The PROSERA Study

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.

Seralutinib
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.

Placebo
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

1

Screening

Up to 4 weeks

Circle

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

Circle

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

Circle

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

Circle

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

Circle

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

Study Locations

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

National University of Singapore

Distance

Address:

5 Lower Kent Ridge Road, Singapore, Singapore 119082

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National Heart Centre

Distance

Address:

5 Hospital Drive, Singapore, Singapore 169609

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Pontificia Universidad Catolica de Chile

Distance

Address:

Portugal 61, 8320000 Santiago, Región Metropolitana, Chile

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Hospital Privado Centro Médico de Córdoba S.A

Distance

Address:

Cordoba, Provincia de Cordoba X5016KEH

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Nepean Hospital

Distance

Address:

Nepean Hospital, Cardiac Services Level 5, Building C, NSW, 2747

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Onassis Cardiac Surgery Center

Distance

Address:

Leof. Andrea Siggrou 356, Kallithea 176 74, Greece

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Institute of Clinical and Experimental Medicine

Distance

Address:

Vídeňská 1958, 140 21 Praha 4, Czechia

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Ordensklinikum Linz Elisabethinen

Distance

Address:

Fadingerstraße 1, 4020 Linz, Austria

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VU University Medical Center

Distance

Address:

De Boelelaan 1117, 1081 HV Amsterdam, Netherlands

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Erasmus University Medical Center

Distance

Address:

Dr. Molewaterplein 40, Rotterdam, Zuid-Holland 3015 GD

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Hospital Universitario Vall d'Hebron

Distance

Address:

Vall d'Hebron 119-129, Barcelona, Barcelona 08035

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IRCCS Opsedale Policlinico San Martino

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Address:

Largo Rosanna Benzi 10, Genova, Liguria 16132

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Klinikum Würzburg Mitte gGmbH

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Address:

Salvatorstraße 7, 97074 Würzburg, Germany

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Northwestern University

Distance

Address:

240 E Huron St, Chicago, IL 60611, USA

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University of Minnesota

Distance

Address:

420 Delaware Street MMC 508 Minneapolis, MN 55455, Minnesota, Minnesota

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Norton Pulmonary Specialists

Distance

Address:

100 W Market St Ste 2, Louisville, Kentucky 40202-1332

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Duke University Medical Center

Distance

Address:

330 Trent Dr, Durham, NC 27710, USA

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Medical University of South Carolina

Distance

Address:

96 Jonathan Lucas St, Charleston, SC 29425, USA

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St. Luke's Health Baylor College of Medicine Medical Center

Distance

Address:

7200 Cambridge St, Houston, TX 77030, USA

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Cardiologia Palermo

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Address:

Comunidad Autonoma de Buenos Aires, Ciudad Autonoma de Buenos Aires C1425BNG

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Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina

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Address:

Borowa 14/18, 05-400 Otwock, Poland

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UZ Leuven Campus Gasthuisberg

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Address:

Herestraat 49, 3000 Leuven, Belgium

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Complejo Asistencial Universitario de Salamanca – H. Clinico

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Address:

P.º de San Vicente, 58, 37007 Salamanca, Spain

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Hospital Universitario Marques de Valdecilla

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Address:

Av. de Valdecilla, s/n, 39008 Santander, Cantabria, Spain

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Puerta de Hierro Majadahonda University Hospital

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Address:

C. Joaquín Rodrigo, 1, 28222 Majadahonda, Madrid, Spain

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Hammersmith Hospital

Distance

Address:

72 Du Cane Rd, London W12 0HS

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University of Connecticut

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Address:

263 Farmington Ave, Farmington, CT 06032, USA

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Aurora Saint Luke's Medical Center

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Address:

2900 W Oklahoma Ave, Milwaukee, WI 53215, United States

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University of Nebraska Medical Center

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Address:

42nd and, Emile St, Omaha, NE 68198, United States

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UC Davis Health Medical Center

