A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus

To be considered for this study, you must be an adult aged between 18 and 80 years old. You need to have active cutaneous lupus (CLE) with certain skin symptoms, such as specific types of rashes or sores. If you also have systemic lupus (SLE), you'll need to have had a positive blood test for specific antibodies and meet certain diagnostic criteria, while also being on stable treatment for your SLE.

There are also some reasons why you might not be able to join. For example, if you have certain infections, significant liver problems, or have had drug-induced lupus (rather than the more common type). You also wouldn't be able to participate if you have other inflammatory skin or joint conditions unrelated to lupus, or certain other health issues like active severe neurological lupus or cancer within a recent period (with some exceptions). The study also has rules around recent use of strong steroid medications or hospital stays for severe lupus flares.

If you decide to take part in this study, you'll first be given either the study medicine, VENT-03, or a placebo (a dummy pill) for 4 weeks. After this initial period, everyone in the study will then switch to taking VENT-03 for another 8 weeks. So, the total time you'll be taking the study medication or placebo is 12 weeks.

Throughout the study, you'll need to visit the clinic about once a month. These visits are important for the research team to carry out check-ups, conduct various tests (like blood tests), and monitor how you're responding to the treatment and if you're experiencing any side effects. These regular check-ups help ensure your safety and collect all the necessary information for the study.