Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)

NCT06274801 | Active Not Recruiting Phase 3 DMC FDA Drug FDA Device

• 2 other identifiers: GB002-31022023-506334-75
• Study Type: interventional
• Target: 316
• Locations: 30 countries
• Sites: 115

Brief Summary

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

Conditions

Pulmonary Arterial Hypertension

Keywords

seralutinib; GB002; PROSERA; PROSERA-EXT

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  From baseline to end of study (up to 48 months or availability of commercial product)

Secondary Outcomes (2)

• Changes in distance achieved on the Six-Minute Walk Test (6MWT)

  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)

• Changes in NT-proBNP

  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)

Study Arms (1)

Seralutinib 90 mg

EXPERIMENTAL

Seralutinib inhaled orally twice per day (BID)

Drug: Seralutinib; Device: Gereic Dry Powder Inhaler

Interventions

Seralutinib DRUG

Capsule containing seralutinib

Seralutinib 90 mg

Gereic Dry Powder Inhaler DEVICE

Generic dry powder inhaler for seralutinib delivery

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:

• Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
• 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.
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
• 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.
• 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.

You may not qualify if:

• 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).
• Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.

Sponsors & Collaborators

• GB002, Inc.: lead

Study Sites (115)

Valley Advanced Lung Diseases Institute

Fresno, California, 93720, United States

Location

Department of Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

UC Davis Health Medical Center

Sacramento, California, 95817, United States

Location

Stanford Healthcare

Stanford, California, 94305, United States

Location

University of Florida Health

Gainesville, Florida, 32610, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead

Atlanta, Georgia, 30309, United States

Location

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Northside Hospital - Atlanta

Atlanta, Georgia, 30342, United States

Location

UI Health Hospital

Chicago, Illinois, 60612, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Norton Pulmonary Specialists

Louisville, Kentucky, 40202, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, 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

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

INTEGRIS Cardiovascular Physicians

Oklahoma City, Oklahoma, 73112, 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

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

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

Cardiologia Palermo

Buenos Aires, Argentina

Location

Instituto de Cardiologia de Corrientes Juana Francisca Cabral

Corrientes, Argentina

Location

Instuto de Investigacion Clinicas Quilmes

Quilmes, Argentina

Location

Instituto Medico Rio Cuarto

Río Cuarto, Argentina

Location

Hospital Provincial Dr. Jose Maria Cullen

Santa Fe, Argentina

Location

Wesley Research Institute

Auchenflower, Australia

Location

St Vincent's Hospital (Melbourne)

Fitzroy, Australia

Location

Royal Hobart Hospital

Hobart, Australia

Location

University Hospitals of Leuven (Campus Gasthuisberg)

Leuven, Belgium

Location

Instituto das Pequenas Missionarias de Maria Imaculada - Hospital Madre Teresa

Belo Horizonte, Brazil

Location

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

Blumenau, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Brazil

Location

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

Location

Instituto do Coracao do Hospital das Clinicas da Faculdade de medicina da Universidade de Sao Paulo

São Paulo, Brazil

Location

Nucleo de Gestao de Pesquisa/Hospital Sao Paulo - SPDM/UNIFESP

São Paulo, Brazil

Location

Peter Lougheed Center

Calgary, Canada

Location

London Health Sciences Centre - Victoria Hospital

London, Canada

Location

University of Ottawa Heart Institute

Ottawa, Canada

Location

University Health Network, Toronto General Hospital

Toronto, Canada

Location

Centro de Investigacion Clinica UC-CICUC

Santiago, Chile

Location

Enroll SpA

Santiago, Chile

Location

Fundacion Abood Shaio

Bogotá, Colombia

Location

Fundacion Neumologica Colombiana

Bogotá, Colombia

Location

Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenze

Prague, Czechia

Location

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

Prague, Czechia

Location

Aarhus Universiteshospital

Aarhus, Denmark

Location

CHU Bicetre, Service de Pneumologie et Reanimation Respiratorie

Le Kremlin-Bicêtre, France

Location

Centre Hospitalier REgional Universitaire de Lille Hopital Cardiologique - Institut Coeur Poumon Service de Cardiologie

Lille, France

Location

CHU de Nice - Hopital Pasteur

Nice, France

Location

CHU de Poitiers

Poitiers, France

Location

Zentrum fur Pulmonale Hypertonie, Klinik Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternistische lntensivmedizin), Herzzentrum der Universitat zu Koln

Cologne, Germany

Location

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

Giessen, Germany

Location

Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie

Heidelberg, Germany

Location

Klinikum der LMU Medizinische Klinik und Poliklinik V

Munich, Germany

Location

Krankenhaus Neuwittelsbach

München, Germany

Location

Klinikum Würzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin

Würzburg, Germany

Location

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

Athens, Greece

Location

ATTIKON University Hospital, 2nd Critical Care Department

Athens, Greece

Location

Onassis Cardiac Surgery Center, Non-Invasive Cardiology Department

Kallithea, Greece

Location

AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic

Thessaloniki, Greece

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

Lady Davis Carmel Medical Center

Haifa, Israel

Location

IRCCS Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - UOC Cardiologia

Bologna, Italy

Location

Azienda Ospedaliera Dei Colli - Ospedale Monaldi

Naples, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Location

A.O.U. Policlinico Umberto I

Roma, Italy

Location

University of Tokyo Hospital

Bunkyō City, Japan

Location

Kyushu University Hospital

Fukuoka, Japan

Location

Kyorin University Hospital

Mitaka, 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

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

Unidad de Investigacion Clinica en Medicina, S.C.

Monterrey, Mexico

Location

Amsterdam UMC, location VU mc

Amsterdam, Netherlands

Location

Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn z Pododdzialem Intensywnego Nadzoru Kardiologicznego

Krakow, Poland

Location

Europejskie Centrum Zdrowia Otwock Sp.zo.o. Szpital im. Fryderyka Chopina Oddzial Kardiologiczny

Otwock, Poland

Location

Unidade Local de Saude de Santa Maria, E.P.E. Hospital Pulido Valente

Lisbon, Portugal

Location

Unidade Local de Saude de Santo Antonio, E.P.E. Hospital de Santo Antonio

Porto, Portugal

Location

Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Cardiology 2

Bucharest, Romania

Location

"Niculae Stancioiu" Emergency Heart Institute for Cardiovascular Diseases, Cardiology 1 Department

Cluj-Napoca, Romania

Location

King Fahad Medical City

Riyadh, Saudi Arabia

Location

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia

Location

University Clinical Centre of Serbia, Cardiology Clinic

Belgrade, Serbia

Location

National 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

Hospital Clinic I Provincial

Barcelona, Spain

Location

Hospital Universitario 12 De Octubre

Madrid, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

Hospital Universitario de Toledo

Toledo, Spain

Location

Royal Papworth Hospital NHS Foundation Trust

Cambridge, United Kingdom

Location

Golden Jubilee National Hospital

Clydebank, United Kingdom

Location

Hammersmith Hospital

London, United Kingdom

Location

Royal Free Hospital, Clinical Research Facility

London, United Kingdom

Location

Freeman Hospital

Newcastle, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 23, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2); BE (1); FR (4); ME (2); NL (1); AR (5); CL (2); ES (5); IE (1); BR (6); DE (6); LI (1); SA (2); RO (2); US (33); CA (4); GB (6); IL (1); DK (1); AU (3); PL (2); JP (7); IT (4); SE (1); LA (1); PT (2); SG (1); KR (3); CZ (2); GR (4)