BridgeMD
Tests treatment safety and results for Cutaneous Lupus Erythematosus (CLE)
Official title 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
ClinicalTrials.gov ID: NCT07260877
What this study is testing
What is VENT-03?
VENT-03 is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for cutaneous lupus erythematosus (cle).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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;
You likely can't join if
- Meet protocol-specified infection or lab criteria; any other laboratory test results that, in the investigator's opinion, might place participant at...
- 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;
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beverly Hills, California, United States
- Clearwater, Florida, United States
- DeBary, Florida, United States
- Tampa, Florida, United States
- Saint Joseph, Missouri, United States
- Fairport, New York, United States
- Memphis, Tennessee, United States
- Allen, Texas, United States
- Arlington, Texas, United States
- Colleyville, Texas, United States
- Haskovo, Bulgaria
- Plovdiv, Bulgaria
- Sofia, Bulgaria
- Paris, France
- Toulouse, France
- Tbilisi, Georgia
- Szeged, Hungary
- Bialystok, Poland
- Oświęcim, Poland
- Poznan, Poland
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beverly Hills, California, United States; Clearwater, Florida, United States; DeBary, Florida, United States; Tampa, Florida, United States; Saint Joseph, Missouri, United States; Fairport, New York, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.