Recruiting
Phase 3

Seralutinib

Sponsor:

Gossamer Bio USA, Inc.

Code:

NCT06274801

Conditions

Pulmonary Arterial Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Seralutinib

Gereic Dry Powder Inhaler

Study Details

Brief summary:

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

Conditions

Pulmonary Arterial Hypertension

Study ID

NCT06274801

Start date

Sep 3, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

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.

Study Design

Enrollment

330 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Seralutinib 90 mg

Seralutinib inhaled orally twice per day (BID)

Interventions

Seralutinib

Capsule containing seralutinib

Gereic Dry Powder Inhaler

Generic dry powder inhaler for seralutinib delivery

Primary outcome measure

  • Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: From baseline to end of study (up to 48 months or availability of commercial product) ]

Central Contacts and Locations

Locations

Valley Advanced Lung Diseases Institute

Recruiting

Fresno, California, United States, 93720

Department of Veterans Affairs Greater Los Angeles Healthcare System

Recruiting

Los Angeles, California, United States, 90073

UC Davis Health Medical Center

Recruiting

Sacramento, California, United States, 95817

Stanford Healthcare

Recruiting

Stanford, California, United States, 94305

University of Florida Health

Recruiting

Gainesville, Florida, United States, 32610

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead

Recruiting

Atlanta, Georgia, United States, 30309

The Emory Clinic

Recruiting

Atlanta, Georgia, United States, 30322

Northside Hospital - Atlanta

Recruiting

Atlanta, Georgia, United States, 30342

UI Health Hospital

Recruiting

Chicago, Illinois, United States, 60612

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Norton Pulmonary Specialists

Recruiting

Louisville, Kentucky, United States, 40202

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

NYU Langone Health

Recruiting

New York, New York, United States, 10016

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

The Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Temple Heart and Vascular Institute (Outpatient Clinic)

Recruiting

Philadelphia, Pennsylvania, United States, 19140

UPMC Presbyterian Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Medical University of South Carolina - Nexus Research Center

Recruiting

Charleston, South Carolina, United States, 29425

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

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

Recruiting

Houston, Texas, United States, 77030

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

University of Utah Hospital

Recruiting

Salt Lake City, Utah, United States, 84132

Inova Fairfax Medical Campus

Recruiting

Falls Church, Virginia, United States, 22042

Pulmonary Associates of Richmond, Inc.

Recruiting

Richmond, Virginia, United States, 23230

Peter Lougheed Center

Recruiting

Calgary, Canada

London Health Sciences Centre - Victoria Hospital

Recruiting

London, Canada

More Information

Sponsor

Gossamer Bio USA, Inc.

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • seralutinib
  • GB002
  • PROSERA
  • PROSERA-EXT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Gossamer Bio USA, Inc. on 2026-07-29.