A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease (NCT07191444) | Clinical Trial Compass
RecruitingNot Applicable
A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease
China20 participantsStarted 2025-09-24
Plain-language summary
The purpose of this study is to compare the efficacy and safety of firsekibart versus anakinra in patients with AOSD.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: This study will include subjects aged 18 to 75 years (inclusive), regardless of gender.
* Subjects must be willing to participate in the study and voluntarily sign an informed consent form.
* Diagnosis of AOSD will be based on the Yamaguchi criteria: Major criteria: (1) Fever ≥39°C lasting for ≥1 week; (2) Arthralgia lasting for ≥2 weeks; (3) Typical rash; (4) White blood cell count ≥10×10\^9/L with neutrophils ≥80%. Minor criteria: (1) Sore throat or pharyngitis; (2) Lymphadenopathy and/or splenomegaly; (3) Abnormal liver function; (4) Negative rheumatoid factor and antinuclear antibody. Exclusion criteria: (1) Infectious diseases (especially sepsis and EBV infection); (2) Malignancies (especially lymphoma); (3) Other rheumatic diseases (particularly systemic vasculitis). After excluding the above exclusion criteria, a diagnosis of AOSD requires meeting ≥5 of the above criteria (including at least 2 major criteria).
* Active disease is defined as meeting 2 Yamaguchi criteria along with the presence of fever or CRP \>10 mg/L.
* If currently receiving glucocorticoid therapy, the dose must have been stable for at least 1 week prior to randomization. The maximum allowed dose is 1 mg/kg/day.
* Subjects (including their partners) must have no pregnancy plans from the screening period until 28 days after the last dose and must voluntarily use contraception.
Exclusion Criteria:
* Pre-randomization Medications: a) Received BTK inhibitors, JAK inhibitors,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of subjects achieving clinical inactive disease (CID) at Week 24, where CID is defined as the absence of Still's disease-related symptoms with normal ESR or CRP levels.
Timeframe: At Week 24 from initiation of treatment