At a glance
ClinicalIndex Comparison RecordN/ARecruiting· 221 target
Drug / intervention
GenaKumabdrug
Likely dose
GenaKumab 3.0mg/kgfrom record
Key inclusion· 6
- ✓Male and female patients aged ≥2 and <18 years old
- ✓Confirmed sJIA diagnosis for ≥2 months using 2001 ILAR criteria
- ✓Onset age must be <16 years
- ✓≥1 case of arthritis with ≥2 weeks of recurrent remittent fever (≥3 consecutive days, maximum daily temperature ≥39°C)
Key exclusion· 11
- ✕Pregnant or lactating female subjects
- ✕History of allergic reactions to investigational drugs or structurally similar molecules
- ✕Cannot receive intramuscular injections
- ✕History of pericarditis, myocarditis, serositis, bacterial heart valve disease, or endocarditis within 6 months before screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
Changchun GeneScience Pharmaceutical Co., Ltd.·interventional·Posted Jun 29, 2023·Updated Sep 23, 2024
In Brief
A clinical study evaluating GenaKumab for Active Systemic Juvenile Idiopathic Arthritis. Currently recruiting, targeting 221 participants across 10 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--
Timeline
N/ARecruiting
20242025202620272028
First PostedJun 2023
Enrollment StartDec 2023
TodayJul 2026
Primary CompletionMar 2028
Study CompletionJun 2028
First PostedJun 29, 2023
Enrollment StartDec 1, 2023
Primary CompletionMar 24, 2028
Study CompletionJun 29, 2028
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 3.0 years agoPrimary completion in 1.7 years
Interventions
GenaKumabdrug
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