Actively Recruiting
A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease
Led by Ruijin Hospital · Updated on 2026-04-13
20
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to compare the efficacy and safety of firsekibart versus anakinra in patients with AOSD.
CONDITIONS
Official Title
A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years inclusive
- Willingness to participate and sign informed consent
- Diagnosis of Adult-Onset Still's Disease based on Yamaguchi criteria with at least 5 criteria including 2 major ones
- Active disease defined by 2 Yamaguchi criteria plus fever or CRP >10 mg/L
- Stable glucocorticoid dose for at least 1 week prior to randomization, maximum 1 mg/kg/day
- No pregnancy plans and agreement to use contraception from screening until 28 days after last dose
You will not qualify if you...
- Recent use of BTK inhibitors, JAK inhibitors, intravenous immunoglobulin, plasmapheresis, or traditional Chinese medicine within 4 weeks prior to screening
- Use of anakinra within 1 day prior to randomization
- Use of etoposide within 12 weeks prior to baseline
- Recent increase or addition of new non-biologic agents for rheumatic/autoimmune diseases within 3 days prior to baseline unless discontinued
- History of hypersensitivity to study drugs
- Presence or suspicion of hemophagocytic lymphohistiocytosis (HLH) at baseline or within 2 months
- History or current hematologic diseases
- Recent serious cardiovascular events or severe heart conditions
- Significant pulmonary diseases with abnormal lung function
- History of malignancy within 5 years except certain skin cancers
- Uncontrolled or significant acute/chronic diseases or planned risky medical procedures
- Mycobacterium tuberculosis infection or latent tuberculosis
- Positive serology for hepatitis B, hepatitis C, HIV, or syphilis
- Uncontrolled infection at screening
- Planned surgery or medical conditions making participation unsafe
- History of major organ or bone marrow transplant
- Renal impairment with abnormal kidney function tests
- Pregnancy or breastfeeding
- Participation in other clinical trials within 3 months
- Live vaccinations within 30 days prior to screening
- History of alcohol abuse within 3 months
- Positive drug screen for specified substances
- Any other condition increasing risk or interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
C
Chengde Yang
CONTACT
Q
Qiongyi Hu
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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