drugset
drugset / Trial / NCT07706868

An Efficacy and Safety Study of Subcutaneous Anakinra in Chinese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD)

NCT07706868 ↗

Phase 4 Withdrawn Swedish Orphan Biovitrum Tigermed Consulting Co., Ltd · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of anakinra in Chinese patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD).The study consists of up to four weeks screening, to see if a patient is suitable to the study, 48 weeks of treatment with anakinra and 4 weeks safety follow up after last dose of anakinra. In total 60 patients(expected allocation is 30 SJIA and 30 AOSD), male or female patients, 8 months of age or older with a body weight ≥ 10 kg, will be enrolled to the study.

Timeline

Start
2025-09-01
Primary completion
2028-09-30
Completion
2028-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Anakinra Protein / enzyme biologic 1 mg/kg Subcutaneous
Subject Anakinra Protein / enzyme biologic 2 mg/kg Subcutaneous
Subject Anakinra Protein / enzyme biologic 4 mg/kg Subcutaneous
Subject Anakinra Protein / enzyme biologic 100 mg Subcutaneous

Indications

adult-onset Still disease systemic-onset juvenile idiopathic arthritis