Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
Study Purpose
The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or
- III. The secondary objective for this trial is to determine time to clinical worsening.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 75 Years |
Gender | All |
Inclusion Criteria:
1. Adult subjects aged 18 to 75 years. 2. Body mass index (BMI) ≥ 17 kg/m^2 and ≤ 40 kg/m^2. 3. Diagnosis of PAH classified by one of the following: 1. Idiopathic PAH (IPAH) or heritable PAH (HPAH). 2. PAH associated with connective tissue disease (CTD-APAH); PAH associated with anorexigen or PAH associated with methamphetamine use. 3. Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair. 4. 6MWDs ≥ 150 meters and ≤ 450 meters at Screening. 5. WHO FC II or- III. 6.
Exclusion Criteria:
1. Evidence of chronic thromboembolic disease or acute pulmonary embolism. 2. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure > 160 mm Hg or sitting diastolic blood pressure > 100 mm Hg. 3. Systolic blood pressure < 90 mm Hg during Screening. 4. WHO Pulmonary Hypertension Group 2- - 5.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05934526 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
GB002, Inc. |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Richard Aranda, MD |
Principal Investigator Affiliation | Gossamer Bio Inc. |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Australia, Austria, Belgium, Chile, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Netherlands, Poland, Portugal, Puerto Rico, Romania, Serbia, Singapore, Spain, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Pulmonary Arterial Hypertension |
Arms
Placebo Comparator: Placebo
Placebo inhaled orally twice daily (BID) up to 48 weeks
Experimental: Seralutinib 90 mg
Seralutinib inhaled orally BID up to 48 weeks
Interventions
Drug: - Placebo
Matching capsule containing placebo
Drug: - Seralutinib
Capsule containing seralutinib
Device: - Generic Dry Powder Inhaler
Generic dry powder inhaler for seralutinib or placebo delivery
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Keck Medical Center of USC
Los Angeles, California, 90033
Status
Recruiting
Address
Dept of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Status
Recruiting
Address
University of California, Irvine Medical Center
Orange, California, 92868
Status
Recruiting
Address
UC Davis Health
Sacramento, California, 95817
Status
Recruiting
Address
Medical Corporation
Santa Barbara, California, 93105
Status
Recruiting
Address
University of Colorado Hospital
Aurora, Colorado, 80445
Status
Recruiting
Address
UConn Health/Clinical Research Center
Farmington, Connecticut, 06030
Status
Recruiting
Address
The George Washington University Medical Faculty Associates
Washington, District of Columbia, 20037
Status
Recruiting
Address
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta, Georgia, 30309
Status
Recruiting
Address
Northwestern Memorial Hospital, Clinical Research Unit
Chicago, Illinois, 60611
Status
Recruiting
Address
UI Health Hospital
Chicago, Illinois, 60612
Status
Recruiting
Address
University of Kansas Medical Center
Kansas City, Kansas, 66160
Status
Recruiting
Address
Norton Hospital
Louisville, Kentucky, 40202
Status
Recruiting
Address
Tufts Medical Center
Boston, Massachusetts, 02111
Status
Recruiting
Address
Massachusetts General Hospital
Boston, Massachusetts, 02114
Status
Recruiting
Address
University of Michigan
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, 55455
Status
Recruiting
Address
University of Missouri
Columbia, Missouri, 65212
Status
Recruiting
Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Status
Recruiting
Address
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
Status
Recruiting
Address
University of Rochester Medical Center
Rochester, New York, 14642
Status
Recruiting
Address
Duke University Medical Center - Duke South
Durham, North Carolina, 27710
Status
Recruiting
Address
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Status
Recruiting
Address
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Status
Recruiting
Address
INTEGRIS Cardiovascular Physicians, LLC
Oklahoma City, Oklahoma, 73112
Status
Recruiting
Address
Oregon Health & Science University
Portland, Oregon, 97239
Status
Recruiting
Address
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Status
Recruiting
Address
Medical University of South Carolina - Nexus Research Center
Charleston, South Carolina, 29425
Status
Recruiting
Address
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, Texas, 77030
Status
Recruiting
Address
Houston Methodist Outpatient Center
Houston, Texas, 77030
Status
Recruiting
Address
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23230
Status
Recruiting
Address
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
International Sites
Status
Recruiting
Address
Cardiologia Palermo
Buenos Aires, ,
Status
Recruiting
Address
Instituto Cardiovascular de Buenos Aires
Buenos Aires, ,
Status
Recruiting
Address
Instituto de Cardiologia de Corrientes Juana Francisca Cabral
Corrientes, ,
Status
Recruiting
Address
Hospital Privado Centro Medico de Cordóba S.A.
Córdoba, ,
Status
Recruiting
Address
Instituto de Investigaciones Clinicas Quilmes
Quilmes, ,
Status
Recruiting
Address
Sanatorio Parque S.A.
Rosario, ,
Status
Recruiting
Address
Instituto Medico Rio Cuarto
Río Cuarto, ,
Status
Recruiting
Address
Macquarie University
North Ryde, New South Wales,
Status
Recruiting
Address
St Vincent's Hospital
Melbourne, Victoria, 3065
Status
Recruiting
Address
Nepean Hospital
Kingswood, ,
Status
Recruiting
Address
Religious Hospital Linz GmbH
Linz, ,
Status
Recruiting
Address
Hôpital Erasme
Anderlecht, ,
Status
Recruiting
Address
University Hospitals of Leuven (Campus Gasthuisberg)
Leuven, ,
Status
Recruiting
Address
Enroll SpA
Santiago, Region Metropolitana, 7500587
Status
Recruiting
Address
Centro de Investigacion Clinica UC-CICUC
Santiago, ,
Status
Recruiting
Address
Institut Klinicke a Experimentalni Mediciny
Praha, ,
Status
Recruiting
Address
Všeobecná fakultní nemocnice v Praze Il. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hypertenzi
Praha, ,
Status
Recruiting
Address
Aarhus Universitetshospital, Department of Cardiology
Aarhus, ,
Status
Recruiting
Address
Rigshospitalet, Department of Cardiology
Copenhagen, ,
Status
Recruiting
Address
CHU Bicêtre
Le Kremlin-Bicêtre, ,
Status
Recruiting
Address
Institut Coeur Poumon
Lille, ,
Status
Recruiting
Address
CHU de Montpellier
Montpellier, ,
Status
Recruiting
Address
Hôpital Pasteur
Nice, ,
Status
Recruiting
Address
CHU de Poitiers
Poitiers, ,
Status
Recruiting
Address
Centre Hospitalier Universitaire - Hôpital d´Adultes de Brabois
Vandœuvre-lès-Nancy, ,
Status
Recruiting
Address
DRK Kliniken Berlin Westend
Berlin, ,
Status
Recruiting
Address
Universitatsklinikum Giessen und Marburg GmbH Zentrum fur Innere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale Hypertonie
Gießen, ,
Status
Recruiting
Address
Universitätsklinikum Halle (Saale) / Martin-Luther-Universität Halle- Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I
Halle, ,
Status
Recruiting
Address
Universitätsklinikum Hamburg-Eppendorf Zentrum für Onkologie Studienzentrum Pneumologie
Hamburg, ,
Status
Recruiting
Address
Medizinische Hochschule Hannover Klinik für Pneumologie und Infektiologie
Hannover, ,
Status
Recruiting
Address
Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie
Heidelberg, ,
Status
Recruiting
Address
Klinikum Wurzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin
Würzburg, ,
Status
Recruiting
Address
ATTIKON University Hospital, 2nd Critical Care Department
Athens, ,
Status
Recruiting
Address
Onassis Cardiac Surgery Center
Kallithéa, ,
Status
Recruiting
Address
AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic
Thessaloníki, ,
Status
Recruiting
Address
Lady Davis Carmel Medical Center
Haifa, , 3436212
Status
Recruiting
Address
Meir Medical Center
Kfar Saba, , 4428164
Status
Recruiting
Address
Rabin Medical Center
Petach Tikva, ,
Status
Recruiting
Address
The Chaim Sheba Medical Center
Ramat Gan, ,
Status
Recruiting
Address
Tel Aviv Sourasky Medical Center
Tel Aviv, ,
Status
Recruiting
Address
IRCCS Ospedale Policlinico San Martino - Cardiovascular Diseases Unit - Cardiac, Thoracic and Vascular Department
Genova, ,
Status
Recruiting
