Clinical trial NCT06859931: Clinical Trial of TQB3702 Tablets in Subjects With Systemic Lupus Erythematosus (SLE)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: SLE response index -4 (SRI-4)
timeFrame: Baseline to week 24
Secondary outcomes:
measure: SLE response index -4 (SRI-4)
timeFrame: Baseline to weeks 4 and 12
measure: SLE response index -6 (SRI-6)
timeFrame: Baseline to weeks 4, 12, and 24
measure: SLE Disease Activity Index -2000 score
timeFrame: Baseline to weeks 4, 12, and 24
measure: Cutaneous lupus erythematosus Area and Severity Index (CLASI score)
timeFrame: Baseline to weeks 4, 12, and 24
measure: Number of active (tender + swollen) joints
timeFrame: Baseline to weeks 4, 12, and 24
measure: Medical Outcomes Study 36-Item Summary Health Survey (SF-36)
timeFrame: Baseline to weeks 12
measure: The change of Anti double-stranded DeoxyriboNucleic Acid(ds-DNA) antibody Anti-dsdna antibody and antinuclear antibody (ANA)
timeFrame: Baseline to weeks 4, 12, and 24
measure: Changes in Complement 3 (C3) values and Complement 4 (C4) values
timeFrame: Baseline to weeks 4, 12, and 24
measure: Immunoglobulin G (IgG), Immunoglobulin M (IgM), Immunoglobulin A (IgA) levels
timeFrame: Baseline to weeks 4, 12, and 24
measure: Cytokine expression levels
timeFrame: Baseline to weeks 4, 12, and 24
measure: Total B cell count
timeFrame: Baseline to weeks 4, 12, and 24
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: Baseline to weeks 4, 12, and 24
measure: Frequency of adverse event (AE)
timeFrame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
measure: Severity of adverse event (AE)
timeFrame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
measure: Peak time (Tmax)
timeFrame: 1, 84, 112, 140 and 168 Days
measure: Target occupancy
timeFrame: Day 1, 14 and 168
measure: Peak concentration (Cmax)
timeFrame: 1, 84, 112, 140 and 168 Days
measure: Area under the blood drug concentration time curve (AUC0-24h, AUC0-t, AUC0- ∞),
timeFrame: 1, 84, 112, 140 and 168 Days
measure: Apparent volume of distribution (Vd/F)
timeFrame: 1, 84, 112, 140 and 168 Days
measure: Plasma clearance rate (CL/F)
timeFrame: 1, 84, 112, 140 and 168 Days
measure: Plasma elimination half-life (t1/2)
timeFrame: 1, 84, 112, 140 and 168 Days
measure: Steady-state peak time (Tmax, ss)
timeFrame: 1, 84, 112, 140 and 168 Days
measure: Steady-state peak concentration (Cmax, ss)
timeFrame: 1, 84, 112, 140 and 168 Days
measure: Steady-state trough concentration (Cmin, ss)
timeFrame: 1, 84, 112, 140 and 168 Days
measure: Average steady-state blood drug concentration (Cav, ss)
timeFrame: 1, 84, 112, 140 and 168 Days
measure: Area under the steady-state blood drug concentration time curve (AUCss)
timeFrame: 1, 84, 112, 140 and 168 Days
measure: Accumulation ratio (Rac)
timeFrame: 1, 84, 112, 140 and 168 Days
measure: Volatility (DF)
timeFrame: 1, 84, 112, 140 and 168 Days
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affilliated Hospital of Bengbu Medical University
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Lanzhou
country: China
facility: The People's Hospital of Gansu Province
state: Gansu
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen second people's hospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Langfang
country: China
facility: Hebei petro China central hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The second hospital of hebei medical university
state: Heibei
city: Puyang
country: China
facility: Puyang Oilfield General Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Shiyan
country: China
facility: Shiyan People's Hospital
state: Hubei
city: Wuhan
country: China
facility: Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Third Hospital of Central South University
state: Hunan
city: Shaoyang
country: China
facility: Shaoyang Central Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Meihekou
country: China
facility: Meihekou Central Hospital
state: Jilin
city: Shenyang
country: China
facility: Shenjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: The First Hospital Affiliated to the Army Medical University
state: Shaanxi
city: Jinan
country: China
facility: Affiliated hospital of Shandong Academy of Medical Sciences
state: Shandong
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine，Renji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Taiyuan
country: China
facility: First Hospital of Shangxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
state: Sichuan
city: Mianyang
country: China
facility: Mianyang central hispital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
city: Kunming
country: China
facility: Third People's Hospital of Yunnan Province
state: Yunnan
city: Pu'er
country: China
facility: Pu'er People's Hospital
state: Yunnan
city: Taizhou
country: China
facility: Taizhou Central Hospital（Taizhou University Hospital）
state: Zhejiang
city: Wenzhou
country: China
facility: The 1th School of Medicine,School of Information and Engineering,The 1th Affiliated Hospital of WMU
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou People's Hospital
state: Zhejiang
Study officials:
References: