Systemic Lupus ErythematosusPhase 2NCT07509892
A Clinical Trial on the Efficacy and Safety of TQH3906 in the Treatment of Systemic Lupus Erythematosus
A Phase 2 study testing TQH3906 capsule in people with Systemic Lupus Erythematosus, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 35 sites in China.
Trial summary
To assess the efficacy and safety of TQH3906 in treating systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- TQH3906 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 35 sitesChina
- Study dates
- 22 Jun 2026to Mar 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign a written informed consent form, which must meet the following requirements:
- Willingness to participate in the study and ability to sign an informed consent form.
- Willingness and ability to complete all research-related procedures and site visits.
- Characteristics of participants in the Systemic Lupus Erythematosus (SLE) trial:
- Screen for patients with a confirmed diagnosis of SLE dating back to at least 24 weeks prior to the visit.
- Diagnosed with systemic lupus erythematosus according to the 2019 classification criteria of the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).
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- Meet one of the following criteria: elevated levels of antinuclear antibodies (ANA) ≥ 1:80, positive results for anti-double-stranded DNA (anti-dsDNA) (positive results include indeterminate results), or positive results for anti-Smith (anti-Sm) antibodies.
- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2k) score ≥ 8 and clinical SLEDAI-2K score ≥ 4, with involvement of joints and/or skin vasculitis and/or rash manifestations (Note: Clinical SLEDAI-2K manifestations do not include complement deficiency and positivity for anti-ds-DNA antibodies).
- Age between 18 and 75 years old (based on the date of signing the informed consent form).
- Medications for SLE treatment:
- Prior to the screening visit, there must be a period of background therapy of at least 12 weeks. The therapy must have been administered at a stable dose for at least 4 weeks prior to the screening visit and remain stable until randomization and throughout the duration of the study participation. If antimalarial or immunosuppressive therapy is discontinued prior to the screening visit, the last dose must have been administered at least 4 weeks prior. Detailed information on specific medications is as follows:
- Immunosuppressants (can be used only one type; combination use is not permitted): Antimalarial drugs: Hydroxychloroquine (allowed for monotherapy; allowed in combination with one type of immunosuppressant) (maximum 400 mg/day).
- Duration of clearance when using other immunomodulatory drugs or biologics.
- Corticosteroids (CS) (prednisone or equivalent medication) is permitted but not required as background therapy. For trial participants using CS, the dose must be stable for at least 2 weeks prior to the screening visit, not exceed 40 mg/day during screening, and remain stable prior to randomization. Monotherapy with CS is not permitted.
- The requirements for trial participants currently receiving long-term treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) are as follows:
- The dosage must remain stable for a period of 14 days prior to the screening visit and must remain stable until randomization and throughout the study period. The use of NSAIDs alone is not permitted.
- A maximum of one oral NSAID (at a stable dosage) may be used during the study period.
- The concurrent use of aspirin as a cardiovascular protective agent/to prevent thrombosis (in addition to other NSAIDs) is permitted throughout the study period, provided that the dosage remains stable.
- Women of childbearing age must agree to use effective contraceptive measures during the study period and for 6 months thereafter, and undergo a blood pregnancy test that is negative within 7 days prior to enrollment in the study. Men must agree to use effective contraceptives during the study period and for the subsequent 6 months.
