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

Last updated: March 20, 2025
Sponsor: GB002, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Circulation Disorders

Stress

Williams Syndrome

Treatment

Seralutinib

Gereic Dry Powder Inhaler

Clinical Study ID

NCT06274801
GB002-3102
2023-506334-75
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects must have completed a qualifying last visit in a prior seralutinib PAHstudy on investigational product (IP) and in accordance with the protocol.

  2. 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 studyprior to initiation of any subject-mandated procedures.

  3. Willingness and ability to comply with scheduled visits, treatment plan, laboratorytests, and other study procedures

  4. Women of childbearing potential (WOCBP) must have a negative urine or serumpregnancy test at enrollment visit before first administration of InvestigationalProduct (IP) in this study.

  5. WOCBP who are not abstinent and intend to be sexually active with a non-sterilizedmale partner must be willing to use a highly effective method of contraception fromconsent through 30 days following the last administration of IP.

  6. Male subjects: Non-sterilized male subjects who are not abstinent and intend to besexually active with a female partner of childbearing potential must use a malecondom from consent through 90 days after the last dose of IP.

Exclusion

Exclusion Criteria:

  1. Severe acute or chronic medical or laboratory abnormality that may increase the riskassociated with study participation or seralutinib administration, unless associatedwith an ongoing AE and discussed with the Sponsor's medical monitor (MM) (ordesignee).

  2. Have any other condition or reason that, in the opinion of the Investigator, wouldprohibit the subject from participating in the study.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Seralutinib
Phase: 3
Study Start date:
September 03, 2024
Estimated Completion Date:
December 31, 2026

Study Description

The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.

Connect with a study center

  • Cardiologia Palermo

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Instituto de Cardiologia de Corrientes Juana Francisca Cabral

    Corrientes,
    Argentina

    Active - Recruiting

  • Instituto Medico Rio Cuarto

    Río Cuarto,
    Argentina

    Active - Recruiting

  • Hospital Provincial Dr. Jose Maria Cullen

    Santa Fe,
    Argentina

    Active - Recruiting

  • St Vincent's Hospital (Melbourne)

    Fitzroy,
    Australia

    Active - Recruiting

  • Hopital Erasme

    Anderlecht,
    Belgium

    Active - Recruiting

  • Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenze

    Praha,
    Czechia

    Active - Recruiting

  • Aarhus Universiteshospital

    Aarhus,
    Denmark

    Active - Recruiting

  • CHU Bicetre, Service de Pneumologie et Reanimation Respiratorie

    Le Kremlin-Bicêtre,
    France

    Active - Recruiting

  • CHU de Nice - Hopital Pasteur

    Nice,
    France

    Active - Recruiting

  • Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie

    Heidelberg,
    Germany

    Active - Recruiting

  • Klinikum Würzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin

    Würzburg,
    Germany

    Active - Recruiting

  • ATTIKON University Hospital, 2nd Critical Care Department

    Athens,
    Greece

    Active - Recruiting

  • AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic

    Thessaloníki,
    Greece

    Active - Recruiting

  • Lady Davis Carmel Medical Center

    Haifa,
    Israel

    Active - Recruiting

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

    Bologna,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia,
    Italy

    Active - Recruiting

  • A.O.U. Policlinico Umberto I

    Roma,
    Italy

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Pauls Stradins Clinical University Hospital

    Riga,
    Latvia

    Active - Recruiting

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas,
    Lithuania

    Active - Recruiting

  • Erasmus MC

    Rotterdam,
    Netherlands

    Active - Recruiting

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

    Porto,
    Portugal

    Active - Recruiting

  • University Clinical Centre of Serbia, Cardiology Clinic

    Belgrade,
    Serbia

    Active - Recruiting

  • National Heart Centre Singapore

    Singapore,
    Singapore

    Active - Recruiting

  • National University Heart Centre

    Singapore,
    Singapore

    Active - Recruiting

  • Hospital Clinic I Provincial

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario 12 De Octubre

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Sevilla,
    Spain

    Active - Recruiting

  • Royal Papworth Hospital NHS Foundation Trust

    Cambridge,
    United Kingdom

    Active - Recruiting

  • Golden Jubilee National Hospital

    Clydebank,
    United Kingdom

    Active - Recruiting

  • Department of Veterans Affairs Greater Los Angeles Healthcare System

    Los Angeles, California 90073
    United States

    Active - Recruiting

  • Northside Hospital - Atlanta

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Norton Pulmonary Specialists

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Houston Methodist Outpatient Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Inova Fairfax Medical Campus

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia 23230
    United States

    Active - Recruiting

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