Clinical Trial of TQB3702 Tablets in Subjects With Systemic Lupus Erythematosus (SLE)

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.