Clinical Trial of TQB3702 Tablets in Subjects With Systemic Lupus Erythematosus (SLE)

Официальное название

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

Обзор

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.

Вмешательства

• Препарат TQB3702 Tablets
  TQB3702 is a selective kinase inhibitor.
• Препарат 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.
• Препарат TQB3702 Placebo
  TQB3702 Placebo without drug substance.

Первичные конечные точки

• SLE response index -4 (SRI-4) [Срок оценки: Baseline to week 24]

Вторичные конечные точки (12)

• SLE response index -4 (SRI-4) [Срок оценки: Baseline to weeks 4 and 12]
• SLE response index -6 (SRI-6) [Срок оценки: Baseline to weeks 4, 12, and 24]
• SLE Disease Activity Index -2000 score [Срок оценки: Baseline to weeks 4, 12, and 24]
• Cutaneous lupus erythematosus Area and Severity Index (CLASI score) [Срок оценки: Baseline to weeks 4, 12, and 24]
• Number of active (tender + swollen) joints [Срок оценки: Baseline to weeks 4, 12, and 24]
• Medical Outcomes Study 36-Item Summary Health Survey (SF-36) [Срок оценки: Baseline to weeks 12]
• The change of Anti double-stranded DeoxyriboNucleic Acid(ds-DNA) antibody Anti-dsdna antibody and antinuclear antibody (ANA) [Срок оценки: Baseline to weeks 4, 12, and 24]
• Changes in Complement 3 (C3) values and Complement 4 (C4) values [Срок оценки: Baseline to weeks 4, 12, and 24]
• Immunoglobulin G (IgG), Immunoglobulin M (IgM), Immunoglobulin A (IgA) levels [Срок оценки: Baseline to weeks 4, 12, and 24]
• Cytokine expression levels [Срок оценки: Baseline to weeks 4, 12, and 24]
• Total B cell count [Срок оценки: Baseline to weeks 4, 12, and 24]
• Erythrocyte sedimentation rate (ESR) [Срок оценки: Baseline to weeks 4, 12, and 24]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 37 центров

• The First Affilliated Hospital of Bengbu Medical University — Bengbu
• Anhui Provincial Hospital — Хэфэй
• Peking University Third Hospital — Пекин
• The People's Hospital of Gansu Province — Lanzhou
• The Third Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
• Shenzhen second people's hospital — Шэньчжэнь
• The First Affiliated Hospital of Guangxi Medical University — Nanning
• Hebei petro China central hospital — Langfang
• … и ещё 29 центров

Идентификаторы

NCT: NCT06859931 · TQB3702-II-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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