Pulmonary Arterial HypertensionPhase 3NCT04691154
A Phase 3 Study to Evaluate the Safety and Tolerability of L606 in Subjects With PAH or PH-ILD
A Phase 3 study testing L606 inhalation suspension in people with Pulmonary Arterial Hypertension and Pulmonary Hypertension Due to Lung Diseases, run by Liquidia Technologies, Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Pulmonary Hypertension Due to Lung Diseases
- What is being tested?
- L606 inhalation suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Aug 2021to 31 Mar 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥18 and ≤80 years of age.
- Diagnosed with
- PAH belonging to at least 1 of the following subgroups of Group 1 pulmonary hypertension (PH) per European Society of Cardiology/European Respiratory Society Guidelines for the diagnosis and treatment of PH at least 1 year prior to screening. or
- PH-ILD Group 3 European Society of Cardiology/European Respiratory Society Guidelines for the diagnosis and treatment of PH. Subjects with Group 3 PH that is not related to underlying ILD are not eligible.
- Subjects with PAH: Documentation of having PAH as confirmed by RHC meeting the following criteria:
- Mean PAP >20 mmHg. ii. Pulmonary arterial wedge pressure ≤15 mmHg. iii. Pulmonary vascular resistance >3 Wood units. Subjects with PH-ILD: Confirmation of the underlying ILD must be based on HRCT imaging with demonstration of diffuse parenchymal lung disease and documented by the Investigator or radiology report. Subjects may have any form of ILD or CPFE.
Show all 9Show fewer
- NYHA functional class II, III, or IV at the screening visit.
- Can complete a screening 6MWD of ≥150 meters
- For subjects with PAH: >65% of predicted and FEV1/FVC ratio >65% at screening. For subjects with PH-ILD: >40% of predicted and FEV1/FVC ratio >70% at screening.
Who cannot join
- LVEF of ≤45% on a historical echocardiogram.
- History of sleep apnea, or left-sided heart disease (including but not limited to aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease) per investigator's discretion.
- Experienced an acute exacerbation of disease or hospitalization for any reason within 30 days of signing the ICF or prior to baseline.
- Musculoskeletal disorder (eg, arthritis affecting the lower limbs, recent hip or knee joint replacement) or any disease that would likely be the primary limit to ambulation or subject is connected to a machine that is not portable enough to allow for a 6MWT.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Summit Health Eastside Clinic
Bend, Oregon, 97701
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
VA Greater Los Angeles Healthcare
Los Angeles, California, 90073
Icahn School of Medicine at Mount Sinai
New York, New York, 10029-6504
Arizona Pulmonary Specialists
Scottsdale, Arizona, 85258
University of South Florida
Tampa, Florida, 33606
Baylor Scott and White Research Institute
Temple, Texas, 76508
About this study
Official title: A Phase 3, 2-Part, Open-Label Study to Evaluate the Safety and Tolerability of Liposomal Treprostinil Inhalation Suspension (L606) in Subjects With Pulmonary Arterial Hypertension or Pulmonary Hypertension Associated With Interstitial Lung Disease
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.
Read the detailed 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.
- Being tested
- L606 inhalation suspension
- Keywords
- treprostinil, Pulmonary Arterial Hypertension, inhalation, Pulmonary Hypertension Due to Lung Diseases
- Medical subject headings
- Pulmonary Arterial Hypertension, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L606 inhalation suspensionCombination product
L606 inhalation suspension
| Study group | Role | What they receive |
|---|---|---|
| L606 | Experimental | Not described Receives: Combination Product: L606 inhalation suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs
(MSP for Cohort A): Proportion of patients with PAH or PH-ILD on a stable Tyvaso dose who would develop treatment-emergent AEs/SAEs after switching to L606 dosing for up to 2 weeks during MSP.
