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RECRUITING
NCT07260877
PHASE2

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.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-12-03

Completion Date

2026-09

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

DRUG

VENT-03

VENT-03 is a tablet

DRUG

Placebo

Placebo is a tablet

Locations (27)

Investigative Site

Beverly Hills, California, United States

Investigative Site

Clearwater, Florida, United States

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DeBary, Florida, United States

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Tampa, Florida, United States

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Saint Joseph, Missouri, United States

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Fairport, New York, United States

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Memphis, Tennessee, United States

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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

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Wroclaw, Poland

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Pretoria, South Africa

Investigative Site

Stellenbosch, South Africa

Investigative Site

Badajoz, Spain