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
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Evaluate the effect of VENT-03 on the interferon gene signature in the skin — Baseline to End of Double-Blind Treatment (up to Day 28) Percent change from baseline in interferon gene signature in the skin at Day 28
Trial sites (32)
Facility
City
Region
Status
Investigative Site
Beverly Hills
California
Recruiting
Investigative Site
Clearwater
Florida
Recruiting
Investigative Site
DeBary
Florida
Recruiting
Investigative Site
Tampa
Florida
Recruiting
Investigative Site
Indianapolis
Indiana
Recruiting
Investigative Site
Flint
Michigan
Recruiting
Investigative Site
Troy
Michigan
Recruiting
Investigative Site
Saint Joseph
Missouri
Recruiting
Investigative Site
Fairport
New York
Recruiting
Investigative Site
Memphis
Tennessee
Recruiting
Investigative Site
Allen
Texas
Recruiting
Investigative Site
Arlington
Texas
Recruiting
Investigative Site
Colleyville
Texas
Recruiting
Investigative Site
Haskovo
Bulgaria
Recruiting
Investigative Site
Plovdiv
Bulgaria
Recruiting
Investigative Site
Sofia
Bulgaria
Recruiting
Investigative Site
Paris
France
Recruiting
Investigative Site
Toulouse
France
Recruiting
Investigative Site
Tbilisi
Georgia
Recruiting
Investigative Site
Szeged
Hungary
Recruiting
Investigative Site
Bialystok
Poland
Recruiting
Investigative Site
Oświęcim
Poland
Recruiting
Investigative Site
Poznan
Poland
Recruiting
Investigative Site
Rzeszów
Poland
Recruiting
Investigative Site
Śląskie
Poland
Recruiting
Investigative Site
Warsaw
Poland
Recruiting
Investigative Site
Wroclaw
Poland
Recruiting
Investigative Site
Durban
South Africa
Recruiting
Investigative Site
Pretoria
South Africa
Recruiting
Investigative Site
Somerset West
South Africa
Recruiting
Investigative Site
Badajoz
Spain
Recruiting
Investigative Site
Madrid
Spain
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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