RecruitingNot ApplicableNCT05925452

To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.

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.


Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Enrollment

221 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called GenaKumab for people with active systemic juvenile idiopathic arthritis. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 2 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGenaKumab

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

View Full Details on ClinicalTrials.gov

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NCT05925452