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CS1 Added to Standard of Care Therapy for Pulmonary Arterial Hypertension

NCT07761572 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CS1

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

DRUG

Placebo

Matching placebo capsules taken orally once daily in the evening

Sponsors & Collaborators

  • Cereno Scientific AB

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2029-02-02
Completion
2029-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07761572 on ClinicalTrials.gov