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
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Ventus Therapeutics U.S., Inc. · Industry
Who this trial is looking for
This trial is looking for adults with cutaneous lupus who may also have systemic lupus. Participants will take the study drug VENT-03 or a placebo for a total of 12 weeks and visit the clinic monthly for checkups.
Are You a Good Fit for This Trial?
You may be able to join if
I have cutaneous lupus with a CLASI-A score of 8 or more
I have at least one active lesion of discoid lupus or subacute CLE
I have a history of systemic lupus and a positive antinuclear antibody test
I am currently taking at least one stable medication for systemic lupus
You may not be able to join if
I have severe liver problems
I have a history of inflammatory joint or skin disease other than lupus
I have an active severe form of neuropsychiatric lupus
I was hospitalized for a severe lupus flare in the last 3 months
I have a history of anti-phospholipid syndrome
I have received treatment with corticosteroids for more than 2 weeks in the last 24 weeks
I have an active cancer or suspicious cancer screening results
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
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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 particip…
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.
Trial Locations
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Eligibility Criteria
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 …
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.
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