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Clinical Trial NCT05925452 for Active Systemic Juvenile Idiopathic Arthritis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis. 221 Randomized
Clinical Trial NCT05925452 is an interventional study for Active Systemic Juvenile Idiopathic Arthritis that is recruiting. It started on December 1, 2023 with plans to enroll 221 participants. Led by Changchun GeneScience Pharmaceutical Co., Ltd., it is expected to complete by June 29, 2028. The latest data from ClinicalTrials.gov was last updated on September 23, 2024.
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.
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.
Conditions
Active Systemic Juvenile Idiopathic ArthritisPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- GenSci048-201
NCT ID Number
Start Date (Actual)
2023-12-01
Last Update Posted
2024-09-23
Completion Date (Estimated)
2028-06-29
Enrollment (Estimated)
221
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalGenaKumab 15 subjects: GenaKumab 3.0mg/kg dose group and 4.0 mg/kg dose group, Subcutaneous injection, Q4w | 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
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period | 24 Week |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
2 Years
Eligible Sexes
All
- 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.
Changchun GeneScience Pharmaceutical Co., Ltd.Study Central Contact
Contact: Lijun Tang, +86 18570616501, [email protected]
10 Study Locations in 1 Countries
Benjing
Children's Hospital Affiliated to Capital Medical University, Beijing, Benjing, 100045, China
Caifeng Li, Doctor, Contact, +86-10-59616316, [email protected]
Recruiting
Chongqing Municipality
Children's Hospital Affiliated to Chongqing Medical University, Chongqing, Chongqing Municipality, 400015, China
Xuemei Tang, Doctor, Contact, +86-0731-85356314, [email protected]
Not yet recruiting
Hunan
Hunan Children's Hospital, Changsha, Hunan, 410323, China
Zhihui Li, Doctor, Contact, +86-023-68370205, [email protected]
Not yet recruiting
Jiangsu
Children's Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu, 210008, China
Qihua Feng, Doctor, Contact, +86-0521-80698511, [email protected]
Not yet recruiting
Children's Hospital of Soochow University, Suzhou, Jiangsu, 215002, China
Cuihua Liu, Doctor, Contact, +86- 0371-85515853, [email protected]
Not yet recruiting
Shanghai Municipality
Affiliated Pediatric Hospital of Fudan University, Shanghai, Shanghai Municipality, 201102, China
Li Sun, Doctor, Contact, +86-021-64931990, [email protected]
Not yet recruiting
Shanxi
Xi'an Children's Hospital, Xi’an, Shanxi, 710002, China
Xiaoqing Zuo, Doctor, Contact, +86-029- 87692043, [email protected]
Not yet recruiting
Sichuan
Chengdu Women and Children's Central Hospital, Chengdu, Sichuan, 610073, China
Wenjie Zheng, Doctor, Contact, +86-0557-81732562, [email protected]
Not yet recruiting
Zhejiang
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310016, China
Meiping Lu, Doctor, Contact, +86-0571- 81732562, [email protected]
Not yet recruiting
The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325099, China
Haiguo Yu, Doctor, Contact, +86-025-8311750, [email protected]
Not yet recruiting