Who cannot join
- Conditions other than SLE:
- drug-induced SLE;
- Trial participants with other autoimmune diseases (e.g. multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) were excluded. Test participants with secondary dry syndrome could not be excluded;
- Excluded trial participants with overlapping syndromes of SLE, such as systemic sclerosis and mixed associative weaving disease;
- In the case of a combination of antiphospholipid syndrome secondary to systemic lupus erythematosus, prior severe blood clots / obstetric complications need to be ruled out; Prophylaxis with low-dose aspirin (50-100 mg / d) in the absence of thrombotic events or obstetric comorbidities and with high-risk antiphospholipid antibody (aPL) characteristics may be included;
- Trial participants who had had lupus encephalopathy before screening were excluded;
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- Excluding active, severe lupus nephritis requiring cytotoxic drugs (CTX) or high-dose CS treatment, excluding lupus pinocytosis, thrombotic microangiopathy; Trial participants with lupus nephritis, but who are currently controlled, may be included;
- Other medical conditions and medical history;
- Study participants who are pregnant or breastfeeding;
- Evidence of a significant disease / condition or unstable clinical condition (e.g. kidney, Liver, blood, gastrointestinal, endocrine, lung, immune, psychiatric) or locally active infection / infectious disease which, according to medical judgement, will significantly increase the risk of the trial participants if they participate in the study;
- Have had any major surgery within 30 days prior to the first dose of the study treatment, or planned to have any surgery during the course of the study;
- Cancer or a history of cancer or lymphotrophic disease within the past 5 years (except adequately treated basal cell carcinoma or squamous cell carcinoma with no evidence of recurrence);
- Class III or IV congestive heart failure as defined by the New York Heart Association (NYHA) or any recent episode of heart failure resulting in symptoms of NYHA Class III / IV; Or a history of clinically significant ventricular arrhythmia (e.g. persistent ventricular arrythmia , ventricular tremor, sharp twisted ventricular articular arrhythmia) or an arrhythmia that requires continuous anti-arrhythmic medication;
- A history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) and / or any major cerebrovascular disease within 24 weeks prior to screening;
- Currently or recently (within 3 months prior to randomization) had a gastrointestinal disease, including gastrointestinal surgery, that was likely to affect treatment absorption in the study;
- In medical judgment, the trial participants had non-SLE concomitant conditions that may require additional systemic corticosteroid therapy during the study (e.g., asthma);
- Severe blood loss (> 500 mL) or transfusion within 4 weeks prior to randomization;
- It is not possible to take the drugs orally;
- Unable to receive venous punctures and / or tolerate venous pathways;
- Persons who have a history of substance abuse and cannot quit or who have psychiatric disorders;
- Any other medical, spiritual and / or social reasons determined by medical judgement;
- Previous and combined drug use:
- Unable to adhere to restricted and prohibited treatments; Unable to comply with the discontinuation requirement;
- Use more than one immunosuppressant;
- Previous exposure to other TYK2 inhibitors;
- Participants who were previously exposed to anti-interferon targeted drug trials such as Anilumab, Rontalizumab, nterferon Alpha Kinoid (INFaKinoid), etc.;
- Other research drugs must be discontinued for at least 12 weeks or 5 half-lives (whichever is longer) before screening.
- Infection Related:
- Chest radiology within 6 months prior to screening showed the presence of active Tuberculosis (TB) in the trial participants. Test participants who were negative for chest radiology within 3 months prior to screening were eligible to participate in the study:
- Hepatitis C, hepatitis B, or human immunodeficiency virus (HIV) infection, characterized by antibodies to hepatitis C (anti-HCV) and all HCV-RNA positive, surface antigens to hepatitis B (HBsAg) positive, core antibodies to the hepatitis A (HBcAb) and all HIV-DNA positive, or HIV antibody screening positive;
- is currently receiving any treatment regarding chronic infections;
- Persons in need of treatment for syphilis;
- Have a congenital or acquired immunodeficiency disorder;
- Have a history of repeated infections requiring hospitalization or treatment outside the bowel (muscle or intravenous) and receiving intravenous antibiotics; Or need to be hospitalized and / or given intravenous anti-infective treatment within 30 days of the random, or receive any infection requiring oral anti-infectious treatment within 14 weeks of the random;
- Prior history of systemic shingles; Or have two or more recurrent shingles in two years; Or the shingles infection did not completely subside within 12 weeks prior to screening;
- Vaccinated live within 90 days of randomization or inactivated within 30 days of randomisation;
- Abnormalities in physical or laboratory tests:
- Clinically significant chest X-ray or ECG abnormalities
- A laboratory test of clinical significance is abnormal. A screening period laboratory test with abnormal results may be repeated once to confirm abnormal results. If the results are restored to programme acceptable during the screening period without intervention, trial participants may be admitted to the study;
- Any other significant laboratory abnormalities that may, in medical judgement, pose an unacceptable risk to the trial participants during the study period;
- Other exclusion criteria:
- Have a history of any significant drug allergy (e.g. causing an allergic reaction or causing liver toxicity); He is known to be allergic to the ingredients of research drugs;
- those who are unable to comply with the pilot programme;
- Persons who are ready to undergo or have previously undergone a heterotopic bone marrow transplant or a solid organ transplant;
- In the judgement of the investigator, there is a situation that seriously endangers the safety of the test participants or affects the completion of the study by the test participant.
