Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

Last updated: April 16, 2024
Sponsor: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Pulmonary Arterial Hypertension

Williams Syndrome

Stress

Treatment

Generic Dry Powder Inhaler

GB002 (seralutinib)

Clinical Study ID

NCT04816604
GB002-2102
  • Ages 18-80
  • All Genders

Study Summary

This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.

Eligibility Criteria

Inclusion

Inclusion Criteria: Type of Subject and Disease Characteristics

  1. Subjects must have completed a prior GB002 PAH study and, in the opinion of theInvestigator and Sponsor, have been compliant with study procedures and have completedtreatment with IP through parent study end-of-treatment (EOT) visit.
  2. Treatment with standard of care PAH disease-specific background therapies (stabledose). Informed Consent
  3. Review and signature of an IRB-approved informed consent form.

Exclusion

Exclusion Criteria: Medical Conditions

  1. Persistent and clinically significant systemic hypertension or hypotension.
  2. Interval history of newly developed left-sided heart disease.
  3. Potentially life-threatening cardiac arrhythmia with an ongoing risk.
  4. Uncontrolled bacterial, viral, or fungal infections which require systemic therapy.
  5. Other severe acute or chronic medical or laboratory abnormality that may increase therisk associated with study participation or GB002 administration or may interfere withthe interpretation of study results and, in the judgment of the Investigator, wouldmake the subject inappropriate for entry into this study.
  6. History of portopulmonary hypertension or portal hypertension due to cirrhosisclassified as Child-Pugh Class A or higher.
  7. Subjects with a history of severe milk protein allergy. In addition, subjects withknown intolerance or hypersensitivity to lactose who, in the opinion of theinvestigator, may experience severe symptoms following the ingestion of lactose.
  8. Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topicalmarijuana is allowed, per local restrictions and regulations.
  9. Current alcohol use disorder as defined by DSM-5, and/or history of currentutilization of drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine [PCP]).
  10. Have any other condition or reason that, in the opinion of the Investigator and/or theSponsor's Medical Monitor (or designee), would prohibit the subject from participatingin the study. Diagnostic Assessments
  11. Chronic renal insufficiency
  12. Hemoglobin (Hgb) concentration <8.5 g/dL.
  13. Absolute neutrophil count (ANC) < 1x 10^9/L.
  14. Platelet count <50 x 10^9/L. Prior Therapy
  15. Use of inhaled prostanoids.
  16. Chronic use of oral anticoagulants (ie, vitamin K antagonist such as warfarin or noveloral anticoagulant [NOAC]/direct oral anticoagulant [DOAC]).
  17. Chronic use of any prohibited medication. NOTE: Additional inclusion/exclusion criteria may apply, per protocol.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Generic Dry Powder Inhaler
Phase: 2
Study Start date:
April 05, 2021
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • St Vincent's Hospital, Heart & Lung Transplant Unit

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Royal Hobart Hospital

    Hobart, Tasmania 7000
    Australia

    Active - Recruiting

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • University Hospital of Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • Všeobecná fakultní nemocnice v Praze

    Praha, 128 08
    Czechia

    Active - Recruiting

  • AP-HP Hôpital de Bicêtre

    Le Kremlin-Bicêtre, 94270
    France

    Active - Recruiting

  • Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik IV und V

    Gießen,
    Germany

    Active - Recruiting

  • Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule

    Hannover, 30625
    Germany

    Active - Recruiting

  • Thoraxklinik-Heidelberg gGmbH

    Heidelberg, 69126
    Germany

    Active - Recruiting

  • Klinik und Poliklinik f. Innere Medizin II Universitätsklinikum Regensburg

    Regensburg, 93053
    Germany

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Royal Papworth Hospital NHS Foundation Trust

    Cambridge, CB2 OAY
    United Kingdom

    Active - Recruiting

  • Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited

    London,
    United Kingdom

    Active - Recruiting

  • Dept. of Veterans Affairs Greater Los Angeles Healthcare System

    Los Angeles, California 90073
    United States

    Active - Recruiting

  • University of California, Davis Medical Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Medical Corporation

    Santa Barbara, California 93105
    United States

    Active - Recruiting

  • Stanford Health Care

    Stanford, California 94305
    United States

    Active - Recruiting

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA

    Torrance, California 90502
    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

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • New York Presbyterian Hospital - Weill Cornell Medicine

    New York, New York 10065
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • INTEGRIS Baptist Medical Center, Inc.

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Utah Health

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

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