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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subjects must have completed 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 or his/her legal representative, 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 pregnancy test at Screening and on Day 1 before first administration of Investigational Product (IP). 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 or in the opinion of the Sponsor's MM (or designee) in consultation with the Investigator, would prohibit the subject from participating in the study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06274801
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	GB002, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Richard Aranda, MD
Principal Investigator Affiliation	Gossamer Bio Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Arterial Hypertension

Additional Details

The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.

Arms & Interventions

Arms

Experimental: Seralutinib 90 mg

Seralutinib inhaled orally twice per day (BID)

Interventions

Drug: - Seralutinib

Capsule containing seralutinib

Device: - Gereic Dry Powder Inhaler

Generic dry powder inhaler for seralutinib delivery

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Kansas Medical Center, Kansas City, Kansas

Status

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Site Contact

ClinicalTrials@gossamerbio.com

1-866-668-4083

Pulmonary Associates of Richmond, Inc., Richmond, Virginia

Status

Address

Pulmonary Associates of Richmond, Inc.