Still's Disease, Adult-OnsetNCT07191444
A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease
An observational study of Still's Disease, Adult-Onset, run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of this study is to compare the efficacy and safety of firsekibart versus anakinra in patients with AOSD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Still's Disease, Adult-Onset
- What is being tested?
- Firsekibart and Anakinra
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2025to 31 Jul 2027
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study participants will be patients with active Adult-Onset Still's Disease recruited from Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.
Who may be able to join
- 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.
Who cannot join
- Pre-randomization Medications: a) Received BTK inhibitors, JAK inhibitors, intravenous immunoglobulin, plasmapheresis, or traditional Chinese medicine within 4 weeks prior to screening or 5 half-lives of the known drug (whichever is shorter). b) Received anakinra therapy within 1 day prior to randomization. c) Received etoposide (VP-16) therapy within 12 weeks prior to the baseline visit. d) Increase in dose or addition of new non-biologic agents for treating rheumatic/autoimmune diseases (e.g., immunosuppressants, immunomodulators, antimalarials) within 3 days prior to the baseline visit, unless deemed ineffective by the investigator and discontinued prior to baseline. Specific agents include: i Immunosuppressants/Immunomodulators: Methotrexate, azathioprine, leflunomide, mycophenolate mofetil (or mycophenolate sodium), mizoribine, calcineurin inhibitors (e.g., tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine, thalidomide, total glucosides of paeony. ii Antimalarials: Hydroxychloroquine, chloroquine, quinacrine.
- History of hypersensitivity to any component of the investigational product.
- Presence or suspicion of hemophagocytic lymphohistiocytosis (HLH) at baseline, or diagnosis of HLH within 2 months prior to randomization. According to the HLH-2004 diagnostic criteria, the diagnosis can be established by meeting any one of the following two conditions: (1) Molecular diagnosis consistent with HLH. (2) Fulfillment of ≥5 of the following 8 criteria: a) Fever: Temperature >38.5°C for >7 days. b) Splenomegaly. c) Cytopenias (affecting ≥2 lineages): Hemoglobin <90 g/L, neutrophils <1.0×10⁹/L, not due to reduced bone marrow function. d) Hypertriglyceridemia and/or hypofibrinogenemia: Triglycerides ≥ 3 mmol/L or >3 SD above age-specific norms, and/or Fibrinogen ≤ 1.5 g/L or <3 SD below age-specific norms.e) Identification of hemophagocytes in bone marrow, spleen, or lymph nodes. f) Elevated serum ferritin (≥500 μg/L). g) Low or absent NK cell activity. h) Elevated soluble IL-2 receptor (sCD25 ≥2400 U/mL).
- Hematologic Diseases: History or current presence of hematologic disorders (including but not limited to myelofibrosis, aplastic anemia, leukemia, lymphoma).
- Cardiovascular Diseases: Acute myocardial infarction or unstable angina within 6 months; severe arrhythmias (multifocal frequent ventricular premature beats, ventricular tachycardia, ventricular fibrillation); NYHA Class III-IV heart failure.
- Pulmonary Diseases: Including but not limited to asthma, COPD, interstitial lung disease, pulmonary alveolar proteinosis, or pulmonary granulomatosis, with abnormal pulmonary function tests (FVC <80% predicted or FEV1/FVC <70%); or any pulmonary condition deemed by the investigator to significantly impair lung function and unsuitable for study participation.
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- Malignancy: History of malignancy within the past 5 years (regardless of treatment), except successfully treated basal cell or squamous cell skin carcinoma.
- Other Diseases: Current clinically significant, unstable, or inadequately controlled acute/chronic diseases (e.g., acute pneumonia, pulmonary hypertension, diabetic ketoacidosis, acute pancreatitis); or planned medical/surgical procedures that may place the subject at undue risk or impair their ability to participate.
- Mycobacterium tuberculosis infection, including latent infection with positive T-SPOT.TB or PPD test.
- Positive serology for HBsAg, HBcAb, HCV-Ab, HIV-Ab, or Treponema pallidum antibody (by TPPA). If HBcAb is positive, HBV-DNA must be below the lower limit of quantification.
- Infection: Uncontrolled infection at screening as judged by the investigator (e.g., tuberculosis, pneumocystis, cytomegalovirus, herpes simplex, herpes zoster, atypical mycobacteria, Histoplasma capsulatum, Salmonella; or recurrent sinusitis, genital herpes, osteomyelitis, urinary tract infections).
- Surgery/Other Conditions: Planned surgery or any other medical history, laboratory abnormality, or condition that, in the investigator's judgment, renders the subject unsuitable for the study.
- Transplant History: History of major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplant.
- Renal impairment: Serum creatinine or BUN >1.5 × ULN; or eGFR ≤60 mL/min/1.73m² (calculated by MDRD formula: eGFR = 186 × [SCr (mg/dL)]-¹.¹⁵⁴ × [Age]-⁰.²⁰³ × [0.742 if female] × 1.233) prior to screening.
