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

NCT05679570 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Japan Agency for Medical Research and Development

    collaborator OTHER_GOV

  • Keio University

    collaborator OTHER

  • Chugai Pharmaceutical

    collaborator INDUSTRY

  • International University of Health and Welfare

    lead OTHER

Principal Investigators

  • Yuichi Tamura · International University of Health and Welfare

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-12
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05679570 on ClinicalTrials.gov