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Clinical Trials in China / NCT06859931
Starting soon Phase 2

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

NCT06859931 · tracked via the Priya Life Science China tracker
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase
Phase 2
Started
2025-03
Last updated
2025-03-05

Condition(s) studied

Systemic Lupus Erythematosus

Investigational drug(s) / intervention(s)

TQB3702 TabletsTQB3702 Tablets+TQB3702 PlaceboTQB3702 Placebo

TQB3702 Tablets: TQB3702 is a selective kinase inhibitor.

TQB3702 Tablets+TQB3702 Placebo: TQB3702 is a selective kinase inhibitor; A placebo is a simulated drug whose physical properties, such as appearance, size, color, dosage form, weight, taste, and odor are substantially the same as the test drug, but cannot contain the active ingredients of the test drug.

TQB3702 Placebo: TQB3702 Placebo without drug substance.

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
The First Affilliated Hospital of Bengbu Medical University Bengbu Anhui
Anhui Provincial Hospital Hefei Anhui
Peking University Third Hospital Beijing Beijing Municipality
The People's Hospital of Gansu Province Lanzhou Gansu
The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
Shenzhen second people's hospital Shenzhen Guangdong
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
Hebei petro China central hospital Langfang Hebei
The second hospital of hebei medical university Shijiazhuang Heibei
Puyang Oilfield General Hospital Puyang Henan
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Shiyan People's Hospital Shiyan Hubei
Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei
Xiangya Third Hospital of Central South University Changsha Hunan
Shaoyang Central Hospital Shaoyang Hunan
Jiangsu Provincial People's Hospital Nanjing Jiangsu
The First Affiliated Hospital of Soochow University Suzhou Jiangsu
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
The First Hospital of Jilin University Changchun Jilin
Meihekou Central Hospital Meihekou Jilin
Shenjing Hospital of China Medical University Shenyang Liaoning
The First Affiliated Hospital of China Medical University Shenyang Liaoning
The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi
The First Hospital Affiliated to the Army Medical University Xi'an Shaanxi
Affiliated hospital of Shandong Academy of Medical Sciences Jinan Shandong
Shanghai Jiao Tong University School of Medicine,Renji Hospital Shanghai Shanghai Municipality
Changhai Hospital of Shanghai Shanghai Shanghai Municipality
Shanxi Bethune Hospital Taiyuan Shanxi
First Hospital of Shangxi Medical University Taiyuan Shanxi
Chengdu Second People's Hospital Chengdu Sichuan
Mianyang central hispital Mianyang Sichuan
Tianjin First Central Hospital Tianjin Tianjin Municipality
Third People's Hospital of Yunnan Province Kunming Yunnan
Pu'er People's Hospital Pu'er Yunnan
Taizhou Central Hospital(Taizhou University Hospital) Taizhou Zhejiang
The 1th School of Medicine,School of Information and Engineering,The 1th Affiliated Hospital of WMU Wenzhou Zhejiang
Wenzhou People's Hospital Wenzhou Zhejiang

More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06859931 on ClinicalTrials.gov ↗ ← All trials in China