2026-06-24
notable
Study Status, Contacts/Locations v6
Trial status changed: Active, Not Recruiting → Recruiting
Trial sites expanded: 18 → 23 locations
2026-02-05
notable
Recruiting→Active, Not Recruiting Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-07-30→2027-07-31
Completion date2026-10-31→2028-02-08
Enrollment target60→80
Study sites23→18
Study arms1→2
InterventionsLIQ861 (Combination Product)→LIQ861 (Drug)
Eligibility criteria-4,001 characters
Cohort A Key Inclusion Criteria:
Males or Females between 18 years to 80 years of age.
Has a confirmed diagnosis of WHO Group 3 PH-ILD based on CT chest imaging performed, which demonstrates evidence of diffuse parenchymal lung disease and FEV1/FVC (absolute values) ≥ 70% and are required to have evidence of pulmonary hypertension [...] An Institutionalexploratory Reviewsubset Boardof subjects with ILD: i) Pulmonary vascular resistance (IRBPVR) approved≥ informed3 consentWood Units (WU) and ii) Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and iii) A mean pulmonary arterial pressure (mPAP) [...] [...]
Primary endpoints1 to 2 entries
Cohort A: Incident of treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs)
Cohort B: Number of participants with treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs)
Study description-314 characters
Study LTI-401 is an openOpen-label, multicenter study which will evaluate the safety and [...] rtension associated with interstitial lung disease (PH-ILD)
AdditionalCohort cohortsB fromwill eitherinclude Groupapproximately 120 orsubjects who have WHO Group 3 mayPH-ILD, behave definedbeen in futureon protocol amendments.
Scheduledspecified studydosing visitsof toinhaled thetreprostinil clinicQID, will occurnot at Screening,treatment Baseline, Week 8, Week 16, Week 24goal, and Weekable 52.
Duringto thistransition time,to dose titration may be ordered at the Investigator's discretion and in accordance w [...] [...]
2025-05-30
minor
Study Status, Contacts/Locations v4
2024-10-01
minor
Study Status, Contacts/Locations v3
2024-07-23
minor
Study Status, Contacts/Locations v2
2024-01-30
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-12-01→confirmed 2023-12-28
2023-11-10
minor
Original filing