Table of Contents
- Trial overview
- Who can participate
- Study design and treatment groups
- What is being measured
- Trial status and size
Trial overview
The available study is a multicenter, randomized, double-blind, placebo-controlled Phase 2a trial of VENT-03 in adults with active cutaneous lupus erythematosus, with or without systemic lupus erythematosus.[1]
The study is designed to evaluate the efficacy and safety of VENT-03, and it also includes an open-label extension part.[1]
Who can participate
This trial is for adult participants with active cutaneous lupus erythematosus.[1]
People may join whether or not they also have systemic lupus erythematosus, so the study includes a broader lupus population than skin disease alone.[1]
Study design and treatment groups
Participants are assigned to study groups by chance in a randomized design, which helps make the comparison fair.[1]
The trial is double-blind, which means the participants and the study team do not know who receives VENT-03 or placebo during the blinded part of the study.[1]
The placebo tablets are made from the same excipients found in VENT-03 tablets and are identical in appearance, so the comparison is more reliable.[1]
The study also includes an open-label extension, which is a follow-up period where treatment is no longer hidden and participants can continue in the study.[1]
What is being measured
The main endpoint is the percent change from baseline in the IFN gene signature in the skin at Day 28.[1]
This means the study looks at how much the skin immune signal changes after treatment compared with the starting point before the study began.[1]
The brief summary says the trial is evaluating the effect of VENT-03 on the interferon gene signature in the skin, which shows that the study is focused on a skin-based immune marker.[1]
Trial status and size
The trial status is Authorised, and the planned enrollment is 23 participants.[1]
This is a small Phase 2 study, so it is mainly meant to learn more about possible benefit and safety in the target group before larger studies, if needed.[1]
