Evaluating GenaKumab for treating active systemic juvenile idiopathic arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Lijun Tang
• Email: tanglijun@genscigroup.com
• Phone: +86 18570616501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.