Trial locations and contacts
35 sites in 1 country. Contact the study team or a site near you to ask about taking part.
35 sites in 1 country
China35 sites, 35 recruiting
- Not yet recruiting
Anyang People's Hospital
Anyang, Henan, 455099
Xiao hu Wang, Master, 13938696506, wangpenghu98@126.com
- Not yet recruiting
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Juan Meng, Doctor, 13810582509, mserena@163.com
- Not yet recruiting
The First Affillated Hospital of Bengbu Medical Universit
Bengbu, Anhui, 233000
Changhao Xie, Doctor, 15255227208, uglboy2002@126.com
- Not yet recruiting
Bozhou People's Hospital
Bozhou, Anhui, 236805
Yuhui Zhang, Doctor, 18905688161, clearhui1118@126.com
- Not yet recruiting
DAQING OILFIELD GENERAL HOSPITAL DAQING Jilin Provincial People's Hospital
Changchun, Jilin, 130000
GUOPING JIANG, Master, 13756113726, jianggp0808@163.com
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Zhenyv Jiang, Doctor, 15843079623, jzyd0197@163.com
- Not yet recruiting
Hunan University of Medicine General Hospital
Changsha, Hunan, 418000
Liang Song, Bachelor, 18674558206, 18674558206@163.com
- Not yet recruiting
Southwest Hospital, Third Military Medical University (Army Medical University)
Chongqing, Chongqing Municipality, 400038
Bing Zhong, Master, 18203063388, dune_zhong@163.com
- Not yet recruiting
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163001
Junsong Li, Master, 18004591903, Lijunsong71@163.com
- Not yet recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yunfeng Pan, Doctor, 13609760302, p-yunfeng@163.com
- Not yet recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Liangchun Wang, Doctor, 13926496797, wliangch@mail.sysu.edu.cn
- Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jing Xiu, Doctor, 13858121751, jingxue@zju.edu.cn
- Not yet recruiting
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
Chujun Ouyang, Bachelor, 13630480333, chelly@126.com
- Not yet recruiting
Jingzhou Central Hospital
Jingzhou, Hubei, 434020
Xianrong Luo, Master, 18107167929, 531835651@qq.com
- Recruiting
Gansu Provincial People's Hospital
Lanzhou, Gansu, 730000
Shuhong Zhou, Doctor, 18793135421, Zshlz1973@163.com
- Not yet recruiting
LinFen Central Hospital
Linfen, Shanxi, 041000
Shuhua Qiang, Bachelor, 18636785653, qsh18636785653@126.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Rui Wu, Doctor, 13970997559, 13970997559@139.com
- Recruiting
Jiansu PeopinceHospital
Nanjing, Jiangsu, 210001
Wenfeng Tan, Doctor, 13770769608, Tanwenfeng@gmail.com
- Not yet recruiting
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530007
CunDong Mi, Master, 15807801372, Md-392@126.com
- Not yet recruiting
The First Affiliated Hospital Of GuangXi Medical University
Nanning, Guangxi, 530021
Hanyou Mo, Master, 13707730655, 419459292@qq.com
- Not yet recruiting
Puyang Oilfield General Hospital
Puyang, Henan, 457001
Fengju Li, Bachelor, 13030300169, 13030300169@163.com
- Not yet recruiting
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200001
Fang Du, Doctor, 13564643358, dufangya@126.com
- Not yet recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
Meiying Wang, Doctor, 13723769919, wmy99wmy99@163.com
- Not yet recruiting
Taizhou Central Hospital
Taizhou, Zhejiang, 318000
Guofen Wang, Master, 13906598161, Wanggf7226@tzzxy.com
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Na Zhang, Doctor, 13820489562, lunazhang22@163.com
- Not yet recruiting
Weifang People's Hospital
Weifang, Shandong, 261000
Jingjing Ma, Master, 13626469450, wfmjj001@163.com
- Not yet recruiting
Tongji Hospital Tongji Medical college of HUST
Wuhan, Hubei, 430030
Lingli Dong, Doctor, 18672912727, tjhdongll@163.com
- Not yet recruiting
The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710000
Zhaohui Zheng, Doctor, 13571924267, zhengzh@fmmu.edu.cn
- Not yet recruiting
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710000
Yuan Feng, Doctor, 13720635945, 1545688082@qq.com
- Not yet recruiting
Xuchang Central Hospital
Xuchang, Henan, 461000
Weitao Yang, Master, 15188538118, yangfan256@126.com
- Not yet recruiting
