A Phase 3 Study of Sotatercept in Japanese PAH Participants

JRCT ID: jRCT2031230046

Registered date:21/04/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Pulmonary Arterial Hypertension (PAH)
• Date of first enrollment: 10/05/2023
• Target sample size: 35
• Study type: Interventional
• Intervention(s): MK-7962 (Sotatercept) is administered subcutaneously (SC) starting at a dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks (21days)

Outcome(s)

Primary Outcome

1. Pulmonary vascular resistance
2. Adverse events
3. Adverse events leading to discontinuation
of study intervention

Secondary Outcome

1. 6 minutes walk distance
2. WHO functional class
3. NT-proBNP

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Documented diagnostic RHC at any time prior to screening confirming the diagnosis of WHO PAH Group 1 in any of the following subtypes:
- Idiopathic PAH
- Heritable PAH
- Drug/toxin-induced PAH
- PAH associated with connective tissue disease
- PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
2. PAH classified as WHO FC I or symptomatic PAH classified as WHO FC II to IV
3. Baseline RHC performed during the Screening Period documenting a minimum PVR of >=400 dyn*sec/cm5 (5 Wood unit)
4. On stable doses of background PAH therapy (i.e., patient-specific dose goal for each therapy already achieved) and diuretics (if applicable) for at least 90 days prior to
screening.
5. 6MWD >= 150 and <= 500 m repeated twice at screening (measured at least 4 hours apart, but no longer than 1 week), and both values are within 15% of each other (calculated from the highest value).

Exclude criteria

1. Diagnosis of PH WHO Groups 2, 3, 4, or 5.
2. Diagnosis of the following PAH Group 1 subtypes:
- human immunodeficiency virus (HIV)-associated PAH
- PAH associated with portal hypertension
- schistosomiasis-associated PAH
- PAH with features of significant venous/capillary (PVOD/PCH) involvement
3. Pregnant or breastfeeding women.
4. History of full or partial pneumonectomy.
5. Pulmonary function test (PFT) values of forced vital capacity (FVC) < 60% predicted at the screening visit or within 6 months prior to the screening visit.

Related Information

• Primary Sponsor: Kobayashi Masayuki
• Secondary ID(s): NCT05818137