Measured: 2 weeks
Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs
(MSP for Cohort B): Proportion of patients with PAH (not initially on prostacyclin therapy) who would develop treatment-emergent AEs/SAEs during 12 weeks of the MSP with titration on twice daily L606.
Measured: 12 weeks
Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs (long-term)
(OEP for Cohorts A and B): Proportion of subjects with PAH or PH-ILD, choosing to continue twice daily L606 dosing for up to 48 weeks, who would develop treatment emergent AEs/SAEs up to 48 hours after the last dose.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Aug 2021
- Primary completion20 Mar 2025
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort A: Tyvaso stabilized PAH or PH-ILD patients Cohort B: Prostacyclin naive - PAH patients
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liquidia Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691154
- Sponsor's protocol ID
- PBI L606p3
- Status last verified
- Mar 2026
- First submitted
- 21 Dec 2020
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, 2-Part, Open-Label Study to Evaluate the Safety and Tolerability of Liposomal Treprostinil Inhalation Suspension (L606) in Subjects With Pulmonary Arterial Hypertension or Pulmonary Hypertension Associated With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT04691154
- Acronym / sponsor ID
- PBI L606p3
- Keywords
- treprostinil, Pulmonary Arterial Hypertension, inhalation, Pulmonary Hypertension Due to Lung Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Liquidia Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort A: Tyvaso stabilized PAH or PH-ILD patients Cohort B: Prostacyclin naive - PAH patients
| Arm | Type | Receives |
|---|---|---|
| L606 | Experimental | Combination Product: L606 inhalation suspension |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females ≥18 and ≤80 years of age.
- Diagnosed with
- Subjects with PAH: Documentation of having PAH as confirmed by RHC meeting the following criteria:
- NYHA functional class II, III, or IV at the screening visit.
- Can complete a screening 6MWD of ≥150 meters
Key exclusion criteria (4 listed)
- LVEF of ≤45% on a historical echocardiogram.
- History of sleep apnea, or left-sided heart disease (including but not limited to aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease) per investigator's discretion.
- Experienced an acute exacerbation of disease or hospitalization for any reason within 30 days of signing the ICF or prior to baseline.
- Musculoskeletal disorder (eg, arthritis affecting the lower limbs, recent hip or knee joint replacement) or any disease that would likely be the primary limit to ambulation or subject is connected to a machine that is not portable enough to allow for a 6MWT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L606 inhalation suspensionL606 inhalation suspension | Combination product | L606 |
Primary outcome
Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs
Time frame: 2 weeks
(MSP for Cohort A): Proportion of patients with PAH or PH-ILD on a stable Tyvaso dose who would develop treatment-emergent AEs/SAEs after switching to L606 dosing for up to 2 weeks during MSP.
Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs
Time frame: 12 weeks
(MSP for Cohort B): Proportion of patients with PAH (not initially on prostacyclin therapy) who would develop treatment-emergent AEs/SAEs during 12 weeks of the MSP with titration on twice daily L606.
Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs (long-term)
Time frame: 48 weeks
(OEP for Cohorts A and B): Proportion of subjects with PAH or PH-ILD, choosing to continue twice daily L606 dosing for up to 48 weeks, who would develop treatment emergent AEs/SAEs up to 48 hours after the last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
Related trials for Pulmonary Arterial Hypertension
Not yet recruitingPhase 4
A Clinical Study of MK-7962 in Chinese Participants With Pulmonary Arterial Hypertension (MK-7962-022)
Hypertension, Pulmonary
Not yet recruiting
Large Language Model Support for CTEPH Differential Diagnosis
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
RecruitingPhase 2
A Clinical Trial of NS-863 in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
RecruitingPhase 2
Clinical Trial of NS-863 in Participants With Pulmonary Arterial Hypertension (PAH)
Pulmonary Arterial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L606 inhalation suspension in people with Pulmonary Arterial Hypertension and Pulmonary Hypertension Due to Lung Diseases, run by Liquidia Technologies, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.