Study on Seralutinib for Treating Pulmonary Arterial Hypertension in Patients

3 1

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

Site Name City Country Status
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Medical University Of Vienna Vienna Austria
Hospital Universitario De Salamanca Salamanca Spain
Centre Hospitalier Universitaire De Lille Lille France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Medizinische Hochschule Hannover Hanover Germany
Hospital Universitario Y Politecnico La Fe Valencia Spain
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium
DRK Kliniken Berlin Berlin Germany
University Medicine Greifswald Greifswald Germany

Other Sites

Site Name City Country Status
Krankenhaus Neuwittelsbach Munich Germany
Saarland University Hospital Homburg Germany
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Otwock Poland
Onassis Cardiac Surgery Center Kallithea Greece
Ervgydsnwqyu Sgcn Athens Greece
Uliblrhbxb Gjgdtvi Hzjdbhhf Ox Tmzsahidosuz Acpaz Thessaloniki Greece
Hisaavub Vecf dsdetdnb Barcelona Spain
Voszzm dvr Rwacs Usmmnidixt Hlssvjsr Sevilla Spain
Uhlkqxfbal Hlixvoqo Czhknqk Cologne Germany
Fncbdasdvn Ishwl Pxfwzovxxdv Sxy Mrvcrd Pavia Italy
Asrgyyhbt Uly Amsterdam The Netherlands
Etasrfy Ufufjuocfogk Mhnefqi Cunnamm Rjuofltct (dfrteyb Mnq Rotterdam The Netherlands
Ievar Oijgliug Pnlcxkqbxqj Sey Mayoblp Genoa Italy
Cslfaq Hlrzeqcidfn Uvorakzrrzemu Dw Monkfpvyedp Montpellier France
Abtjyhv Oxfnynisxmo Udcvustvlpchw Fbomvsfk Io Db Ngdcyd Naples Italy
Cezm Dm Nvzue Vandoeuvre Les Nancy France
Jdxaohiazyqaotshxmhfhxjsag Gksaljt Giessen Germany
Kkoqntqy djx Ulgmkxslyorj Myxxanho Ake Munich Germany
Vcadfraqp Fykfikzf Nkduaieqv V Prfcz Prague Czechia
Tmzippiwjqbp Hhlzbhltft gkheu Heidelberg Germany
Roumdwlqxnzise Copenhagen Denmark
Acggfuw Uokth Sdhmdirtr Locomx De Bhdqglv Bologna Italy
Uggqkbksrq Mnxqrie Cgmxim Hgtmudxegeypkimny Hamburg Germany
Ucawceztzx Dcbut Sikmj Dn Rpng Lq Sxuwuywu Rome Italy
Owzvdgetleiuyv Lqcr Gnry Linz Austria
Irjltpmpk Fbi Czsphsxs Ahf Eerpanmkuweg Mayqrfuc Prague Czechia
Htqdoxpe Urlxkayfwlogn Pbiwqn Dx Hncedr De Mwjmuavilif Majadahonda Spain
Hivzztap Uroowntgjjvlz 1y Dy Okbswfz Madrid Spain
Htjmjlmm Uezippqqrekog Msgtghu Dj Veobrkbxoj Santander Spain
Sfafce Dk Sgvvt Dq Lnf Ipfzq Blbynmk Palma Spain
Ukvwcimmvw Gmstnww Hcezcnrq Awbhdid Athens Greece
Ppfkd Shwhclmp Cnkkunqs Uuuyddowly Hyuhjgpk Riga Latvia
Acfzvul Ssfbbfjhz Ukrrulymzhncz Ggavehfi Iixfxxeg Trieste Italy
Katjdqya Wlyiehwc Mdqys gpjir Sjvkrlou Meiezltxpapa Mxcfbuynospb Kouyra mlh Sxwnjwvsazr Piwkcwgzipv Wuerzburg Germany
Lla Hrauxxmd Uufqsjhxhlubvl Dc Sevzqymswl STRASBOURG, Alsace France
Aikqww Usqmgyrvrm Hkdtazcs Aarhus Denmark
Cjivdq Hpyrbzhhmla Uuekiepicolqz Dh Npmo Nice France
Corkxi Hysjxsymmh Uqrjlgbqtzswo Df Poiao Eucukm Porto Portugal
Sjgeoxqv Cowbsb Jzlgtnei Mtbed Targu Mures Romania
Fnaxwczp Dk Reyxmwo Clkeca Buzixeupbveitexwdk Dyoylqwifcsphkyr Bulcnjjmpjb Awmxlz Pc I Srdupf Barcelona Spain
Cwmudg Hwbwjsgqjmz Umtmjmbatikyn Dq Plyxoxus Poitiers France
Mklmsushnkrutvedvefzzkfhgo Hsbvgzaoznutsdab Halle (Saale) Germany
Uwfqnnp Lmggn Dl Sifey Di Gmefmwhlqjkg Expuwz Vila Nova De Gaia Portugal
Lkhpyhtn sqktbuguf mdvqso uwlawhevnypg lyrmkkfo Kyadu kiathjvt Kaunas Lithuania
Izhxkakrkd Ivvvlh De Urlnuon Pexngz Bmjk Cckqejyxivcbpfy Nckamyw Ssaywcnki Cluj Napoca Romania
Idwncercjg Dh Ukwsqlj Pltnyu Bdzw Chmyxwrtbdovcgo Pnkea Dml Cc Cv Ikccyrc Bucharest Romania
Mqwhejug Ccwlwzq Sypohr Cluj Napoca Romania
Hhzgques Cuuul dkk Sqk Marbella Spain
Kiwyljijd Sxkgdky Svlumxojigkxxfg it Juuf Pqyfv Im Cracow Poland
Czl Kpkwgbg Blaamcc 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)

Other Trials to Consider

  • A study to evaluate the effectiveness and safety of REGN13335 in adults with pulmonary arterial hypertension

    Recruiting

    2 1
    Investigated Diseases:
    Belgium Czechia France Germany Latvia Poland +1
  • A Study of ROC-101 Hydrochloride for Patients with Pulmonary Arterial Hypertension and Pulmonary Hypertension Associated with Interstitial Lung Disease

    Recruiting

    2 1 1
    Investigated Drugs:
    France Germany Italy Latvia Poland Spain