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
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus, SLE, SLE (Systemic Lupus), CLE
In brief
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 facts
- Study ID
- NCT07260877
- Run by
- Ventus Therapeutics U.S., Inc.
- People needed
- 24
- Starts
- 2025-12-03
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Investigative Site — Beverly Hills, California, United States (enrolling)
- Investigative Site — Clearwater, Florida, United States (enrolling)
- Investigative Site — DeBary, Florida, United States (enrolling)
- Investigative Site — Tampa, Florida, United States (enrolling)
- Investigative Site — Indianapolis, Indiana, United States (enrolling)
- Investigative Site — Flint, Michigan, United States (enrolling)
- Investigative Site — Troy, Michigan, United States (enrolling)
- Investigative Site — Saint Joseph, Missouri, United States (enrolling)
- Investigative Site — Fairport, New York, United States (enrolling)
- Investigative Site — Memphis, Tennessee, United States (enrolling)
- Investigative Site — Allen, Texas, United States (enrolling)
- Investigative Site — Arlington, Texas, United States (enrolling)
- Investigative Site — Colleyville, Texas, United States (enrolling)
- Investigative Site — Haskovo, Bulgaria (enrolling)
- Investigative Site — Plovdiv, Bulgaria (enrolling)
- Investigative Site — Sofia, Bulgaria (enrolling)
- Investigative Site — Paris, France (enrolling)
- Investigative Site — Toulouse, France (enrolling)
- Investigative Site — Tbilisi, Georgia (enrolling)
- Investigative Site — Szeged, Hungary (enrolling)
- Investigative Site — Bialystok, Poland (enrolling)
- Investigative Site — Oświęcim, Poland (enrolling)
- Investigative Site — Poznan, Poland (enrolling)
- Investigative Site — Rzeszów, Poland (enrolling)
- Investigative Site — Śląskie, Poland (enrolling)
Full record on ClinicalTrials.gov
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