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;
Ventus Therapeutics U.S., Inc.
Lead sponsor