Open-Label Phase 2 Study of TX000045 for Pulmonary Hypertension Caused by Interstitial Lung Disease in Adults 18 to 80 Years

What this Trial Is About

Researchers are evaluating the drug TX000045 in adults with pulmonary hypertension caused by interstitial lung disease PH-ILD. The study aims to assess how TX000045 affects pulmonary vascular resistance PVR and to monitor its safety and tolerability in this group. This is a phase 2, open-label treatment trial focusing on participants aged 18 to 80 years with confirmed fibrotic lung disease and pulmonary hypertension. Participants will receive subcutaneous injections of TX000045 at a dose of 300 milligrams every four weeks, starting from Week 1 through Week 13. The treatment period lasts for 16 weeks, during which researchers will track changes in various heart and lung function measures, including pulmonary arterial pressure and oxygen levels. The study does not involve a placebo group and all participants receive the active drug. Throughout the study, participants will undergo assessments including right heart catheterization or echocardiograms, safety laboratory tests, 12-lead ECGs, vital sign monitoring, and 6-minute walk tests to measure oxygen saturation and exercise capacity. Researchers will monitor adverse events and clinically significant changes in safety parameters up to 21 weeks. Total participation spans from screening, through treatment and follow-up evaluations to assess the effects and safety of TX000045.

Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease