NCT06274801RecruitingPhase 3
An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)
Gossamer Bio USA, Inc.314 sites in 20 countries330 target enrollmentStarted: September 3, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Gossamer Bio USA, Inc.
- Enrollment
- 330
- Locations
- 314
- Primary Endpoint
- Incidence of treatment-emergent adverse events (TEAEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Seralutinib 90 mg
Experimental
Seralutinib inhaled orally twice per day (BID)
Intervention: Seralutinib (Drug)
Seralutinib 90 mg
Experimental
Seralutinib inhaled orally twice per day (BID)
Intervention: Gereic Dry Powder Inhaler (Device)
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: From baseline to end of study (up to 48 months or availability of commercial product)
Secondary Outcomes
- 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))
- 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))
Investigators
Study Sites (314)
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