A Clinical Trial on the Efficacy and Safety of TQH3906 in the Treatment of Systemic Lupus Erythematosus
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
1 other identifier
interventional
198
1 country
34
Brief Summary
To assess the efficacy and safety of TQH3906 in treating systemic lupus erythematosus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2026
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedFirst Posted
Study publicly available on registry
April 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
May 12, 2026
February 1, 2026
1.6 years
March 28, 2026
May 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline to week 32.
Secondary Outcomes (5)
The percentage of participants who achieved SRI-4
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
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
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)
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)
Baseline to week 24, baseline to week 32, baseline to week 48
Study Arms (3)
16 mg TQH3906 capsule
EXPERIMENTAL16 mg TQH3906 capsule, oral administration, once daily, for a duration of 48 weeks.
24 mg TQH3906 capsules
EXPERIMENTAL24 mg TQH3906 capsule, oral administration, once daily, for a duration of 48 weeks.
TQH3906 placebo
PLACEBO COMPARATORPlacebo, oral administration, once daily, for a duration of 48 weeks.
Interventions
The TQH3906 capsule is a Tyrosine Kinase 2 (TYK2) inhibitor.
Eligibility Criteria
You may qualify if:
- 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).
- 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:
- +4 more criteria
You may not qualify if:
- 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;
- 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;
- +29 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
The First Affillated Hospital of Bengbu Medical Universit
Bengbu, Anhui, 233000, China
Bozhou People's Hospital
Bozhou, Anhui, 236805, China
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020, China
Southwest Hospital, Third Military Medical University (Army Medical University)
Chongqing, Chongqing Municipality, 400038, China
Gansu Provincial People's Hospital
Lanzhou, Gansu, 730000, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530007, China
The First Affiliated Hospital Of GuangXi Medical University
Nanning, Guangxi, 530021, China
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163001, China
Puyang Oilfield General Hospital
Puyang, Henan, 457001, China
Xuchang Central Hospital
Xuchang, Henan, 461000, China
The First Affiliated Hospital of Henan University of CM
Zhengzhou, Henan, 450003, China
Jingzhou Central Hospital
Jingzhou, Hubei, 434020, China
Tongji Hospital Tongji Medical college of HUST
Wuhan, Hubei, 430030, China
Yichang Central People's Hospital
Yichang, Hubei, 443100, China
Hunan University of Medicine General Hospital
Changsha, Hunan, 418000, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007, China
Jiansu PeopinceHospital
Nanjing, Jiangsu, 210001, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
DAQING OILFIELD GENERAL HOSPITAL DAQING Jilin Provincial People's Hospital
Changchun, Jilin, 130000, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710000, China
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710000, China
Weifang People's Hospital
Weifang, Shandong, 261000, China
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200001, China
LinFen Central Hospital
Linfen, Shanxi, 041000, China
The first People's Hospital of Yibin
Yibin, Sichuan, 644000, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Taizhou Central Hospital
Taizhou, Zhejiang, 318000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
March 28, 2026
First Posted
April 3, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
May 12, 2026
Record last verified: 2026-02