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To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Summary
A multicenter, randomized Phase II/III clinical study to evaluate the efficacy and safety of GenaKumab in the treatment of active systemic juvenile idiopathic arthritis.
Official title: A Multicenter, Randomized Phase II/III Clinical Study to Evaluate the Efficacy and Safety of GenaKumab in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
221
Start Date
2023-12-01
Completion Date
2028-06-29
Last Updated
2024-09-23
Healthy Volunteers
No
Interventions
GenaKumab
GenaKumab 3.0mg/kg dose group : GenaKumab 3.0 mg/kg, Subcutaneous injection, Q4w; GenaKumab 4.0 mg/kg dose group : GenaKumab 4.0 mg/kg, Subcutaneous injection, Q4w
Locations (10)
Children's Hospital Affiliated to Capital Medical University
Beijing, Benjing, China
Children's Hospital Affiliated to Chongqing Medical University
Chongqing, Chongqing Municipality, China
Hunan Children's Hospital
Changsha, Hunan, China
Children's Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Affiliated Pediatric Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Xi'an Children's Hospital
Xi’an, Shanxi, China
Chengdu Women and Children's Central Hospital
Chengdu, Sichuan, China
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China