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NCT07260877PHASE2Recruiting

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

Ventus Therapeutics U.S., Inc.

Start Date

12/3/2025

Completion Date

9/1/2026

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 Criteria

Age Range: 18 years to 80 years

Key Inclusion Criteria: * Cutaneous lupus: * CLASI-A score ≥8; * At least 1 active discoid lupus erythematosus (DLE) lesion, OR at least 1 active subacute CLE lesion * If participant has previous SLE diagnosis: * Positive antinuclear antibody test at Screening by immunofluorescent assay at the central laboratory with titer ≥ 1:80; * Meets the American College of Rheumatology/ European Alliance of Associations for Rheumatology 2019 criteria for SLE; and * Currently receiving at least one of the specified SLE medication treatments, at stable doses. Key Exclusion Criteria: * Meet protocol-specified infection or lab criteria; any other laboratory test results that, in the investigator's opinion, might place participant at unacceptable risk for participating in this study; * Moderate or severe liver impairment as classified by the Child-Pugh criteria (categories B and C); * Has drug-induced lupus, rather than 'idiopathic' lupus; * History of, or current, inflammatory joint or skin disease other than SLE and cutaneous lupus; * Diagnosis of select potentially confounding autoimmune disorders * Active severe or unstable neuropsychiatric SLE; * Hospitalization for a severe lupus flare in the past 3 months, or active severe SLE-driven disease, including lupus nephritis, for which in the opinion of the PI the protocol-specified SOC is insufficient; * History of or current diagnosis of anti-phospholipid syndrome; * History of any non-lupus disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to Day 1; * Meets protocol specified medical history of infectious diseases and infections and/or opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within specified timeframes; * Cancer screening results suspicious of malignancy or history of cancer within time specified with exceptions for curative therapy for squamous or basil cell carcinoma and cervical cancer in situ; and * Meets protocol specified exclusions related to concomitant medications.

Interventions

DRUG

VENT-03

DRUG

Placebo

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Conditions

Cutaneous Lupus Erythematosus (CLE)Systemic Lupus ErythematosusSLESLE (Systemic Lupus)CLE

Locations

Investigative Site

Beverly Hills, California 90211

United States

Investigative Site

Clearwater, Florida 33765

United States

Investigative Site

DeBary, Florida 32713

United States

Investigative Site

Tampa, Florida 33606

United States

Investigative Site

Indianapolis, Indiana 46250

United States

Investigative Site

Flint, Michigan 48439

United States

Investigative Site

Troy, Michigan 48084

United States

Investigative Site

Saint Joseph, Missouri 64506

United States

Investigative Site

Fairport, New York 14450

United States

Investigative Site

Memphis, Tennessee 38119

United States

Investigative Site

Allen, Texas 75013

United States

Investigative Site

Arlington, Texas 76012

United States

Investigative Site

Colleyville, Texas 76034

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

Durban,

South Africa

Investigative Site

Pretoria,

South Africa

Investigative Site

Somerset West,

South Africa

Investigative Site

Badajoz,

Spain

Investigative Site

Madrid,

Spain