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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ventus Therapeutics U.S., Inc.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
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.
