CS1 Added to Standard of Care Therapy for Pulmonary Arterial Hypertension

Phase 2Not Yet RecruitingNCT07761572

Cereno Scientific AB126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

126

Conditions

Pulmonary Arterial Hypertension

Interventions

CS1DRUG

160 mg delayed release capsules taken orally once daily in the evening

PlaceboDRUG

Matching placebo capsules taken orally once daily in the evening

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline in pulmonary vascular resistance (PVR)

Pulmonary vascular resistance calculated from right heart catheterization measurements using the Thermodilution or Fick method for determination of cardiac output.