- Pregnancy or lactation.
- Participation in any clinical trial (including investigational vaccines) within 3 months prior to enrollment, or previous use of invasive investigational medical devices, or current enrollment in an interventional study.
- Live vaccination within 30 days prior to screening.
- History or evidence of alcohol abuse within 3 months prior to screening.
- Positive urine drug screen for morphine, ketamine, tetrahydrocannabinol, methamphetamine, or methylenedioxymethamphetamine.
- Any other condition that, in the investigator's opinion, would increase the risk associated with study participation, interfere with the evaluation of the investigational product, or confound the interpretation of study results.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Efficacy and Safety of Firsekibart Versus Anakinra in Adult-Onset Still's Disease
The purpose of this study is to compare the efficacy and safety of firsekibart versus anakinra in patients with AOSD.
- Conditions
- Still's Disease, Adult-Onset
- Being tested
- Firsekibart, Anakinra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FirsekibartBiological
Firsekibart will be administered according to the protocol
AnakinraBiological
Anakinra will be administered according to the protocol
| Study group | Role | What they receive |
|---|---|---|
| Firsekibart group | Not described Receives: Biological: Firsekibart | |
| Anakinra group | Not described Receives: Biological: Anakinra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 24 from initiation of treatment
Secondary outcomes (14)
Proportion of subjects achieving afebrile status with either ≥50% reduction in CRP levels or CRP within normal range at Weeks 2, 4, and 8.
Efficacy Endpoints
Measured: At Weeks 2, 4, and 8 after treatment initiation
Proportion of subjects achieving afebrile status with either ≥70% reduction in CRP levels or CRP within normal range at Week 12.
Efficacy Endpoints
Measured: At Week 12 after treatment initiation
Proportion of subjects achieving afebrile status with either ≥70% reduction in CRP levels or CRP within normal range, and glucocorticoid dose ≤0.2 mg/kg/day at Week 12.
Efficacy Endpoints
Measured: At Week 12 after treatment initiation
Proportion of subjects achieving afebrile status with either ≥70% reduction in CRP levels or CRP within normal range, and glucocorticoid dose ≤0.1 mg/kg/day at Week 12.
Efficacy Endpoints
Measured: At Week 12 after treatment initiation
Proportion of subjects achieving clinical inactive disease (CID) with discontinuation of glucocorticoids
Efficacy Endpoints
Measured: At Week 24 after treatment initiation
Proportion of subjects without disease relapse at Weeks 12 and 24.
Efficacy Endpoints
Measured: At Weeks 12 and 24 after treatment initiation
ACR30, ACR50, ACR70, and ACR90 response rates at Weeks 2, 4, 8, 12, 16, 20, and 24.
Efficacy Endpoints
Measured: At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation
Change from baseline in ferritin levels at Weeks 2, 4, 8, 12, 16, 20, and 24.
Efficacy Endpoints
Measured: At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation
Change from baseline in cytokine levels (including sIL-2R) at Weeks 2, 4, 8, 12, 16, 20, and 24.
Efficacy Endpoints
Measured: At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation
Change from baseline in ESR at Weeks 2, 4, 8, 12, 16, 20, and 24.
Efficacy Endpoints
Measured: At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation
Change from baseline in CRP levels at Weeks 2, 4, 8, 12, 16, 20, and 24
Efficacy Endpoints
Measured: At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation
Change from baseline in Pouchot score at Weeks 2, 4, 8, 12, 16, 20, and 24.
Efficacy Endpoints. Pouchot score ranges from 0 to 12 points, with higher scores indicating a poorer outcome.
Measured: At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation
Change from baseline in glucocorticoid dose at Weeks 2, 4, 8, 12, 16, 20, and 24.
Efficacy Endpoints
Measured: At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start24 Sep 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Still's Disease, Adult-OnsetStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191444
- Sponsor's protocol ID
- IMM-M-L-002
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Firsekibart Versus Anakinra in Adult-Onset Still's Disease
- ClinicalTrials.gov ID
- NCT07191444
- Acronym / sponsor ID
- IMM-M-L-002
- Conditions
- Still's Disease, Adult-Onset
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 24 Sep 2025 (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.
