Systemic Lupus ErythematosusPhase 2NCT06859931
Clinical Trial of TQB3702 Tablets in Subjects With Systemic Lupus Erythematosus (SLE)
A Phase 2 study testing TQB3702 Tablets in people with Systemic Lupus Erythematosus, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 37 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- TQB3702 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 37 sitesChina
- Study dates
- Mar 2025to Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
37 sites in 1 country. Contact the study team or a site near you to ask about taking part.
37 sites in 1 country
China37 sites
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Rong Mu, Doctor, 13501170870, bysyfsmyk@163.com
The First Affilliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000
Changhao Xie, Master, 152 5522 7208, uglboy2002@126.com
The First Hospital of Jilin University
Changchun, Jilin, 130021
Zhenyv Jiang, Doctor, 15843079623, 745149057@qq.com
Xiangya Third Hospital of Central South University
Changsha, Hunan, 41000
Hao Zhang, Doctor, 13975806919, zhanghaoliaoqing@163.com
Chengdu Second People's Hospital
Chengdu, Sichuan, 610000
Nan Mao, Doctor, 15528461208, maonanlyb@163.com
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yunfeng Pan, Doctor, 020-85252205, panyunfeng@medmail.con.cn
Anhui Provincial Hospital
Hefei, Anhui, 230001
Zhu Chen, Doctor, 13956963042, doczchen2023@126.com
Affiliated hospital of Shandong Academy of Medical Sciences
Jinan, Shandong, 250011
Bing Fan, Doctor, 18560769178, icii@163.com
Third People's Hospital of Yunnan Province
Kunming, Yunnan, 650034
Yuqiong Yang, Bachelor, 13888934627, yangyuqiong2024@sina.com
Hebei petro China central hospital
Langfang, Hebei, 65000
Wei Gou, Master, 13503266841, tiandiyouxia7280@163.com
The People's Hospital of Gansu Province
Lanzhou, Gansu, 730030
Meihekou Central Hospital
Meihekou, Jilin, 135000
Jingping Hu, Bachelor, 13944579960, Ap2376@sohu.com
Mianyang central hispital
Mianyang, Sichuan, 621099
Jinmei Zou, Master, 15681932263, ltter.zjm@163.com
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Rui Wu, Doctor, 139 7099 7559, tcmclinic@163.com
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000
Wenfeng Tan, Doctor, 13770769608, Tanwenfeng@gmail.com
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
HanYou Mo, Master, 13707730655, 419459292@qq.com
Pu'er People's Hospital
Pu'er, Yunnan, 665099
ChaoEn Zheng, Bachelor, 18087991755, zce163163@163.com
Puyang Oilfield General Hospital
Puyang, Henan, 457001
Fengju Li, Bachelor, 13030300169, 13030300169@163.com
Shanghai Jiao Tong University School of Medicine，Renji Hospital
Shanghai, Shanghai Municipality, 200001
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, 200433
Jie Gao, Doctor, 13585561861, 4872530759195@qq.com
Shaoyang Central Hospital
Shaoyang, Hunan, 422000
Jia Chen, Bachelor, 17707393600, 2084334@qq.com
Shenjing Hospital of China Medical University
Shenyang, Liaoning, 110000
Ning Zhang, Doctor, 18940251818, zhangningyaoli@163.com
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000
Rong Zhang, Doctor, 13840523456, 18102455555@189.cn
Shenzhen second people's hospital
Shenzhen, Guangdong, 518035
Meiying Wang, Doctor, 13723769919, wmy99wmy99@163.com
The second hospital of hebei medical university
Shijiazhuang, Heibei, 05000
Huifang Guo, Doctor, 15803210965, 15803210965@qq.com
Shiyan People's Hospital
Shiyan, Hubei
Hong Tao, Master, 13733578758, 63886515@qq.com
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Jian Wu, Doctor, 15358805676, njwujian@163.com
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000
LiYun Zhang, Doctor, 13834547708, 1315710223@qq.com
First Hospital of Shangxi Medical University
Taiyuan, Shanxi, 030001
Zili Fu, Master, 13834676095, fuzili72@163.com
Taizhou Central Hospital（Taizhou University Hospital）
Taizhou, Zhejiang, 318001
Guofen Wang, Master, 13906598161, wanggf7226@tzzxyy.com
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300190
Chunyyu Kong, Master, 18622105096, kongchunyu72@aliyun.com
The 1th School of Medicine,School of Information and Engineering,The 1th Affiliated Hospital of WMU
Wenzhou, Zhejiang, 325027
Li Sun, Doctor, 13777750055, grassandsun@126.com
Wenzhou People's Hospital
Wenzhou, Zhejiang, 325200
Suxian Lin, Master, 13957741565, 13957741565@qq.com
Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Qiubai Li, Doctor, 13995671635, 158656507@qq.com
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
Lan He, Doctor, 13809156236, xajdljn@126.com
The First Hospital Affiliated to the Army Medical University
Xi'an, Shaanxi, 710000
Zhaohui Zheng, Doctor, 13571924267, zhengzh@fmmu.edu.cn
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Shengyun Liu, Doctor, 13837192659, fccliusy2@zzu.edu.cn
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Trial Evaluating the Efficacy and Safety of TQB3702 Tablets in Patients With Systemic Lupus Erythematosus
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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- TQB3702 Tablets, TQB3702 Tablets+TQB3702 Placebo, TQB3702 Placebo
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3702 TabletsDrug
TQB3702 is a selective kinase inhibitor.
