ACTIVE_NOT_RECRUITING

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

Conditions

Pulmonary Arterial Hypertension seralutinib

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2021-04-05

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04816604

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

Richard Aranda

STUDY_DIRECTOR

Gossamer Bio Inc.

Study Locations (Sites)

Dept. of Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, 90073

United States

University of California, Davis Medical Center

Sacramento, California, 95817

United States

Medical Corporation

Santa Barbara, California, 93105

United States

Stanford Health Care

Stanford, California, 94305

United States

Lundquist Institute for Biomedical Innovation at Harbor UCLA

Torrance, California, 90502

United States

Mayo Clinic

Jacksonville, Florida, 32224

United States

Cleveland Clinic Florida

Weston, Florida, 33331

United States

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

Norton Pulmonary Specialists

Louisville, Kentucky, 40202

United States

Tufts Medical Center

Boston, Massachusetts, 02111

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

NYU Langone Health

New York, New York, 10016

United States

New York Presbyterian Hospital - Weill Cornell Medicine

New York, New York, 10065

United States

University of Rochester Medical Center

Rochester, New York, 14642

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

United States

INTEGRIS Baptist Medical Center, Inc.

Oklahoma City, Oklahoma, 73112

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

UT Southwestern Medical Center

Dallas, Texas, 75390

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

University of Utah Health

Salt Lake City, Utah, 84132

United States

Collaborators and Investigators

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

Richard Aranda, STUDY_DIRECTOR, Gossamer Bio Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-05

Study Completion Date2027-12

Study Record Updates

Study Start Date2021-04-05

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

seralutinib

Additional Relevant MeSH Terms

Pulmonary Arterial Hypertension