Study on Seralutinib for Treating Pulmonary Arterial Hypertension in Patients

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What is this study about?

This clinical trial is focused on studying Pulmonary Arterial Hypertension (PAH), a condition characterized by high blood pressure in the arteries of the lungs. The study will evaluate the effectiveness and safety of a treatment called seralutinib, which is administered as an inhalation powder in a hard capsule. Participants will either receive seralutinib or a placebo, which looks identical to the treatment but does not contain the active substance.

The purpose of the study is to assess how seralutinib affects exercise capacity after 24 weeks of treatment when used alongside existing PAH medications. Participants will be randomly assigned to receive either seralutinib or the placebo, and neither the participants nor the researchers will know who is receiving which treatment. The study will last for a total of 48 weeks, during which participants will continue their regular PAH treatment while adding the study medication or placebo.

Throughout the study, participants will undergo various assessments to monitor their health and the effects of the treatment. These assessments will include measuring the distance they can walk in six minutes, which helps evaluate their exercise capacity. The study aims to provide valuable information on whether seralutinib can improve the quality of life for individuals with PAH by enhancing their ability to exercise and perform daily activities.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the investigational drug seralutinib or a placebo. The placebo is an inhalation powder that looks identical to the drug and is administered in the same way.

2 medication administration

The participant will use the assigned inhalation powder, either seralutinib or placebo, through an inhaler device. The specific dosage and frequency of administration will be provided by the study team.

3 treatment duration

The treatment will last for a period of 24 weeks. During this time, the participant will continue their background medication for pulmonary arterial hypertension (PAH) as prescribed.

4 exercise capacity evaluation

The main objective of the study is to evaluate the effect of seralutinib on exercise capacity. This will be measured by the change in distance achieved on the six-minute walk test from the start of the study to week 24.

5 monitoring and assessments

Throughout the study, the participant will undergo regular assessments to monitor their health and the effects of the treatment. This includes checking for any adverse events and measuring specific health indicators.

6 study completion

At the end of the 24-week treatment period, the participant will complete a final set of assessments to evaluate the overall impact of the treatment.

Who Can Join the Study?

  • Adults aged between 18 and 75 years can participate.
  • Participants should have a Body Mass Index (BMI) between 17 and 40. BMI is a measure of body fat based on height and weight.
  • Participants must have a diagnosis of Pulmonary Arterial Hypertension (PAH), which can be idiopathic (unknown cause), heritable (runs in families), associated with connective tissue disease, linked to certain drugs, or related to congenital heart disease.
  • Participants should be able to walk between 150 and 475 meters in a 6-minute walk test.
  • Participants should be classified as WHO Functional Class II or III, which indicates the severity of their symptoms.
  • Participants need a certain score on the REVEAL Lite 2 Risk Score or specific levels of NT-proBNP or PVR, which are measures related to heart and lung function.
  • Participants must have had a cardiac catheterization recently, which is a test to check heart and lung pressures.
  • Participants should be on stable treatment with at least one PAH-specific medication for at least 12 weeks before the study.
  • Participants need to have recent pulmonary function tests, which check how well the lungs are working.
  • Women who can have children must have a negative pregnancy test before starting the study and use effective birth control if they are sexually active.
  • Men who are sexually active with women who can have children must use a condom during the study and for 90 days after the last dose of the study medication.

Who Cannot Join the Study?

  • Patients who have a different condition than Pulmonary Arterial Hypertension cannot participate. This condition affects the blood vessels in the lungs, making it hard for the heart to pump blood through them.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for participants in certain age groups.
  • Patients who are not taking specific medications for Pulmonary Arterial Hypertension as part of their current treatment cannot participate. These medications are important for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy
Centre Hospitalier Universitaire De Nice Nice France
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Pauls Stradins Clinical University Hospital Riga Latvia
Evangelismos S.A. Athens Greece
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Klinikum Würzburg Mitte gGmbH Standort Missioklinik Medizinische Klinik mit Schwerpunkt Pneumologie Wuerzburg Germany
Virgen del Rocío University Hospital Sevilla Spain
Les Hopitaux Universitaires De Strasbourg STRASBOURG, Alsace France
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Saarland University Hospital Homburg Germany
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Justus-Liebig-Universitaet Giessen Giessen Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Rigshospitalet Copenhagen Denmark
Spitalul Clinic Judetean Mures Targu Mures Romania
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Servei De Salut De Les Illes Balears Palma Spain
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Otwock Poland
Onassis Cardiac Surgery Center Kallithea Greece
Institutul Inimii De Urgenta Pentru Boli Cardiovasculare Niculae Stancioiu Cluj Napoca Romania
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Bucharest Romania
Mediprax Centrum S.R.L. Cluj Napoca Romania
Hospital Costa del Sol Marbella Spain
Krankenhaus Neuwittelsbach Munich Germany
Ackhiaxwr Uee Amsterdam The Netherlands
Cpsi Dg Nxxos Vandoeuvre Les Nancy France
Uerrduwopz Hneegmiz Cxfckoi Cologne Germany
Eydyuis Uahviywxzzep Motkyqo Ccmjizw Rtlcfvzab (proajzs Mav Rotterdam The Netherlands
Atqhvb Udcsulqvsr Hxugbnah Aarhus Denmark
Clpntz Hpnkmvyrar Ujpvjuvackzpu Da Pkbkj Enrzjw Porto Portugal
Kmwvhgmc dzt Uptntlkrvzwo Mbauvgeu Ajd Munich Germany
Asjuqze Ujgfp Syvmidxwx Lspdty Da Bbwjizl Bologna Italy
Urcrnnjtsb Mqggalr Cqxpvf Hpxcfcydxwlpesmje Hamburg Germany
Umfctnepgh Dypli Sqgfa Dm Raze Lz Sgylwyyl Rome Italy
Oqwtcvytsaugye Lacz Gxke Linz Austria
Iwtlcmwxb Fyx Cpvjdjra Aop Ewbpxsbpkavo Mmwnazrv Prague Czechia
Mjvkjcgxodbpvdqsnoizozpspg Hjahrvrepbxwjuxr Halle (Saale) Germany
Hlrsliva Uhzlfiskdpeae Mtidlwi Da Vcuaikvauh Santander Spain
Hwucuikl Vqlf dnqpaszm Barcelona Spain
Umkijpmgth Gxqnwbd Hfwqvjtx Atvajvl Athens Greece
Kpddpwpun Svvncxi Shgwemvrlmzpbnb if Joog Pweeg Ii Cracow Poland
Coy Ktycnqu Buhbtlq Le Kremlin-Bicetre France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
31.01.2024
Belgium Belgium
Not recruiting
31.01.2024
Czechia Czechia
Not recruiting
31.01.2024
Denmark Denmark
Not recruiting
31.01.2024
France France
Not recruiting
31.01.2024
Germany Germany
Not recruiting
31.01.2024
Greece Greece
Not recruiting
31.01.2024
Ireland Ireland
Not recruiting
31.01.2024
Italy Italy
Not recruiting
31.01.2024
Latvia Latvia
Not recruiting
31.01.2024
Lithuania Lithuania
Not recruiting
31.01.2024
Poland Poland
Not recruiting
31.01.2024
Portugal Portugal
Not recruiting
31.01.2024
Romania Romania
Not recruiting
31.01.2024
Spain Spain
Not recruiting
31.01.2024
The Netherlands The Netherlands
Not recruiting
31.01.2024

Trial locations

Investigated drugs:

Seralutinib is an investigational medication being studied for its potential to help people with pulmonary arterial hypertension (PAH). It is taken through oral inhalation, which means it is breathed in through the mouth. The goal of using seralutinib in this study is to see if it can improve exercise capacity, which is how well a person can perform physical activities, after 24 weeks of treatment. This medication is being tested to see if it can provide additional benefits when used alongside other PAH-specific treatments that patients are already taking.

Investigated diseases:

Pulmonary Arterial Hypertension – Pulmonary Arterial Hypertension is a condition characterized by high blood pressure in the arteries that supply the lungs. This disease causes the small arteries in the lungs to become narrow or blocked, leading to increased resistance to blood flow. As a result, the heart must work harder to pump blood through the lungs, which can lead to heart strain and enlargement. Over time, this increased workload can weaken the heart muscle and reduce its ability to pump blood effectively. Symptoms often include shortness of breath, fatigue, dizziness, and swelling in the ankles or legs. The progression of the disease can vary, with symptoms gradually worsening over time.

Trial ID:
2023-503614-80-00
Protocol code:
GB002-3101
NCT ID:
NCT05934526
Trial Phase:
Therapeutic confirmatory (Phase III)

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