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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

TREATMENT

Phase

PHASE3

Trial ID

NCT06274801

Intervention or treatment

DRUG: Seralutinib

DEVICE: Gereic Dry Powder Inhaler

Conditions

• Pulmonary Arterial Hypertension

Image related to Pulmonary Arterial Hypertension

Condition: Pulmonary Arterial Hypertension
DRUG: Seralutinib and other drugs
Fitzroy, Not Specified, Australia
Sponsor: GB002, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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

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 Seralutinib inhaled orally twice per day (BID)	DRUG: Seralutinib Capsule containing seralutinib

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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)

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

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