This study is a multicentre, randomised, double-blind, double-dummy, phase II clinical trial with a positive-control group, designed to evaluate the efficacy and safety of dihydroartemisinin tablets in the treatment of discoid lupus erythematosus (DLE).
Participants are able to understand the purpose and risks of the study and voluntarily sign an informed consent form;
Aged between 18 and 65 years (inclusive);
Body weight ≥ 45 kg;
Diagnosed with discoid lupus erythematosus (DLE) at the screening visit (refer to the '2021 Guidelines for the Diagnosis, Treatment and Long-term Management of Cutaneous Lupus Erythematosus'); new patients must undergo a skin biopsy and provide a pathology report, whilst existing patients must provide a biopsy pathology report dated within the last 5 years;
Patients with systemic lupus erythematosus (SLE) or those at high risk of developing SLE;
Drug-induced lupus;
Patients with a history of resistance to antimalarial treatment;
At screening, aspartate transaminase (AST) or alanine transaminase (ALT) or gamma-glutamyltransferase (GGT) levels exceeding twice the upper limit of normal (ULN); or alkaline phosphatase (ALP) or total bilirubin levels exceeding 1.5 times the upper limit of normal (ULN); or serum creatinine (Cr) or urea (UREA) levels exceeding 1.5 times the upper limit of normal (ULN);