TQB3702 Tablets+TQB3702 PlaceboDrug
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 PlaceboDrug
TQB3702 Placebo without drug substance.
| Study group | Role | What they receive |
|---|---|---|
| TQB3702 Tablets | Experimental | Administer orally on an empty stomach, once daily, for 24 consecutive weeks. Receives: Drug: TQB3702 Tablets |
| TQB3702 Tablets+TQB3702 Placebo | Experimental | Administer orally on an empty stomach, once daily, for 24 consecutive weeks. Placebo was administered orally once a day for 24 weeks. Receives: Drug: TQB3702 Tablets+TQB3702 Placebo |
| TQB3702 Placebo | Placebo comparator | Placebo was administered orally once a day for 24 weeks. Receives: Drug: TQB3702 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLE response index -4 (SRI-4)
≥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).
Measured: Baseline to week 24
Secondary outcomes (28)
SLE response index -4 (SRI-4)
≥4 point reduction from baseline in SLEDAI-2k score AND no new BILAG A score and no more than one new BILAG B organ domain score compared with baseline AND no worsening in PGA (<0.3 points increase from baseline)
Measured: Baseline to weeks 4 and 12
SLE response index -6 (SRI-6)
≥6 point reduction from baseline in SLEDAI-2k score AND no new BILAG A score and no more than one new BILAG B organ domain score compared with baseline AND no worsening in PGA (<0.3 points increase from baseline)
Measured: Baseline to weeks 4, 12, and 24
SLE Disease Activity Index -2000 score
A tool for assessing disease activity in systemic lupus erythematosus (SLE), with a score based primarily on whether a patient develops clinical symptoms within 28 days.
The higher the score, the higher the patient's disease activity.
Measured: Baseline to weeks 4, 12, and 24
Cutaneous lupus erythematosus Area and Severity Index (CLASI score)
A useful tool for assessing skin activity in patients with lupus erythematosus. The higher the score, the higher the patient's disease activity.
Measured: Baseline to weeks 4, 12, and 24
Number of active (tender + swollen) joints
Changes in the number of joints subject moves (tenderness + swelling)
Measured: Baseline to weeks 4, 12, and 24
Medical Outcomes Study 36-Item Summary Health Survey (SF-36)
Changes in 36 summary health surveys in the Medical Outcomes Study. The higher the score, the better the patient's self-reported quality of life.
Measured: Baseline to weeks 12
The change of Anti double-stranded DeoxyriboNucleic Acid(ds-DNA) antibody Anti-dsdna antibody and antinuclear antibody (ANA)
The change of anti-dsDNA antibody value and ANA value
Measured: Baseline to weeks 4, 12, and 24
Changes in Complement 3 (C3) values and Complement 4 (C4) values
Changes in C3 values and C4 values
Measured: Baseline to weeks 4, 12, and 24
Immunoglobulin G (IgG), Immunoglobulin M (IgM), Immunoglobulin A (IgA) levels
Changes of IgG, IgM and IgA levels.
Measured: Baseline to weeks 4, 12, and 24
Cytokine expression levels
Changes in cytokine expression levels
Measured: Baseline to weeks 4, 12, and 24
Total B cell count
Changes in total B cell count
Measured: Baseline to weeks 4, 12, and 24
Erythrocyte sedimentation rate (ESR)
Changes in erythrocyte sedimentation rate
Measured: Baseline to weeks 4, 12, and 24
Frequency of adverse event (AE)
The occurrence of all adverse medical events after the first injection.
Measured: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Severity of adverse event (AE)
The severity of all adverse medical events after the first injection.
Measured: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Peak time (Tmax)
Peak time (Tmax)
Measured: 1, 84, 112, 140 and 168 Days
Target occupancy
The extent to which the drug occupies the target on the cell surface
Measured: Day 1, 14 and 168
Peak concentration (Cmax)
Peak concentration (Cmax)
Measured: 1, 84, 112, 140 and 168 Days
Area under the blood drug concentration time curve (AUC0-24h, AUC0-t, AUC0- ∞),
Area under the blood drug concentration time curve (AUC0-24h, AUC0-t, AUC0- ∞),
Measured: 1, 84, 112, 140 and 168 Days
Apparent volume of distribution (Vd/F)
Apparent volume of distribution (Vd/F)
Measured: 1, 84, 112, 140 and 168 Days
Plasma clearance rate (CL/F)
Measured: 1, 84, 112, 140 and 168 Days
Plasma elimination half-life (t1/2)
Plasma elimination half-life (t1/2)
Measured: 1, 84, 112, 140 and 168 Days
Steady-state peak time (Tmax, ss)
Steady-state peak time (Tmax, ss)
Measured: 1, 84, 112, 140 and 168 Days
Steady-state peak concentration (Cmax, ss)
Steady-state peak concentration (Cmax, ss)
Measured: 1, 84, 112, 140 and 168 Days
Steady-state trough concentration (Cmin, ss)
Steady-state trough concentration (Cmin, ss)
Measured: 1, 84, 112, 140 and 168 Days
Average steady-state blood drug concentration (Cav, ss)
Average steady-state blood drug concentration (Cav, ss)
Measured: 1, 84, 112, 140 and 168 Days
Area under the steady-state blood drug concentration time curve (AUCss)
Area under the steady-state blood drug concentration time curve (AUCss)
Measured: 1, 84, 112, 140 and 168 Days
Accumulation ratio (Rac)
Accumulation ratio (Rac)
Measured: 1, 84, 112, 140 and 168 Days
Volatility (DF)
Volatility (DF)
Measured: 1, 84, 112, 140 and 168 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859931
- Sponsor's protocol ID
- TQB3702-II-01
- Status last verified
- Dec 2024
- First submitted
- 27 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No