Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Device: Gereic Dry Powder Inhaler
- Registration Number
- NCT06274801
- Lead Sponsor
- GB002, Inc.
- 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
- Detailed Description
The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
- 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.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- 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.
- 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.
- 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.
- 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).
- Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Seralutinib 90 mg Seralutinib Seralutinib inhaled orally twice per day (BID) Seralutinib 90 mg Gereic Dry Powder Inhaler Seralutinib inhaled orally twice per day (BID)
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs) From baseline to end of study (up to 48 months or availability of commercial product)
- Secondary Outcome Measures
Name Time Method Changes in distance achieved on the Six-Minute Walk Test (6MWT) Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product) Δ6MWT from Baseline to End of Study
Changes in NT-proBNP Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product) Change in NT-proBNP from Baseline to End of Study
Trial Locations
- Locations (114)
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
University Hospitals of Leuven (Campus Gasthuisberg)
🇧🇪Leuven, Belgium
Instituto das Pequenas Missionarias de Maria Imaculada - Hospital Madre Teresa
🇧🇷Belo Horizonte, Brazil
Peter Lougheed Center
🇨🇦Calgary, Canada
London Health Sciences Centre - Victoria Hospital
🇨🇦London, Canada
NHO Okayama Medical Center
🇯🇵Okayama, Japan
King Fahad Medical City
🇸🇦Riyadh, Saudi Arabia
Valley Advanced Lung Diseases Institute
🇺🇸Fresno, California, United States
Department of Veterans Affairs Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
UC Davis Health Medical Center
🇺🇸Sacramento, California, United States
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