[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06274801":3,"trial-entities:NCT06274801":830,"trial-summary:NCT06274801":833},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":48,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":64,"locations":67,"central_contacts":818,"overall_officials":824,"references":828,"see_also_links":829},"NCT06274801","GB002-3102","Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)","An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)","RECRUITING","2026-12","2026-07","2026-07-29","2024-09-03","Gossamer Bio USA, Inc.","INDUSTRY",true,"This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study","The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.",[19],"Pulmonary Arterial Hypertension",[21,22,23,24],"seralutinib","GB002","PROSERA","PROSERA-EXT","INTERVENTIONAL","TREATMENT",[28],"PHASE3",{"count":30,"type":31},330,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","Seralutinib","Capsule containing seralutinib",[38],"Seralutinib 90 mg",{"type":40,"name":41,"description":42,"armGroupLabels":43},"DEVICE","Gereic Dry Powder Inhaler","Generic dry powder inhaler for seralutinib delivery",[38],[45],{"measure":46,"timeFrame":47},"Incidence of treatment-emergent adverse events (TEAEs)","From baseline to end of study (up to 48 months or availability of commercial product)",[49,53],{"measure":50,"description":51,"timeFrame":52},"Changes in distance achieved on the Six-Minute Walk Test (6MWT)","Δ6MWT from Baseline to End of Study","Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)",{"measure":54,"description":55,"timeFrame":52},"Changes in NT-proBNP","Change in NT-proBNP from Baseline to End of Study","ALL","18 Years","75 Years",false,{"inclusion":61,"exclusion":62,"raw_text":63},[],[],"Inclusion Criteria:\n\n1. Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.\n2. Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures.\n3. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n4. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at enrollment visit before first administration of Investigational Product (IP) in this study.\n5. WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of IP.\n6. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP.\n\nExclusion Criteria:\n\n1. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor's medical monitor (MM) (or designee).\n2. 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Institut Coeur Poumon Service de Cardiologie","Lille",{"lat":475,"lon":476},50.63391,3.05512,{"facility":478,"status":179,"city":479,"country":467,"geoPoint":480},"CHU de Nice - Hopital Pasteur","Nice",{"lat":481,"lon":482},43.70313,7.26608,{"facility":484,"status":8,"city":485,"country":467,"geoPoint":486},"CHU de Poitiers","Poitiers",{"lat":487,"lon":488},46.58261,0.34348,{"facility":490,"status":8,"city":491,"country":492,"geoPoint":493},"Zentrum fur Pulmonale Hypertonie, Klinik Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternistische lntensivmedizin), Herzzentrum der Universitat zu Koln","Cologne","Germany",{"lat":494,"lon":495},50.93333,6.95,{"facility":497,"status":359,"city":498,"country":492,"geoPoint":499},"Universitätsklinikum Dresden, Medizinische Klinik I \u002F Pneumologisches Studiensekretariat","Dresden",{"lat":500,"lon":501},51.05089,13.73832,{"facility":503,"status":8,"city":504,"country":492,"geoPoint":505},"Universitatsklinikum Giessen und Marburg GmbH Zentrum fur lnnere Medizin, Med. 