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
Recruiting · NCT07260877 · Interventional (participants receive a specific treatment) · Lead sponsor: Ventus Therapeutics U.S., Inc.
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboVENT-03
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
32 locations listed across 8 US states.
- Investigative Site - Beverly Hills, California, United States
- Investigative Site - Clearwater, Florida, United States
- Investigative Site - DeBary, Florida, United States
- Investigative Site - Tampa, Florida, United States
- Investigative Site - Indianapolis, Indiana, United States
- Investigative Site - Flint, Michigan, United States
- Investigative Site - Troy, Michigan, United States
- Investigative Site - Saint Joseph, Missouri, United States
- Investigative Site - Fairport, New York, United States
- Investigative Site - Memphis, Tennessee, United States
- Investigative Site - Allen, Texas, United States
- Investigative Site - Arlington, Texas, United States
- Investigative Site - Colleyville, Texas, United States
- Investigative Site - Badajoz, Spain
- Investigative Site - Bialystok, Poland
- Investigative Site - Durban, South Africa
- Investigative Site - Haskovo, Bulgaria
- Investigative Site - Madrid, Spain
- Investigative Site - Oświęcim, Poland
- Investigative Site - Paris, France
- Investigative Site - Plovdiv, Bulgaria
- Investigative Site - Poznan, Poland
- Investigative Site - Pretoria, South Africa
- Investigative Site - Rzeszów, Poland
- Investigative Site - Sofia, Bulgaria
- Investigative Site - Somerset West, South Africa
- Investigative Site - Szeged, Hungary
- Investigative Site - Tbilisi, Georgia
- Investigative Site - Toulouse, France
- Investigative Site - Warsaw, Poland
- Investigative Site - Wroclaw, Poland
- Investigative Site - Śląskie, Poland