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A Study of LIQ861 (Inhaled Treprostinil) in Adults With Systemic Sclerosis Who Have Symptomatic Raynaud's Phenomenon Attacks

Study acronym: RE-WARM
StatusNot Yet Recruiting
PhasePhase 2
Started2026-10-26
View on ClinicalTrials.gov ↗

Amendment history

2026-08-05
Study Status, Arms and Interventions v1
InterventionsLIQ861 (treprostinil) inhalation powder (Combination Product)→LIQ861 (treprostinil) inhalation powder - Dose Titration Arm (Combination Product), LIQ861 (treprostinil) inhalation powder - fixed dose…
2026-07-31
Original filing
Systemic sclerosis (SSc) is a rare autoimmune disease in which many patients experience Raynaud's phenomenon (RP) - painful episodes where commonly fingers or toes change color and become painful, numb, or tingly, usually triggered by cold or stress. This open-label study is testing an inhaled powder form of treprostinil (LIQ861) to find out which doses can be taken safely and comfortably by adults with SSc who have frequent symptomatic RP attacks. About 75 adults will be randomly assigned (2 to 1) to either a dose-titration group or a fixed low-dose group. The study also explores whether treatment reduces the number, severity, and impact of RP attacks. The main goal is to identify tolerated dose(s).
Trial Details
NCT Number NCT07748000
Lead Sponsor Liquidia Technologies, Inc.
Conditions Raynaud's Phenomenon Secondary to Systemic Sclerosis
Enrollment 75 participants
Start Date 2026-10-26
Primary Completion 2027-02 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-07