The purpose of this study is to compare the efficacy and safety of firsekibart versus anakinra in patients with AOSD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Firsekibart group | – | Biological: Firsekibart |
| Anakinra group | – | Biological: Anakinra |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study participants will be patients with active Adult-Onset Still's Disease recruited from Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- Pre-randomization Medications: a) Received BTK inhibitors, JAK inhibitors, intravenous immunoglobulin, plasmapheresis, or traditional Chinese medicine within 4 weeks prior to screening or 5 half-lives of the known drug (whichever is shorter). b) Received anakinra therapy within 1 day prior to randomization. c) Received etoposide (VP-16) therapy within 12 weeks prior to the baseline visit. d) Increase in dose or addition of new non-biologic agents for treating rheumatic/autoimmune diseases (e.g., immunosuppressants, immunomodulators, antimalarials) within 3 days prior to the baseline visit, unless deemed ineffective by the investigator and discontinued prior to baseline. Specific agents include: i Immunosuppressants/Immunomodulators: Methotrexate, azathioprine, leflunomide, mycophenolate mofetil (or mycophenolate sodium), mizoribine, calcineurin inhibitors (e.g., tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine, thalidomide, total glucosides of paeony. ii Antimalarials: Hydroxychloroquine, chloroquine, quinacrine.
- History of hypersensitivity to any component of the investigational product.
- Presence or suspicion of hemophagocytic lymphohistiocytosis (HLH) at baseline, or diagnosis of HLH within 2 months prior to randomization. According to the HLH-2004 diagnostic criteria, the diagnosis can be established by meeting any one of the following two conditions: (1) Molecular diagnosis consistent with HLH. (2) Fulfillment of ≥5 of the following 8 criteria: a) Fever: Temperature >38.5°C for >7 days. b) Splenomegaly. c) Cytopenias (affecting ≥2 lineages): Hemoglobin <90 g/L, neutrophils <1.0×10⁹/L, not due to reduced bone marrow function. d) Hypertriglyceridemia and/or hypofibrinogenemia: Triglycerides ≥ 3 mmol/L or >3 SD above age-specific norms, and/or Fibrinogen ≤ 1.5 g/L or <3 SD below age-specific norms.e) Identification of hemophagocytes in bone marrow, spleen, or lymph nodes. f) Elevated serum ferritin (≥500 μg/L). g) Low or absent NK cell activity. h) Elevated soluble IL-2 receptor (sCD25 ≥2400 U/mL).
- Hematologic Diseases: History or current presence of hematologic disorders (including but not limited to myelofibrosis, aplastic anemia, leukemia, lymphoma).
- Cardiovascular Diseases: Acute myocardial infarction or unstable angina within 6 months; severe arrhythmias (multifocal frequent ventricular premature beats, ventricular tachycardia, ventricular fibrillation); NYHA Class III-IV heart failure.
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 |
|---|---|---|
| FirsekibartFirsekibart will be administered according to the protocol | Biological | Firsekibart group |
| AnakinraAnakinra will be administered according to the protocol | Biological | Anakinra group |
Primary outcome
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.
Time frame: At Week 24 from initiation of treatment
14 secondary outcomes
Proportion of subjects achieving afebrile status with either ≥50% reduction in CRP levels or CRP within normal range at Weeks 2, 4, and 8.
Time frame: At Weeks 2, 4, and 8 after treatment initiation
Proportion of subjects achieving afebrile status with either ≥70% reduction in CRP levels or CRP within normal range at Week 12.
Time frame: At Week 12 after treatment initiation
Proportion of subjects achieving afebrile status with either ≥70% reduction in CRP levels or CRP within normal range, and glucocorticoid dose ≤0.2 mg/kg/day at Week 12.
Time frame: At Week 12 after treatment initiation
Proportion of subjects achieving afebrile status with either ≥70% reduction in CRP levels or CRP within normal range, and glucocorticoid dose ≤0.1 mg/kg/day at Week 12.
Time frame: At Week 12 after treatment initiation
Proportion of subjects achieving clinical inactive disease (CID) with discontinuation of glucocorticoids
Time frame: At Week 24 after treatment initiation
Proportion of subjects without disease relapse at Weeks 12 and 24.
Time frame: At Weeks 12 and 24 after treatment initiation
ACR30, ACR50, ACR70, and ACR90 response rates at Weeks 2, 4, 8, 12, 16, 20, and 24.
Time frame: At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation
Change from baseline in ferritin levels at Weeks 2, 4, 8, 12, 16, 20, and 24.
Time frame: At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation
Change from baseline in cytokine levels (including sIL-2R) at Weeks 2, 4, 8, 12, 16, 20, and 24.
Time frame: At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation
Change from baseline in ESR at Weeks 2, 4, 8, 12, 16, 20, and 24.
Time frame: At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation
Change from baseline in CRP levels at Weeks 2, 4, 8, 12, 16, 20, and 24
Time frame: At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation
Change from baseline in Pouchot score at Weeks 2, 4, 8, 12, 16, 20, and 24.
Time frame: At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation
Change from baseline in glucocorticoid dose at Weeks 2, 4, 8, 12, 16, 20, and 24.
Time frame: At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Through study completion, an average of 1 year
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Still's Disease, Adult-Onset, run by Ruijin Hospital at 1 site 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 6 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: At Week 24 from initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.