Distance

Address:

Pulmonary, Critical Care and Sleep Medicine Research , Sacramento, California 95817

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University of Rochester

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Address:

601 Elmwood Ave, Rochester, NY 14642, USA

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Allegheny General Hospital

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Address:

320 E North Ave, Pittsburgh, PA 15212, United States

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Centro Hospitalar de Santo António

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Address:

Largo do Prof. Abel Salazar, 4099-001 Porto, Portugal

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Hospital Universitario Son Espases

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Address:

Carretera de Valldemossa, 79, Nord, 07120 Palma, Illes Balears, Spain

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Northside Hospital

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Address:

1000 Johnson Ferry Rd NE, Atlanta, GA 30342, USA

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NYU Langone Health

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Address:

462 1st Ave., New York, NY 10016, USA

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Sanatorio Parque S.A.

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Address:

Blvd. Oroño 860, S2000 Rosario, Santa Fe, Argentina

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Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil

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Address:

1 Pl. de l'Hôpital, 67000 Strasbourg, France

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Hospital Provincial Dr. Jose Maria Cullen

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Address:

Av. Gdor. Freyre 2138, S3000EOM S3000EOM, Santa Fe, Argentina

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INTEGRIS Family Care Central

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Address:

3400 Northwest Expy Building C, Suite 500, Oklahoma City, OK 73112, United States

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Mayo Clinic

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Address:

200 1st St SW, Rochester, MN 55905, United States

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Instituto de Cardiologia de Corrientes Juana Francisca Cabral

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Address:

Bolívar 1334, W3400CDS Corrientes, Argentina

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Tel Aviv Sourasky Medical Center

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Address:

Weizmann St 6, Tel Aviv-Yafo, Israel

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Meir MC

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Address:

Tchernichovsky St 59, Kefar Sava, 4428164, Israel

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The Chaim Sheba Medical Center

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Address:

Derech Sheba 2, Ramat Gan, Israel

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Hadassah University Hospital Ein-Karem

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Address:

Kalman Ya'akov Man St, Jerusalem, Israel

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Lady Davis Carmel Medical Center

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Address:

Mikhal St 7, Haifa, 3436212, Israel

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Rabin Medical Center

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Address:

ז'בוטינסקי 39, Petah Tikva, 4941492, Israel

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Seoul National University Hospital

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Address:

101 Daehak-ro, Jongno-gu, Seoul, South Korea

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Samsung Medical Center

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Address:

81 Irwon-ro, Gangnam-gu, Seoul, South Korea

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Gachon University Gil Medical Center

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Address:

21 Namdong-daero 774beon-gil, Guwol-dong, Namdong-gu, Incheon, South Korea

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Severance Hospital Yonsei University Health System

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Address:

50-1 Yonsei-ro, Sinchon-dong, Seodaemun-gu, Seoul, South Korea

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Asan Medical Center

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Address:

88 Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea

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The Catholic University of Korea, Seoul St. Mary's Hospital

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Address:

222 Banpo-daero, Seocho-gu, Seoul, South Korea

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Macquarie University Hospital

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Address:

Level 3, 75 Talavera Rd, Macquarie Park NSW 2113, Australia

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St Vincents Hospital Melbourne

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Address:

41 Victoria Parade, Fitzroy VIC 3065, Australia

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Hospital of Lithuanian University of Health Sciences Kaunas Clinics

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Address:

Eivenių g. 2, 50161 Kaunas, Lithuania

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P.Stradins Clinical University Hospital

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Address:

Pilsoņu iela 13, Zemgales priekšpilsēta, Rīga, LV-1002, Latvia

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Piedmont Healthcare

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Address:

275 Collier Rd NW unit 450, Atlanta, GA 30309, United States

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Centro Hospital Universitário de Coimbra, EPE

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Address:

