A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

To be considered for this study, you must be an adult aged between 18 and 70 years old with a confirmed diagnosis of cutaneous lupus erythematosus (CLE). Your CLE needs to be active and bothering you, and you must have tried antimalarial treatments for it without enough success, or you couldn't tolerate them.

There are also some health conditions that would mean you couldn't join the study. These include having a history of tuberculosis, severe forms of systemic lupus erythematosus (SLE) or Sjögren's Syndrome, or other active skin problems that might interfere with the study's results. You also couldn't take part if you have a history of serious infections requiring hospitalisation, certain blood clotting disorders, a recent COVID-19 infection, or past severe allergic reactions to similar types of medications.

All participants will also need to meet specific health criteria based on blood tests and other checks to ensure it's safe for them to take part. Both men and women would need to follow specific contraception guidelines during the study.

If you join this study, you'll be involved for about a year and three months in total. For the first 24 weeks (around six months), you'll be randomly assigned to receive either the study medication, anifrolumab, or a placebo (a dummy treatment, which looks the same but contains no active drug). Neither you nor your study doctor will know which one you're receiving during this time. You'll regularly visit the study clinic for assessments and to receive your treatment, which will be given as an injection under the skin.

After these first 24 weeks, all participants will then receive anifrolumab for the next 28 weeks (about seven months). During this entire treatment period, there will be regular checks of your health, your CLE symptoms, and any side effects. After all treatments are completed, you'll have a final 12-week safety follow-up period, where researchers will continue to monitor your health. Your commitment to these visits and assessments is crucial for the study to gather important information.