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VENT-03 for Cutaneous Lupus Erythematosus

This study is testing a new tablet called VENT-03 for adults with cutaneous lupus erythematosus (CLE), a skin condition, who may or may not also have systemic lupus erythematosus (SLE). Researchers want to see if VENT-03 can improve CLE symptoms and if it is safe. You would take either VENT-03 or a placebo (a tablet with no medicine) for 4 weeks, then all participants would take VENT-03 for another 8 weeks. The main way success will be measured is by looking at how VENT-03 affects certain genetic markers in your skin. This study is currently recruiting about 24 participants.

Study design
This is a randomized, double-blind (meaning neither you nor your doctor will know if you're getting VENT-03 or placebo), placebo-controlled study with an open-label extension, involving about 24 adult participants.
What's involved
You would take VENT-03 or a placebo for 4 weeks, then VENT-03 for another 8 weeks. You would also visit the clinic once a month for checkups and tests.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint evaluates the effect of VENT-03 up to Day 28.

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NCT07260877

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
PHASE2Ages 18–80InterventionalTreatment
Ventus Therapeutics U.S., Inc.
~24 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:VENT-03Placebo

At a glance

Recruiting sites
32 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the effect of VENT-03 on the interferon gene signature in the skin
Measured over Baseline to End of Double-Blind Treatment (up to Day 28)

Conditions

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

Explore related trials

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Where it's being run

32 sites across 15 states
Poland7
Florida3
Texas3
Bulgaria3
South Africa3
Michigan2
France2
Spain2

Who to contact

Krista Miller
[email protected]
913-410-2156
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Evaluate the effect of VENT-03 on the interferon gene signature in the skinBaseline to End of Double-Blind Treatment (up to Day 28)

    Percent change from baseline in interferon gene signature in the skin at Day 28