A Study to Evaluate Anifrolumab in Adults with Active Subacute or Chronic Cutaneous Lupus Erythematosus
Official Title
A Multicenter Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/or Subacute Cutaneous Lupus Erythematosus who are Refractory and/or Intolerant to Antimalarial Therapy
Purpose
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Subject must have a diagnosis of cutaneous lupus erythematosus
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Subject must have tried antimalarial treatment (i.e., hydroxychloroquine, quinacrine, or chloroquine) for at least 12 weeks (about 3 months) or was unable to tolerate antimalarial treatment due to side effects
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Subject must be in good general health with no history of tuberculosis, cancer, HIV, or hepatitis B or C
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Female subjects must not be pregnant, breastfeeding, or considering becoming pregnant for the duration of the study
Could this study be right for you?
- Subject must have a diagnosis of cutaneous lupus erythematosus
- Subject must have tried antimalarial treatment (i.e., hydroxychloroquine, quinacrine, or chloroquine) for at least 12 weeks (about 3 months) or was unable to tolerate antimalarial treatment due to side effects
- Subject must be in good general health with no history of tuberculosis, cancer, HIV, or hepatitis B or C
- Female subjects must not be pregnant, breastfeeding, or considering becoming pregnant for the duration of the study