Clareo Health | 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
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
* 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.
You may not be if
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.
