NCT07761572Not yet recruitingPhase 2
CS1 Added to Standard of Care Therapy for Pulmonary Arterial Hypertension
A Phase 2b, Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Study, to Compare the Efficacy and Safety/Tolerability of CS1 Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 6 Aug 2026
- Start date
- Sept 2026
- Primary completion date
- Feb 2029
- Lead sponsor
- Cereno Scientific AB
- NCT number
- NCT07761572
- EU CT number
- 2026-526523-22-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 126
- From Sept 2026 to the primary completion date, Feb 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior heart or heart-lung transplantation or active lung transplant listing
- Current use of prohibited medications that cannot be discontinued
Other illness
- Pulmonary hypertension WHO Group 2, 3, 4, or 5
- Significant left-sided heart disease
Other
- Recent major cardiovascular or cerebrovascular event
- Significant renal or hepatic dysfunction
- Pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.