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
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
- 否
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
研究点 (33)
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