Ireland
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Recruiting Not applicable

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

NCT05925452 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2023-12-01
Last updated
2026-09-17

Condition(s) studied

Active Systemic Juvenile Idiopathic Arthritis

Investigational drug(s) / intervention(s)

GenaKumab

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

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Male and female patients, with the remaining before age 2 years old or more and \& lt; 18 years old; * 2001 ILAR classification criteria for the diagnosis of confirmed sJIA 2 or more months: onset age must \& lt; At 16 years of age, symptoms included: ≥1 case of arthritis, accompanied by or prior to ≥2 weeks of recurrent fever, including remittenor fever for ≥3 consecutive days (maximum daily body temperature ≥39 ° C, body temperature falling below 37 ° C between 2 heat peaks), accompanied by at least one of the following symptoms: ① a transient, non-fixed erythematous rash; ② systemic lymph node enlargement; Swelling of the liver and/or spleen; ④ Serositis. * Agree to use effective means of contraception throughout the study period and for 6 months after the end of treatment. Exclusion Criteria: * Pregnant or lactating female subjects * A history of allergic reactions to investigational drugs or to molecules with similar structures; Those who cannot be given intramuscular injections; * History of pericarditis, myocarditis, serositis, bacterial heart valve or endocarditis within 6 months before screening; Patients who had been diagnosed with MAS within 6 months prior to screening, or had relevant symptoms and signs at screening, and were suspected of having MAS as assessed by the investigators; * There are other rheumatic diseases such as Kawasaki disease, polyarteritis nodosa and so on. History of autoinflammatory diseases such as familial Mediterranean fever, high IgD syndrome, NLRP3-related autoinflammatory diseases; * Patients with a history of interstitial lung disease, pulmonary fibrosis, alveolar proteinosis, or pulmonary hypertension; Patients with a history of repeated invasive fungal infection; In the 7 days prior to randomization, there were infections that required control with systemic antigenic microbiotics (including antibacterial, antiviral, antifungal, etc.); * Subjects with a history of TB exposure or suspected TB symptoms.

Primary outcome measure(s)

  • Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period — 24 Week

Trial sites (10)

FacilityCityRegionStatus
Children's Hospital Affiliated to Capital Medical University Beijing Benjing Recruiting
Children's Hospital Affiliated to Chongqing Medical University Chongqing Chongqing Municipality Not Yet Recruiting
Hunan Children's Hospital Changsha Hunan Not Yet Recruiting
Children's Hospital Affiliated to Nanjing Medical University Nanjing Jiangsu Not Yet Recruiting
Children's Hospital of Soochow University Suzhou Jiangsu Not Yet Recruiting
Affiliated Pediatric Hospital of Fudan University Shanghai Shanghai Municipality Not Yet Recruiting
Xi'an Children's Hospital Xi’an Shanxi Not Yet Recruiting
Chengdu Women and Children's Central Hospital Chengdu Sichuan Not Yet Recruiting
Children's Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Not Yet Recruiting
The Second Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05925452 on ClinicalTrials.gov ↗ ← All trials in China