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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
Led by Ventus Therapeutics U.S., Inc. · Updated on 2026-04-06
24
Participants Needed
27
Research Sites
38 weeks
Total Duration
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AI-Summary
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Cutaneous lupus with CLASI-A score 8 or higher
- At least one active discoid lupus erythematosus lesion or one active subacute cutaneous lupus erythematosus lesion
- If previously diagnosed with systemic lupus erythematosus (SLE): positive antinuclear antibody test with titer 1:80 or higher
- Meets 2019 criteria for SLE
- Currently receiving at least one specified SLE medication at stable doses
You will not qualify if you...
- Infection or lab results that place participant at unacceptable risk
- 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 or cutaneous lupus
- Diagnosis of certain confounding autoimmune disorders
- Active severe or unstable neuropsychiatric SLE
- Hospitalization for severe lupus flare in past 3 months or active severe SLE-driven disease needing other treatment
- History or current anti-phospholipid syndrome
- Non-lupus disease treated with corticosteroids for more than 2 weeks in last 24 weeks
- History of serious infections requiring hospitalization or intravenous treatment within specified timeframes
- Cancer history or suspicious cancer screening results except certain skin or cervical cancers
- Use of certain medications excluded by protocol
AI-Screening
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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
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3
Investigative Site
DeBary, Florida, United States, 32713
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4
Investigative Site
Tampa, Florida, United States, 33606
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5
Investigative Site
Saint Joseph, Missouri, United States, 64506
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6
Investigative Site
Fairport, New York, United States, 14450
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7
Investigative Site
Memphis, Tennessee, United States, 38119
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8
Investigative Site
Allen, Texas, United States, 75013
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9
Investigative Site
Arlington, Texas, United States, 76012
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10
Investigative Site
Colleyville, Texas, United States, 76034
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11
Investigative Site
Haskovo, Bulgaria
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12
Investigative Site
Plovdiv, Bulgaria
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13
Investigative Site
Sofia, Bulgaria
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14
Investigative Site
Paris, France
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15
Investigative Site
Toulouse, France
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16
Investigative Site
Tbilisi, Georgia
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17
Investigative Site
Szeged, Hungary
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18
Investigative Site
Bialystok, Poland
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19
Investigative Site
Oświęcim, Poland
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20
Investigative Site
Poznan, Poland
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21
Investigative Site
Rzeszów, Poland
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22
Investigative Site
Śląskie, Poland
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23
Investigative Site
Warsaw, Poland
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24
Investigative Site
Wroclaw, Poland
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25
Investigative Site
Pretoria, South Africa
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26
Investigative Site
Stellenbosch, South Africa
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27
Investigative Site
Badajoz, Spain
Actively Recruiting
Research Team
K
Krista Miller
CONTACT
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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