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VENT-03 treatment for adults with active cutaneous lupus, with or without systemic lupus

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

Phase 2 Interventional Ventus Therapeutics U.S., Inc. · NCT07260877

The treatment VENT-03 will be tested to see if it reduces skin disease and symptoms in adults with active cutaneous lupus, including those who also have systemic lupus.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment24 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorVentus Therapeutics U.S., Inc. Industry-sponsored
Locations27 sites (Beverly Hills, California and 26 other locations)
Trial IDNCT07260877 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2a trial with an open-label extension enrolling adults who have active cutaneous lupus, with or without systemic lupus. Participants are randomized to take VENT-03 or a matching placebo for 4 weeks, then all participants switch to VENT-03 for an additional 8 weeks, with monthly clinic visits for exams and testing. The study collects safety data, pharmacokinetic information, and measures of skin disease activity (for example CLASI-A) to see whether VENT-03 improves skin lesions and symptoms. The trial excludes people with certain laboratory abnormalities, moderate-to-severe liver impairment, drug-induced lupus, or other conditions that increase risk.

Who should consider this trial

Good fit: Adults with active cutaneous lupus (CLASI-A ≥ 8) who have at least one active discoid or subacute CLE lesion, and those with SLE who meet ACR/EULAR 2019 criteria, have a positive ANA (titer ≥1:80) and are on stable SLE therapy, are the intended participants.

Not a fit: People with drug-induced lupus, moderate or severe liver impairment, specified infection or lab exclusions, or uncontrolled inflammatory joint disease are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, VENT-03 could reduce the severity of skin lesions and improve symptoms in people with cutaneous lupus, offering a new targeted treatment option.

How similar studies have performed: Targeting the cGAS pathway is a relatively new approach; preclinical and very early clinical data show promise but robust clinical proof of benefit is still limited.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Beverly Hills, California and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cutaneous Lupus ErythematosusSystemic Lupus ErythematosusSLECLECLE, SLE, lupus, cutaneous lupus erythematosus, systemic lupus erythematosus, VENT-03cGAS
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.