Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)

NCT05934526 | Completed Phase 3 DMC FDA Drug FDA Device

• 2 other identifiers: GB002-31012023-503614-80-00
• Study Type: interventional
• Target: 390
• Locations: 30 countries
• Sites: 164

Brief 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.

Conditions

Pulmonary Arterial Hypertension

Keywords

seralutinib; GB002; PROSERA

Outcome Measures

Primary Outcomes (1)

• Change in distance achieved on the six-minute walk test (6MWT), six-minute walk distance (Δ6MWD) from baseline to Week 24

  Baseline to 24 weeks

Secondary Outcomes (9)

• Time to first event of Clinical Worsening from first dose of Investigational Product (IP) through end of study

  Baseline to 48 weeks

• Proportion of subjects who achieve all of the following components of clinical improvement at Week 24, in the absence of clinical worsening:

  Baseline to 24 weeks

• Change in NT-proBNP from baseline to Week 24

  Baseline to 24 weeks

• Proportion of subjects with ≥ 1 point decrease from baseline in US Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) Lite 2 Risk Score at Week 24

  Baseline to 24 weeks

• Proportion of subjects with each of the Clinical Worsening Outcomes:

  Baseline to 52 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo inhaled orally twice daily (BID) up to 48 weeks

Drug: Placebo; Device: Generic Dry Powder Inhaler

Seralutinib 90 mg

EXPERIMENTAL

Seralutinib inhaled orally BID up to 48 weeks

Drug: Seralutinib; Device: Generic Dry Powder Inhaler

Interventions

Placebo DRUG

Matching capsule containing placebo

Placebo

Seralutinib DRUG

Capsule containing seralutinib

Seralutinib 90 mg

Generic Dry Powder Inhaler DEVICE

Generic dry powder inhaler for seralutinib or placebo delivery

Placebo; Seralutinib 90 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• MWDs ≥ 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.

You may not qualify if:

• Evidence of chronic thromboembolic disease or acute pulmonary embolism.
• Uncontrolled systemic hypertension as evidenced by systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg.
• Systolic blood pressure \< 90 mm Hg during Screening.
• WHO Pulmonary Hypertension Group 2 - 5.
• Human immunodeficiency virus (HIV)-associated PAH, schistosomiasis associated PAH, PAH associated with portal hypertension, or pulmonary veno-occlusive disease (PVOD).
• Recent history of left-sided heart disease and/or clinically significant cardiac disease within 48 weeks of Screening.
• Left ventricular ejection fraction (LVEF) ≤ 50% within 24 weeks of Screening.
• Hemodynamically significant valvular heart disease or uncontrolled symptomatic coronary disease.
• History of atrial septostomy.
• Uncontrolled atrial fibrillation or paroxysmal atrial fibrillation.
• Untreated severe obstructive sleep apnea.
• Hepatic dysfunction defined as Child-Pugh Class A or higher, or as evidenced by one of the following at Screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 x upper limit of normal (ULN) or total bilirubin ≥ 1.5 x ULN.
• Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or IP administration (eg, history of intracranial hemorrhage, recurrent syncope).
• Any musculoskeletal disease, injury, or any other disease that limits evaluation of 6MWT.
• Initiation of an exercise program for cardiopulmonary rehabilitation within 12 weeks prior to Screening or planned during the study.

Sponsors & Collaborators

• GB002, Inc.: lead

Study Sites (166)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Valley Advanced Lung Diseases Institute

Fresno, California, 93711, United States

Location

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

Dept of Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

UC Davis Health

Sacramento, California, 95817, United States

Location

Stanford Healthcare

Stanford, California, 94305, United States

Location

Winchester Center for Lung Disease

New Haven, Connecticut, 06519, United States

Location

The George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

University of Florida Clinical Research Center

Gainesville, Florida, 32610, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead

Atlanta, Georgia, 30309, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northside Hospital Laboratory - Atlanta

Atlanta, Georgia, 30342, United States

Location

UI Health Hospital

Chicago, Illinois, 60612, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Norton Hospital

Louisville, Kentucky, 40202, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

M Health Fairview University of Minnesota Medical Center - East Bank

Minneapolis, Minnesota, 55455, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

UNC Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Medical Center - Duke South

Durham, North Carolina, 27710, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

INTEGRIS Cardiovascular Physicians, LLC

Oklahoma City, Oklahoma, 73112, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple Heart and Vascular Institute (Outpatient Clinic)

Philadelphia, Pennsylvania, 19140, United States

Location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina - Nexus Research Center

Charleston, South Carolina, 29425, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

CHI St. Luke's Health Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States

Location

Houston Methodist Outpatient Center

Houston, Texas, 77030, United States

Location

Baylor Scott & White Medical Center - The Heart Hospital

Plano, Texas, 75024, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, 23230, United States

Location

Advocate Aurora Health-Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Froedtert Hospital/Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Cardiologia Palermo

Buenos Aires, Argentina

Location

Instituto Cardiovascular de Buenos Aires

Buenos Aires, Argentina

Location

Instituto de Cardiologia de Corrientes Juana Francisca Cabral

Corrientes, Argentina

Location

Hospital Privado Centro Medico de Cordóba S.A.