Address
Azienda Ospedaliera Dei Colli - Ospedale Monaldi Centro per la Diagnosi e Terapia dell'Ipertensione Polmonare
Napoli, ,
Status
Recruiting
Address
Azienda Ospealiero Universitaria Policlinico Umberto I - Dipartamento di Scienze Cliniche Internistiche Anestesiologiche e Cardiovascolari - VIII Padglione
Rome, ,
Status
Recruiting
Address
Gachon University Gil Medical Center
Incheon, ,
Status
Recruiting
Address
Samsung Medical Center
Seoul, ,
Status
Recruiting
Address
Seoul National University Hospital
Seoul, ,
Status
Recruiting
Address
Severance Hospital, Yonsei University Health System Seoul
Seoul, ,
Status
Recruiting
Address
The Catholic University of Korea, Seoul St. Mary´s Hospital
Seoul, ,
Status
Recruiting
Address
Pauls Stradins Clinical University Hospital
Riga, ,
Status
Recruiting
Address
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, ,
Status
Recruiting
Address
Amsterdam UMC, location VUmc
Amsterdam, ,
Status
Recruiting
Address
Erasmus MC
Rotterdam, ,
Status
Recruiting
Address
Krakowski Szpital Specjalistyczny Im. Św. Jana Pawła II Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego
Kraków, ,
Status
Recruiting
Address
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Szpital irn. Fryderyka Chopina Oddzial Kardiologiczny
Otwock, ,
Status
Recruiting
Address
Centro Hospitalar e Universitário de Coimbra
Coimbra, ,
Status
Recruiting
Address
Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital Pulido Valente
Lisboa, ,
Status
Recruiting
Address
Centro Hospitalar Vila Nova De Gaia
Vila Nova De Gaia, ,
Status
Recruiting
Address
CardioPulmonary Research Center
Guaynabo, ,
Status
Recruiting
Address
Emergency Institute of Cardiovascular Diseases "Prof. Dr. C.C. Iliescu" Bucharest, Cardiology 2
Bucharest, ,
Status
Recruiting
Address
"Niculae Stanciolu" Emergency Heart Institute for Cardivascular Diseases
Cluj-Napoca, ,
Status
Recruiting
Address
Mediprax Centrum S.R.L
Cluj-Napoca, ,
Status
Recruiting
Address
Targu-Mures Emergency Clinical County Hospital, Internal Medicine II
Târgu-Mureş, ,
Status
Recruiting
Address
Institute for Cardiovascular Diseases "Dedinje" Clinic for Cardiology
Belgrade, ,
Status
Recruiting
Address
University Clinical Centre of Serbia, Cardiology Clinic
Belgrade, ,
Status
Recruiting
Address
National Heart Centre Singapore
Singapore, ,
Status
Recruiting
Address
National University Heart Centre Singapore
Singapore, ,
Status
Recruiting
Address
Hospital Clinic I Provincial
Barcelona, ,
Status
Recruiting
Address
Hospital Universitari Vall d'Hebron
Barcelona, ,
Status
Recruiting
Address
Hospital Universitario 12 De Octubre
Madrid, ,
Status
Recruiting
Address
Hospital Universitario Puerta De Hierro Majadahonda
Majadahonda, ,
Status
Recruiting
Address
Hospital Costa del Sol
Marbella, ,
Status
Recruiting
Address
Hospital Universitario Marques de Valdecilla
Santander, ,
Status
Recruiting
Address
Hospital Universitario Virgen del Rocío
Sevilla, ,
Status
Recruiting
Address
Golden Jubilee National Hospital, Agamemnon Street
Clydebank, ,
Status
Recruiting
Address
Hammersmith Hospital
London, ,
Status
Recruiting
Address
Royal Brompton Hospital, Pulmonary Hypertension Service, Sydney Street
London, ,