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

Primary Purpose

Active Systemic Juvenile Idiopathic Arthritis

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
GenaKumab
Sponsored by
Changchun GeneScience Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active Systemic Juvenile Idiopathic Arthritis

Eligibility Criteria

2 Years - 17 Years (Child)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital Affiliated to Capital Medical University
  • Children's Hospital Affiliated to Chongqing Medical University
  • Hunan Children's Hospital
  • Children's Hospital Affiliated to Nanjing Medical University
  • Children's Hospital of Soochow University
  • Affiliated Pediatric Hospital of Fudan University
  • Xi'an Children's Hospital
  • Chengdu Women and Children's Central Hospital
  • Children's Hospital, Zhejiang University School of Medicine
  • The Second Affiliated Hospital of Wenzhou Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GenaKumab

Arm Description

15 subjects: GenaKumab 0.5mg/kg dose group and 4.0 mg/kg dose group, Subcutaneous injection, Q4w

Outcomes

Primary Outcome Measures

Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period

Secondary Outcome Measures

Full Information

First Posted
June 21, 2023
Last Updated
July 5, 2023
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05925452
Brief Title
To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 16, 2023 (Anticipated)
Primary Completion Date
July 26, 2024 (Anticipated)
Study Completion Date
October 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Systemic Juvenile Idiopathic Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GenaKumab
Arm Type
Experimental
Arm Description
15 subjects: GenaKumab 0.5mg/kg dose group and 4.0 mg/kg dose group, Subcutaneous injection, Q4w
Intervention Type
Drug
Intervention Name(s)
GenaKumab
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period
Time Frame
24 Week

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jintao Yue
Phone
+86 15333202381
Email
yuejintao@gensci-china.com
Facility Information:
Facility Name
Children's Hospital Affiliated to Capital Medical University
City
Beijing
State/Province
Benjing
ZIP/Postal Code
100045
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caifeng Li, Doctor
Phone
+86-10-59616316
Email
caifeng_li@yeah.net
Facility Name
Children's Hospital Affiliated to Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400015
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuemei Tang, Doctor
Phone
+86-0731-85356314
Email
tangxuemei2008@163.com
Facility Name
Hunan Children's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410323
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihui Li, Doctor
Phone
+86-023-68370205
Email
Lizh0731@aliyun.com
Facility Name
Children's Hospital Affiliated to Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qihua Feng, Doctor
Phone
+86-0521-80698511
Email
fqhwmh@163.com
Facility Name
Children's Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215002
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cuihua Liu, Doctor
Phone
+86- 0371-85515853
Email
Lchlch123@126.com
Facility Name
Affiliated Pediatric Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Sun, Doctor
Phone
+86-021-64931990
Email
lillysun@263.net
Facility Name
Xi'an Children's Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710002
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoqing Zuo, Doctor
Phone
+86-029- 87692043
Email
xa_lxq@163.com
Facility Name
Chengdu Women and Children's Central Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610073
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjie Zheng, Doctor
Phone
+86-0557-81732562
Email
wzwjzheng@sina.com
Facility Name
Children's Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meiping Lu, Doctor
Phone
+86-0571- 81732562
Email
meipinglu@126.com
Facility Name
The Second Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325099
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiguo Yu, Doctor
Phone
+86-025-8311750
Email
yuhaiguo73@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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