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.
CLASI-A score ≥8;
At least 1 active discoid lupus erythematosus (DLE) lesion, OR at least 1 active subacute CLE lesion
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
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;
Parallel
VENT-03
DrugVENT-03 is a tablet
Placebo
DrugPlacebo is a tablet
Evaluate the effect of VENT-03 on the interferon gene signature in the skin
Percent change from baseline in interferon gene signature in the skin at Day 28
Evaluate the effect of VENT-03 on CLE disease severity
Percent change from baseline in CLASI-A score at Day 28
Evaluate effect of VENT-03 on CLE disease severity
Percentage of participants achieving CLASI-A 50 response (≥ 50% improvement in CLASI A score compared with baseline) at Day 28
Change from Baseline in Myxovirus-Resistant Protein A (MXA) Immunostaining in Skin Biopsy
Number of participants with at least one Treatment Emergent Adverse Event (TEAE) and/or Serious Adverse Event (SAE)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug. An SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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