Córdoba, Argentina

Location

Instituto de Investigaciones Clinicas Quilmes

Quilmes, Argentina

Location

Instituto Medico Rio Cuarto

Río Cuarto, Argentina

Location

Sanatorio Parque S.A.

Rosario, Argentina

Location

Hospital Provincial Dr. José María Cullen

Santa Fe, Argentina

Location

St Vincent's Hospital

Melbourne, Victoria, 3065, Australia

Location

Wesley Research Institute

Auchenflower, Australia

Location

Royal Hobart Hospital

Hobart, Australia

Location

Nepean Hospital

Kingswood, Australia

Location

Religious Hospital Linz GmbH

Linz, Austria

Location

AKH-Vienna Medical Univesity of Vienna Internal Medicine II-Cardiology

Vienna, Austria

Location

Hôpital Erasme

Anderlecht, Belgium

Location

University Hospitals of Leuven (Campus Gasthuisberg)

Leuven, Belgium

Location

Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

Belo Horizonte, Brazil

Location

Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia do Pulmao

Blumenau, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Brazil

Location

Uniao Brasileira de Educaçao e Assistência Hospital São Lucas da PUCRS

Porto Alegre, Brazil

Location

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

Location

Núcleo de Gestão de Pesquisa/Hospital São Paulo - SPDM/UNIFESP

São Paulo, Brazil

Location

London Health Science Centre - Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

Peter Lougheed Center

Calgary, Canada

Location

University Health Network

Toronto, Canada

Location

Enroll SpA

Santiago, Santiago Metropolitan, 7500587, Chile

Location

Centro de Investigacion Clinica UC-CICUC

Santiago, Chile

Location

Fundación Abood Shaio

Bogotá, Colombia

Location

Fundación Neumologica Colombiana

Bogotá, Colombia

Location

Institut Klinicke a Experimentalni Mediciny

Prague, Czechia

Location

Všeobecná fakultní nemocnice v Praze Il. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hypertenzi

Prague, Czechia

Location

Aarhus Universitetshospital, Department of Cardiology

Aarhus, Denmark

Location

Rigshospitalet, Department of Cardiology

Copenhagen, Denmark

Location

CHU Bicêtre

Le Kremlin-Bicêtre, France

Location

Institut Coeur Poumon

Lille, France

Location

CHU de Montpellier

Montpellier, France

Location

Hôpital Pasteur

Nice, France

Location

CHU de Poitiers

Poitiers, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Location

Centre Hospitalier Universitaire - Hôpital d´Adultes de Brabois

Vandœuvre-lès-Nancy, France

Location

DRK Kliniken Berlin Westend

Berlin, Germany

Location

Zentrum fur Pulmona le Hypertonie, Klini k Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternlstische lntensiv medizin), Herzzentrum der Universitat zu Koln

Cologne, Germany

Location

Universitatsklinikum Dresden, Medizinische Klinik / Pneumologisches Studiensekretariat

Dresden, Germany

Location

Universitatsklinikum Giessen und Marburg GmbH Zentrum fur Innere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale Hypertonie

Giessen, Germany

Location

Universitätsklinikum Greifswald Klinik und Poliklinik für Innere Medizin B

Greifswald, Germany

Location

Universitätsklinikum Halle (Saale) / Martin-Luther-Universität Halle- Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I

Halle, Germany

Location

Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie

Heidelberg, Germany

Location

Krankenhaus Neuwittelsbach

Munich, Germany

Location

Klinikum der LMU Medizinische Klinik und Poliklinik V

München, Germany

Location

Klinikum Wurzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin

Würzburg, Germany

Location

"Evangelismos" General Hospital, 1st Department of Clinical Care & Pulmonary Hypertension Clinic

Athens, Greece

Location

ATTIKON University Hospital, 2nd Critical Care Department

Athens, Greece

Location

Onassis Cardiac Surgery Center

Kallithea, Greece

Location

AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic

Thessaloniki, Greece

Location

Mater Misericordiae University Hospital, Respiratory Department

Dublin, Ireland

Location

Lady Davis Carmel Medical Center

Haifa, 3436212, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

The Chaim Sheba Medical Center

Ramat Gan, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

IRCCS Azienda Ospedaliero Universitaria Di Bologna Policlinico 5 Orsola Malpighi - U.O.C. Cardiologia

Bologna, Italy

Location

Azienda Ospedaliera Dei Colli - Ospedale Monaldi Centro per la Diagnosi e Terapia dell'Ipertensione Polmonare

Naples, Italy

Location

Fondazione IRCCS Policlinico San Matteo - U.O. di Cardiologia

Pavia, Italy

Location

Azienda Ospealiero Universitaria Policlinico Umberto I - Dipartamento di Scienze Cliniche Internistiche Anestesiologiche e Cardiovascolari - VIII Padglione

