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ACTIVE NOT RECRUITING
NCT05679570
PHASE2

Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial)

Sponsor: International University of Health and Welfare

View on ClinicalTrials.gov

Summary

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.

Official title: Satralizumab,an Anti-IL-6 Receptor Antibody, in the Treatment of Pulmonary Arterial Hypertension; Safety and Efficacy Evaluation in Japan -Multicenter, Investigator-sponsored Trial-

Key Details

Gender

All

Age Range

20 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-07-12

Completion Date

2026-06-30

Last Updated

2025-09-03

Healthy Volunteers

No

Interventions

DRUG

Satralizumab (Genetical Recombination)

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.

Locations (9)

Kagoshima University Hospital

Kagoshima, Kagoshima-ken, Japan

Chiba University Hospital

Chiba, Japan

Kyushu University Hospital

Fukuoka, Japan

Kobe University Hospital

Kobe, Japan

Kurume University Hospital

Kurume, Japan

Kyorin University Hospital

Mitaka, Japan

Nagoya University Hospital

Nagoya, Japan

Hokkaido University Hospital

Sapporo, Japan

International University of Health and Welfare Mita Hospital

Tokyo, Japan