Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
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.
Study details:
The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT06274801
Intervention or treatment
DRUG: Seralutinib
DEVICE: Gereic Dry Powder Inhaler
Conditions
- Pulmonary Arterial Hypertension
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Wesley Research Institute
Select from list below to view details:
Wesley Research Institute
Auchenflower, Australia
St Vincent's Hospital (Melbourne)
Fitzroy, Australia
Royal Hobart Hospital
Hobart, Australia
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Who is running the clinical trial?
GB002, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Seralutinib 90 mg
| Drug: Seralutinib, Device: Gereic Dry Powder Inhaler |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Not Specified | From baseline to end of study (up to 48 months or availability of commercial product) |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Changes in distance achieved on the Six-Minute Walk Test (6MWT) | Δ6MWT from Baseline to End of Study | 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) |
| Changes in NT-proBNP | Change in NT-proBNP from Baseline to End of Study | 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) |
References
Clinical Trials Gov: Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)Other trials to consider
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