NCT05679570

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: International University of Health and Welfare · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-12
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2023-01-11
• Last updated: 2025-09-03

Locations

9 sites across 1 country: Japan