Actively Recruiting
A Phase 2a Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Open-Label Extension Evaluating VENT-03 in Adults With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
Led by Ventus Therapeutics U.S., Inc. · Updated on 2026-04-06
24
Participants Needed
27
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating VENT-03, an oral tablet, to treat adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). The study aims to understand if VENT-03 affects CLE activity and severity, assess its safety, and learn how the body processes the drug. This Phase 2a trial compares VENT-03 to a placebo to determine its effects on the skin's interferon gene signature and disease severity. Participants will be randomly assigned to receive either VENT-03 or a placebo tablet daily for 4 weeks during a double-blind period. After this, all participants will take VENT-03 for an additional 8 weeks in an open-label extension. Clinic visits will occur monthly for checkups, tests, and to monitor treatment effects and side effects. During the study, participants will undergo skin biopsies and lab tests to evaluate immune markers and drug levels in the body. Researchers will track disease severity changes and record any side effects or adverse events throughout the 12-week treatment period. Safety assessments and drug concentration measurements will be done at set times to understand how VENT-03 is absorbed and tolerated.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Active cutaneous lupus erythematosus with a CLASI-A score of 8 or higher
- At least one active discoid lupus erythematosus lesion or one active subacute CLE lesion
- If previously diagnosed with systemic lupus erythematosus, positive antinuclear antibody test with titer of 1:80 or higher
- Meets 2019 criteria for systemic lupus erythematosus diagnosis
- Currently receiving specified SLE medications at stable doses
You will not qualify if you...
- Infection or laboratory results that pose unacceptable risk per investigator
- Moderate or severe liver impairment (Child-Pugh categories B and C)
- Drug-induced lupus instead of idiopathic lupus
- History or current inflammatory joint or skin disease other than SLE and CLE
- Diagnosis of other specified autoimmune disorders
- Active severe or unstable neuropsychiatric SLE
- Hospitalization for severe lupus flare within past 3 months or active severe SLE disease with insufficient standard care
- History or current diagnosis of anti-phospholipid syndrome
- Non-lupus diseases treated with corticosteroids for more than 2 weeks in past 24 weeks
- History of infectious diseases requiring hospitalization or parenteral antimicrobial treatment within specified timeframes
- Suspicious cancer screening results or recent cancer history except certain skin or cervical cancers
- Use of prohibited concomitant medications as defined by protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive either VENT-03 or placebo tablets to evaluate the effect on cutaneous lupus erythematosus.
Multiple visits during treatment including baseline and follow-up visits up to Day 84
Trial Site Locations
Total: 27 locations
1
Investigative Site
Beverly Hills, California, United States, 90211
Actively Recruiting
2
Investigative Site
Clearwater, Florida, United States, 33765
Actively Recruiting
3
Investigative Site
DeBary, Florida, United States, 32713
Actively Recruiting
4
Investigative Site
Tampa, Florida, United States, 33606
Actively Recruiting
5
Investigative Site
Saint Joseph, Missouri, United States, 64506
Actively Recruiting
6
Investigative Site
Fairport, New York, United States, 14450
Actively Recruiting
7
Investigative Site
Memphis, Tennessee, United States, 38119
Actively Recruiting
8
Investigative Site
Allen, Texas, United States, 75013
Actively Recruiting
9
Investigative Site
Arlington, Texas, United States, 76012
Actively Recruiting
10
Investigative Site
Colleyville, Texas, United States, 76034
Actively Recruiting
11
Investigative Site
Haskovo, Bulgaria
Actively Recruiting
12
Investigative Site
Plovdiv, Bulgaria
Actively Recruiting
13
Investigative Site
Sofia, Bulgaria
Actively Recruiting
14
Investigative Site
Paris, France
Actively Recruiting
15
Investigative Site
Toulouse, France
Actively Recruiting
16
Investigative Site
Tbilisi, Georgia
Actively Recruiting
17
Investigative Site
Szeged, Hungary
Actively Recruiting
18
Investigative Site
Bialystok, Poland
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19
Investigative Site
Oświęcim, Poland
Actively Recruiting
20
Investigative Site
Poznan, Poland
Actively Recruiting
21
Investigative Site
Rzeszów, Poland
Actively Recruiting
22
Investigative Site
Śląskie, Poland
Actively Recruiting
23
Investigative Site
Warsaw, Poland
Actively Recruiting
24
Investigative Site
Wroclaw, Poland
Actively Recruiting
25
Investigative Site
Pretoria, South Africa
Actively Recruiting
26
Investigative Site
Stellenbosch, South Africa
Actively Recruiting
27
Investigative Site
Badajoz, Spain
Actively Recruiting
Research Team
K
Krista Miller
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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