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

NCT06859931 | Not Yet Recruiting Phase 2

• 1 other identifier: TQB3702-II-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 37

Brief 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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• SLE response index -4 (SRI-4)

  ≥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 Outcomes (28)

• 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

Study Arms (3)

TQB3702 Tablets

EXPERIMENTAL

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

Drug: TQB3702 Tablets

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.

Drug: TQB3702 Tablets+TQB3702 Placebo

TQB3702 Placebo

PLACEBO COMPARATOR

Placebo was administered orally once a day for 24 weeks.

Drug: TQB3702 Placebo

Interventions

TQB3702 Tablets DRUG

TQB3702 is a selective kinase inhibitor.

TQB3702 Tablets

TQB3702 Tablets+TQB3702 Placebo DRUG

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.

TQB3702 Tablets+TQB3702 Placebo

TQB3702 Placebo DRUG

TQB3702 Placebo without drug substance.

TQB3702 Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (37)

The First Affilliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233000, China

Location

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

The People's Hospital of Gansu Province

Lanzhou, Gansu, 730030, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Shenzhen second people's hospital

Shenzhen, Guangdong, 518035, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Hebei petro China central hospital

Langfang, Hebei, 65000, China

Location

The second hospital of hebei medical university

Shijiazhuang, Heibei, 05000, China

Location

Puyang Oilfield General Hospital

Puyang, Henan, 457001, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

Shiyan People's Hospital

Shiyan, Hubei, China

Location

Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

Xiangya Third Hospital of Central South University

Changsha, Hunan, 41000, China

Location

Shaoyang Central Hospital

Shaoyang, Hunan, 422000, China

Location

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210000, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Meihekou Central Hospital

Meihekou, Jilin, 135000, China

Location

Shenjing Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

The First Hospital Affiliated to the Army Medical University

Xi'an, Shaanxi, 710000, China

Location

Affiliated hospital of Shandong Academy of Medical Sciences

Jinan, Shandong, 250011, China

Location

Shanghai Jiao Tong University School of Medicine，Renji Hospital

Shanghai, Shanghai Municipality, 200001, China

Location

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, 200433, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030000, China

Location

First Hospital of Shangxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Chengdu Second People's Hospital

Chengdu, Sichuan, 610000, China

Location

Mianyang central hispital

Mianyang, Sichuan, 621099, China

Location

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300190, China

Location

Third People's Hospital of Yunnan Province

Kunming, Yunnan, 650034, China

Location

Pu'er People's Hospital

Pu'er, Yunnan, 665099, China

Location

Taizhou Central Hospital（Taizhou University Hospital）

Taizhou, Zhejiang, 318001, China

Location

The 1th School of Medicine,School of Information and Engineering,The 1th Affiliated Hospital of WMU

Wenzhou, Zhejiang, 325027, China

Location

Wenzhou People's Hospital

Wenzhou, Zhejiang, 325200, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Chunde Bao, Doctor

CONTACT

86-21-63284622; Baochunde_1678@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2025

Record last verified: 2024-12

Locations

CN (37)