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 (RVT 2301-201)
Recipient organisationNIHR Wellcome Trust Cambridge Clinical Research Facility
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 a severe lung condition that makes it hard to breathe and strains the heart. This matters because pulmonary hypertension associated with interstitial lung disease (PH-ILD) is a progressive, often fatal condition with limited treatment options. The lungs become scarred, and the blood vessels in them narrow, forcing the heart to work harder. Current therapies can slow the disease but do not reverse it. Mosliciguat is an investigational medicine designed to relax these narrowed blood vessels, potentially improving blood flow and oxygen exchange. If the trial shows mosliciguat is safe and effective, it could become a new treatment option for people with PH-ILD. That would mean better exercise tolerance, less breathlessness, and a slower decline in lung function for patients who currently have few alternatives. The trial runs for up to four and a half years, including a placebo-controlled phase and an open-label extension where all participants eventually receive the drug, allowing researchers to assess both short-term efficacy and long-term safety.
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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