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

July 5, 2023 updated by: GeneScience Pharmaceuticals Co., Ltd.

A Multicenter, Randomized, Open-label Phase IIb Clinical Study to Evaluate the Efficacy and Safety of GenaKumab in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.

A multicenter, randomized, open-label Phase IIb clinical study to evaluate the efficacy and safety of GenaKumab in the treatment of active systemic juvenile idiopathic arthritis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Benjing
      • Beijing, Benjing, China, 100045
        • Children's Hospital Affiliated to Capital Medical University
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400015
        • Children's Hospital Affiliated to Chongqing Medical University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410323
        • Hunan Children's Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Children's Hospital Affiliated to Nanjing Medical University
        • Contact:
          • Qihua Feng, Doctor
          • Phone Number: +86-0521-80698511
          • Email: fqhwmh@163.com
      • Suzhou, Jiangsu, China, 215002
        • Children's Hospital of Soochow University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Affiliated Pediatric Hospital of Fudan University
        • Contact:
    • Shanxi
      • Xi'an, Shanxi, China, 710002
        • Xi'an Children's Hospital
        • Contact:
          • Xiaoqing Zuo, Doctor
          • Phone Number: +86-029- 87692043
          • Email: xa_lxq@163.com
    • Sichuan
      • Chengdu, Sichuan, China, 610073
        • Chengdu Women and Children's Central Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Children's Hospital, Zhejiang University School of Medicine
        • Contact:
      • Wenzhou, Zhejiang, China, 325099
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GenaKumab
15 subjects: GenaKumab 0.5mg/kg dose group and 4.0 mg/kg dose group, Subcutaneous injection, Q4w
Drug: GenaKumab
GenaKumab 0.5mg/kg dose group : GenaKumab 0.5 mg/kg, Subcutaneous injection, Q4w, Dose adjustable, The maximum is 4.0 mg/kg; GenaKumab 4.0 mg/kg dose group : GenaKumab 4.0 mg/kg fixed dose, Subcutaneous injection, Q4w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period
Time Frame: 24 Week
24 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GeneScience Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 16, 2023

Primary Completion (Estimated)

July 26, 2024

Study Completion (Estimated)

October 22, 2024

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 29, 2023

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GenSci048-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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