EUCTR2021-000271-36-DE进行中（未招募）1 期
Guselkumab in Patients with Oral Lichen Planus - An open label, parallel, randomized, multi- center, phase II trial
Philipps University Marburg0 个研究点目标入组 45 人开始时间: 2021年6月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Signed written informed consent form
- •2.Capability and willingness to comply with study procedures
- •3.Adult patients = 18 years
- •4.Moderate to severe Oral LP with variable phenotype (erosive, ulcerating, hyperplastic/leukoplakic, and combined forms and other side manifestations like skin manifestations)
- •5.Oral involvement = 3 month
- •6.Escudier-Score = 10
- •7.Histology characteristic for LP
- •8.Refractory to topical therapy with high-potency glucocorticoids (group I, II, III as per WHO definition)
- •9.For women of child-bearing potential: a negative result in a pregnancy test AND agreement to practice a highly effective method of contraception during the entire period from informed consent up to 90 days after the last administration of the IMP.
- •10.For non-sterilised males who are sexually active with a female partner of child-bearing potential: Agreement to practice highly effective methods of contraception during the entire period from first study intervention up to 90 days after the last administration of the IMP
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1.1.Subjects with either a chronic infection, a prior history of recurrent infection, or a clinically important active infection (e.g. active tuberculosis) should not be administered Guselkumab.
- •2.History of latent tuberculosis
- •3.Patients with clinical relevant illnesses (e.g. severe renal, heart and/ or liver insufficiency, malignancies) and clinical relevant changes in lab parameter (e.g. WBC, absolute neutrophile count, hemoglobin, AST/ALT, bilirubin)
- •4.History of any malignancy or obligatory precancerous condition of any organ system other than cervical carcinoma of Stage 1B or less, or non-invasive basal cell carcinoma of the skin in the last 5 years before IMP administration
- •5.Patients tested positive for hepatitis B virus (HBV) infection, hepatitis C virus (HCV) or human immunodeficiency viruses (HIV)
- •6.Systemic/topical glucocorticoids of high - ultrahigh potency (group I, II, III as per WHO definition) within 4 weeks days prior to treatment*
- •7.Severe hypersensitivity, intolerance or allergy against Guselkumab, to human immunoglobulin (Ig) proteins, mAbs, or antibody fragments
- •8.Live or inactive vaccine within the 28 days before first study treatment, or a planned vaccination during the study. NOTE: SARS-CoV2 and influenza vaccinations may be performed at the earliest 28 days before or after the last IMP treatment
- •9.Breastfeeding
- •10.Concomitant therapy with immunosuppressive drugs, biologics or phototherapy
- •11.Patients with an increased risk of respiratory infections (e.g. patients with chronic obstructive pulmonary disease)
研究者
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