To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.
- Conditions
- Active Systemic Juvenile Idiopathic Arthritis
- Interventions
- Registration Number
- NCT05925452
- Lead Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Brief Summary
A multicenter, randomized, open-label Phase IIb clinical study to evaluate the efficacy and safety of GenaKumab in the treatment of active systemic juvenile idiopathic arthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GenaKumab GenaKumab 15 subjects: GenaKumab 3.0mg/kg dose group and 4.0 mg/kg dose group, Subcutaneous injection, Q4w
- Primary Outcome Measures
Name Time Method Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period 24 Week
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Children's Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Benjing, China
Children's Hospital Affiliated to Chongqing Medical University
🇨🇳Chongqing, Chongqing, 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, 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