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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
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

NCT07260877

RecruitingPhase 2

Sponsor: Ventus Therapeutics U.S., Inc.

Conditions: Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus, SLE, SLE (Systemic Lupus), CLE

Interventions: VENT-03, Placebo

Countries: United States, Bulgaria, France, Georgia, Hungary, Poland, South Africa, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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.
Locations (32)
  • Beverly Hills, California, United States
  • Clearwater, Florida, United States
  • DeBary, Florida, United States
  • Tampa, Florida, United States
  • Indianapolis, Indiana, United States
  • Flint, Michigan, United States
  • Troy, Michigan, 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
  • Rzeszów, Poland
  • Śląskie, Poland
  • Warsaw, Poland
  • Wroclaw, Poland
  • Durban, South Africa
  • Pretoria, South Africa
  • Somerset West, South Africa
  • + 2 more on CT.gov