Systemic lupus erythematosus
Conditions
Interventions
Low dose group:QX006N/placebo 150mg
Medium dose group:QX006N/placebo 300mg
High dose group:QX006N/placebo 600mg
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 70 years old (including 18 and 70 years old), regardless of gender; 2. Weight =45kg; 3. Adult subjects diagnosed with systemic lupus erythematosus met the 1997 revised classification criteria of the American College of Rheumatology (ACR); 4. The disease activity during screening was confirmed as SLEDAI-2K score =7; 5. Doctor's overall assessment (PGA) = 1.0 score; Subject should not be included if the investigator determines that the subject's disease activity is severe and uncontrollable, which would place the subject at an unreasonable risk during study participation; 6. At the time of screening, you must be receiving one of the following SOC treatments: 1) Oral prednisone (or equivalent) monotherapy: a. Treatment duration: =2 weeks before screening and stable dose =2 weeks before randomization; b. Dose requirement: Maximum daily dose: 1 mg/kg/ day; 2) Immunosuppressants: a. Permitted drugs include: antimalarial drugs, azathioprine, cyclophosphamide, mexicophenolate ester/mexicophenolic acid, methotrexate, midazolibin; b. Treatment duration: = 12 weeks before screening and = 8 weeks before randomization; c. Dose requirements: hydroxychloroquine =400 mg/ day, azathioprine = 100 mg/ day, cyclophosphamide =800 mg/4 weeks, mexicophyphenate/mycophanolic acid = 2g/ day, oral, subcutaneous (SC) or intramural injection of methotrexate = 15 mg/ week, imidazolibin = 150 mg/ day; 3) Oral prednisone (or equivalent) monotherapy plus an immunosuppressant: a. The treatment duration and dose stabilization duration of OCS and immunosuppressant should be met. b. The maximum daily/weekly dose of each drug in (1) and (2) shall not be exceeded; 7. The subject agrees to have no family planning during the study period and for 6 months after the end of the study and voluntarily take effective contraceptive measures as shown in Appendix 3; 8. Subjects are willing to participate in the study and can sign the informed consent and comply with the requirements of the informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women; 2. Participating in other clinical trials (other than those not using investigational drugs) or using any biologics for SLE within 3 months prior to screening and/or currently; 3. Active stage of severe lupus nephritis, creatinine clearance < 60 ml/min/1.73m^2; 4. Severe neuropsychiatric SLE includes but is not limited to the following: Seizures, new or worsening impaired level of consciousness, psychosis, delirium or hazy states of consciousness, aseptic meningitis, rising or transverse myelitis, chorea disease, cerebellar ataxia, multiple mononeuritis, demyelinating syndrome, or conditions that prevent subjects from fully understanding ICF; 5. History or current diagnosis of clinically significant non-SLE associated vasculitis syndrome or overlapping other connective tissue diseases; 6. Any active skin disease other than SLE that may interfere with the study evaluation of SLE, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE manifestations of cutaneous lupus (e.g. cutaneous vascular disease, peri-nail telangiectasia, finger sclerosis, rheumatoid nodules, erythema pleomorpha, leg ulcers), or drug-induced lupus; 7. Patients with a history of lymphoproliferative diseases or who have had or are currently suffering from malignant tumors within the previous 5 years (except for squamous cell carcinoma in situ, basal cell carcinoma and cervical carcinoma in situ after thorough treatment without any evidence of recurrence); 8. Uncontrolled anti-cardiolipin antibody syndrome (APS) patients; 9. History of vital organ transplantation (e.g. heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation; 10. Major surgical procedures (craniotomy, thoracotomy or laparotomy) or open wounds, sores or fractures within 4 weeks prior to screening; 11. Receive live/attenuated vaccine within 8 weeks prior to screening or plan to receive live/attenuated vaccine during the trial; 12. If the subject is allergic to the experimental drug (including excipients) or suffers from a serious allergic disease or is allergic to the drug (such as allergic to two or more drugs, food or pollen), the safety of the subject may be compromised in the judgment of the investigator; 13. Active or latent tuberculosis infection at the time of screening; 14. Severe herpes virus infections such as herpes encephalitis, disseminated herpes and ocular herpes were present during screening; 15. Oral anti-infective drugs (including antiviral drugs) or intravenous antibiotics are required for infection within 2 weeks prior to screening; 16. Hospitalization for opportunistic infections in the 3 months prior to screening; 17. Chinese patent medicine such as tripterygium wilfordii was used within 4 weeks before screening; 18. When HBsAg is positive in five items of hepatitis B (HBsAg is negative but HBcAb is positive), HBV-DNA quantitative examination is needed. Patients with HBV-DNA test results = the upper limit of reference values of each center or who need antiviral treatment are not eligible for study participation), hepatitis C antibody positive (HCV-RNA can be added, if negative can be included), treponema pallidum antibody positive (if treponema pallidum serological test is positive, then non-treponema pallidum serological test will be conducted. Patients judged by researchers to have been infected with syphilis in the past but have been cured
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;pharmacokinetics; | — |
Countries
China
Contacts
Public ContactDing Yanhua /Jiang Zhenyu
The First Hospital of Jilin University
Outcome results
None listed