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
Start Date
12/3/2025
Completion Date
9/1/2026
Summary
The goal of this clinical trial is to learn if VENT-03 works to treat patients with cutaneous lupus erythematosus (CLE) who may or may not have systemic lupus erythematosus (SLE). Another goal is to learn about the safety of VENT-03 and how it is processed by the body. The main questions it aims to answer are: * Does VENT-03 affect the activity and severity of CLE? * What side effects do participants have when taking VENT-03? Researchers will compare VENT-03 to a placebo (a look-alike substance that contains no drug) to see if VENT-03 works to treat patients with CLE. Participants will: * Take VENT-03 or a placebo for 4 weeks, then all participants will switch to VENT-03 for another 8 weeks; * Visit the clinic once a month for checkups and tests.
Eligibility Criteria
Age Range: 18 years to 80 years
Interventions
VENT-03
Placebo
Conditions
Locations
Investigative Site
Beverly Hills, California 90211
United States
Investigative Site
Clearwater, Florida 33765
United States
Investigative Site
DeBary, Florida 32713
United States
Investigative Site
Tampa, Florida 33606
United States
Investigative Site
Indianapolis, Indiana 46250
United States
Investigative Site
Flint, Michigan 48439
United States
Investigative Site
Troy, Michigan 48084
United States
Investigative Site
Saint Joseph, Missouri 64506
United States
Investigative Site
Fairport, New York 14450
United States
Investigative Site
Memphis, Tennessee 38119
United States
Investigative Site
Allen, Texas 75013
United States
Investigative Site
Arlington, Texas 76012
United States
Investigative Site
Colleyville, Texas 76034
United States
Investigative Site
Haskovo,
Bulgaria
Investigative Site
Plovdiv,
Bulgaria
Investigative Site
Sofia,
Bulgaria
Investigative Site
Paris,
France
Investigative Site
Toulouse,
France
Investigative Site
Tbilisi,
Georgia
Investigative Site
Szeged,
Hungary
Investigative Site
Bialystok,
Poland
Investigative Site
Oświęcim,
Poland
Investigative Site
Poznan,
Poland
Investigative Site
Rzeszów,
Poland
Investigative Site
Śląskie,
Poland
Investigative Site
Warsaw,
Poland
Investigative Site
Wroclaw,
Poland
Investigative Site
Durban,
South Africa
Investigative Site
Pretoria,
South Africa
Investigative Site
Somerset West,
South Africa
Investigative Site
Badajoz,
Spain
Investigative Site
Madrid,
Spain