A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)

Status: Active_not_recruiting
Location: See all (164) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Adult subjects aged 18 to 75 years.

• Body mass index (BMI) ≥ 15 kg/m\^2 and ≤ 40 kg/m\^2.

• Diagnosis of PAH classified by one of the following:

∙ Idiopathic PAH (IPAH) or heritable PAH (HPAH).

‣ PAH associated with connective tissue disease (CTD-APAH); PAH associated with anorexigen or PAH associated with methamphetamine use.

‣ Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair.

• 6MWDs ≥ 150 meters and ≤ 475 meters during Screening prior to randomization.

• WHO FC II or III.

• US Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) Lite 2 Risk Score ≥ 5 OR NT-proBNP ≥ 300 ng/L OR PVR ≥ 800 dyne s/cm\^5.

• Cardiac catheterization within the screening period, or a standard of care right heart catheterization (RHC) (with pressure wave forms available for review) up to 48 weeks prior to Screening.

∙ Mean pulmonary arterial pressure (mPAP) \> 20 mmHg (at rest), AND

‣ Pulmonary vascular resistance (PVR) ≥ 400 dyne·s/cm\^5, AND

‣ Pulmonary capillary wedge pressure (PCWP) or left ventricle end-diastolic pressure (LVEDP) ≤ 15 mmHg.

• Treatment with at least one allowed background PAH disease-specific medication prior to Screening.

∙ Subjects receiving treatment with endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, guanylate cyclase stimulators, and/or prostacyclin analogues or prostacyclin receptor agonists are eligible only if on a stable dose for at least 12 weeks prior to and throughout Screening.

‣ Subjects receiving treatment with sotatercept are eligible only if on a stable dose of sotatercept for at least 24 weeks prior to and throughout Screening, with a RHC performed during Screening (or within 2 weeks prior to Screening).

• Pulmonary function tests (PFTs) at Screening or completed no more than 12 weeks prior to Screening.

⁃ Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and on Day 1 before first administration of Investigational Product (IP).

⁃ 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.

⁃ 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.

