RECRUITING Phase 2 ClinicalTrials.gov

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. • ClinicalTrials.gov ID: NCT07260877

Registry updated: 2026-10-05

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Description

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.

Interventions

VENT-03 (Drug)
VENT-03 is a tablet
Placebo (Drug)
Placebo is a tablet

Eligibility criteria

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.

Conditions

Cutaneous Lupus Erythematosus (CLE) Systemic Lupus Erythematosus SLE SLE (Systemic Lupus) CLE

Locations

Investigative Site — Beverly Hills, California, United States
Investigative Site — Clearwater, Florida, United States
Investigative Site — DeBary, Florida, United States
Investigative Site — Miami, Florida, United States
Investigative Site — Tampa, Florida, United States
Investigative Site — Indianapolis, Indiana, United States
Investigative Site — Flint, Michigan, United States
Investigative Site — Troy, Michigan, United States
Investigative Site — Saint Joseph, Missouri, United States
Investigative Site — Albuquerque, New Mexico, United States
Investigative Site — Fairport, New York, United States
Investigative Site — Memphis, Tennessee, United States
Investigative Site — 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
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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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