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

Description

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

Conditions

Pulmonary Arterial Hypertension

Study Overview

Study Details

Study overview

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

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)

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

Condition
Pulmonary Arterial Hypertension
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Dept. of Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California, United States, 90073

Sacramento

University of California, Davis Medical Center, Sacramento, California, United States, 95817

Santa Barbara

Medical Corporation, Santa Barbara, California, United States, 93105

Stanford

Stanford Health Care, Stanford, California, United States, 94305

Torrance

Lundquist Institute for Biomedical Innovation at Harbor UCLA, Torrance, California, United States, 90502

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66160

Louisville

Norton Pulmonary Specialists, Louisville, Kentucky, United States, 40202

Boston

Tufts Medical Center, Boston, Massachusetts, United States, 02111

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.,

Richard Aranda, STUDY_DIRECTOR, Gossamer Bio Inc.

Study Record Dates

2027-12