跳至主要内容
临床试验/NCT07260877
NCT07260877招募中2 期

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

Ventus Therapeutics U.S., Inc.33 个研究点 分布在 8 个国家目标入组 24 人开始时间: 2025年12月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
24
试验地点
33
主要终点
Evaluate the effect of VENT-03 on the interferon gene signature in the skin

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Sponsor

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

VENT-03

Experimental

VENT-03

干预措施: VENT-03 (Drug)

结局指标

主要结局

Evaluate the effect of VENT-03 on the interferon gene signature in the skin

时间窗: Baseline to End of Double-Blind Treatment (up to Day 28)

Percent change from baseline in interferon gene signature in the skin at Day 28

次要结局

  • Change from Baseline in Myxovirus-Resistant Protein A (MXA) Immunostaining in Skin Biopsy(Baseline to End of Treatment (up to Day 84))
  • Number of participants with at least one Treatment Emergent Adverse Event (TEAE) and/or Serious Adverse Event (SAE)(Baseline to End of Treatment (up to Day 84))
  • Number of participants with Moderate or Severe Treatment Emergent Adverse Events (TEAEs)(Baseline to End of Treatment (up to Day 84))
  • Percentage of Participants with ≥ 1 Treatment Emergent Adverse Event (AE) leading to Treatment Discontinuation(Baseline to End of Treatment (up to Day 84))
  • Cmax: Maximum Observed Plasma Concentration for VENT-03(Day 1 pre-dose and at multiple time points (up to 6 hours) post-dose; Day 28 pre-dose and post-dose; Day 56 and Day 84 pre-dose)
  • AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for VENT-03(Day 1 pre-dose and at multiple time points (up to 6 hours) post-dose; Day 28 pre-dose and post-dose; Day 56 and Day 84 pre-dose)
  • Evaluate the effect of VENT-03 on CLE disease severity(Baseline to End of Double-Blind Treatment (up to Day 28))
  • Change from Baseline in Myxovirus-Resistant Protein A (MXA) Immunostaining in Skin Biopsy(Baseline to End of Treatment (up to Day 84))
  • Evaluate effect of VENT-03 on CLE disease severity(Baseline to End of Double-Blind Treatment (up to Day 28))
  • Number of participants with at least one Treatment Emergent Adverse Event (TEAE) and/or Serious Adverse Event (SAE)(Baseline to End of Treatment (up to Day 84))
  • Number of participants with Moderate or Severe Treatment Emergent Adverse Events (TEAEs)(Baseline to End of Treatment (up to Day 84))
  • Percentage of Participants with ≥ 1 Treatment Emergent Adverse Event (AE) leading to Treatment Discontinuation(Baseline to End of Treatment (up to Day 84))
  • Cmax: Maximum Observed Plasma Concentration for VENT-03(Day 1 pre-dose and at multiple time points (up to 6 hours) post-dose; Day 28 pre-dose and post-dose; Day 56 and Day 84 pre-dose)
  • AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for VENT-03(Day 1 pre-dose and at multiple time points (up to 6 hours) post-dose; Day 28 pre-dose and post-dose; Day 56 and Day 84 pre-dose)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (33)

Loading locations...

相似试验