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A Phase 3 Non-randomized, Non-controlled, Open Label Clinical Study to Evaluate the Efficacy and Safety of MK-7962 (Sotatercept) add-on to Background Therapy in Japanese Participants with Pulmonary Arterial Hypertension (PAH)

A Phase 3 Study of Sotatercept in Japanese PAH Participants

Kobayashi Masayuki

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Not Recruiting

April. 27, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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).

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.

Both

Pulmonary Arterial Hypertension (PAH)

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)

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

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

+81-47-473-1281

Mar. 20, 2023

Yes

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

none