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

NCT ID: NCT05925452
Registry status: Recruiting
Study type: Not specified in the registry data
Phase: Not applicable
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 290 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages: Not specified in the registry data
Sex: Not specified in the registry data
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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.

Study locations

10 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: China

Benjing, China: 1
Chongqing Municipality, China: 1
Hunan, China: 1
Jiangsu, China: 2
Shanghai Municipality, China: 1
Shanxi, China: 1
Sichuan, China: 1
Zhejiang, China: 2

Sample of listed locations

Children's Hospital Affiliated to Capital Medical University — Beijing, Benjing, 100045, China — Site recruitment status not specified in the registry data
Children's Hospital Affiliated to Chongqing Medical University — Chongqing, Chongqing Municipality, 400015, China — Site recruitment status not specified in the registry data
Hunan Children's Hospital — Changsha, Hunan, 410323, China — Site recruitment status not specified in the registry data
Children's Hospital Affiliated to Nanjing Medical University — Nanjing, Jiangsu, 210008, China — Site recruitment status not specified in the registry data
Children's Hospital of Soochow University — Suzhou, Jiangsu, 215002, China — Site recruitment status not specified in the registry data
Affiliated Pediatric Hospital of Fudan University — Shanghai, Shanghai Municipality, 201102, China — Site recruitment status not specified in the registry data
Xi'an Children's Hospital — Xi’an, Shanxi, 710002, China — Site recruitment status not specified in the registry data
Chengdu Women and Children's Central Hospital — Chengdu, Sichuan, 610073, China — Site recruitment status not specified in the registry data
Children's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, 310016, China — Site recruitment status not specified in the registry data
The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, 325099, China — Site recruitment status not specified in the registry data

Study details

Start date: December 1, 2023
Primary completion date: March 24, 2028
First posted: June 29, 2023

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT05925452
Registry last updated: September 17, 2026
QualifiedStudies registry data refreshed: September 21, 2026

View NCT05925452 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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