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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2028-06-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Active Systemic Juvenile Idiopathic Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GenaKumab

15 subjects: GenaKumab 3.0mg/kg dose group and 4.0 mg/kg dose group, Subcutaneous injection, Q4w

Group Type EXPERIMENTAL

GenaKumab

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospital Affiliated to Capital Medical University

Beijing, Benjing, China

Site Status RECRUITING