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

March 3, 2025 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233000
        • The First Affilliated Hospital of Bengbu Medical University
        • Contact:
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • The People's Hospital of Gansu Province
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • The Third Affiliated Hospital of Sun Yat-Sen University
        • Contact:
      • Shenzhen, Guangdong, China, 518035
        • Shenzhen Second People's Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Hebei
      • Langfang, Hebei, China, 65000
    • Heibei
      • Shijiazhuang, Heibei, China, 05000
        • The Second Hospital of Hebei Medical University
        • Contact:
    • Henan
      • Puyang, Henan, China, 457001
        • Puyang Oilfield General Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Shiyan, Hubei, China
        • Shiyan People's Hospital
        • Contact:
      • Wuhan, Hubei, China, 430000
        • Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 41000
        • Xiangya Third Hospital of Central South University
        • Contact:
      • Shaoyang, Hunan, China, 422000
        • Shaoyang Central Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Jiangsu Provincial People's Hospital
        • Contact:
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
        • Contact:
      • Meihekou, Jilin, China, 135000
        • Meihekou Central Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • The First Affiliated Hospital of China Medical University
        • Contact:
      • Shenyang, Liaoning, China, 110000
        • Shenjing Hospital of CHINA MEDICAL UNIVERSITY
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, China, 710000
        • The First Hospital Affiliated to the Army Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250011
        • Affiliated hospital of Shandong Academy of Medical Sciences
        • Contact:
          • Bing Fan, Doctor
          • Phone Number: 18560769178
          • Email: icii@163.com
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai Hospital of Shanghai
        • Contact:
      • Shanghai, Shanghai, China, 200001
        • Shanghai Jiao Tong University School of Medicine，Renji Hospital
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Shanxi Bethune Hospital
        • Contact:
      • Taiyuan, Shanxi, China, 030001
        • First Hospital of Shangxi Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Chengdu Second People's Hospital
        • Contact:
      • Mianyang, Sichuan, China, 621099
        • Mianyang central hispital
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300190
        • Tianjin First Central Hospital
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650034
        • Third People's Hospital of Yunnan Province
        • Contact:
      • Pu'er, Yunnan, China, 665099
        • Pu'er People's Hospital
        • Contact:
    • Zhejiang
      • Taizhou, Zhejiang, China, 318001
        • Taizhou central hospital(Taizhou university hospital)
        • Contact:
      • Wenzhou, Zhejiang, China, 325027
        • The 1th School of Medicine,School of Information and Engineering,The 1th Affiliated Hospital of WMU
        • Contact:
      • Wenzhou, Zhejiang, China, 325200
        • Wenzhou People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB3702 Tablets
Administer orally on an empty stomach, once daily, for 24 consecutive weeks.
Drug: TQB3702 Tablets
TQB3702 is a selective kinase inhibitor.
Experimental: TQB3702 Tablets+TQB3702 Placebo
Administer orally on an empty stomach, once daily, for 24 consecutive weeks. Placebo was administered orally once a day for 24 weeks.
Drug: 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.
Placebo Comparator: TQB3702 Placebo
Placebo was administered orally once a day for 24 weeks.
Drug: TQB3702 Placebo
TQB3702 Placebo without drug substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SLE response index -4 (SRI-4)
Time Frame: 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).
Baseline to week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of adverse event (AE)
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.
The severity of all adverse medical events after the first injection.
From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Frequency of adverse event (AE)
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.
The occurrence of all adverse medical events after the first injection.
From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
SLE response index -4 (SRI-4)
Time Frame: Baseline to weeks 4 and 12
≥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)
Baseline to weeks 4 and 12
SLE response index -6 (SRI-6)
Time Frame: Baseline to weeks 4, 12, and 24
≥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)
Baseline to weeks 4, 12, and 24
SLE Disease Activity Index -2000 score
Time Frame: Baseline to weeks 4, 12, and 24

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.
Baseline to weeks 4, 12, and 24
Cutaneous lupus erythematosus Area and Severity Index (CLASI score)
Time Frame: Baseline to weeks 4, 12, and 24
A useful tool for assessing skin activity in patients with lupus erythematosus. The higher the score, the higher the patient's disease activity.
Baseline to weeks 4, 12, and 24
Number of active (tender + swollen) joints
Time Frame: Baseline to weeks 4, 12, and 24
Changes in the number of joints subject moves (tenderness + swelling)
Baseline to weeks 4, 12, and 24
Medical Outcomes Study 36-Item Summary Health Survey (SF-36)
Time Frame: Baseline to weeks 12
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.
Baseline to weeks 12
The change of Anti double-stranded DeoxyriboNucleic Acid(ds-DNA) antibody Anti-dsdna antibody and antinuclear antibody (ANA)
Time Frame: Baseline to weeks 4, 12, and 24
The change of anti-dsDNA antibody value and ANA value
Baseline to weeks 4, 12, and 24
Changes in Complement 3 (C3) values and Complement 4 (C4) values
Time Frame: Baseline to weeks 4, 12, and 24
Changes in C3 values and C4 values
Baseline to weeks 4, 12, and 24
Immunoglobulin G (IgG), Immunoglobulin M (IgM), Immunoglobulin A (IgA) levels
Time Frame: Baseline to weeks 4, 12, and 24
Changes of IgG, IgM and IgA levels.
Baseline to weeks 4, 12, and 24
Cytokine expression levels
Time Frame: Baseline to weeks 4, 12, and 24
Changes in cytokine expression levels
Baseline to weeks 4, 12, and 24
Total B cell count
Time Frame: Baseline to weeks 4, 12, and 24
Changes in total B cell count
Baseline to weeks 4, 12, and 24
Erythrocyte sedimentation rate (ESR)
Time Frame: Baseline to weeks 4, 12, and 24
Changes in erythrocyte sedimentation rate
Baseline to weeks 4, 12, and 24
Peak time (Tmax)
Time Frame: 1, 84, 112, 140 and 168 Days
Peak time (Tmax)
1, 84, 112, 140 and 168 Days
Target occupancy
Time Frame: Day 1, 14 and 168
The extent to which the drug occupies the target on the cell surface
Day 1, 14 and 168
Peak concentration (Cmax)
Time Frame: 1, 84, 112, 140 and 168 Days
Peak concentration (Cmax)
1, 84, 112, 140 and 168 Days
Area under the blood drug concentration time curve (AUC0-24h, AUC0-t, AUC0- ∞),
Time Frame: 1, 84, 112, 140 and 168 Days
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)
Time Frame: 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)
Time Frame: 1, 84, 112, 140 and 168 Days
1, 84, 112, 140 and 168 Days
Plasma elimination half-life (t1/2)
Time Frame: 1, 84, 112, 140 and 168 Days
Plasma elimination half-life (t1/2)
1, 84, 112, 140 and 168 Days
Steady-state peak time (Tmax, ss)
Time Frame: 1, 84, 112, 140 and 168 Days
Steady-state peak time (Tmax, ss)
1, 84, 112, 140 and 168 Days
Steady-state peak concentration (Cmax, ss)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 1, 84, 112, 140 and 168 Days
Accumulation ratio (Rac)
1, 84, 112, 140 and 168 Days
Volatility (DF)
Time Frame: 1, 84, 112, 140 and 168 Days
Volatility (DF)
1, 84, 112, 140 and 168 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB3702-II-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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