A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease

NCT07191444 | Recruiting

• 1 other identifier: IMM-M-L-002
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (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.

  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.

  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.

  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.

  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.

  At Week 12 after treatment initiation

• Proportion of subjects achieving clinical inactive disease (CID) with discontinuation of glucocorticoids

  At Week 24 after treatment initiation

Study Arms (2)

Firsekibart group

Biological: Firsekibart

Anakinra group

Biological: Anakinra

Interventions

Firsekibart BIOLOGICAL

Firsekibart will be administered according to the protocol

Firsekibart group

Anakinra BIOLOGICAL

Anakinra will be administered according to the protocol

Anakinra group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Interventions

Interleukin 1 Receptor Antagonist Protein

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Chengde Yang

CONTACT

13501717833; yangchengde@sina.com

Qiongyi Hu

CONTACT

18317071395; hugiongyi131@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 24, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)