NCT06859931尚未招募2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 37
- 主要终点
- SLE response index -4 (SRI-4)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
TQB3702 Tablets
Experimental
Administer orally on an empty stomach, once daily, for 24 consecutive weeks.
干预措施: TQB3702 Tablets (Drug)
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.
干预措施: TQB3702 Tablets+TQB3702 Placebo (Drug)
TQB3702 Placebo
Placebo Comparator
Placebo was administered orally once a day for 24 weeks.
干预措施: TQB3702 Placebo (Drug)
结局指标
主要结局
SLE response index -4 (SRI-4)
时间窗: 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).
次要结局
- SLE response index -4 (SRI-4)(Baseline to weeks 4 and 12)
- SLE response index -6 (SRI-6)(Baseline to weeks 4, 12, and 24)
- SLE Disease Activity Index -2000 score(Baseline to weeks 4, 12, and 24)
- Cutaneous lupus erythematosus Area and Severity Index (CLASI score)(Baseline to weeks 4, 12, and 24)
- Number of active (tender + swollen) joints(Baseline to weeks 4, 12, and 24)
- Medical Outcomes Study 36-Item Summary Health Survey (SF-36)(Baseline to weeks 12)
- The change of Anti double-stranded DeoxyriboNucleic Acid(ds-DNA) antibody Anti-dsdna antibody and antinuclear antibody (ANA)(Baseline to weeks 4, 12, and 24)
- Changes in Complement 3 (C3) values and Complement 4 (C4) values(Baseline to weeks 4, 12, and 24)
- Immunoglobulin G (IgG), Immunoglobulin M (IgM), Immunoglobulin A (IgA) levels(Baseline to weeks 4, 12, and 24)
- Total B cell count(Baseline to weeks 4, 12, and 24)
- Peak concentration (Cmax)(1, 84, 112, 140 and 168 Days)
- Cytokine expression levels(Baseline to weeks 4, 12, and 24)
- Erythrocyte sedimentation rate (ESR)(Baseline to weeks 4, 12, and 24)
- Peak time (Tmax)(1, 84, 112, 140 and 168 Days)
- Frequency of adverse event (AE)(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)(From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.)
- Target occupancy(Day 1, 14 and 168)
- Area under the blood drug concentration time curve (AUC0-24h, AUC0-t, AUC0- ∞),(1, 84, 112, 140 and 168 Days)
- Apparent volume of distribution (Vd/F)(1, 84, 112, 140 and 168 Days)
- Plasma clearance rate (CL/F)(1, 84, 112, 140 and 168 Days)
- Steady-state peak time (Tmax, ss)(1, 84, 112, 140 and 168 Days)
- Volatility (DF)(1, 84, 112, 140 and 168 Days)
- Plasma elimination half-life (t1/2)(1, 84, 112, 140 and 168 Days)
- Steady-state peak concentration (Cmax, ss)(1, 84, 112, 140 and 168 Days)
- Steady-state trough concentration (Cmin, ss)(1, 84, 112, 140 and 168 Days)
- Average steady-state blood drug concentration (Cav, ss)(1, 84, 112, 140 and 168 Days)
- Area under the steady-state blood drug concentration time curve (AUCss)(1, 84, 112, 140 and 168 Days)
- Accumulation ratio (Rac)(1, 84, 112, 140 and 168 Days)
研究者
研究点 (37)
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