Evaluating GenaKumab for treating active systemic juvenile idiopathic arthritis

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.

This study is testing a new medication called GenaKumab to see if it helps children and teens with active systemic juvenile idiopathic arthritis feel better and stay safe while using it.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 221 (estimated)
• Ages: 2 Years to 17 Years
• Sex: All
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: GenaKumab
• Locations: 10 sites (Beijing, Benjing and 9 other locations)
• Trial ID: NCT05925452 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, randomized study aimed at assessing the efficacy and safety of GenaKumab in children and adolescents diagnosed with active systemic juvenile idiopathic arthritis (sJIA). Participants will be monitored for their response to the treatment over a specified period, with a focus on both clinical outcomes and safety profiles. The study will include patients aged 2 to under 18 years who meet specific diagnostic criteria for sJIA, ensuring a targeted approach to this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are male and female patients aged 2 to under 18 years diagnosed with active systemic juvenile idiopathic arthritis.

Not a fit: Patients who are pregnant, lactating, or have a history of allergic reactions to investigational drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for managing active systemic juvenile idiopathic arthritis in young patients.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies targeting juvenile idiopathic arthritis have shown promise in the past, indicating potential for success.

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.

Where this trial is running

Beijing, Benjing and 9 other locations

• Children's Hospital Affiliated to Capital Medical University — Beijing, Benjing, China (RECRUITING)
• Children's Hospital Affiliated to Chongqing Medical University — Chongqing, Chongqing Municipality, China (NOT_YET_RECRUITING)
• Hunan Children's Hospital — Changsha, Hunan, China (NOT_YET_RECRUITING)
• Children's Hospital Affiliated to Nanjing Medical University — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
• Children's Hospital of Soochow University — Suzhou, Jiangsu, China (NOT_YET_RECRUITING)
• Affiliated Pediatric Hospital of Fudan University — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
• Xi'an Children's Hospital — Xi’an, Shanxi, China (NOT_YET_RECRUITING)
• Chengdu Women and Children's Central Hospital — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• Children's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)
• The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Lijun Tang

Conditions: Active Systemic Juvenile Idiopathic Arthritis