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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
TQB3702 is a selective kinase inhibitor.
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 without drug substance.
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).
Time frame: Baseline to week 24
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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Baseline to weeks 4, 12, and 24
Number of active (tender + swollen) joints
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The First Affilliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The People's Hospital of Gansu Province
Lanzhou, Gansu, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Shenzhen second people's hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Hebei petro China central hospital
Langfang, Hebei, China
The second hospital of hebei medical university
Shijiazhuang, Heibei, China
Puyang Oilfield General Hospital
Puyang, Henan, China
...and 27 more locations
Changes in the number of joints subject moves (tenderness + swelling)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline to weeks 4, 12, and 24
Immunoglobulin G (IgG), Immunoglobulin M (IgM), Immunoglobulin A (IgA) levels
Changes of IgG, IgM and IgA levels.
Time frame: Baseline to weeks 4, 12, and 24
Cytokine expression levels
Changes in cytokine expression levels
Time frame: Baseline to weeks 4, 12, and 24
Total B cell count
Changes in total B cell count
Time frame: Baseline to weeks 4, 12, and 24
Erythrocyte sedimentation rate (ESR)
Changes in erythrocyte sedimentation rate
Time frame: Baseline to weeks 4, 12, and 24
Frequency of adverse event (AE)
The occurrence of all adverse medical events after the first injection.
Time frame: 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.
Time frame: 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)
Time frame: 1, 84, 112, 140 and 168 Days
Target occupancy
The extent to which the drug occupies the target on the cell surface
Time frame: Day 1, 14 and 168
Peak concentration (Cmax)
Peak concentration (Cmax)
Time frame: 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- ∞),
Time frame: 1, 84, 112, 140 and 168 Days
Apparent volume of distribution (Vd/F)
Apparent volume of distribution (Vd/F)
Time frame: 1, 84, 112, 140 and 168 Days
Plasma clearance rate (CL/F)
Time frame: 1, 84, 112, 140 and 168 Days
Plasma elimination half-life (t1/2)
Plasma elimination half-life (t1/2)
Time frame: 1, 84, 112, 140 and 168 Days
Steady-state peak time (Tmax, ss)
Steady-state peak time (Tmax, ss)
Time frame: 1, 84, 112, 140 and 168 Days
Steady-state peak concentration (Cmax, ss)
Steady-state peak concentration (Cmax, ss)
Time frame: 1, 84, 112, 140 and 168 Days
Steady-state trough concentration (Cmin, ss)
Steady-state trough concentration (Cmin, ss)
Time frame: 1, 84, 112, 140 and 168 Days
Average steady-state blood drug concentration (Cav, ss)
Average steady-state blood drug concentration (Cav, ss)
Time frame: 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)
Time frame: 1, 84, 112, 140 and 168 Days
Accumulation ratio (Rac)
Accumulation ratio (Rac)
Time frame: 1, 84, 112, 140 and 168 Days
Volatility (DF)
Volatility (DF)
Time frame: 1, 84, 112, 140 and 168 Days