Working to make a difference to the lives of people with pulmonary arterial hypertension

Explore Study Locations

Welcome to the PROSERA Study

We hope you find this information helpful. If participating in the study may be of interest to you, click here to view the summary. You can also print it and take it to discuss with your doctor or specialist.

About The Study

What is the PROSERA Study?

The PROSERA Study is a Phase 3 clinical research study designed to help researchers understand whether an inhaled investigation product called seralutinib* may be an effective and safe future treatment for adults with pulmonary arterial hypertension.

Understanding pulmonary arterial hypertension

Pulmonary arterial hypertension is a rare, progressive disease that occurs when there is an overgrowth of cells in the small blood vessels that supply the lungs. This overgrowth causes the arteries to become narrower and stiffer, disrupting the flow of blood through the heart and lungs.

There are three connected pathways that contribute to pulmonary arterial hypertension and its progression: inflammation, proliferation and fibrosis. Inflammation occurs when an injury in the body activates the immune system to start the healing process. In pulmonary arterial hypertension, this inflammatory response is abnormally activated, and causes cells in the blood vessel walls of the lung to multiply too much, known as proliferation. This proliferation of cells ultimately changes tissue flexibility because the blood vessel walls thicken, causing the small arteries in the lungs to become narrow and constricted. As the disease progresses, the walls of these blood vessels can scar and become rigid, known as fibrosis. Symptoms of pulmonary arterial hypertension include shortness of breath, chest pain, fatigue, and/or lack of energy.

Watch Professor Luke Howard (Consultant Pulmonologist) discussing pulmonary arterial hypertension in more detail

Investigation Study Drugs

The PROSERA Study is a randomized double-blind clinical trial, which means each participant will be randomly allocated to receive either seralutinib or placebo. In order to test one against the other, neither the participant nor the study doctor will know which treatment they will receive. This is standard practice, it helps prevent bias when doctors evaluate the participant outcomes, improving the reliability of the study results.

With the PROSERA Study, we hope to understand the effect of seralutinib on specific pathways in the body that lead to the inflammation, proliferation and fibrosis associated with pulmonary arterial hypertension. Currently there is no treatment available that targets these specific pathways collectively.

This study is designed to see if, by blocking these pathways, seralutinib can prevent or reverse the effects of pulmonary arterial hypertension when added to currently approved therapies. It is produced as a fine dry powder to be inhaled using a small hand-held device. During the study, we also hope to gain an understanding of the safety and tolerability of seralutinib.

A placebo looks like the active drug, but does not contain any active medication. Using a placebo allows the research team to compare the effectiveness and safety of seralutinib in a standardized manner.

What's involved?

At all stages of the study, you will undergo some tests and procedures. These tests will track your health and progress, and may include the following:

Medical history and physical examinations

6-minute walk tests (6MWT)

You will be asked to walk as far as you can in six minutes

Blood and urine tests

Lung function tests

You will be asked to take deep breaths and blow into a machine to measure how well your lungs are working

Echo and electrocardiograms

Tests that provide images of your heart and check its rate and rhythm

Right heart catheterization

A procedure performed to measure the blood pressure inside your lungs and the blood flow and function in the right side of your heart. Right heart catheterization will be required at screening, unless you have had one within the last 6 months

*Seralutinib has not been approved for commercial use by the US FDA or any other regulatory agency.

Could I Be Eligible?

Please answer the following questions to see whether you might be eligible to take part in the PROSERA Study.

After completing all questions, please click “SUBMIT". It’s important to note that clicking “SUBMIT” does not mean that you agree to participate in the study.

Question 1

Are you an adult aged 18 to 75 years?

Question 2

Have you been diagnosed with pulmonary arterial hypertension?

Question 3

Are you being treated with at least one pulmonary arterial hypertension disease-specific medication?

Question 4

Do you have a body mass index (BMI) between 17 and 40 kg/m2?

If you are unsure, click here to help calculate your body mass index

Question 5

Could you be pregnant?

Questionnaire Submitted

Thank you for submitting your questionnaire.


Based on your provided answers, you may be eligible for taking part in the PROSERA Study. Please consult your doctor if you are interested in taking part in the PROSERA Study. Click here to view the summary which you can download or print, and take to discuss with your doctor or specialist.


Based on your responses, it appears that you do not currently meet the eligibility criteria for the study. If there are changes in your answers to any of these questions in the future, please check again to re-evaluate your eligibility. If you have a confirmed diagnosis of pulmonary arterial hypertension and are still interested in taking part in the PROSERA Study, please contact your doctor or specialist who may be able to advise you further. We appreciate your interest in the PROSERA Study. Thank you.

What next?

If you think this clinical research study might be for you, and you are interested in taking part, download this summary or email it to your doctor or specialist to discuss it further.

The PROSERA Study Timeline

The PROSERA Study will be conducted for a minimum of 24 weeks and involve screening, treatment, and follow-up appointments.

