Efficacy and Safety of Seralutinib in Adult Subjects with PAH

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051230191

Enrollment

Registered

2024-02-27

Start date

2024-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension, PAH, 6MWT

Interventions

Subjects will receive IP BID, inhaled orally with a dry powder inhaler (DPI), for a minimum of 24 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Diagnosis of PAH. 2.Two 6MWDs = > 150 meters and = 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) = 400 to 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. *Please contact us for more details.

Exclusion criteria

Exclusion criteria: *Please contact us for more details.

Design outcomes

Primary

Measure	Time frame
Change in distance achieved on the six-minute walk test (6MWT), (6MWD) from baseline to Week 24	—

Secondary

Measure	Time frame
-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 *Please contact us for more details.	—

Measure

Time frame

-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 *Please contact us for more details.

—

Countries

etc., France, Germany, Japan, UK, USA

Contacts

Public ContactNaoko Matsushima

Japan Clinical Research Operations K.K.

naoko.matsushima@jcro.jp+81-3-6205-4165

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026