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

Inclusion Criteria:

• 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

Exclusion Criteria:

• ≥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).