ClinicalTrials.gg
RecruitingNCT05925452Updated Sep 17, 2026

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

An interventional study of GenaKumab in Active Systemic Juvenile Idiopathic Arthritis, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Recruiting at 10 sites in China. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
290
Allocation
Not applicable
Ages
2 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Active Systemic Juvenile Idiopathic Arthritis

Browse trials for

03

In context

Arthritis, Juvenile

365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.

This study's planned enrollment of 290 is above the median of 52 across 230 interventional studies indexed under Arthritis, Juvenile.

Browse Arthritis, Juvenile studies →

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 111 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 throughout the study period and for 6 months after the end of treatment.

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating female subjects
  • A history of allergic reactions to 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
290 participants (estimated)

Study arms

  • Experimental
    GenaKumab

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

    Drug: GenaKumab

Interventions

  • DrugGenaKumab

    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

06

What researchers measure

Primary outcomes

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

    Time frame: 24 Week

07

Study locations

1 of 10 sites recruiting
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2023 (actual). Primary completion is estimated for Mar 2028, 51 months after the start.

Of 56 interventional studies with no phase under Arthritis, Juvenile, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 39. This study's planned 51 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2023
First posted
Jun 29, 2023
StartActual
Dec 1, 2023
Primary completionEst.
Mar 24, 2028
CompletionEst.
Jun 29, 2028
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05925452
Responsible party
Sponsor
First posted
Jun 29, 2023
Start date
Dec 1, 2023
Primary completion
Mar 24, 2028 (estimated)
Completion
Jun 29, 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Lijun Tang
Contact
tanglijun@genscigroup.com
+86 18570616501

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion