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)
SLE response index -4 (SRI-4) — Baseline to week 24 ≥4 point reduction from baseline in systemic lupus erythematosus disease activity index 2000 (SLEDAI-2k) score and no new the British Isles Lupus Assessment Group (BILAG) A score and no more than one new BILAG B organ domain score compared with baseline and no worsening in Physician Global Assessment (PGA) (\<0.3 points increase from baseline).
Trial sites (37)
Facility
City
Region
Status
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.