Phase 3 Pulmonary Hypertension Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have a confirmed diagnosis of pulmonary arterial hypertension (PAH) classified as WHO Group 1, specifically one of these types: idiopathic PAH (no known cause), heritable PAH (genetic), drug or toxin-induced PAH, PAH linked to a connective tissue disease, or PAH linked to a simple congenital heart defect that was surgically repaired at least 1 year ago
• People aged 18 to 75 years (inclusive), of any gender
• People with a body mass index (BMI) between 18.5 and 35.0 at the time of screening
• People whose results from a right heart catheterisation (a procedure to measure pressure and blood flow in the heart and lungs) during the screening period show specific values indicating significant PAH (confirm exact values with trial site)
• People who have been on a stable dose of approved PAH medications — such as endothelin receptor antagonists, phosphodiesterase-5 inhibitors, prostacyclins, or soluble guanylate cyclase stimulators — for at least 90 days before screening, and who are not currently taking sotatercept
• People whose 6-minute walk distance (a standard test of exercise ability) falls between 100 and 475 metres

Who may not be able to join:

• People whose PAH is classified as WHO Groups 2, 3, 4, or 5
• People with specific types of Group 1 PAH, including HIV-associated PAH, PAH linked to portal hypertension (high blood pressure in the liver's blood vessels), schistosomiasis-associated PAH, or pulmonary veno-occlusive disease
• People with uncontrolled high blood pressure, very low blood pressure, or who have experienced a fainting episode within 3 months before screening
• People with a history of certain heart muscle diseases (restrictive, constrictive, or congestive cardiomyopathy)
• People whose heart electrical activity test (ECG) shows a measurement called QTcF that is above specific thresholds at screening (confirm exact values with trial site)
• People with a personal or family history of a heart rhythm condition called long QT syndrome, or a history of sudden cardiac death in the family
• People who have an implanted heart monitoring device, such as a CardioMEMS device
• People whose lung function test (measuring how much air the lungs can hold) shows results below a certain level, unless additional scans confirm only mild lung disease (confirm details with trial site)
• People with a history of atrial fibrillation or atrial flutter (irregular heart rhythms)
• People with a history of stroke, bleeding in the brain, or a head injury from a fall within 3 months of screening, at any time in their life (for stroke or brain bleed) (confirm with trial site)
• People who have experienced acute right heart failure within 30 days before screening, as assessed by the study doctor
• People with significant heart disease affecting the heart valves, blood supply, or heart function, as determined by the study doctor
• People who have had a lung removal surgery (pneumonectomy)
• People with sleep apnoea that is untreated or not adequately treated, as determined by the study doctor
• People with an active hepatitis B or hepatitis C infection, based on specific blood test results (people who previously had hepatitis C and completed treatment may be considered — confirm with trial site)
• People with a history of or current bleeding disorder, including conditions such as haemophilia, von Willebrand disease, low platelet counts, or any significant bleeding event that required medical attention
• People currently taking certain medications, including strong CYP3A inducers or inhibitors (a category of drugs that affect how other medicines are processed by the body), any blood-thinning medication, or sotatercept (people who stopped sotatercept more than 6 months before screening may be considered — confirm with trial site)
• People who have recently started a cardiopulmonary rehabilitation exercise programme within 90 days before screening, or who plan to start one during the study (people already in the stable maintenance phase of an existing programme may be eligible)
• People who have had an atrial septostomy (a heart procedure) within 180 days before screening
• People currently participating in another clinical trial or who have taken an experimental medication within 90 days before screening
• People who have previously been enrolled in this trial or another trial of the same study drug (IKT-001)
• People for whom the study doctor believes completing the study would not be possible for social, behavioural, or medical reasons
• People who are currently pregnant, breastfeeding, or planning to become pregnant during the study
• People who have previously received a solid organ transplant or stem cell transplant
• People who have planned surgery during the study that would interrupt the study medication or interfere with study assessments (minor procedures may be allowed — confirm with trial site)
• People who have had a cancer diagnosis within the past 5 years, with certain exceptions such as fully treated non-spreading skin cancers, in situ cervical cancer, or very low to low risk prostate cancer under active monitoring (confirm details with trial site)

Important: Always verify eligibility with the trial site directly before applying.