A Multicentre, Randomised, Double-blind, Positive-control Clinical Trial Evaluating Dihydroartemisinin Tablets for the Treatment of Discoid Lupus Erythematosus
China100 participantsStarted 2026-04-30
Plain-language summary
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).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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;
✓. At the time of screening, the Cutaneous Lupus Erythematosus Area and Severity Index (CLASI-A) must be ≥4.
Exclusion criteria
✕. 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);
✕. Patients diagnosed with anaemia within 3 months prior to randomisation, or patients with haemoglobin levels below 110 g/L at screening;
What they're measuring
1
Percentage change from baseline in the Cutaneous Lupus Erythematosus Area and Severity Index (CLASI-A) score at week 24
✕. Patients who have used any antimalarial drug (hydroxychloroquine sulphate, chloroquine phosphate or chloroquine) within 4 weeks prior to randomisation;
✕. Patients who have used topical corticosteroids (e.g. mometasone furoate cream or others) or topical calcineurin inhibitors (e.g. tacrolimus ointment or others) within 2 weeks prior to randomisation;
✕. Patients treated with biologics (e.g. adalimumab, secukinumab or others) within 12 weeks prior to randomisation;