Status: Not yet recruiting

CS1 Added to Standard of Care Therapy for Pulmonary Arterial Hypertension

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.

Participants needed: 126

Trial details

Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: Cereno Scientific ABUpdated: Aug 12, 2026

Eligibility criteria

Age 18 to 80 years [+6]

Pulmonary hypertension WHO Group 2, 3, 4, or 5 [+6]

Status: Available

Safety and Efficacy of Continued CS1 Treatment of Patients With Pulmonary Arterial Hypertension

CS1-004 will be an extension of the CS1-003 Study. The primary objective of the CS1-004 study is to evaluate long-term safety and tolerability of continued treatment with CS1.

Trial details

Age: 18-80Biological sex: AllType: Expanded AccessSponsor: Cereno Scientific ABUpdated: Mar 20, 2024Locations: 1

Eligibility criteria

Patient has derived benefit from CS1 treatment in parent Study CS1-003 based on... [+4]

Patient has a concomitant medical disorder that is expected to limit the patient... [+13]

Clinical trials

CS1 Added to Standard of Care Therapy for Pulmonary Arterial Hypertension

Safety and Efficacy of Continued CS1 Treatment of Patients With Pulmonary Arterial Hypertension