CS1 Added to Standard of Care Therapy for Pulmonary Arterial Hypertension (NCT07761572) | Clinical Trial Compass
Not Yet RecruitingPhase 2
CS1 Added to Standard of Care Therapy for Pulmonary Arterial Hypertension
126 participantsStarted 2026-09-15
Plain-language summary
This Phase 2 study (EPIMODE) will evaluate the efficacy and safety of CS1 compared with placebo when added to standard-of-care therapy in participants with pulmonary arterial hypertension.
Participants completing Treatment Period 1 (Week 36) will be re-randomized to continue or switch study treatment for Treatment Period 2 through Week 52.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 to 80 years
* WHO Group 1 pulmonary arterial hypertension
* WHO Functional Class II or III
* REVEAL Lite 2 score ≥6
* Receiving stable standard-of-care PAH therapy for at least 90 days prior to screening
* Hemodynamic confirmation of PAH by right heart catheterization
* 6-minute walk distance ≥150 m and \<550 m
Exclusion Criteria:
* Pulmonary hypertension WHO Group 2, 3, 4, or 5
* Significant left-sided heart disease
* Recent major cardiovascular or cerebrovascular event
* Prior heart or heart-lung transplantation or active lung transplant listing
* Significant renal or hepatic dysfunction
* Current use of prohibited medications that cannot be discontinued
* Pregnant or breastfeeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in pulmonary vascular resistance (PVR)