Examine the efficacy of satralizumab in patients with pulmonary arterial hypertension (PAH) with immune-responsive phenotype serum interleukin-6 (IL-6) ≥ 2.73 pg/mL who have an inadequate response to existing drugs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Efficacy Evaluation Period: The study drug will be administered at a dose of 120 mg subcutaneously at initial, 2-week, 4-week, and 4-week intervals thereafter. Efficacy will be assessed after 24 weeks of study drug administration. Subjects who demonstrate efficacy and wish to continue treatment will receive the study drug for 24 weeks and moving to the continuous treatment period. In all other cases, the study will be terminated after 24 weeks of the efficacy evaluation period without the administration of study drug. Continuation Dosing Period\[1\]: Subjects who demonstrate efficacy during the efficacy evaluation period and wish to continue will receive continued 28 weeks (52 weeks total) treatment with satralizumab. Continuation Dosing Period\[2\]: Subjects completed continuation dosing period\[1\], clinically capable of continued administration, and wish to continue will receive continued treatment with satralizumab until the end of this study period.
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan
Chiba University Hospital
Chiba, Japan
Kyushu University Hospital
Fukuoka, Japan
Kobe University Hospital
Kobe, Japan
Percent change in total pulmonary vascular resistance (PVR) from baseline to 24 weeks.
Time frame: 24 weeks
The change in the 6-minute walking distance from baseline to 24 weeks.
Time frame: 24 weeks
Comparison of the percent change in PVR from baseline to 24 weeks between the satralizumab group in this study and an external control group (selected from patients enrolled in JAPHR).
Time frame: 24 weeks
Number of participants with treatment-related adverse events as assessed by MedDRA and changes in general laboratory test values.
Time frame: 52 weeks, beyond 52 weeks(1 year)
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Kyorin University Hospital
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Nagoya University Hospital
Nagoya, Japan
Hokkaido University Hospital
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International University of Health and Welfare Mita Hospital
Tokyo, Japan