2025-522870-35-00招募中2 期
Upadacitinib in adult patients with erosive mucosal Lichen Planus and Lichen Planopilaris: a prospective multicenter randomized placebo-controlled study. (Upa30-LP)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 5
- 主要终点
- Achievement of IGA response (absolute IGA score ≤2) at Week 16
研究概览
简要总结
To assess the clinical efficacy of upadacitinib 30 mg daily (QD) in subjects with erosive MLP and in subjects with LPP when compared to placebo after 16 weeks of treatment
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before any assessment is performed
- •Female and male patients ≥ 18 years and < 65 years old at Baseline Visit
- •Subjects must have biopsy-confirmed forms of mucosal lichen planus (MLP) or active lichen planopilaris (LPP) eligible for systemic therapy based on the following criteria: · Rated IGA of ≥ 3 (moderate or severe) AND · Inadequate response to topical corticosteroids of high - ultrahigh potency in the opinion of the investigator
- •A negative serum pregnancy test for all female subjects considered to be of childbearing potential at the Screening Visit and a negative urine pregnancy test at baseline prior to the first dose of study drug.
排除标准
- •Clinical history suspicious for lichenoid drug eruption
- •Clinical picture or history suspicious of paraneoplastic mucosal lichen planus
- •Mucosal lichen planus of the oral cavity or gastrointestinal involvement requiring the patient to use parenteral nutrition or feeding tube
- •Clinical picture of burnt-out cicatricial alopecia (alopecia of Brocq)
- •Patients diagnosed with frontal fibrosing alopecia (FFA) without active patches of LPP
- •Hepatitis C antibody positive at screening unless viral load is 0
- •Subjects with active TB or latent TB without history of appropriate prophylaxis
研究组 & 干预措施
RINVOQ 30 mg prolonged-release tablets
Test
干预措施: RINVOQ 30 mg prolonged-release tablets (Drug)
Placebo is identifical in composition to rinovq but does not contain the substance medical
Placebo
干预措施: Placebo is identifical in composition to rinovq but does not contain the substance medical (Drug)
结局指标
主要结局
Achievement of IGA response (absolute IGA score ≤2) at Week 16
Achievement of IGA response (absolute IGA score ≤2) at Week 16
次要结局
- Achievement of 2 points improvement in the IGA at Week 32
- Achievement of DLQI 0/1 score at Week 16 and Week 32
- PGIS at Week 16 and Week 32
- PGIC at Week 16 and Week 32
- Adverse events, laboratory values, vital signs from baseline to end of study visit analysis
- Absolute and relative change in REU, OLPSSM and NRS score at Week 16 and Week 32
- Absolute and relative change in LPPAI and SCALPDEX Questionnaire score at Week 16 and Week 32
研究者
Pr Thierry Passeron
Scientific
Centre Hospitalier Universitaire De Nice
研究点 (5)
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