Rome, Italy

Location

Azienda Sanitaria Universitaria Giuliano Isontina /ASUGI - Ospedale di Cattinara - Cardiovascular Department Coronary Intensive Care Unit

Trieste, Italy

Location

Kyushu University Hospital

Fukuoka, Japan

Location

Kurume University Hospital

Kurume, Japan

Location

Nagoya University Hospital

Nagoya, Japan

Location

NHO Okayama Medical Center

Okayama, Japan

Location

Keio University Hospital

Shinjuku-Ku, Japan

Location

National Cerebral and Cardiovascular Center

Suita, Japan

Location

Kyorin University Hospital

Tokyo, Japan

Location

University of Tokyo Hospital

Tokyo, Japan

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, Lithuania

Location

Instituto nacional de Cardiologia Ignacio Chavez

Mexico City, Mexico

Location

Hospital Universitario Dr. José Eleuterio González Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas

Monterrey, Mexico

Location

Unidad de Investigacion Clinica en Medicina, S.C.

Monterrey, Mexico

Location

Amsterdam UMC, location VUmc

Amsterdam, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Krakowski Szpital Specjalistyczny Im. Św. Jana Pawła II Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego

Krakow, Poland

Location

Europejskie Centrum Zdrowia Otwock Sp. z o.o. Szpital irn. Fryderyka Chopina Oddzial Kardiologiczny

Otwock, Poland

Location

Centro Hospitalar e Universitário de Coimbra

Coimbra, Portugal

Location

Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital Pulido Valente

Lisbon, Portugal

Location

Centro Hospitalar Universitário de Santo António

Porto, Portugal

Location

Emergency Institute of Cardiovascular Diseases "Prof. Dr. C.C. Iliescu" Bucharest, Cardiology 2

Bucharest, Romania

Location

"Niculae Stanciolu" Emergency Heart Institute for Cardivascular Diseases

Cluj-Napoca, Romania

Location

Mediprax Centrum S.R.L

Cluj-Napoca, Romania

Location

Targu-Mures Emergency Clinical County Hospital, Internal Medicine II

Târgu Mureş, Romania

Location

King Fahad Medical City

Riyadh, Saudi Arabia

Location

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia

Location

Institute for Cardiovascular Diseases "Dedinje" Clinic for Cardiology

Belgrade, Serbia

Location

University Clinical Centre of Serbia, Cardiology Clinic

Belgrade, Serbia

Location

National Heart Centre Singapore

Singapore, Singapore

Location

National University Heart Centre Singapore

Singapore, Singapore

Location

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital, Yonsei University Health System Seoul

Seoul, South Korea

Location

The Catholic University of Korea, Seoul St. Mary´s Hospital

Seoul, South Korea

Location

Hospital Clinic I Provincial

Barcelona, Spain

Location

Hospital Universitario 12 De Octubre

Madrid, Spain

Location

Hospital Universitario Puerta De Hierro Majadahonda

Majadahonda, Spain

Location

Hospital Costa del Sol

Marbella, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital Universitario de Toledo

Toledo, Spain

Location

Royal Papworth Hospital NHS Foundation Trust

Cambridge, United Kingdom

Location

Golden Jubilee National Hospital, Agamemnon Street

Clydebank, United Kingdom

Location

Hammersmith Hospital

London, United Kingdom

Location

Royal Brompton Hospital, Pulmonary Hypertension Service, Sydney Street

London, United Kingdom

Location

Royal Free Hospital

London, United Kingdom

Location

Freeman Hospital

Newcastle, United Kingdom

Location

Sheffield Clinical Research Facility, Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

Related Publications (1)

• Sitbon O, Sahay S, Escribano Subias P, Zolty RL, Kingrey JF, Ryan JJ, Sobol I, Sood N, Benza RL, Channick RN, Chin KM, Frantz RP, Ghofrani HA, Hemnes AR, McLaughlin VV, Vachiery JL, Zamanian RT, Ter Veer A, Roscigno RF, Mottola D, Parsley E, Aranda R, Zisman LS, Howard LS; TORREY Study Investigators. Seralutinib for the Treatment of Pulmonary Arterial Hypertension in Adults: TORREY Open-Label Extension Study. Adv Ther. 2025 Oct;42(10):5104-5123. doi: 10.1007/s12325-025-03297-2. Epub 2025 Aug 11.

  PMID: 40788460 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Richard Aranda, MD

  Gossamer Bio Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 7, 2023
• Study Start: December 28, 2023
• Primary Completion: November 27, 2025
• Study Completion: December 22, 2025
• Last Updated: May 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2); KR (5); NL (2); ES (8); BR (6); PT (3); SA (2); BE (2); PL (2); IL (5); IE (1); RO (4); LI (1); FR (7); GR (4); GB (7); US (50); LA (1); CA (4); SG (2); IT (5); AU (4); DE (10); CL (2); CO (2); CZ (2); DK (2); ME (3); AR (8); JP (8)