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Purpose

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-3 or a placebo every day 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

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Cutaneous lupus based on: - CLASI-A score ≥8; - CLE diagnosis confirmed by prior biopsy; and - 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.

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; - 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VENT-03 		VENT-03, QD
  • Drug: VENT-03
    VENT-03 is a tablet, swallowed once daily, for 8-12 weeks total
Placebo Comparator
Placebo 		Placebo, QD
  • Drug: Placebo
    Placebo is a tablet swallowed once daily for 4 weeks total

Recruiting Locations

Investigative Site
Beverly Hills 5328041, California 5332921 90211

Investigative Site
Clearwater 4151316, Florida 4155751 33765

Investigative Site
DeBary 4152926, Florida 4155751 32713

Investigative Site
Tampa 4174757, Florida 4155751 33606

Investigative Site
Saint Joseph 4407010, Missouri 4398678 64506

Investigative Site
Fairport 5116815, New York 5128638 14450

Investigative Site
Memphis 4641239, Tennessee 4662168 38119

Investigative Site
Allen 4670300, Texas 4736286 75013

Investigative Site
Arlington 4671240, Texas 4736286 76012

Investigative Site
Colleyville 4682478, Texas 4736286 76034

More Details

Status
Recruiting
Sponsor
Ventus Therapeutics U.S., Inc.

Study Contact

Krista Miller
913-410-2156
AERIS@iconplc.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.