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Policlinico Umberto I","Roma",{"lat":591,"lon":592},44.99364,11.10642,{"facility":594,"status":8,"city":595,"country":596,"geoPoint":597},"University of Tokyo Hospital","Bunkyō City","Japan",{"lat":598,"lon":599},35.5331,139.4217,{"facility":601,"status":8,"city":602,"country":596,"geoPoint":603},"Kyushu University Hospital","Fukuoka",{"lat":604,"lon":605},33.6,130.41667,{"facility":607,"status":8,"city":608,"country":596,"geoPoint":609},"Kyorin University Hospital","Mitaka",{"lat":610,"lon":611},35.68361,139.56002,{"facility":613,"status":8,"city":614,"country":596,"geoPoint":615},"Nagoya University Hospital","Nagoya",{"lat":616,"lon":617},35.18147,136.90641,{"facility":619,"status":8,"city":620,"country":596,"geoPoint":621},"NHO Okayama Medical Center","Okayama",{"lat":622,"lon":623},34.65,133.93333,{"facility":625,"status":8,"city":626,"country":596},"Keio University Hospital","Shinjuku-Ku",{"facility":628,"status":8,"city":629,"country":596,"geoPoint":630},"National Cerebral and Cardiovascular Center","Suita",{"lat":631,"lon":632},34.76143,135.51567,{"facility":634,"status":8,"city":635,"country":636,"geoPoint":637},"Pauls Stradins Clinical University Hospital","Riga","Latvia",{"lat":638,"lon":639},56.946,24.10589,{"facility":641,"status":8,"city":642,"country":643,"geoPoint":644},"Hospital of Lithuanian University of Health Sciences Kauno klinikos","Kaunas","Lithuania",{"lat":645,"lon":646},54.90156,23.90909,{"facility":648,"status":8,"city":649,"country":650,"geoPoint":651},"Instituto Nacional de Cardiologia Ignacio Chavez","Mexico City","Mexico",{"lat":652,"lon":653},19.42847,-99.12766,{"facility":655,"status":8,"city":656,"country":650,"geoPoint":657},"Unidad de Investigacion Clinica en Medicina, S.C.","Monterrey",{"lat":658,"lon":659},25.68435,-100.31721,{"facility":661,"status":179,"city":662,"country":663,"geoPoint":664},"Amsterdam UMC, location VU mc","Amsterdam","Netherlands",{"lat":665,"lon":666},52.37403,4.88969,{"facility":668,"status":359,"city":669,"country":663,"geoPoint":670},"Erasmus MC","Rotterdam",{"lat":671,"lon":672},51.9225,4.47917,{"facility":674,"status":8,"city":675,"country":676,"geoPoint":677},"Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn z Pododdzialem Intensywnego Nadzoru Kardiologicznego","Krakow","Poland",{"lat":678,"lon":679},50.06143,19.93658,{"facility":681,"status":8,"city":682,"country":676,"geoPoint":683},"Europejskie Centrum Zdrowia Otwock Sp.zo.o. Szpital im. Fryderyka Chopina Oddzial Kardiologiczny","Otwock",{"lat":684,"lon":685},52.10577,21.26129,{"facility":687,"status":8,"city":688,"country":689,"geoPoint":690},"Unidade Local de Saude de Santa Maria, E.P.E. Hospital Pulido Valente","Lisbon","Portugal",{"lat":691,"lon":692},38.72509,-9.1498,{"facility":694,"status":8,"city":695,"country":689,"geoPoint":696},"Unidade Local de Saude de Santo Antonio, E.P.E. Hospital de Santo Antonio","Porto",{"lat":697,"lon":698},41.1485,-8.61097,{"facility":700,"status":8,"city":701,"country":702,"geoPoint":703},"Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Cardiology 2","Bucharest","Romania",{"lat":704,"lon":705},44.43225,26.10626,{"facility":707,"status":8,"city":708,"country":702,"geoPoint":709},"\"Niculae Stancioiu\" Emergency Heart Institute for Cardiovascular Diseases, Cardiology 1 Department","Cluj-Napoca",{"lat":710,"lon":711},46.76667,23.6,{"facility":713,"status":179,"city":714,"country":715,"geoPoint":716},"King Fahad Medical City","Riyadh","Saudi Arabia",{"lat":717,"lon":718},24.68773,46.72185,{"facility":720,"status":179,"city":714,"country":715,"geoPoint":721},"King Faisal Specialist Hospital and Research Center",{"lat":717,"lon":718},{"facility":723,"status":8,"city":724,"country":725,"geoPoint":726},"University Clinical Centre of Serbia, Cardiology Clinic","Belgrade","Serbia",{"lat":727,"lon":728},44.80401,20.46513,{"facility":730,"status":8,"city":731,"country":731,"geoPoint":732},"National Heart Centre Singapore","Singapore",{"lat":733,"lon":734},1.28967,103.85007,{"facility":736,"status":359,"city":731,"country":731,"geoPoint":737},"National University Heart Centre",{"lat":733,"lon":734},{"facility":739,"status":8,"city":740,"country":741,"geoPoint":742},"Asan