The study has 4 parts

Timeline Tree Timeline Tree



Up to 4 weeks



Up to 4 weeks


  • You will be required to stay on your current pulmonary arterial hypertension medications at the same dose for 12 weeks prior to screening

Confirming your eligibility to take part in the study

  • Screening period of up to 4 weeks
  • Full medical check-up, including discussing medical history
  • Blood and urine sample tests
  • Tests and checks on your heart and lungs (e.g., echo and electrocardiogram, 6MWT, and lung function test)
  • Right heart catheterization will be required at screening, unless you have had one within the last 6 months


Treatment Period

Minimum 24 weeks


Treatment Period

Minimum 24 weeks

Study period

  • You will be randomized after screening to receive seralutinib or placebo capsules twice a day, inhaled with a dry powder inhaler
  • You will be required to attend check-up appointments to monitor your disease and assess the safety of the study drug throughout the study
  • Neither you nor the study doctor will know which study drug you will be taking
  • The study will last up to 48 weeks, or until the last patient in the PROSERA Study has completed 24 weeks of treatment



4 weeks after final dose



4 weeks after final dose

After the final dose

  • If you decide not to take part in the PROSERA-EXT Study (open-label extension), 4 weeks after your last dose, you will attend a follow-up appointment
  • The follow-up allows the study doctor to monitor your health after you have stopped receiving treatment
  • Tests may include full medical check-up and blood and urine sample tests



Long-term study



Long-term study

Open-Label Extension Study

  • Once you complete the main study, you will have the opportunity to join an open-label extension (OLE) study, called PROSERA-EXT
  • You will have the chance to continue taking seralutinib, or switch to seralutinib if you were taking placebo


End of Study


End of Study


  • Upon study completion and finalization of the study report, results will be made available via and
  • Once the study is over for all participants, your study doctor will be able to let you know if you received seralutinib or placebo

Study Locations

Type in your city or ZIP code and your closest study sites will appear as blue pinpoints on the map.

Discover Your Local Patient Support Groups

Use your mouse to move the map and discover your local support group by clicking on the red pin

Above Country Support Groups

Alliance for Pulmonary Hypertension

PHA Europe

Sociedad Latina Hipertension Pulmonar

Global Allergy & Airways Patient Platform

Frequently Asked Questions

About the PROSERA Study

What is a clinical research study?

Clinical trials are a type of research that investigate new treatments and evaluate their effects on human health outcomes.

What is 'informed consent'?

The informed consent process provides you with relevant information about the clinical research study, so you can decide if you want to participate. It involves:

  • Reporting all the relevant study details
  • Summarizing why the research is being conducted
  • Voluntary decision-making

The informed consent process gives you the opportunity to be an informed participant in your healthcare decisions. You choose to enter a clinical research study freely (voluntarily), based on receiving complete information on what it means to take part. You must read and sign the informed consent form to be able to join the study.

Have any studies been conducted on seralutinib previously, and what were the results?

Seralutinib has previously been studied in the Phase 2 TORREY Study. More details of the TORREY Study can be found here:

For how long will I take part in this study?

After a 4-week screening period to assess your eligibility to participate, the study will last up to 48 weeks, or until the last participant has completed 24 weeks of treatment, with a follow-up visit 4 weeks after your final dose (10-15 visits in total). All participants who complete the study will be invited to continue/switch to seralutinib in the PROSERA-EXT Study.

Can I still take my current pulmonary arterial hypertension medication during the study?

Yes, you can take up to three medicines to help manage your pulmonary arterial hypertension, in addition to the study treatment.

Will I be compensated for participating in the study?

Yes. The study medicine, device, tests and procedures will be provided to you at no cost, and you may be reimbursed for study-related time and expenses.

What side effects might I experience?

The most common side effect reported from participants in the Phase 2 TORREY Study was a mild-to-moderate cough. This can be associated with taking the medication through dry powder inhalers. If you experience any side effects while taking the study medication, please report these to the study doctor as soon as possible.

What is a 'placebo'?

A treatment that looks like the active drug, but does not contain any active medication.

Will there be an option to transfer to the study drug if on the placebo?

At the end of the treatment period, you will have the chance to continue taking seralutinib – or switch to it if you were on placebo – in the PROSERA-EXT Study.

Privacy, Withdrawing, Costs, and Permission

What happens to my personal information if I participate?

Basic personal information may be recorded in your study medical records, including your name, contact details, gender, height, weight and racial origin, as well as information about your medical history, and clinical data collected during your participation in the study.

Your confidentiality will be respected, and no information that discloses your identity will be published without your consent unless required by law.

Can I withdraw from the clinical trial early?

You can change your mind and withdraw your consent at any time, and for any reason, without your usual medical treatment being affected.

If you have any further questions about your eligibility, or about the PROSERA Study, please contact your doctor or specialist.

Share this study

Copy and paste the link below to tell a friend or family member about the PROSERA Study