The first People's Hospital of Yibin
Yibin, Sichuan, 644000
Jiangtao Li, Doctor, 13684158012, 68721784@qq.com
- Not yet recruiting
Yichang Central People's Hospital
Yichang, Hubei, 443100
Xiaoqiang Hou, Master, 13487237625, hxqhjz@163.com
- Not yet recruiting
The First Affiliated Hospital of Henan University of CM
Zhengzhou, Henan, 450003
Hongtao Guo, Doctor, 187399916938, guoht2009@126.com
- Not yet recruiting
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007
Zhenhua Wen, Master, 13607339923, 151728544@qq.com
- Not yet recruiting
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Xiaoli Pan, Master, 18209836340, 570210191@qq.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Clinical Trial Evaluating the Efficacy and Safety of TQH3906 in the Treatment of Systemic Lupus Erythematosus
To assess the efficacy and safety of TQH3906 in treating systemic lupus erythematosus.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- TQH3906 capsule, TQH3906 placebo
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQH3906 capsuleDrug
The TQH3906 capsule is a Tyrosine Kinase 2 (TYK2) inhibitor.
TQH3906 placeboDrug
Placebo without drug.
| Study group | Role | What they receive |
|---|---|---|
| 16 mg TQH3906 capsule | Experimental | 16 mg TQH3906 capsule, oral administration, once daily, for a duration of 48 weeks. Receives: Drug: TQH3906 capsule |
| 24 mg TQH3906 capsules | Experimental | 24 mg TQH3906 capsule, oral administration, once daily, for a duration of 48 weeks. Receives: Drug: TQH3906 capsule |
| TQH3906 placebo | Placebo comparator | Placebo, oral administration, once daily, for a duration of 48 weeks. Receives: Drug: TQH3906 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of participants who achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4)
The percentage of trial participants who reached SRI-4 by week 32.
Measured: Baseline to week 32.
Secondary outcomes (5)
The percentage of participants who achieved SRI-4
The percentage of trial participants who reached SRI-4 by weeks 24 and 48
Measured: Baseline to week 24, baseline to week 48
Percentage of trial participants achieving composite lupus assessment (BICLA) remission based on the British Isles Lupus Assessment Group (BILAG) index
Percentage of trial participants achieving composite lupus assessment according to the British Isles Lupus Assessment Group (BILAG) index by weeks 24, 32, and 48 (BICLA remission)
Measured: Baseline to week 24, baseline to week 32, baseline to week 48
The percentage of trial participants who achieved low disease activity status (LDA) for lupus
The percentage of trial participants who achieved low disease activity status (LDA) for lupus by weeks 24, 32, and 48
Measured: Baseline to week 24, baseline to week 32, baseline to week 48
The proportion of trial participants with baseline Clinical Lupus Activity Index (CLASI) activity score ≥ 10 and achieving CLASI response (defined as a reduction in CLASI activity score of ≥ 50% from baseline at weeks 24, 32, and 48)
The proportion of trial participants with baseline Clinical Lupus Activity Index (CLASI) activity score ≥ 10 and achieving CLASI response (defined as a reduction in CLASI activity score of ≥ 50% from baseline at weeks 24, 32, and 48)
Measured: Baseline to week 24, baseline to week 32, baseline to week 48
The percentage of trial participants who achieved a joint count of 50 (defined as having ≥ 6 joints affected at baseline and a reduction in joint involvement of ≥ 50% from baseline)
Percentage of trial participants who achieved a joint count of 50 (defined as having ≥ 6 joints affected at baseline and a reduction in joint involvement of ≥ 50% from baseline) by weeks 24, 32, and 48
Measured: Baseline to week 24, baseline to week 32, baseline to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start22 Jun 2026
- Primary completionNov 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509892
- Sponsor's protocol ID
- TQH3906-II-03
- Status last verified
- Feb 2026
- First submitted
- 28 Mar 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No