clinical trial of tqb3702 tablets in subjects with systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: tqb3702 is a selective kinase inhibitor. this is a phase ii clinical study aimed at evaluating the efficacy and safety of tqb3702 tablets in patients with systemic lupus erythematosus.


Eligibility criteria:
inclusion criteria: * the subjects voluntarily participate in the study and sign the informed consent; * male and female, ≥18 years old and ≤70 years old (subject to the date of signing the informed consent); * the diagnosis meets the classification criteria of sle established by the international clinical collaboration on lupus research (slicc) in 2012 and has been in place for at least 6 months (appendix 16), excluding drug-related lupus; * meet the systemic lupus erythematosus disease activity index-2k score requirements * positive for one or more of the following antibodies: positive for anti-nuclear antibodies (ana titers greater than or equal to 1:80 by immunofluorescence) and/or positive for anti-dsdna antibodies and/or positive for anti-smith(anti-sm); * subjects were receiving standard treatment for sle and had received treatment for at least 3 months prior to randomization. standard therapeutic doses of sle were stable for at least 30 days and glucocorticoids were stable for at least 2 weeks prior to initial administration. the standard treatment for sle may be corticosteroids, and/or antimalarial drugs, and/or immunosuppressants * at the time of screening, if the subject is taking an angiotensin-converting enzyme inhibitor or an angiotensin-ii receptor blocker or a non-steroidal anti-inflammatory drug (nsaid) orally, it must be at least 2 weeks since the pre-screening dose stabilized; * subjects must stop all opioids at least 1 week before the first dose; * fertile subjects must consent to and commit to using a medically accepted form of contraception throughout the study period and for at least 6 months after the final trial drug administration. exclusion criteria: * subjects who are pregnant or lactating, or who plan to have a child in the 12 months prior to the first dosing. * severe lupus nephritis within 30 days prior to initial administration; * central nervous system diseases caused by sle or not caused by sle in the 12 months before the first dose; * current or past autoimmune diseases other than sle * there is an active and uncontrolled infection, or an infection that has recently required intravenous anti-infective therapy, or is currently being treated for any chronic infection * subjects whose chest radiology within 6 months prior to screening indicates active tuberculosis * have active hepatitis, or hepatitis b surface antigen (hbsag) positive, or hepatitis b core antibody (hbcab) positive + hepatitis b virus (hbv) dna positive, or hepatitis c virus (hcv) rna positive; or a history of human immunodeficiency virus (hiv) infection, or a positive hiv serological result at screening; the specific antibody of treponema pallidum was positive and the confirmatory test was positive. if hbv core antibody is positive but hbv-dna is negative, hbv-dna should be monitored once every 3 months. * herpes or shingles infection, or a history of disseminated/complicated shingles in the 12 weeks prior to screening; * cardiovascular and cerebrovascular abnormalities; * have a lung disease that the investigator determines is not suitable for participation in the study * subjects with a history or suspected demyelinating disease of the central nervous system; * subjects with a history of or suspected demyelinating disease of the central nervous system; * subjects with any type of active malignancy or with a history of malignancy; * have a history of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation; * the subject has any medical condition that may affect the absorption of oral medications (e.g., bariatric/obesity surgery, or the subject is unable to take oral medications; * previous use of specific drugs; * patients who underwent plasma replacement within 12 weeks prior to initial administration or treated with human immunoglobulin 4 weeks prior to initial administration; * cyclophosphamide had been used within 3 months before the first dose; * rituximab or any other b-cell depletion therapy within 6 months prior to initial administration; * use beliuzumab, taitacept, tumor necrosis factor (tnf) antagonists, or other biologics before initial administration unless the elution time is met, as specified in appendix 17; * participants who have suffered a major trauma, fracture, or surgical procedure in the 4 weeks prior to screening, or who are expected to require major surgical procedures during the study period; * participants who received live attenuated vaccine within 28 days before the start of study treatment, inactivated vaccine within 7 days, or planned vaccination during the study period.