To assess the efficacy and safety of TQH3906 in treating systemic lupus erythematosus.
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.
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).
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;
Parallel
TQH3906 capsule
DrugThe TQH3906 capsule is a Tyrosine Kinase 2 (TYK2) inhibitor.
TQH3906 placebo
DrugPlacebo without drug.
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.
The percentage of participants who achieved SRI-4
The percentage of trial participants who reached SRI-4 by weeks 24 and 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)
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
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)
Click on the lead sponsor to view all of their trials.