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
California
Valley Advanced Lung Diseases Institute
Fresno
Dept of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles
Keck Medical Center of USC
Los Angeles
University of California, Irvine Medical Center
Orange
UC Davis Health
Sacramento
Stanford Healthcare
Stanford
Connecticut
Winchester Center for Lung Disease
New Haven
Washington, D.c.
The George Washington University Medical Faculty Associates
Washington D.c.
Florida
University of Florida Clinical Research Center
Gainesville
Mayo Clinic
Jacksonville
Georgia
Emory University
Atlanta
Northside Hospital Laboratory - Atlanta
Atlanta
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta
Iowa
University of Iowa Hospitals & Clinics
Iowa City
Illinois
UI Health Hospital
Chicago
Kansas
University of Kansas Medical Center
Kansas City
Kentucky
Norton Hospital
Louisville
Massachusetts
Massachusetts General Hospital
Boston
Tufts Medical Center
Boston
Michigan
University of Michigan
Ann Arbor
Minnesota
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis
Missouri
University of Missouri
Columbia
Washington University School of Medicine
St Louis
North Carolina
UNC Hospitals
Chapel Hill
Duke University Medical Center - Duke South
Durham
Nebraska
University of Nebraska Medical Center
Omaha
New Mexico
University of New Mexico Health Sciences Center
Albuquerque
New York
NYU Langone Health
New York
University of Rochester Medical Center
Rochester
Ohio
University of Cincinnati Medical Center
Cincinnati
Cleveland Clinic Foundation
Cleveland
Oklahoma
INTEGRIS Cardiovascular Physicians, LLC
Oklahoma City
Oregon
Oregon Health & Science University
Portland
Pennsylvania
Temple Heart and Vascular Institute (Outpatient Clinic)
Philadelphia
The Hospital of the University of Pennsylvania
Philadelphia
UPMC Presbyterian Hospital
Pittsburgh
Rhode Island
Rhode Island Hospital
Providence
South Carolina
Medical University of South Carolina - Nexus Research Center
Charleston
Texas
UT Southwestern Medical Center
Dallas
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston
Houston Methodist Outpatient Center
Houston
Baylor Scott & White Medical Center - The Heart Hospital
Plano
University of Texas Health Science Center at San Antonio
San Antonio
Utah
Intermountain Medical Center
Murray
University of Utah Hospital
Salt Lake City
Virginia
Inova Fairfax Medical Campus
Falls Church
Pulmonary Associates of Richmond, Inc.
Richmond
Wisconsin
Advocate Aurora Health-Aurora St. Luke's Medical Center
Milwaukee
Froedtert Hospital/Medical College of Wisconsin
Milwaukee
Other Locations
Argentina
Cardiologia Palermo
Buenos Aires
Instituto Cardiovascular de Buenos Aires
Buenos Aires
Hospital Privado Centro Medico de Cordóba S.A.
Córdoba
Instituto de Cardiologia de Corrientes Juana Francisca Cabral
Corrientes
Instituto de Investigaciones Clinicas Quilmes
Quilmes
Instituto Medico Rio Cuarto
Río Cuarto
Sanatorio Parque S.A.
Rosario
Hospital Provincial Dr. José María Cullen
Santa Fe
Australia
Wesley Research Institute
Auchenflower
Royal Hobart Hospital
Hobart
Nepean Hospital
Kingswood
St Vincent's Hospital
Melbourne
Austria
Religious Hospital Linz GmbH
Linz
AKH-Vienna Medical Univesity of Vienna Internal Medicine II-Cardiology
Vienna
Belgium
Hôpital Erasme
Anderlecht
University Hospitals of Leuven (Campus Gasthuisberg)
Leuven
Brazil
Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
Belo Horizonte
Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia do Pulmao
Blumenau
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre
Uniao Brasileira de Educaçao e Assistência Hospital São Lucas da PUCRS
Porto Alegre
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo
Núcleo de Gestão de Pesquisa/Hospital São Paulo - SPDM/UNIFESP
São Paulo
Canada
Peter Lougheed Center
Calgary
London Health Science Centre - Victoria Hospital
London
University of Ottawa Heart Institute
Ottawa
University Health Network
Toronto
Chile
Centro de Investigacion Clinica UC-CICUC
Santiago
Enroll SpA
Santiago
Colombia
Fundación Abood Shaio
Bogotá
Fundación Neumologica Colombiana
Bogotá
Denmark
Aarhus Universitetshospital, Department of Cardiology
Aarhus
Rigshospitalet, Department of Cardiology
Copenhagen
France
CHU Bicêtre
Le Kremlin-bicêtre
Institut Coeur Poumon
Lille
CHU de Montpellier
Montpellier
Hôpital Pasteur
Nice
CHU de Poitiers
Poitiers
Hôpitaux Universitaires de Strasbourg
Strasbourg
Centre Hospitalier Universitaire - Hôpital d´Adultes de Brabois
Vandœuvre-lès-nancy
Germany
DRK Kliniken Berlin Westend
Berlin
Zentrum fur Pulmona le Hypertonie, Klini k Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternlstische lntensiv medizin), Herzzentrum der Universitat zu Koln
Cologne
Universitatsklinikum Dresden, Medizinische Klinik / Pneumologisches Studiensekretariat
