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Clinical Trial of TQB3702 Tablets in Subjects With Systemic Lupus Erythematosus (SLE) | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

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

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

NCT06859931•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

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
+12 more criteria

Locations (37)

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

Key Dates

Start Date

March 1, 2025

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

March 5, 2025

Enrollment

120

ESTIMATED participants

Conditions

Systemic Lupus Erythematosus

Interventions

TQB3702 Tablets

DRUG

TQB3702 Tablets+TQB3702 Placebo

DRUG

TQB3702 Placebo

DRUG

Contacts

Chunde Bao, Doctor

CONTACT

86-21-63284622 Baochunde_1678@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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