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.

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.

As this study will enroll patients from the EU, the sponsor needs to consider that an IPD plan is compliant with GDPR. The sponsor needs to analyze and determine whether an IPD Plan can comply with GDPR based on plans and processes in place for the study in order to ensure legality and ethical data handling.

Sponsor