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NCT07748000Not yet recruitingPhase 2

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

A Phase 2a Randomized, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of LIQ861 in Participants With Systemic Sclerosis Experiencing Symptomatic Raynaud's Phenomenon Attacks / RE-WARM

Source: ClinicalTrials.gov · Last updated 7 Aug 2026

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
75 (estimated)
First submitted
31 Jul 2026
Start date
26 Oct 2026
Primary completion date
Feb 2027
Lead sponsor
Liquidia Technologies, Inc.
NCT number
NCT07748000

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 75
  • From 26 Oct 2026 to the primary completion date, Feb 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any parenteral, inhaled, or oral prostacyclin or prostacyclin receptor agonist within 12 weeks of screening; initiation/dose change of vasodilators within 4 weeks of screening; non-topical CYP2C8 inhibitors/inducers (unless discontinued for \>5 half-lives before randomization).

Other illness

  • ≥3 digital ulcers at screening; a new digital ulcer between screening and randomization; gangrene or amputation within 6 months; digital ulcer infection within 3 months.
  • History of cervical/digital sympathectomy or hand botulinum toxin injections within 90 days (or planned during the study).
  • Known WHO Group 1-5 pulmonary hypertension; significant obstructive (FEV1 \<65%) or restrictive (FVC \<60%) lung disease; need for supplemental oxygen; severe asthma.
  • Severe uncontrolled hypertension (SBP ≥160 and/or DBP \>100 mmHg) or severe hypotension (SBP \<85 mmHg).

Lab values

  • Clinically significant bleeding risk, coagulation disorder, or platelet count \<100 x 10\^9/L.

Who the study is looking for

  • Male or female ≥18 years of age
  • Classification of SSc per the 2013 ACR/EULAR criteria.
  • Diagnosis or history of Raynaud's phenomenon
  • Minimum of 12 (maximum 100) symptomatic RP attacks documented in the ePRO diary over ≥4 separate days

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.