NCT07748000

Brief Summary

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 Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
4mo left

Started Oct 2026

Shorter than P25 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

October 26, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 5, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 31, 2026

Last Update Submit

July 31, 2026

Conditions

Raynaud's Phenomenon Secondary to Systemic Sclerosis

Keywords

systemic sclerosisRaynaud's phenomenonDigital ischemiatreprostinilprostacyclin analogdry powder inhalervasodilator

Outcome Measures

Primary Outcomes (1)

  • Participant incidence of tolerated dose(s) of LIQ861 defined as a dose level or dose regimen at which ≥80% of participants complete the Treatment Period with ≥80% compliance without permanent discontinuation of LIQ861 due to a TEAE

    21 days

Study Arms (2)

Arm 1: LIQ861 Dose Titration Arm

EXPERIMENTAL
Combination Product: LIQ861 (treprostinil) inhalation powder

Arm 2: LIQ861 Fixed Dose

EXPERIMENTAL
Combination Product: LIQ861 (treprostinil) inhalation powder

Interventions

LIQ861 (treprostinil) inhalation powderCOMBINATION_PRODUCT

Treprostinil inhalation powder supplied as capsules in strengths of 26.5, 53, 79.5, and 106 mcg, administered by oral inhalation QID (approximately 3-4 hours apart during waking hours) for 21 days using the RS00 Model 8 Monodose DPI

Also known as: treprostinil inhalation powder, YUTREPIA
Arm 1: LIQ861 Dose Titration ArmArm 2: LIQ861 Fixed Dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Scleroderma, SystemicRaynaud Disease

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesLivedoid VasculopathyThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSkin Diseases, Vascular

Central Study Contacts

Liquidia Point of Contact

CONTACT

1-888-241-6906LiquidiaStudies@liquidia.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2026

First Posted

August 5, 2026

Study Start (Estimated)

October 26, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

August 5, 2026

Record last verified: 2026-07