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

CTTQ

Status and phase: Not yet enrolling; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: TQB3702 Placebo; Drug: TQB3702 Tablets+TQB3702 Placebo; Drug: TQB3702 Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06859931

TQB3702-II-01

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

TQB3702 Tablets

Experimental group

Description:

Administer orally on an empty stomach, once daily, for 24 consecutive weeks.

Treatment:

Drug: TQB3702 Tablets

TQB3702 Tablets+TQB3702 Placebo

Experimental group

Description:

Administer orally on an empty stomach, once daily, for 24 consecutive weeks. Placebo was administered orally once a day for 24 weeks.

Treatment:

Drug: TQB3702 Tablets+TQB3702 Placebo

TQB3702 Placebo

Placebo Comparator group

Description:

Placebo was administered orally once a day for 24 weeks.

Treatment:

Drug: TQB3702 Placebo