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A Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (PAH) (TROPOS).
EU CTIS ID: 2022-502378-17-00
What this study is testing
Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background pulmonary arterial hypertension (PAH) therapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult participants ≥ 18 years of age.
- Symptomatic World Health Organization (WHO) Group 1 Pulmonary Hypertension (PAH) classified by one of the following subgroups: a. Idiopathic pulmonary arterial hypertension (IPAH) b. Hereditary pulmonary arterial hypertension (HPAH) c. Associated with drugs and toxins d. PAH associated with: i. Connective tissue disease (CTD), ii. Congenital systemic-pulmonary intracardiac shunt (must have surgical correction or repair with closure device at least 1 year prior to Screening, AND have no, or clinically insignificant, shunt fraction in the opinion of Investigator [1.0 ≤ pulmonary-systemic flow ratio ≤ 1.5]).
- Has the following hemodynamic parameters that are consistent with the diagnosis of PAH: a. Mean pulmonary arterial pressure (mPAP) > 20 mmHg at rest, AND b. Pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg, AND c. PVR ≥ 5 Wood units (400 dyn·sec·cm−5). Note: RHC to assess eligibility performed within 6 weeks from Visit 1 (Day 1).
- Has WHO/New York Heart Association (NYHA) Functional Class (FC) II or III symptoms as assessed by the Investigator at Screening and Day 1.
- Must be on a stable PAH background therapy with either an endothelin-receptor antagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE5-I) or soluble guanylate cyclase (sGC) stimulator and/or prostacyclin analogue or receptor agonist (oral/inhaled/SC/intravenous): a. Stable therapy is defined as no change in dose/regimen for at least 90 days prior to baseline and would be expected to be maintained for the duration of the study.
- 6MWD ≥ 150 and ≤ 500 meters repeated twice at Screening (measured at least 4 hours apart but no longer than 1 week), and both values within 15% of each other (calculated from the highest value).
You likely can't join if
- Evidence or history of left ventricular dysfunction and/or clinically significant cardiac disease.
- Prior participation in another interventional clinical study with medicinal products within 30 days or 5 half-lives prior to Screening, whichever is longer. Sites in France, check section A7-1.1.
- Has pulmonary function tests (PFTs) at Screening or within 180 days prior to the Screening with evidence of significant obstructive or parenchymal lung disease.
- Evidence of thromboembolic disease assessed by ventilation perfusion (V/Q) lung scan or other local standard of care diagnostic evaluation at the time of PAH diagnosis or after.
- Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mmHg or sitting diastolic BP > 100 mmHg at Screening.
- Hemoglobin < 9 g/dL at Screening.
See the full eligibility criteria
Who can join
- Adult participants ≥ 18 years of age.
- Symptomatic World Health Organization (WHO) Group 1 Pulmonary Hypertension (PAH) classified by one of the following subgroups: a. Idiopathic pulmonary arterial hypertension (IPAH) b. Hereditary pulmonary arterial hypertension (HPAH) c. Associated with drugs and toxins d. PAH associated with: i. Connective tissue disease (CTD), ii. Congenital systemic-pulmonary intracardiac shunt (must have surgical correction or repair with closure device at least 1 year prior to Screening, AND have no, or clinically insignificant, shunt fraction in the opinion of Investigator [1.0 ≤ pulmonary-systemic flow ratio ≤ 1.5]).
- Has the following hemodynamic parameters that are consistent with the diagnosis of PAH: a. Mean pulmonary arterial pressure (mPAP) > 20 mmHg at rest, AND b. Pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg, AND c. PVR ≥ 5 Wood units (400 dyn·sec·cm−5). Note: RHC to assess eligibility performed within 6 weeks from Visit 1 (Day 1).
- Has WHO/New York Heart Association (NYHA) Functional Class (FC) II or III symptoms as assessed by the Investigator at Screening and Day 1.
- Must be on a stable PAH background therapy with either an endothelin-receptor antagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE5-I) or soluble guanylate cyclase (sGC) stimulator and/or prostacyclin analogue or receptor agonist (oral/inhaled/SC/intravenous): a. Stable therapy is defined as no change in dose/regimen for at least 90 days prior to baseline and would be expected to be maintained for the duration of the study.
- 6MWD ≥ 150 and ≤ 500 meters repeated twice at Screening (measured at least 4 hours apart but no longer than 1 week), and both values within 15% of each other (calculated from the highest value).
- Provide written (signed and dated) informed consent form before the initiation of any Screening tests or procedures. Sites in Germany, check section A7-1.2 of the study protocol.
What rules you out
- Evidence or history of left ventricular dysfunction and/or clinically significant cardiac disease.
- Prior participation in another interventional clinical study with medicinal products within 30 days or 5 half-lives prior to Screening, whichever is longer. Sites in France, check section A7-1.1.
- Has pulmonary function tests (PFTs) at Screening or within 180 days prior to the Screening with evidence of significant obstructive or parenchymal lung disease.
- Evidence of thromboembolic disease assessed by ventilation perfusion (V/Q) lung scan or other local standard of care diagnostic evaluation at the time of PAH diagnosis or after.
- Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mmHg or sitting diastolic BP > 100 mmHg at Screening.
- Hemoglobin < 9 g/dL at Screening.
- Prior heart or heart-lung transplants, active on the lung transplant list, or life expectancy of < 12 months per Investigator assessment.
- Diagnosis of pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis.
- Initiation or discontinuation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to baseline or planned initiation during the study.
- Prior participation in a KER-012 study, or prior treatment with a therapy targeting TGF-β (e.g., sotatercept).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Brazil
- Taiwan
- Australia
- Turkey
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Brazil; Taiwan; Australia; Turkey and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.