NCT07761572Not yet recruitingPhase 2
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Cereno Scientific AB
- Enrollment
- 126
- Primary Endpoint
- Change from baseline in pulmonary vascular resistance (PVR)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CS1 640 mg
Experimental
4 capsules of CS1 160 mg
Intervention: CS1 (Drug)
CS1 320 mg
Experimental
2 capsules of CS1 160 mg and 2 capsules of placebo
Intervention: Placebo (Drug)
Placebo
Placebo Comparator
4 capsules of placebo
Intervention: Placebo (Drug)
CS1 320 mg
Experimental
2 capsules of CS1 160 mg and 2 capsules of placebo
Intervention: CS1 (Drug)
Outcomes
Primary Outcomes
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
- Incidence of treatment-emergent adverse events (TEAEs)(Up to Week 56)
- Incidence of serious adverse events (SAEs)(Up to Week 56)
- Change from baseline in 6-minute walk distance (6MWD)(Baseline to Week 36)
- Change from baseline in Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension Disease Management (REVEAL) Lite 2 score(Baseline to Week 36)
- Change from baseline in REVEAL Risk Score (RRS) 2.0(Baseline to Week 36)
- Change from baseline in tricuspid annular plane systolic excursion (TAPSE)(Baseline to Week 36)
- Change from baseline in right ventricular (RV) strain(Baseline to Week 36)
- Time to first clinical worsening event(Baseline through Week 36)
- Change from baseline in World Health Organization (WHO) Functional Class(Baseline to Week 36)
- Percentage of participants with improvement in WHO Functional Class(Week 36)
- Change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) or B-type natriuretic peptide (BNP)(Baseline to Week 36)
- Change from baseline in mean pulmonary arterial pressure (mPAP)(Baseline to Week 36)
- Change from baseline in cardiac output (CO)(Baseline to Week 36)
- Percentage of participants with clinical worsening of pulmonary arterial hypertension (PAH)(Week 36)
- Change from baseline in PAH-SYMPACT (Pulmonary Arterial Hypertension Symptoms and Impact Questionnaire) domain scores(Baseline to Week 36)
- Change in 6MWD from Week 36(Week 36 to Week 52)
- Change in TAPSE from Week 36(Week 36 to Week 52)
- Change in RV strain from Week 36(Week 36 to Week 52)
- Change in NT-proBNP or BNP from Week 36(Week 36 to Week 52)
- Change in WHO Functional Class from Week 36(Week 36 to Week 52)
- Change in REVEAL Lite 2 score from Week 36(Week 36 to Week 52)
Investigators
Similar Trials
Recruiting
Phase 3
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Piclidenoson (CF101) Administered Orally in Subjects with Moderate-to-Severe Plaque PsoriasisPlaque psoriasis2024-519919-34-00Can-Fite Biopharma Ltd.248
Withdrawn
Phase 1
Phase I, double-blind, randomized, placebo-controlled study investigating the safety, tolerability and concentrations of the study product KAND145 in healthy volunteersOvarian cancer2023-503909-11-00Kancera AB80
Not yet recruiting
Phase 3
A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Active Thyroid Eye DiseaseThyroid Eye DiseaseNCT07720635Beijing Kanghong Biological Medicine Co., Ltd.60
Recruiting
Phase 2
A Study of CP-COV03 Compared With Placebo in Participants With Dengue (Part 1) and Dengue-like Illness (Part 2)DengueNCT07576868Hyundai Bioscience Co., Ltd.210
Not yet recruiting
Phase 1
A Study of HL40626S Tablets in Healthy AdultsPsoriasis (PsO)Immune System DiseaseSkin Diseases, PapulosquamousSkin DiseaseNCT07736586HighsLab Therapeutics Inc.64