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 80 years old (those over 70 would need approval from a medical monitor overseeing the trial)
• People who have been diagnosed with pulmonary hypertension associated with interstitial lung disease (PH-ILD), confirmed by a CT scan within the past year, linked to one of the following: a group of lung scarring conditions called idiopathic interstitial pneumonias (including IPF, idiopathic nonspecific interstitial pneumonia, RB-ILD, or unclassifiable types), chronic hypersensitivity pneumonitis, or a connective tissue disease affecting the lungs with breathing test results below a certain level
• People whose breathing test results within the past 6 months show reduced lung capacity above a minimum threshold, as confirmed by specialised lung imaging (people who have had part or all of a lung removed may have eligibility assessed differently — confirm with trial site)
• People whose heart and lung pressure measurements from a right heart procedure show readings consistent with a specific type of pulmonary hypertension (precapillary PH), with particular pressure and resistance values (confirm with trial site)
• People whose pulmonary hypertension symptoms fall into WHO Functional Class II or III, meaning they experience some limitations with physical activity
• People whose walking distance in a standard 6-minute walk test falls between 100 and 450 metres, with two test results during screening that are within 15% of each other
• People who have been on a stable, standard-of-care treatment for pulmonary hypertension for at least 90 days before screening, with no dose changes during that time
• Women who could become pregnant must have two negative pregnancy tests before starting the study, use highly effective contraception for at least 30 days before starting, throughout, and for 90 days after the study treatment ends, and must not breastfeed or donate eggs or blood during the study or for 90 days after the last dose
• Men must use a condom (latex or non-latex synthetic, not natural membrane) during sexual contact with a woman who is pregnant or could become pregnant, throughout the study and for at least 90 days after stopping treatment, and must not donate sperm during the study or for 90 days after the last dose
• People who are able to attend all required study visits and follow the study procedures
• People who are able to understand the study and provide written consent to participate

Who may not be able to join:

• People with moderate to severe emphysema shown on imaging or clinical assessment
• People diagnosed with a specific type of pulmonary hypertension caused by blood clots in the lungs (chronic thromboembolic pulmonary hypertension, or CTEPH), confirmed by imaging
• People who received certain intravenous heart-support medications (such as dobutamine or dopamine) within the 30 days before the study start
• People with moderate to severe obstructive sleep apnea that is not being treated
• People who have taken oral sirolimus or any similar drug (mTOR inhibitor) within the past 90 days
• People who have smoked, vaped, or used e-cigarettes within the 90 days before the study start
• People who started a new cardiopulmonary rehabilitation exercise programme within 90 days before the study start, or who plan to start one during the study (those already in a stable maintenance phase of an existing programme may still be considered)
• People with uncontrolled high blood pressure, specifically a sitting systolic reading above 170 mmHg or diastolic above 100 mmHg at screening
• People with low blood pressure, specifically a systolic reading below 90 mmHg at screening or at the study start
• People with a known history of a condition causing the sac around the heart to tighten (pericardial constriction)
• People for whom the treating doctor determines that a right heart catheter procedure (used during the study) is not safe
• People with a personal or family history of a heart rhythm condition called long QTc syndrome, or a history of sudden cardiac death
• People who have had a stroke within the 90 days before the study start
• People with a history of a type of heart muscle disease that restricts or constricts the heart's function
• People whose heart pumping function (left ventricular ejection fraction) was measured below 45% on an ultrasound of the heart within 6 months before or during screening
• People who have had a heart attack, heart bypass surgery, a coronary artery procedure, or chest pain from heart disease within the 6 months before screening
• People diagnosed by heart ultrasound with significant leaking of the mitral or aortic heart valves (rated 2+ or higher)
• People whose blood test results during screening show significantly elevated liver enzymes or bilirubin, or significantly reduced kidney function, or who have needed kidney replacement therapy (such as dialysis) within the past 90 days
• People who have had a serious opportunistic infection (such as certain fungal infections) within 6 months before screening, or a serious local or systemic infection within 3 months before screening
• People with a known history of severe allergic or anaphylactic reactions to proteins used in biological medicines, or to lactose used in the study treatment
• People who have had major surgery within 8 weeks before the study start, or who have not fully recovered from previous surgery
• People who have previously had a heart or heart-lung transplant
• People whose treating doctor estimates their life expectancy to be less than 12 months
• Women who are pregnant or currently breastfeeding
• People who, in the 30 days before screening, took more than 20 mg per day of prednisone or an equivalent steroid dose, or who started or changed their steroid dose during that time (stable doses of 20 mg or less per day may be permitted)
• People with a history of an active cancer diagnosis within the past 5 years, with the exception of certain fully treated skin or cervical conditions as specified (confirm with trial site)
• People with other significant medical conditions unrelated to pulmonary hypertension — such as heart, liver, kidney, neurological, psychiatric, or immune conditions — that the investigator determines could limit safe participation
• People who have participated in another clinical trial using an investigational or approved-for-investigation drug within 4 weeks before the study start, or within 5 times the clearance period of that drug, whichever is longer
• People who have participated in another clinical trial involving an investigational medical device within 4 weeks before the study start
• People who have used recreational drugs (such as cocaine or marijuana) within the 90 days before the study start
• People who are unwilling or unable to follow the procedures required by the study protocol

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