DRKS00024971已完成2 期
Guselkumab In Patients With Oral Lichen Planus - An open label, parallel, randomized, multi- center, phase II trial - Lichen Planus
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 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-sterilized 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.
排除标准
- •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, hemoglobin, AST and 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) within4 weeks days prior to treatment*
- •7. Known hypersensitivity, intolerance or allergy against Guselkumab, to human immunoglobulin (Ig) proteins, mAbs, or antibody fragments
- •8. Live vaccine within the 12 weeks before first IMP application, 12 weeks after the last IMP application or a planned vaccination during the study. NOTE: for inactivated vaccine, as for SARS-CoV2 and Influenza vaccination, there is no timely limit
- •9. pregnancy
- •10. Breastfeeding
- •11. Concomitant therapy with immunosuppressive drugs, biologics or phototherapy
- •12. Patients with an increased risk of respiratory infections (e.g. patients with chronic obstructive pulmonary disease)
- •13. Participation in any other interventional clinical trial within the three months before first study treatment.
研究者
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