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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.
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
VENT-03
VENT-03 is a tablet
Placebo
Placebo is a tablet
Locations (27)
Investigative Site
Beverly Hills, California, United States
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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
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Arlington, Texas, United States
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Colleyville, Texas, United States
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Haskovo, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Paris, France
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Toulouse, France
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Tbilisi, Georgia
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Szeged, Hungary
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Bialystok, Poland
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Oświęcim, Poland
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Poznan, Poland
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Rzeszów, Poland
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Śląskie, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Pretoria, South Africa
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Stellenbosch, South Africa
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Badajoz, Spain