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NCT Number: NCT07761572

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change from baseline in pulmonary vascular resistance (PVR)

    Time frame: Baseline to Week 36

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

Secondary outcomes

  1. Change from baseline in 6-minute walk distance (6MWD)

    Time frame: Baseline to Week 36

  2. Change from baseline in Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension Disease Management (REVEAL) Lite 2 score

    Time frame: Baseline to Week 36

  3. Change from baseline in REVEAL Risk Score (RRS) 2.0

    Time frame: Baseline to Week 36

  4. Change from baseline in tricuspid annular plane systolic excursion (TAPSE)

    Time frame: Baseline to Week 36

  5. Change from baseline in right ventricular (RV) strain

    Time frame: Baseline to Week 36

  6. Change from baseline in World Health Organization (WHO) Functional Class

    Time frame: Baseline to Week 36

    WHO Functional Class ranges from Class I to Class IV, with lower class indicating better functional status.

  7. Percentage of participants with improvement in WHO Functional Class

    Time frame: Week 36

    WHO Functional Class ranges from Class I to Class IV, with lower class indicating better functional status.

  8. Change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) or B-type natriuretic peptide (BNP)

    Time frame: Baseline to Week 36

  9. Change from baseline in mean pulmonary arterial pressure (mPAP)

    Time frame: Baseline to Week 36

  10. Change from baseline in cardiac output (CO)

    Time frame: Baseline to Week 36

  11. Percentage of participants with clinical worsening of pulmonary arterial hypertension (PAH)

    Time frame: Week 36

    Clinical worsening as defined in the study protocol.

  12. Time to first clinical worsening event

    Time frame: Baseline through Week 36

    Clinical worsening as defined in the study protocol.

  13. Change from baseline in PAH-SYMPACT (Pulmonary Arterial Hypertension Symptoms and Impact Questionnaire) domain scores

    Time frame: Baseline to Week 36

    Domain scores assess symptoms and impacts of PAH; higher scores indicate greater symptom burden and disease impact.

  14. Change in 6MWD from Week 36

    Time frame: Week 36 to Week 52

  15. Change in TAPSE from Week 36

    Time frame: Week 36 to Week 52

  16. Change in RV strain from Week 36

    Time frame: Week 36 to Week 52

  17. Change in NT-proBNP or BNP from Week 36

    Time frame: Week 36 to Week 52

  18. Change in WHO Functional Class from Week 36

    Time frame: Week 36 to Week 52

    WHO Functional Class ranges from Class I to Class IV, with lower class indicating better functional status.

  19. Change in REVEAL Lite 2 score from Week 36

    Time frame: Week 36 to Week 52

  20. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to Week 56

  21. Incidence of serious adverse events (SAEs)

    Time frame: Up to Week 56

Interested in participating?

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

Cereno Scientific AB

Industry

Registry information

Official study title

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)

Acronym: EPIMODE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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