Praceta Professor Mota Pinto, 3004-561 Coimbra, Portugal

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Centro Hospitalar de Vila Nova de Gaia e Espinho

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Address:

R. Conceição Fernandes S/N, 4434-502 Vila Nova de Gaia, Portugal

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Centro Hospitalar de Lisboa Norte E.P.E – Hospital Pulido Valente

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Address:

Alameda das Linhas de Torres 117, 1769-001 Lisboa, Portugal

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Targu-Mures Emergency Clinical County Hospital

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Address:

Strada Gheorghe Marinescu 50, Târgu Mureș 540136, Romania

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Krakowski Szpital Specjalistyczny im. Sw.Jana Pawla II

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Address:

Prądnicka 80, 31-202 Kraków, Poland

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Hôpital Erasme (Cliniques Universitaires de Bruxelles)

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Address:

Rte de Lennik 808, 1070 Bruxelles, Belgium

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Hospital Universitario Virgen del Rocio

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Address:

Av. Manuel Siurot, S/n, 41013 Sevilla, Spain

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Hospital Costa del Sol

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Address:

A-7, Km 187, 29603 Marbella, Málaga, Spain

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Hospital Clinic de Barcelona

Distance

Address:

Carrer de Villarroel, 170, 08036 Barcelona, Barcelona, Spain

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Azienda Ospedaliero Universitaria Policlinico Umberto I

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Address:

Viale del Policlinico, 155, 00161 Roma RM, Italy

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CHU de LILLE-Institut Cœur Poumon

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Address:

Bd du Professeur Jules Leclercq, 59000 Lille, France

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CHU de Nancy-Hopital Brabois Adulte

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Address:

4 Av. de Bourgogne, 54500 Vandœuvre-lès-Nancy, France

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CHRU de Poitiers La Miletrie

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Address:

2 Rue de la Milétrie, 86000 Poitiers, France

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Centre Hospitalier Universitaire de Bicêtre

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Address:

78 Rue du Général Leclerc, 94270 Le Kremlin-Bicêtre, France

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CHU Montpellier- Hôpital Arnaud de VIlleneuve

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Address:

371 Avenue du Doyen Gaston Giraud, Montpellier, Hérault, France

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Hôpital Pasteur

Distance

Address:

Hôpital Pasteur, 30 Voie Romaine, Nice, France

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Allianze Pulmonary Research, LLC

Distance

Address:

Maramar Plaza Bldg, Suite 200, Guaynabo, San Juan 00968

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University of California Irvine

Distance

Address:

333 City Blvd W Ste 400, Orange, California 92868-2994, United States

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Oregon Health and Science University

Distance

Address:

3181 Southwest Sam Jackson Park Road, Portland, Oregon 97239, United States

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Wexner Medical Center at The Ohio State University

Distance

Address:

410 W 10th Ave, Columbus, Ohio 43210-1240, United States

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Jeffrey S. Sager, MD Medical Corporation

Distance

Address:

2428 Castillo St. Ste D, Santa Barbara, California 93105-5311, United States

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University of New Mexico Health Sciences Center

Distance

Address:

915 Camino de Salud, NE, Albuquerque, NM 87131, United States

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Houston Methodist Hospital

Distance

Address:

6550 Fannin St, Houston, TX 77030, United States

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University of Michigan

Distance

Address:

South State Street, Ann Arbor, MI 48109, United States

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Pulmonary Associates of Richmond, Inc.

Distance

Address:

Richmond, Virginia 23230, United States

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University of Kansas Medical Center

Distance

Address:

Kansas City, Kansas 66160, United States

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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

www.allianceforpulmonaryhypertension.com

PHA Europe

www.phaeurope.org

Sociedad Latina Hipertension Pulmonar

www.sociedadlatinahp.org

Global Allergy & Airways Patient Platform

www.gaapp.org

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: https://www.gossamerbio.com/pipeline/pipeline-overview/

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

ClinicalTrials.gov