ACTIVE_NOT_RECRUITING

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

Conditions

Pulmonary Arterial Hypertension seralutinib GB002 PROSERA PROSERA-EXT

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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 safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study

Official Title

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)

Quick Facts

Study Start:2024-09-03

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06274801

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 75 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 qualifying last visit in a prior seralutinib PAH study 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 study prior to initiation of any subject-mandated procedures. 3. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures 4. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at enrollment visit before first administration of Investigational Product (IP) in this study. 5. WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of IP. 6. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP.	1. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor's medical monitor (MM) (or designee). 2. Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.

Inclusion Criteria

Exclusion Criteria

1. Subjects must have completed a qualifying last visit in a prior seralutinib PAH study 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 study prior to initiation of any subject-mandated procedures.
3. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
4. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at enrollment visit before first administration of Investigational Product (IP) in this study.
5. WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of IP.
6. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP.

1. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor's medical monitor (MM) (or designee).
2. Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.

Contacts and Locations

Principal Investigator

Richard Aranda, MD

STUDY_DIRECTOR

Gossamer Bio Inc.

Study Locations (Sites)

Valley Advanced Lung Diseases Institute

Fresno, California, 93720

United States

Department of Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, 90073

United States

UC Davis Health Medical Center

Sacramento, California, 95817

United States

Stanford Healthcare

Stanford, California, 94305

United States

University of Florida Health

Gainesville, Florida, 32610

United States

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224

United States

Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead

Atlanta, Georgia, 30309

United States

The Emory Clinic

Atlanta, Georgia, 30322

United States

Northside Hospital - Atlanta

Atlanta, Georgia, 30342

United States

UI Health Hospital

Chicago, Illinois, 60612

United States

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

Norton Pulmonary Specialists

Louisville, Kentucky, 40202

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Washington University School of Medicine

St Louis, Missouri, 63110

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131

United States

NYU Langone Health

New York, New York, 10016

United States

University of Rochester Medical Center

Rochester, New York, 14642

United States

UNC Hospitals

Chapel Hill, North Carolina, 27514

United States

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219

United States

INTEGRIS Cardiovascular Physicians

Oklahoma City, Oklahoma, 73112

United States

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Temple Heart and Vascular Institute (Outpatient Clinic)

Philadelphia, Pennsylvania, 19140

United States

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213

United States

Medical University of South Carolina - Nexus Research Center

Charleston, South Carolina, 29425

United States

UT Southwestern Medical Center

Dallas, Texas, 75390

United States

CHI St. Luke's Health Baylor College of Medicine Medical Center

Houston, Texas, 77030

United States

Houston Methodist Outpatient Center

Houston, Texas, 77030

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Intermountain Medical Center

Murray, Utah, 84107

United States

University of Utah Hospital

Salt Lake City, Utah, 84132

United States

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042

United States

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, 23230

United States

Collaborators and Investigators

Sponsor: GB002, Inc.

Richard Aranda, MD, 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 Date2024-09-03

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-09-03

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

seralutinib
GB002
PROSERA
PROSERA-EXT

Additional Relevant MeSH Terms

Pulmonary Arterial Hypertension