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

PHASE3RECRUITING

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.

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Study details:

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

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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 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 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.
  • 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 pregnancy test at Screening and on Day 1 before first administration of Investigational Product (IP).
  • 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 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.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-09-03

    Primary completion: 2026-12-01

    Study completion finish: 2026-12-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT06274801

    Intervention or treatment

    DRUG: Seralutinib

    DEVICE: Gereic Dry Powder Inhaler

    Conditions

    • Pulmonary Arterial Hypertension

    Find a site

    Closest Location:

    St Vincent's Hospital (Melbourne)

    Research sites nearby

    Select from list below to view details:

    • St Vincent's Hospital (Melbourne)

      Fitzroy, Not Specified, Australia

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    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/ArmIntervention/Treatment
    EXPERIMENTAL: Seralutinib 90 mg
    • Seralutinib inhaled orally twice per day (BID)
    DRUG: Seralutinib
    • Capsule containing seralutinib

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Incidence of treatment-emergent adverse events (TEAEs)Not SpecifiedFrom baseline to end of study (up to 48 months or availability of commercial product)

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Changes in distance achieved on the Six-Minute Walk Test (6MWT)Δ6MWT from Baseline to End of StudyBaseline 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-proBNPChange in NT-proBNP from Baseline to End of StudyBaseline 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)

    Frequently Asked Questions

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    References

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

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