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

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)

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

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Drug: GB002 (seralutinib); Device: Generic Dry Powder Inhaler

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: GB002, Inc.; Phone Number: 1-866-668-4083; Email: ClinicalTrials@gossamerbio.com

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Recruiting
      • St Vincent's Hospital, Heart & Lung Transplant Unit
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Recruiting
      • Royal Hobart Hospital
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • Recruiting
      • St. Vincent's Hospital Melbourne
• Belgium
  • Leuven, Belgium
    • Recruiting
    • University Hospital of Leuven
• Czechia
  • Praha, Czechia, 128 08
    • Recruiting
    • Vseobecna fakultni nemocnice v Praze
• France
  • Le Kremlin-Bicêtre, France, 94270
    • Recruiting
    • AP-HP Hôpital de Bicêtre
• Germany
  • Gießen, Germany
    • Recruiting
    • Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik IV und V
  • Hannover, Germany, 30625
    • Recruiting
    • Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule
  • Heidelberg, Germany, 69126
    • Recruiting
    • Thoraxklinik-Heidelberg gGmbH
  • Regensburg, Germany, 93053
    • Recruiting
    • Klinik und Poliklinik f. Innere Medizin II Universitätsklinikum Regensburg
• Spain
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 De Octubre
  • Santander, Spain, 39008
    • Recruiting
    • Hospital Universitario Marques de Valdecilla
• United Kingdom
  • Cambridge, United Kingdom, CB2 OAY
    • Recruiting
    • Royal Papworth Hospital NHS Foundation Trust
  • London, United Kingdom
    • Recruiting
    • Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited
• United States
  • California
    • Los Angeles, California, United States, 90073
      • Recruiting
      • Dept. of Veterans Affairs Greater Los Angeles Healthcare System
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California, Davis Medical Center
    • Santa Barbara, California, United States, 93105
      • Recruiting
      • Medical Corporation
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford Health Care
    • Torrance, California, United States, 90502
      • Recruiting
      • Lundquist Institute for Biomedical Innovation at Harbor UCLA
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • Norton Pulmonary Specialists
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
    • New York, New York, United States, 10065
      • Recruiting
      • New York Presbyterian Hospital - Weill Cornell Medicine
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Recruiting
      • INTEGRIS Baptist Medical Center, Inc.
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Type of Subject and Disease Characteristics

1. Subjects must have completed a prior GB002 PAH study and, in the opinion of the Investigator and Sponsor, have been compliant with study procedures and have completed treatment with IP through parent study end-of-treatment (EOT) visit.

2. Treatment with standard of care PAH disease-specific background therapies (stable dose).

   Informed Consent

3. Review and signature of an IRB-approved informed consent form.

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 the risk associated with study participation or GB002 administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
6. History of portopulmonary hypertension or portal hypertension due to cirrhosis classified as Child-Pugh Class A or higher.
7. Subjects with a history of severe milk protein allergy. In addition, subjects with known intolerance or hypersensitivity to lactose who, in the opinion of the investigator, may experience severe symptoms following the ingestion of lactose.
8. Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topical marijuana is allowed, per local restrictions and regulations.
9. Current alcohol use disorder as defined by DSM-5, and/or history of current utilization 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 the Sponsor's Medical Monitor (or designee), would prohibit the subject from participating in 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 novel oral anticoagulant [NOAC]/direct oral anticoagulant [DOAC]).
17. Chronic use of any prohibited medication.

NOTE: Additional inclusion/exclusion criteria may apply, per protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GB002 (seralutinib); GB002 (seralutinib) inhaled orally twice per day (BID)	Drug: GB002 (seralutinib); Capsule containing GB002 (seralutinib); Device: Generic Dry Powder Inhaler; Generic dry powder inhaler for GB002 (seralutinib) delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Treatment Emergent Adverse Events	From first dose of study drug up to 80 months or availability of commercial product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Over Time on the Six-Minute Walk Test (6MWT)	Change in the distance achieved on the 6MWT (Δ6MWT)	Baseline, up to 80 months or availability of commercial product

Collaborators and Investigators

• Sponsor: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
• Investigators: Study Director: Richard Aranda, Gossamer Bio Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: seralutinib
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: GB002-2102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes