Efficacy and Safety of Seralutinib in Adult Subjects with PAH

JRCT ID: jRCT2051230191

Registered date:27/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pulmonary Arterial Hypertension
• Date of first enrollment: 01/04/2024
• Target sample size: 16
• Countries of recruitment: USA,Japan,UK,Japan,France,Japan,Germany,Japan,etc.,Japan
• Study type: Interventional
• Intervention(s): Subjects will receive IP BID, inhaled orally with a dry powder inhaler (DPI), for a minimum of 24 weeks.

Outcome(s)

• Primary Outcome: Change in distance achieved on the six-minute walk test (6MWT), (6MWD) from baseline to Week 24

Secondary Outcome

-Time to first event of Clinical Worsening from first dose of Investigational Product (IP) through end of study
-Proportion of subjects who achieve all of the following components of clinical improvement at Week 24, in the absence of clinical worsening
-Change in NT-proBNP from baseline to Week 24
-Proportion of subjects with = > 1 point decrease from baseline in REVEAL Lite 2 Risk Score at Week 24

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Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1.Diagnosis of PAH.
2.Two 6MWDs = > 150 meters and =< 450 meters at Screening.
3.WHO FC II or III.
4.REVEAL Lite 2 Risk Score = > 5 OR NT-proBNP = > 300 ng/L.
5.Cardiac catheterization consistent with the diagnosis of PAH and meeting the following criteria:
a. mPAP > 20mmHg (at rest), AND
b. PVR = > 400 dyne-s/cm^5 AND
c. PCWP or left ventricle end-diastolic pressure (LVEDP) =< 12 mmHg if PVR = > 400 to < 500 dyne-s/cm^5 OR PCWP or LVEDP =< 15 mmHg if PVR = > 500 dyne-s/cm^5
6.Treatment with at least one allowed background PAH disease-specific medication prior to Screening, and on stable regimen and doses for at least 12 weeks prior to and throughout Screening
7.Pulmonary function tests (PFTs) at Screening meeting the following criteria
a. Forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) of = > 70%
b. Total lung capacity (TLC) or FVC = > 70% predicted. Subjects with CTD APAH may have a TLC of between 60-70 % of predicted if high-resolution computed tomography (CT) scan of the chest reveals limited interstitial disease.

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• Exclude criteria: *Please contact us for more details.

Related Information

• Primary Sponsor: Matsushima Naoko