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RECRUITING
NCT05925452
NA

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.

View on ClinicalTrials.gov

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

DRUG

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