CS1 Added to Standard of Care Therapy for Pulmonary Arterial Hypertension

Sponsor
Cereno Scientific AB
Study ID
NCT07761572
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • CS1 — DRUG
    160 mg delayed release capsules taken orally once daily in the evening
  • Placebo — DRUG
    Matching placebo capsules taken orally once daily in the evening

Study Details

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.

Key Dates

First listed
Aug 12, 2026
Start date
Sep 15, 2026
Status verified
Aug 2026
Primary completion
Feb 2, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CS1 320 mg
    2 capsules of CS1 160 mg and 2 capsules of placebo
  • Experimental: CS1 640 mg
    4 capsules of CS1 160 mg
  • Placebo Comparator: Placebo
    4 capsules of placebo

Primary Outcome Measure

Change from baseline in pulmonary vascular resistance (PVR) [ Time Frame: Baseline to Week 36 ]

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