Clinical trial NCT05925452: To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Active Systemic Juvenile Idiopathic Arthritis
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-29
Enrollment: 221
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period
timeFrame: 24 Week
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Children's Hospital Affiliated to Capital Medical University
state: Benjing
city: Chongqing
country: China
facility: Children's Hospital Affiliated to Chongqing Medical University
state: Chongqing
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
city: Nanjing
country: China
facility: Children's Hospital Affiliated to Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: Children's Hospital of Soochow University
state: Jiangsu
city: Shanghai
country: China
facility: Affiliated Pediatric Hospital of Fudan University
state: Shanghai
city: Xi'an
country: China
facility: Xi'an Children's Hospital
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Women and Children's Central Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Children's Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: