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 (NCT06015737)

The D346BC00001 study is designed to evaluate the efficacy and safety of anifrolumab in adults with chronic and/or subacute lupus erythematous. 
Participants receive either trial medication or a placebo (something that looks like the trial drug but has no effect on the body), both administered weekly as injections into the skin (subcutaneous injections). The treatment period will be approximately 52 weeks with all participants moving to active treatment (receiving treatment drug) after Week 24.
 

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Professor Johannes S Kern

Key inclusion data

Aged between 18-70 years of age at screening.

Diagnosed with CLE.

Have had standard antimalaria medications for your CLE which did not sufficiently improve your condition OR were unable to take antimalarial medication due to concerns related to possible side effects.