Phase 2 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 aged 18 to 75 years (inclusive), of any gender
• People who have been diagnosed with a specific type of high blood pressure in the lungs called WHO Group 1 pulmonary arterial hypertension (PAH), confirmed by a special heart test called a right heart catheterization — this includes cases with no known cause, inherited cases, cases caused by drugs or toxins, cases linked to certain inactive connective tissue diseases, or cases linked to simple heart defects that were surgically corrected at least one year ago
• People whose PAH causes symptoms and has been rated as WHO functional class II or III (meaning mild to moderate limitation of physical activity)
• People whose right heart catheterization results show specific pressure measurements in the lungs that meet the trial's required levels (confirm with trial site)
• People whose lung blood vessel resistance measured by right heart catheterization meets the trial's required level (confirm with trial site)
• People who have been on a stable, consistent dose of their current PAH medication(s) for at least 90 days before joining the trial
• People who can walk between 150 and 450 metres in a six-minute walk test during the screening period
• Women who could become pregnant must have a negative pregnancy blood test before starting, agree to regular pregnancy testing during the trial, use highly effective contraception before, during, and for 16 weeks after the last dose, and avoid donating blood or eggs for 16 weeks after the last dose
• Men must agree to use condoms during sexual activity with women who are pregnant or who could become pregnant, during the trial and for 16 weeks after the last dose — even if they have had a vasectomy — and must avoid donating sperm during this time
• People who understand the study procedures, are willing to take part, and have signed a consent form

Who may not be able to join:

• People diagnosed with pulmonary hypertension classified as WHO Group 2, 3, 4, or 5 (types caused by other heart or lung conditions)
• People with specific subtypes of WHO Group 1 PAH, including cases linked to HIV, liver portal hypertension, schistosomiasis (a parasitic infection), certain rare lung vessel conditions, or those who have had a particular positive lung blood vessel reactivity test
• People with poorly controlled blood pressure — specifically, those with a seated reading above certain levels, or a reading that is too low on the first dosing day (confirm with trial site)
• People whose heart electrical activity test (ECG) shows a specific measurement above the acceptable range, or who have a personal or family history of a heart rhythm condition called Long QT Syndrome or sudden cardiac death
• People with untreated sleep apnoea of any severity
• People who have previously had, or are planning to have, a heart or lung transplant, or whose doctor estimates their life expectancy is less than 12 months
• People diagnosed with chronic obstructive pulmonary disease (COPD) or another significant lung disease
• People with evidence of scarring or inflammation in the lungs (interstitial lung disease), based on a chest scan or breathing test within the specified timeframes
• People whose blood test results before the first dose fall outside acceptable ranges for red blood cells, platelets, white blood cells, liver enzymes, or kidney function (confirm with trial site)
• People with a history of high pressure in the liver's blood vessels (portal hypertension) or chronic liver disease, or those who test positive for Hepatitis B, Hepatitis C, HIV, or syphilis (note: people with a past syphilis infection that has been confirmed as fully treated may still be considered eligible — confirm with trial site)
• People who are currently in another clinical trial, or who have taken part in a clinical trial of a drug or medical device within the past 30 days (or within five half-lives of that drug, whichever is longer)
• People who have previously received any treatment targeting the TGF-β protein pathway — for example, a drug called Sotatercept — including through a clinical trial
• People with a known allergy or hypersensitivity to the trial drug, its ingredients, or similar types of biological medicines
• People who have had a serious opportunistic infection (such as certain fungal lung infections) within 6 months before starting, or a serious local or widespread infection within 4 weeks before screening
• People with a current or past history of cancer, except for certain skin cancers or cervical pre-cancerous conditions that were fully treated with no signs of return (confirm with trial site)
• People with a history of chronic kidney disease, or who have needed emergency dialysis for kidney failure within the 3 months before screening
• People who are pregnant or breastfeeding
• People whom the trial doctor considers unsuitable for the study for any other reason

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