Dresden
Universitatsklinikum Giessen und Marburg GmbH Zentrum fur Innere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale Hypertonie
Giessen
Universitätsklinikum Greifswald Klinik und Poliklinik für Innere Medizin B
Greifswald
Universitätsklinikum Halle (Saale) / Martin-Luther-Universität Halle- Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I
Halle
Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie
Heidelberg
Klinikum der LMU Medizinische Klinik und Poliklinik V
München
Krankenhaus Neuwittelsbach
Munich
Klinikum Wurzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin
Würzburg
Greece
ATTIKON University Hospital, 2nd Critical Care Department
Athens
Evangelismos General Hospital, 1st Department of Clinical Care & Pulmonary Hypertension Clinic
Athens
Onassis Cardiac Surgery Center
Kallithea
AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic
Thessaloniki
Ireland
Mater Misericordiae University Hospital, Respiratory Department
Dublin
Israel
Lady Davis Carmel Medical Center
Haifa
Meir Medical Center
Kfar Saba
Rabin Medical Center
Petah Tikva
The Chaim Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical Center
Tel Aviv
Italy
IRCCS Azienda Ospedaliero Universitaria Di Bologna Policlinico 5 Orsola Malpighi - U.O.C. Cardiologia
Bologna
Azienda Ospedaliera Dei Colli - Ospedale Monaldi Centro per la Diagnosi e Terapia dell'Ipertensione Polmonare
Napoli
Fondazione IRCCS Policlinico San Matteo - U.O. di Cardiologia
Pavia
Azienda Ospealiero Universitaria Policlinico Umberto I - Dipartamento di Scienze Cliniche Internistiche Anestesiologiche e Cardiovascolari - VIII Padglione
Rome
Azienda Sanitaria Universitaria Giuliano Isontina /ASUGI - Ospedale di Cattinara - Cardiovascular Department Coronary Intensive Care Unit
Trieste
Japan
Kyushu University Hospital
Fukuoka
Kurume University Hospital
Kurume
Nagoya University Hospital
Nagoya
NHO Okayama Medical Center
Okayama
Keio University Hospital
Shinjuku-ku
National Cerebral and Cardiovascular Center
Suita
Kyorin University Hospital
Tokyo
University of Tokyo Hospital
Tokyo
Latvia
Pauls Stradins Clinical University Hospital
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas
Mexico
Instituto nacional de Cardiologia Ignacio Chavez
Mexico City
Hospital Universitario Dr. José Eleuterio González Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas
Monterrey
Unidad de Investigacion Clinica en Medicina, S.C.
Monterrey
Netherlands
Amsterdam UMC, location VUmc
Amsterdam
Erasmus MC
Rotterdam
Poland
Krakowski Szpital Specjalistyczny Im. Św. Jana Pawła II Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego
Krakow
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Szpital irn. Fryderyka Chopina Oddzial Kardiologiczny
Otwock
Portugal
Centro Hospitalar e Universitário de Coimbra
Coimbra
Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital Pulido Valente
Lisbon
Centro Hospitalar Universitário de Santo António
Porto
Republic of Korea
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System Seoul
Seoul
The Catholic University of Korea, Seoul St. Mary´s Hospital
Seoul
Romania
Emergency Institute of Cardiovascular Diseases Prof. Dr. C.C. Iliescu Bucharest, Cardiology 2
Bucharest
Mediprax Centrum S.R.L
Cluj-napoca
Niculae Stanciolu Emergency Heart Institute for Cardivascular Diseases
Cluj-napoca
Targu-Mures Emergency Clinical County Hospital, Internal Medicine II
Târgu Mureş
Saudi Arabia
King Fahad Medical City
Riyadh
King Faisal Specialist Hospital and Research Center
Riyadh
Serbia
Institute for Cardiovascular Diseases Dedinje Clinic for Cardiology
Belgrade
University Clinical Centre of Serbia, Cardiology Clinic
Belgrade
Singapore
National Heart Centre Singapore
Singapore
National University Heart Centre Singapore
Singapore
Spain
Hospital Clinic I Provincial
Barcelona
Hospital Universitario 12 De Octubre
Madrid
Hospital Universitario Puerta De Hierro Majadahonda
Majadahonda
Hospital Costa del Sol
Marbella
Hospital Universitario Son Espases
Palma De Mallorca
Hospital Universitario Marques de Valdecilla
Santander
Hospital Universitario Virgen del Rocío
Seville
Hospital Universitario de Toledo
Toledo
United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge
Golden Jubilee National Hospital, Agamemnon Street
Clydebank
Hammersmith Hospital
London
Royal Brompton Hospital, Pulmonary Hypertension Service, Sydney Street
London
Royal Free Hospital
London
Freeman Hospital
Newcastle
Sheffield Clinical Research Facility, Royal Hallamshire Hospital
Sheffield
Time Frame
Start Date: 2023-12-28
Completion Date: 2025-12
Participants
Target number of participants: 390
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: GB002, Inc.

This content was sourced from clinicaltrials.gov