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Study identifier: NCT07260877 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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: Cutaneous Lupus Erythematosus (CLE) · Systemic Lupus Erythematosus · SLE  ·  Sponsor: Ventus Therapeutics U.S., Inc.

PhasePhase 2
Planned participants24
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Krista Miller  ·  913-410-2156  ·  AERIS@iconplc.com

Always discuss trial participation with your own doctor first.

Locations (32)

Investigative SiteBeverly Hills, California, United StatesRecruiting
Investigative SiteClearwater, Florida, United StatesRecruiting
Investigative SiteDeBary, Florida, United StatesRecruiting
Investigative SiteTampa, Florida, United StatesRecruiting
Investigative SiteIndianapolis, Indiana, United StatesRecruiting
Investigative SiteFlint, Michigan, United StatesRecruiting
Investigative SiteTroy, Michigan, United StatesRecruiting
Investigative SiteSaint Joseph, Missouri, United StatesRecruiting
Investigative SiteFairport, New York, United StatesRecruiting
Investigative SiteMemphis, Tennessee, United StatesRecruiting
Investigative SiteAllen, Texas, United StatesRecruiting
Investigative SiteArlington, Texas, United StatesRecruiting

+ 20 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07260877