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

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD. · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called TQB3702, which is being tested for its effectiveness and safety in treating patients with systemic lupus erythematosus (SLE), a condition where the immune system mistakenly attacks healthy tissues in the body. The trial is currently not recruiting participants, but it aims to include adults aged 18 to 70 who have been diagnosed with SLE for at least six months. To qualify, participants need to have specific antibodies in their blood related to lupus and must have been on stable standard treatments for the disease for at least three months before joining the trial.

Participants in this study will take TQB3702 tablets and will be monitored for their health and any side effects during the trial. It’s important to note that certain people, such as those who are pregnant, have severe kidney issues, or have other serious health conditions, will not be eligible to participate. This trial is a Phase II study, meaning it’s looking to gather more information about how well the treatment works and its safety profile. If you or a loved one are interested in participating, it’s a good idea to talk to a healthcare provider for more information about eligibility and what to expect.

Gender

ALL

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.