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
Condition(s) studied
Investigational drug(s) / intervention(s)
VENT-03: VENT-03 is a tablet
Placebo: Placebo is a tablet
Study 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
Primary outcome measure(s)
- Evaluate the effect of VENT-03 on the interferon gene signature in the skin — Baseline to End of Double-Blind Treatment (up to Day 28)
Percent change from baseline in interferon gene signature in the skin at Day 28
Trial sites (34)
| Facility | City | Region | Status |
|---|---|---|---|
| Investigative Site | Beverly Hills | California | Recruiting |
| Investigative Site | Clearwater | Florida | Recruiting |
| Investigative Site | DeBary | Florida | Recruiting |
| Investigative Site | Miami | Florida | Recruiting |
| Investigative Site | Tampa | Florida | Recruiting |
| Investigative Site | Indianapolis | Indiana | Recruiting |
| Investigative Site | Flint | Michigan | Recruiting |
| Investigative Site | Troy | Michigan | Recruiting |
| Investigative Site | Saint Joseph | Missouri | Recruiting |
| Investigative Site | Albuquerque | New Mexico | Recruiting |
| Investigative Site | Fairport | New York | Recruiting |
| Investigative Site | Memphis | Tennessee | Recruiting |
| Investigative Site | Allen | Texas | Recruiting |
| Investigative Site | Arlington | Texas | Recruiting |
| Investigative Site | Colleyville | Texas | Recruiting |
| Investigative Site | Haskovo | Bulgaria | Recruiting |
| Investigative Site | Plovdiv | Bulgaria | Recruiting |
| Investigative Site | Sofia | Bulgaria | Recruiting |
| Investigative Site | Paris | France | Recruiting |
| Investigative Site | Toulouse | France | Recruiting |
| Investigative Site | Tbilisi | Georgia | Recruiting |
| Investigative Site | Szeged | Hungary | Recruiting |
| Investigative Site | Bialystok | Poland | Recruiting |
| Investigative Site | Oświęcim | Poland | Recruiting |
| Investigative Site | Poznan | Poland | Recruiting |
| Investigative Site | Rzeszów | Poland | Recruiting |
| Investigative Site | Śląskie | Poland | Recruiting |
| Investigative Site | Warsaw | Poland | Recruiting |
| Investigative Site | Wroclaw | Poland | Recruiting |
| Investigative Site | Durban | South Africa | Recruiting |
| Investigative Site | Pretoria | South Africa | Recruiting |
| Investigative Site | Somerset West | South Africa | Recruiting |
| Investigative Site | Badajoz | Spain | Recruiting |
| Investigative Site | Madrid | Spain | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07260877 on ClinicalTrials.gov ↗ ← All trials in the USA