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

NCT05925452 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2024-09-23

No results posted yet for this study

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.

Conditions

  • Active Systemic Juvenile Idiopathic Arthritis

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

Sponsors & Collaborators

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2028-03-24
Completion
2028-06-29

Countries

  • China

Study Locations

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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 NCT05925452 on ClinicalTrials.gov