autoimmune diseases
Conditions
Interventions
Experimental Group:Subcutaneous Injection of ABO2023
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Must be able to understand and voluntarily sign a written informed consent. 2. Age >= 18 years. 3. Have a clear clinical diagnosis based on the relevant disease classification criteria at least 12 weeks before screening. SLE: Clinically diagnosed as SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria. 2. Lupus Nephritis: Based on the 2003 ISN/RPS diagnostic criteria, meeting the criteria for active class III, IV +/- V, with pathological classification based on renal biopsy results within 180 days before screening. For patients with SLE and lupus nephritis, the SLEDAI-2000 (2K) score during the screening period should be >= 6 points, with a clinical score of >= 4 points. Rheumatoid Arthritis: Clinically diagnosed as RA based on the 2010 ACR/EULAR classification criteria for rheumatoid arthritis. The screening period should show moderate to severe active RA, meeting the following criteria: at least 6/68 tender joints and at least 6/66 swollen joints, erythrocyte sedimentation rate (ESR) >= 28 mm/h, and CRP > 7.0 mg/L. 4. Patients with autoimmune diseases who have poor response to standard treatments (such as steroids, immunosuppressants, etc., at least two first-line treatments), relapse after treatment, or are unsuitable for corresponding treatments for other reasons. 5. During the screening period, based on clinical laboratory tests recognized by the investigator, meeting the following criteria: SLE and lupus nephritis: Positive antinuclear antibody (ANA) and/or positive anti-dsDNA antibody. Lupus nephritis: Urine protein-to-creatinine ratio (UPCR) >= 1.0 g/g, urine protein quantification 1.0-3.0 g/24h; eGFR = 30 mL/min/1.73 m². 6. Receiving the following standard treatments for at least 12 weeks before screening, with the medication regimen stable for at least 4 weeks before enrollment and expected to remain stable during the study period (note: except for dose reduction due to adverse reactions, as decided by the investigator); or if intolerant to basic treatment or discontinued for any reason, can also be included upon confirmation by the investigator. SLE: Using at least one of the following medications: antimalarials; single immunosuppressant; oral corticosteroids (OCS). Dosages are as follows: hydroxychloroquine (HCQ) = 2 years, or women of childbearing potential (including those who are postmenopausal for < 2 years), with a negative pregnancy test, and willing to use effective contraception (e.g., condoms, spermicides, or intrauterine devices) during the
Exclusion criteria
Exclusion criteria: 1. Target Disease Criteria: SLE: History of active severe or unstable neuropsychiatric SLE, including but not limited to poorly controlled seizures, psychosis or acute confusional state, cerebrovascular accident, demyelinating syndrome, cranial neuropathy, or active central nervous system vasculitis. Lupus Nephritis: History of severe active central nervous system (CNS) lupus, including seizures, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, or CNS vasculitis. Severe lupus nephritis within 48 weeks before screening: proteinuria >6 g/24h, or SCr >2.5 mg/dL (221 umol/L), or dialysis, or >=14 days of high-dose steroids (prednisone >100mg/day or equivalent). Rheumatoid Arthritis: Joint surgery or intra-articular corticosteroid injection in the joints to be assessed in this study within 8 weeks before screening; current or past inflammatory joint diseases other than RA, such as juvenile arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, reactive arthritis, systemic vasculitis, or gout. 2. Known Active Infections: Including active tuberculosis, active or recurrent gastrointestinal ulcers requiring hospitalization, intravenous antibiotics within 4 weeks before screening, or oral antibiotics within 2 weeks before screening; herpes zoster within 12 weeks before screening; history of or positive test for human immunodeficiency virus (HIV); positive tuberculosis screening test (T-SPOT) within 1 year before screening. 3. Severe Hypogammaglobulinemia: (IgG 480ms (calculated by Fridericia formula). Left ventricular ejection fraction (LVEF) <50% on echocardiography during screening. Other significant ECG abnormalities, including second-degree type II AV block, third-degree AV block, bradycardia (ventricular rate <50 bpm with clinical symptoms), etc. 8. History of Malignancy: Within the past 5 years, except for cured basal cell carcinoma of the skin, superficial bladder cancer, in situ breast cancer, and in situ cervical cancer. 9. Other Severe Diseases: Including liver disease, neurological/psychiatric disorders, endocrine disorders, hematological disorders (including moderate to severe dyslipidemia and related diseases), judged by the investigator to affect participation in this study. 10. B Cell Targeted Therapy: Within 48 weeks before screening, such as belimumab, rituximab, tabalumab; anti-CD22 drugs (e.g., epratuzumab); anti-CD52 drugs (e.g., alemtuzumab), or other similar biologics. 11. TNF-a Antagonists, IL-6 Antagonists, IL-1 Antagonists, Selective T Cell Co-stimulation Inhibitors: Within 48 weeks before screening. 12. Non-biologic Experimental Drugs: Within 4 weeks or 5 known dr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Emergent Adverse Event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic Biomarker;Pharmacokinetic Assessment;Anti-drug antibodies;Clinical Laboratory Indexes;Clinical efficacy; | — |
Countries
China
Contacts
Public ContactYang Chengde
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed