This trial will help us learn if a study medicine is safe, tolerated, and improves symptoms in people with pulmonary arterial hypertension.
Pulmonary arterial hypertension occurs when small blood vessels in the lungs, called pulmonary arteries, narrow and thicken. This then causes the heart to work harder to pump blood to the lungs, which increases the blood pressure and eventually causes damage to the heart.
Your participation in this study could help advance a potential treatment for people diagnosed with pulmonary arterial hypertension, and you would receive expert care from dedicated healthcare professionals.
Who may participate
Who can take part
You might be able to take part in this trial if you:
- Are aged 18 years old or older
- Have a diagnosis of pulmonary arterial hypertension
- Are receiving a stable dose of at least two vasodilator therapies for the treatment of your pulmonary arterial hypertension*
- Do not have a history of any other serious illnesses
*These are common medicines for people with pulmonary arterial hypertension, as they widen the blood vessels in the lungs to lower the blood pressure. You can ask your doctor if you are currently taking these types of medicines for your condition. There will be other trial requirements that the study team will discuss with you.
Condition
Pulmonary arterial hypertension
Age
18+ years
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If this trial is a good fit for you and you agree to take part, there will be about 9 to 12 study visits over the course of approximately 41 weeks. What happens at each visit will vary, but may include physical examinations, blood and urine tests, heart and lung checks, tests to measure physical activity, and questionnaires.
You will receive the study medicine or a placebo. A placebo does not contain any active ingredients, but the study medicine and the placebo look alike.
The study medicine (or placebo) is given as injections under the skin of the abdomen, thigh, or back of the arm every 4 weeks for 24 weeks (6 doses in total).
You may have the option to join an extension to this study, where all participants will take the study medicine (there is no placebo group in the extension).
Length of study treatment
Approximately 41 weeks
Number of study visits
Approximately 9 to 12 visits
Long-term follow up
12 weeks
About Pulmonary Hypertension
The lungs are full of blood vessels. These include vessels that take oxygen-poor blood from the heart to the lungs, called the pulmonary arteries.
These arteries can become narrow and stiff, which causes the blood travelling to the lungs to slow down and results in high blood pressure in the pulmonary arteries.
This is a condition known as pulmonary arterial hypertension (hypertension is another word for high blood pressure).
Women between the ages of 30 and 60 are more frequently affected by pulmonary arterial hypertension.
The causes of pulmonary arterial hypertension are not well known, increased risk can either be inherited from a parent or caused by environmental factors.
About the study medicine
The study medicine is an antibody that binds to a protein known as BMP9 (bone morphogenetic protein 9). BMP9 is produced by the liver and plays a role in controlling the growth of blood vessels in the lungs. Problems with BMP9 signaling are believed to contribute to the development of the disease “pulmonary arterial hypertension” in which pulmonary blood vessels become blocked.
It is hoped that the study medicine may improve pulmonary arterial hypertension by blocking harmful BMP9 activity in the lungs.
Participants in this study will continue taking their normal medications for pulmonary arterial hypertension.
