Open-label Extension Study of Seralutinib in Adult Subjects with PAH

JRCT ID: jRCT2051240238

Registered date:08/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pulmonary Arterial Hypertension
• Date of first enrollment: 01/02/2025
• 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 up to 156 weeks or until market approval in an applicable country or region (whichever occurs first), or until the study is terminated.

Outcome(s)

• Primary Outcome: Incidence of treatment-emergent adverse events

Secondary Outcome

- Changes in distance achieved on the six-minute walk test (6MWT)
- Changes in NT-proBNP

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) in accordance with the protocol.
*Please contact us for more details.

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

Related Information

• Primary Sponsor: Matsushima Naoko