A Phase 2, Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of Mosliciguat in Participants with Pulmonary Hypertension associated with Interstitial Lung Disease
Recipient organisationNIHR Imperial Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodJan 2025 — Ongoing
In plain English
AI plain-English summary
A new drug, mosliciguat, is being tested in 120 people with pulmonary hypertension linked to scarring lung disease. This matters because pulmonary hypertension—high blood pressure in the lungs—often develops in people with interstitial lung disease, a group of chronic scarring conditions that stiffen the lungs and make breathing difficult. Current treatments are limited, and the combination of both conditions severely reduces quality of life and life expectancy. The trial randomly assigns two-thirds of participants to receive mosliciguat and one-third a placebo for 24 weeks, followed by an open-label extension where everyone receives the drug for up to four years. Researchers will measure changes in lung function, heart function, and exercise capacity. If mosliciguat proves safe and effective, it could become the first targeted therapy for PH-ILD that directly addresses the vascular component of the disease. This would give clinicians a new option to slow disease progression and improve daily function for a patient group that currently has few pharmacological choices. The trial’s long extension period also provides rare data on long-term safety and durability of any benefits.
View original technical description
Pulmovant Inc. is conducting a study of an investigational medicine, called mosliciguat, for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). The purpose is to find out if mosliciguat is safe and effective in treating adults who live with PH-ILD. Approximately 120 people (18 - 80 years old) with a diagnosis of PH-ILD will participate at around 85 sites globally. The study consists of: • Screening (up to 6 weeks) •Part 1 – Placebo-controlled treatment period (24 weeks): Participants will be assigned 2:1 to either mosliciguat or placebo. There will be monthly visits to the study site and weekly virtual visits during the first 2 months. •Part 2 – Extension period (28 weeks and up to about 200 weeks): After completion of Part 1, the participant will be able to continue with Part 2 of the study, also called the extension period. If the participant received mosliciguat during Part 1, they will continue to receive mosliciguat during Part 2. If they received placebo during Part 1, they will receive mosliciguat during Part 2. During the first 28 weeks, the participant will continue to have monthly visits to the study site and virtual visits. Thereafter, they will attend study site about every 3 months and complete virtual visits every 6 weeks.• Final Visit – Safety Follow-up: After the participant has stopped taking mosliciguat, they will have a follow-up visit 2 to 4 weeks after their last dose of mosliciguat, or their last scheduled study visit if they discontinue in Part 1. This final visit will take place whether they stop taking the medicine early, or if they complete the entire study. In total, participants will be in the study for about 4 and a half years. During the study they will be required to make clinic visits in person and they may be able to meet with study staff over the phone/video if applicable. At some of the clinic visits they will have blood drawn and have procedures to test their lungs and heart function
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