RecruitingPhase 2NCT07260877

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


Sponsor

Ventus Therapeutics U.S., Inc.

Enrollment

24 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called VENT-03 for people with cle, cutaneous lupus erythematosus (cle), and other related conditions. The study is currently recruiting participants at 27 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVENT-03

VENT-03 is a tablet

DRUGPlacebo

Placebo is a tablet


Locations(27)

Investigative Site

Beverly Hills, California, United States

Investigative Site

Clearwater, Florida, United States

Investigative Site

DeBary, Florida, United States

Investigative Site

Tampa, Florida, United States

Investigative Site

Saint Joseph, Missouri, United States

Investigative Site

Fairport, New York, United States

Investigative Site

Memphis, Tennessee, United States

Investigative Site

Allen, Texas, United States

Investigative Site

Arlington, Texas, United States

Investigative Site

Colleyville, Texas, 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

Pretoria, South Africa

Investigative Site

Stellenbosch, South Africa

Investigative Site

Badajoz, Spain

View Full Details on ClinicalTrials.gov

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NCT07260877


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