Pulmonary Arterial Hypertension
Conditions
Keywords
seralutinib, GB002, PROSERA, PROSERA-EXT
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.
Interventions
DRUGSeralutinib
Capsule containing seralutinib
DEVICEGereic Dry Powder Inhaler
Generic dry powder inhaler for seralutinib delivery
Sponsors
Gossamer Bio USA, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | From baseline to end of study (up to 48 months or availability of commercial product) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Serbia, Singapore, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTGB002 Inc.
STUDY_DIRECTORRichard Aranda, MD
Gossamer Bio USA, Inc.
Outcome results
None listed