Active Systemic Juvenile Idiopathic ArthritisNCT05925452
To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.
A study testing GenaKumab in people with Active Systemic Juvenile Idiopathic Arthritis, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 10 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Active Systemic Juvenile Idiopathic Arthritis
- What is being tested?
- GenaKumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 10 sitesChina
- Study dates
- 1 Dec 2023to 29 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Children's Hospital Affiliated to Capital Medical University
Beijing, Benjing, 100045
Caifeng Li, Doctor, +86-10-59616316, caifeng_li@yeah.net
- Not yet recruiting
Hunan Children's Hospital
Changsha, Hunan, 410323
Zhihui Li, Doctor, +86-023-68370205, Lizh0731@aliyun.com
- Not yet recruiting
Chengdu Women and Children's Central Hospital
Chengdu, Sichuan, 610073
Wenjie Zheng, Doctor, +86-0557-81732562, wzwjzheng@sina.com
- Not yet recruiting
Children's Hospital Affiliated to Chongqing Medical University
Chongqing, Chongqing Municipality, 400015
Xuemei Tang, Doctor, +86-0731-85356314, tangxuemei2008@163.com
- Not yet recruiting
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Meiping Lu, Doctor, +86-0571- 81732562, meipinglu@126.com
- Not yet recruiting
Children's Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, 210008
Qihua Feng, Doctor, +86-0521-80698511, fqhwmh@163.com
- Not yet recruiting
Affiliated Pediatric Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Li Sun, Doctor, +86-021-64931990, lillysun@263.net
- Not yet recruiting
Children's Hospital of Soochow University
Suzhou, Jiangsu, 215002
Cuihua Liu, Doctor, +86- 0371-85515853, Lchlch123@126.com
- Not yet recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325099
Haiguo Yu, Doctor, +86-025-8311750, yuhaiguo73@163.com
- Not yet recruiting
Xi'an Children's Hospital
Xi’an, Shanxi, 710002
Xiaoqing Zuo, Doctor, +86-029- 87692043, xa_lxq@163.com
About this study
Official title: 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.
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.
- Being tested
- GenaKumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenaKumabDrug
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
| Study group | Role | What they receive |
|---|---|---|
| GenaKumab | Experimental | 15 subjects: GenaKumab 3.0mg/kg dose group and 4.0 mg/kg dose group, Subcutaneous injection, Q4w Receives: Drug: GenaKumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period
Measured: 24 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Dec 2023
- Primary completion24 Mar 2028 (estimated)
- Study completion29 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Active Systemic Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925452
- Sponsor's protocol ID
- GenSci048-201
- Status last verified
- Sep 2026
- First submitted
- 21 Jun 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li C, Zhang J, Yu H, Lu M, Yang S, Liu C, Zeng P, Zhao B, Li X, Zheng W, Du Y, Zhang W, Li Z, Hu X, Lai J, Xu Q, Zhang X, Wang X, Adili P, Qu W. Efficacy and Safety of Firsekibart in Treatment of Active Systemic Juvenile Idiopathic Arthritis: A Randomized Phase 2 Study. Rheumatol Ther. 2026 Jun;13(3):595-610. doi: 10.1007/s40744-026-00830-9. Epub 2026 Mar 11.
PubMed 41814037
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05925452
- Acronym / sponsor ID
- GenSci048-201
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 24 Mar 2028 (estimated)
- Study completion
- 29 Jun 2028 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GenaKumab | Experimental | Drug: GenaKumab15 subjects: GenaKumab 3.0mg/kg dose group and 4.0 mg/kg dose group, Subcutaneous injection, Q4w |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.)；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenaKumabGenaKumab 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 | Drug | GenaKumab |
Primary outcome
Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period
Time frame: 24 Week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 41814037Li C, Zhang J, Yu H, Lu M, Yang S, Liu C, Zeng P, Zhao B, Li X, Zheng W, Du Y, Zhang W, Li Z, Hu X, Lai J, Xu Q, Zhang X, Wang X, Adili P, Qu W. Efficacy and Safety of Firsekibart in Treatment of Active Systemic Juvenile Idiopathic Arthritis: A Randomized Phase 2 Study. Rheumatol Ther. 2026 Jun;13(3):595-610. doi: 10.1007/s40744-026-00830-9. Epub 2026 Mar 11.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GenaKumab in people with Active Systemic Juvenile Idiopathic Arthritis, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lijun Tang (+86 18570616501, tanglijun@genscigroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period (time frame: 24 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05925452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.