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

ConditionPulmonary Arterial Hypertension
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGossamer Bio USA, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Seralutinib

    Drug

    Capsule containing seralutinib

  • Gereic Dry Powder Inhaler

    Device

    Generic dry powder inhaler for seralutinib delivery

Treatment groups

330 Participants
are divided into 1 treatment group
Group A: Seralutinib 90 mgExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

1

Changes in distance achieved on the Six-Minute Walk Test (6MWT)

Δ6MWT from Baseline to End of Study

Time frame
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)
2

Changes in NT-proBNP

Change in NT-proBNP from Baseline to End of Study

Time frame
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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gossamer Bio USA, Inc.

Lead sponsor

Source ClinicalTrials.gov
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