A 2-stage, Phase III study to investigate the efficacy and safety of anifrolumab in adults with chronic and/or subacute cutaneous lupus erythematosus
- Population: Patients aged eighteen years to ≥ 70 years old
- Study Condition: Chronis and/or subacute cutaneous lupus erythematosus
- Study Design:This is a research study to evaluate the efficacy and safety of an investigational drug compared to placebo in the treatment of chronic and/or subacute cutaneous lupus erythematosus. This study will last up to 64 weeks with 18 clinic visits. After signing the informed consent, trial participants will enter the screening period for up to 42 days, and if all eligibility criteria are met, trial participants will be randomized in a 1:1 ratio to either active group or placebo group. Once randomized, trial participants will start a treatment period of 24 weeks, followed by an open-label treatment period of 28 weeks. There will be a safety follow up visit 12 weeks after the last dose.
- Reimbursement will be provided