A clinical study to test how safe and effective a new inhaled treatment (called L606) is for people with high blood pressure in the lungs due to interstitial lung disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Liquidia Technologies Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

21 Apr 2026 → ongoing

Decision date (initial)

2026-03-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Liquidia Technologies, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To evaluate the effect of inhaled L606 on the change in walk distance as measured by the six-minute walk test (6MWT) in WHO Group 3 participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)

Secondary objectives 3

1. To evaluate the effect of inhaled L606 on the time to clinical worsening (TTCW)
2. To evaluate the effect of inhaled L606 on the 6-Minute Walk Distance (6MWD) at Week 24
3. To evaluate the effect of inhaled L606 on the 6-Minute Walk Distance (6MWD) at Week 16

Conditions and MedDRA coding

Pulmonary Hypertension associated with interstitial lung disease (WHO Group 3)

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

IPD will be shared upon request after study completion

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participant is between 18 years to 80 years old
2. Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging
3. Evidence of PH as demonstrated from Right Heart Catheterization (RHC) with the following hemodynamic parameters: a. Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec/cm5, and b. Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and c. Pulmonary capillary wedge pressure (PCWP) or Left-Ventricular End Diastolic Pressure (LVEDP) of ≤ 15 mmHg
4. FEV1/FVC (ratio) > 0.70
5. 6-minute walk distance ≥ 150 meters

Exclusion criteria 7

1. PH in the updated WHO Classification Groups 1, 2, 4, or 5
2. Has evidence of clinically significant left-sided heart disease as defined by echocardiography
3. Participants with history of persistent/permanent or uncontrolled atrial fibrillation
4. Participants with severe obstructive sleep apnea
5. Has experienced exacerbation of underlying lung disease or active respiratory infection requiring antibiotics
6. Initiation of pulmonary rehabilitation
7. Severe coronary heart disease or unstable angina or myocardial infarction within 180 days prior to Screening

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from Baseline to Week 16 in 6-minute walk distance (6MWD)

Secondary endpoints 3

1. Time to first occurrence of 1 of the following clinical worsening event (CWE) criterion are met: -Death (all causes) -Hospitalization due to a cardio-pulmonary indication related to underlying disease -Lung transplant -Decrease in 6MWD > 15% from Baseline related to disease under study, at 2 consecutive visits and at least 1 week apart
2. Change from Baseline to Week 24 in 6-Minute Walk Distance (6MWD)
3. Change from Baseline to Week 16 in 6MWD

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Liquidia Technologies Inc.

Sponsor organisation

Liquidia Technologies Inc.

Address

419 Davis Drive Suite 100

City

Morrisville

Postcode

27560-7551

Country

United States

Scientific contact point

Organisation

Liquidia Technologies Inc.

Contact name

Liquidia Clin Dev and Ops

Public contact point

Organisation

Liquidia Technologies Inc.

Contact name

Liquidia Clin Dev and Ops

Third parties 10

Locations

10 EU/EEA countries · 43 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 85 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications