The PROSERA Study

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

Welcome to the PROSERA Study

We appreciate and value your participation in our Phase 3 clinical research study. You are helping us gather valuable information that we hope will benefit other patients with pulmonary arterial hypertension.

Here are a few words from members of the PROSERA Study team

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

1

Screening

Up to 4 weeks

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Screening

Up to 4 weeks

Pre-screening

  • 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

2

Treatment Period

Minimum 24 weeks

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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

3a

Follow-up

4 weeks after final dose

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Follow-up

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

3b

PROSERA-EXT

Long-term study

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PROSERA-EXT

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

4

End of Study

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End of Study

Results

  • Upon study completion and finalization of the study report, results will be made available via https://euclinicaltrials.eu and http://www.ClinicalTrials.gov
  • Once the study is over for all participants, your study doctor will be able to let you know if you received seralutinib or placebo

4

End of Study

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End of Study

Results

  • Upon study completion and finalization of the study report, results will be made available via https://euclinicaltrials.eu and http://www.ClinicalTrials.gov
  • Once the study is over for all participants, your study doctor will be able to let you know if you received seralutinib or placebo

If you are interested in joining the PROSERA-EXT Study and you are close to the end of the main PROSERA Study, please mention this to a member of the study staff.

Participants Resources

We have prepared some videos and downloadable leaflets to provide you with more information about the PROSERA Study, and to help you know what to expect over the next few months.

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

Thank you for taking part in this study.

Your participation can help make a difference to the pulmonary arterial hypertension community.

Who To Contact?

For further information, or if you have any questions, please contact a member of staff at your study site.