Recruiting NCT05925452
To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GenaKumab.
- Who it may be relevant to
- Registry conditions: Active Systemic Juvenile Idiopathic Arthritis. Basic parameters: 2 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
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
Primary outcome measures
- Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period [Time frame: 24 Week]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 10 centers
- Children's Hospital Affiliated to Capital Medical University — Beijing
- Children's Hospital Affiliated to Chongqing Medical University — Chongqing
- Hunan Children's Hospital — Changsha
- Children's Hospital Affiliated to Nanjing Medical University — Nanjing
- Children's Hospital of Soochow University — Suzhou
- Affiliated Pediatric Hospital of Fudan University — Shanghai
- Xi'an Children's Hospital — Xi’an
- Chengdu Women and Children's Central Hospital — Chengdu
- … and 2 more centers
Publications
- Li C, Zhang J, Yu H, Lu M, Yang S, Liu C, Zeng P, Zhao B, Li X, Zheng W, Du Y, Zhang W, Li Z, Hu X, Lai J, Xu Q, Zhang X, Wang X, Adili P, Qu W. Efficacy and Safety of Firsekibart in Treatment of Active Systemic Juvenile Idiopathic Arthritis: A Randomized Phase 2 Study. Rheumatol Ther. 2026 Jun;13(3):595-610. doi: 10.1007/s40744-026-00830-9. Epub 2026 Mar 11. PMID 41814037
Identifiers
NCT: NCT05925452 · GenSci048-201