Medical Center","Seoul","South Korea",{"lat":743,"lon":744},37.566,126.9784,{"facility":746,"status":8,"city":740,"country":741,"geoPoint":747},"Samsung Medical Center",{"lat":743,"lon":744},{"facility":749,"status":8,"city":740,"country":741,"geoPoint":750},"Seoul National University Hospital",{"lat":743,"lon":744},{"facility":752,"status":359,"city":740,"country":741,"geoPoint":753},"Severance Hospital, Yonsei University Health System",{"lat":743,"lon":744},{"facility":755,"status":8,"city":756,"country":757,"geoPoint":758},"Hospital Clinic I Provincial","Barcelona","Spain",{"lat":759,"lon":760},41.38879,2.15899,{"facility":762,"status":8,"city":763,"country":757,"geoPoint":764},"Hospital Universitario 12 De Octubre","Madrid",{"lat":765,"lon":766},40.4165,-3.70256,{"facility":768,"status":8,"city":769,"country":757,"geoPoint":770},"Hospital Universitario Marques de Valdecilla","Santander",{"lat":771,"lon":772},43.46589,-3.80493,{"facility":774,"status":179,"city":775,"country":757,"geoPoint":776},"Hospital Universitario Virgen del Rocio","Seville",{"lat":777,"lon":778},37.38283,-5.97317,{"facility":780,"status":179,"city":781,"country":757,"geoPoint":782},"Hospital Universitario de Toledo","Toledo",{"lat":783,"lon":784},39.8581,-4.02263,{"facility":786,"status":8,"city":787,"country":788,"geoPoint":789},"Royal Papworth Hospital NHS Foundation Trust","Cambridge","United Kingdom",{"lat":790,"lon":791},52.2,0.11667,{"facility":793,"status":8,"city":794,"country":788,"geoPoint":795},"Golden Jubilee National Hospital","Clydebank",{"lat":796,"lon":797},55.90137,-4.4057,{"facility":799,"status":179,"city":411,"country":788,"geoPoint":800},"Hammersmith Hospital",{"lat":801,"lon":802},51.50853,-0.12574,{"facility":804,"status":8,"city":411,"country":788,"geoPoint":805},"Royal Free Hospital, Clinical Research Facility",{"lat":801,"lon":802},{"facility":807,"status":8,"city":808,"country":788,"geoPoint":809},"Freeman Hospital","Newcastle",{"lat":810,"lon":811},54.21804,-5.88979,{"facility":813,"status":8,"city":814,"country":788,"geoPoint":815},"Royal Hallamshire Hospital","Sheffield",{"lat":816,"lon":817},53.38297,-1.4659,[819],{"name":820,"role":821,"phone":822,"email":823},"GB002 Inc.","CONTACT","1-866-668-4083","ClinicalTrials@gossamerbio.com",[825],{"name":826,"affiliation":13,"role":827},"Richard Aranda, MD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":831,"biomarkers":832},[19],[],{"nct_id":4,"found":15,"summary":834,"prompt_version":844},{"design":835,"status":836,"heading":837,"summary":838,"follow_up":839,"word_count":840,"commitments":841,"compensation":842,"drugs_mentioned":843},"This is an open-label study, meaning both you and the study team will know you are receiving seralutinib. It plans to include about 330 participants.","completed","Extension Study of Seralutinib for Pulmonary Arterial Hypertension (PAH)","This study, called PROSERA-EXT, is an open-label extension study looking at the long-term safety and how well orally inhaled seralutinib works for adults with Pulmonary Arterial Hypertension (PAH). PAH is a type of high blood pressure in the arteries of your lungs. You can join if you are between 18 and 75 years old and have already completed a previous study with seralutinib. The main goal is to track any side effects that happen while taking seralutinib. This study plans to enroll about 330 people and will continue until seralutinib is approved for sale or the study ends.","The study will track side effects from when you start treatment until the end of the study, which could be up to 48 months or until the commercial product is available.",98,"You would take seralutinib using a dry powder inhaler. The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.","Not stated in the trial record.",[35],"v2"]