU)), and
* Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and
* \- Pulmonary capillary wedge pressure (PCWP) or Left-Ventricular End Diastolic Pressure (LVEDP) of ≤ 15 mmHg.
* FEV1/FVC (ratio) \> 0.70.
* 6-minute walk distance ≥ 150 meters

Exclusion Criteria:

* PH in the updated WHO Classification Groups 1, 2, 4, or 5.
* Has evidence of clinically significant left-sided heart disease as defined by echocardiography.
* Participants with history of persistent/permanent or uncontrolled atrial fibrillation.
* Participants with severe obstructive sleep apnea.
* Has experienced exacerbation of underlying lung disease or active respiratory infection requiring antibiotics.
* Initiation of pulmonary rehabilitation.

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

Where it's running

• Dignity Health - St. Joseph's Hospital and Medical Center
  Phoenix, Arizona, United States Recruiting
• Arizona Pulmonary Specialists, Ltd.
  Scottsdale, Arizona, United States Recruiting
• David Geffen School of Medicine at UCLA
  Los Angeles, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• University of Colorado Hospital
  Aurora, Colorado, United States Recruiting
• National Jewish Hospital
  Denver, Colorado, United States Recruiting

Study contacts

• Study coordinator: Liquidia Point of Contact
• Email: LiquidiaStudies@liquidia.com
• Phone: 1-888-241-6906

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NS-863 in PH-ILD: A Phase 2 study for adults with pulmonary hypertension linked to interstitial lung disease

  A phase 2 randomized, double-blind study will test whether NS-863 helps people with PH-ILD, compared with placebo.

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• Rutgers Genetics of Pulmonary Hypertension

  This online project will try to see if genetic differences affect the risk of pulmonary hypertension in U.S. adults, and anyone 18 or older can join whether or not they have PH.

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• Registry for patients with pulmonary hypertension linked to interstitial lung disease

  This study is collecting information from patients with pulmonary hypertension linked to interstitial lung disease to see how different treatments affect their health over time.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.