Pulmonary Arterial HypertensionPhase 2EPIMODENCT07761572
CS1 Added to Standard of Care Therapy for Pulmonary Arterial Hypertension
A Phase 2 study testing CS1 in people with Pulmonary Arterial Hypertension, run by Cereno Scientific AB.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- CS1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 30 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official 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)
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
- Pulmonary Arterial Hypertension
- Being tested
- CS1, Placebo
- Keywords
- CS1, Pulmonary Arterial Hypertension, PAH, Sodium Valproate, Valproic Acid, Pulmonary Vascular Resistance, 6-Minute Walk Distance
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS1Drug
160 mg delayed release capsules taken orally once daily in the evening
PlaceboDrug
Matching placebo capsules taken orally once daily in the evening
| Study group | Role | What they receive |
|---|---|---|
| CS1 320 mg | Experimental | 2 capsules of CS1 160 mg and 2 capsules of placebo Receives: Drug: CS1; Drug: Placebo |
| CS1 640 mg | Experimental | 4 capsules of CS1 160 mg Receives: Drug: CS1 |
| Placebo | Placebo comparator | 4 capsules of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 36
Secondary outcomes (21)
Change from baseline in 6-minute walk distance (6MWD)
Measured: Baseline to Week 36
Change from baseline in Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension Disease Management (REVEAL) Lite 2 score
Measured: Baseline to Week 36
Change from baseline in REVEAL Risk Score (RRS) 2.0
Measured: Baseline to Week 36
Change from baseline in tricuspid annular plane systolic excursion (TAPSE)
Measured: Baseline to Week 36
Change from baseline in right ventricular (RV) strain
Measured: Baseline to Week 36
Change from baseline in World Health Organization (WHO) Functional Class
WHO Functional Class ranges from Class I to Class IV, with lower class indicating better functional status.
Measured: Baseline to Week 36
Percentage of participants with improvement in WHO Functional Class
WHO Functional Class ranges from Class I to Class IV, with lower class indicating better functional status.
Measured: Week 36
Change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) or B-type natriuretic peptide (BNP)
Measured: Baseline to Week 36
Change from baseline in mean pulmonary arterial pressure (mPAP)
Measured: Baseline to Week 36
Change from baseline in cardiac output (CO)
Measured: Baseline to Week 36
Percentage of participants with clinical worsening of pulmonary arterial hypertension (PAH)
Clinical worsening as defined in the study protocol.
Measured: Week 36
Time to first clinical worsening event
Clinical worsening as defined in the study protocol.
Measured: Baseline through Week 36
Change from baseline in PAH-SYMPACT (Pulmonary Arterial Hypertension Symptoms and Impact Questionnaire) domain scores
Domain scores assess symptoms and impacts of PAH; higher scores indicate greater symptom burden and disease impact.
Measured: Baseline to Week 36
Change in 6MWD from Week 36
Measured: Week 36 to Week 52
Change in TAPSE from Week 36
Measured: Week 36 to Week 52
Change in RV strain from Week 36
Measured: Week 36 to Week 52
Change in NT-proBNP or BNP from Week 36
Measured: Week 36 to Week 52
Change in WHO Functional Class from Week 36
WHO Functional Class ranges from Class I to Class IV, with lower class indicating better functional status.
Measured: Week 36 to Week 52
Change in REVEAL Lite 2 score from Week 36
Measured: Week 36 to Week 52
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Up to Week 56
Incidence of serious adverse events (SAEs)
Measured: Up to Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion2 Feb 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cereno Scientific AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761572
- Sponsor's protocol ID
- CS1-005
- Other IDs
- 2026-526523-22-00
- Acronym
- EPIMODE
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07761572
- Acronym / sponsor ID
- EPIMODE / CS1-005
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- CS1, Pulmonary Arterial Hypertension, PAH, Sodium Valproate, Valproic Acid, Pulmonary Vascular Resistance, 6-Minute Walk Distance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Cereno Scientific ABIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 2 Feb 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CS1 320 mg | Experimental | Drug: CS1, Drug: Placebo2 capsules of CS1 160 mg and 2 capsules of placebo |
| CS1 640 mg | Experimental | Drug: CS14 capsules of CS1 160 mg |
| Placebo | Placebo comparator | Drug: Placebo4 capsules of placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CS1160 mg delayed release capsules taken orally once daily in the evening | Drug | CS1 320 mg, CS1 640 mg |
| PlaceboMatching placebo capsules taken orally once daily in the evening | Drug | CS1 320 mg, Placebo |
Primary outcome
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.
21 secondary outcomes
Change from baseline in 6-minute walk distance (6MWD)
Time frame: Baseline to Week 36
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
Change from baseline in REVEAL Risk Score (RRS) 2.0
Time frame: Baseline to Week 36
Change from baseline in tricuspid annular plane systolic excursion (TAPSE)
Time frame: Baseline to Week 36
Change from baseline in right ventricular (RV) strain
Time frame: Baseline to Week 36
Change from baseline in World Health Organization (WHO) Functional Class
Time frame: Baseline to Week 36
Percentage of participants with improvement in WHO Functional Class
Time frame: Week 36
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
Change from baseline in mean pulmonary arterial pressure (mPAP)
Time frame: Baseline to Week 36
Change from baseline in cardiac output (CO)
Time frame: Baseline to Week 36
Percentage of participants with clinical worsening of pulmonary arterial hypertension (PAH)
Time frame: Week 36
Time to first clinical worsening event
Time frame: Baseline through Week 36
Change from baseline in PAH-SYMPACT (Pulmonary Arterial Hypertension Symptoms and Impact Questionnaire) domain scores
Time frame: Baseline to Week 36
Change in 6MWD from Week 36
Time frame: Week 36 to Week 52
Change in TAPSE from Week 36
Time frame: Week 36 to Week 52
Change in RV strain from Week 36
Time frame: Week 36 to Week 52
Change in NT-proBNP or BNP from Week 36
Time frame: Week 36 to Week 52
Change in WHO Functional Class from Week 36
Time frame: Week 36 to Week 52
Change in REVEAL Lite 2 score from Week 36
Time frame: Week 36 to Week 52
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to Week 56
Incidence of serious adverse events (SAEs)
Time frame: Up to Week 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CS1 in people with Pulmonary Arterial Hypertension, run by Cereno Scientific AB.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pulmonary vascular resistance (PVR) (time frame: Baseline to Week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.