A Phase 3 Study to Evaluate the Safety & Tolerability of L606 in Subjects

Status Recruiting

Clinical 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; also evaluate the steady-state pharmacokinetics (PK) of L606 as compared to Tyvaso, effects on exercise ability, quality of life, and treatment satisfaction with L606.

Clinical Trial 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. The current Phase 3 study will help determine the short-term and long-term safety and tolerability of L606 in this patient population. The study will also evaluate the steady-state pharmacokinetics (PK) of L606 as compared to Tyvaso, effects on exercise ability (6-minute walk distance [6MWD] and Borg Dyspnea Score), quality of life (QoL), and treatment satisfaction with L606. Subjects who meet all the inclusion criteria and none of the exclusion criteria will be enrolled to one of the 2 cohorts: Cohort A: Subjects with PAH or PH-ILD receiving prior stable doses of Tyvaso (4 times daily) and willing to switch to L606 (twice daily). 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 MSP for 2 weeks and the OEP for 46 weeks. A subset of up to 15 subjects from Cohort A will also participate in a PK substudy. Cohort B subjects will sequentially participate in the MSP for 12 weeks and the OEP for 36 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04691154
Study type	Interventional
Source	Liquidia Technologies, Inc.
Contact	Marisa C. Law
Phone	919-328-4400
Email	marisa.law@liquidia.com
Status	Recruiting
Phase	Phase 3
Start date	August 1, 2021
Completion date	July 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms