New antibody tested to tame childhood arthritis and cut steroid use
NCT ID NCT05925452
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing an experimental drug called GenaKumab in children and teens with active systemic juvenile idiopathic arthritis, a condition that causes joint inflammation and recurring fevers. The trial enrolls about 290 participants aged 2 to under 18 who have had symptoms for at least two months. Participants receive GenaKumab or a comparison treatment by injection every four weeks. The main goal is to see whether the drug helps children safely reduce their use of glucocorticoid steroids.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental antibody drug called GenaKumab
- What this could lead to
- If it works, GenaKumab could offer children with systemic juvenile idiopathic arthritis a new treatment option and help them take lower doses of steroids.
- What could go wrong
- The drug is still experimental and may not control the disease better than existing treatments. It could cause side effects, and results in a trial may not apply to every child with this condition.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 290 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Pediatric Hospital of Fudan University
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 201102, China
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Chengdu Women and Children's Central Hospital
NOT_YET_RECRUITINGChengdu, Sichuan, 610073, China
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Children's Hospital Affiliated to Capital Medical University
RECRUITINGBeijing, Benjing, 100045, China
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Children's Hospital Affiliated to Chongqing Medical University
NOT_YET_RECRUITINGChongqing, Chongqing Municipality, 400015, China
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Children's Hospital Affiliated to Nanjing Medical University
NOT_YET_RECRUITINGNanjing, Jiangsu, 210008, China
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Children's Hospital of Soochow University
NOT_YET_RECRUITINGSuzhou, Jiangsu, 215002, China
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Children's Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310016, China
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Hunan Children's Hospital
NOT_YET_RECRUITINGChangsha, Hunan, 410323, China
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The Second Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITINGWenzhou, Zhejiang, 325099, China
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Xi'an Children's Hospital
NOT_YET_RECRUITINGXi’an, Shanxi, 710002, China