[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650413":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":32,"locations":11,"responsibleParty":38,"collaborators":11,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":11,"enrollmentInfo":50,"targetDuration":11,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":67,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":11},{"fullName":5,"class":6},"Liquidia Technologies, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: LIQ861 Dose Titration Arm","EXPERIMENTAL",null,[13],"Combination Product: LIQ861 (treprostinil) inhalation powder - Dose Titration Arm",{"label":15,"type":10,"description":11,"interventionNames":16},"Arm 2: LIQ861 Fixed Dose",[17],"Combination Product: LIQ861 (treprostinil) inhalation powder - fixed dose arm",[19,27],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"COMBINATION_PRODUCT","LIQ861 (treprostinil) inhalation powder - Dose Titration Arm","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",[9],[25,26],"treprostinil inhalation powder","YUTREPIA",{"type":20,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"LIQ861 (treprostinil) inhalation powder - fixed dose arm","Treprostinil inhalation powder supplied as 26.5 mcg capsules administered by oral inhalation QID (approximately 3-4 hours apart during waking hours) for 21 days using the RS00 Model 8 Monodose DPI",[15],[25,26],[33],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Liquidia Point of Contact","CONTACT","1-888-241-6906","LiquidiaStudies@liquidia.com",{"type":39,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100650413","phase-2-a-study-of-liq861-inhaled-treprostinil-in-adults-with-systemic-sclerosis-who-have-symptomatic-raynauds-phenomenon-attacks-100650413",false,"NCT07748000","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 \u002F RE-WARM","RE-WARM","Inclusion Criteria:\n\n* Male or female ≥18 years of age\n* Classification of SSc per the 2013 ACR\u002FEULAR criteria.\n* Diagnosis or history of Raynaud's phenomenon\n* Minimum of 12 (maximum 100) symptomatic RP attacks documented in the ePRO diary over ≥4 separate days\n\nExclusion Criteria:\n\n* ≥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.\n* History of cervical\u002Fdigital sympathectomy or hand botulinum toxin injections within 90 days (or planned during the study).\n* Clinically significant bleeding risk, coagulation disorder, or platelet count \\\u003C100 x 10\\^9\u002FL.\n* Known WHO Group 1-5 pulmonary hypertension; significant obstructive (FEV1 \\\u003C65%) or restrictive (FVC \\\u003C60%) lung disease; need for supplemental oxygen; severe asthma.\n* Severe uncontrolled hypertension (SBP ≥160 and\u002For DBP \\>100 mmHg) or severe hypotension (SBP \\\u003C85 mmHg).\n* Any parenteral, inhaled, or oral prostacyclin or prostacyclin receptor agonist within 12 weeks of screening; initiation\u002Fdose change of vasodilators within 4 weeks of screening; non-topical CYP2C8 inhibitors\u002Finducers (unless discontinued for \\>5 half-lives before randomization).","ALL","18 Years",{"count":51,"type":52},75,"ESTIMATED","INTERVENTIONAL",[55],"PHASE2","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).",[58],"Raynaud's Phenomenon Secondary to Systemic Sclerosis",[60,61,62,63,64,65,66],"systemic sclerosis","Raynaud's phenomenon","Digital ischemia","treprostinil","prostacyclin analog","dry powder inhaler","vasodilator","NOT_YET_RECRUITING","2026-08-05",{"date":70,"type":71},"2026-08-07","ACTUAL",{"date":73,"type":52},"2026-10-26",{"date":75,"type":52},"2027-03",{"name":5,"class":6}]