A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-10 in Subjects With Symptomatic Oral Lichen Planus
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 7
- 主要终点
- To evaluate the safety of LP-10 in patients with oral lichen Planus
研究概览
简要总结
This is a multicenter, dose-ranging study including adult male and female subjects (>= 18 years old) with symptomatic Oral Lichen Planus (OLP). A total of approximately 24 subjects will be enrolled at approximately eight (8) study sites in the United States. This study will evaluate the safety, tolerability and efficacy of LP-10 at 0.25 mg, 0.5 mg and 1.0 mg of tacrolimus.The study consists of screening, treatment and follow-up phases. The treatment phase includes 10 mL LP-10 oral rinse for 3 minutes twice a day for 4 weeks. The follow-up phase includes one post-treatment visit 2 weeks after the last oral LP-10 dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent
- •Male or female ≥ 18 years of age
- •Oral biopsy performed within the last 10 years before the Screening Visit demonstrating OLP and/or oral lichenoid mucositis in the absence of cancer or dysplasia
- •Moderate OLP based on an OLP Investigator Global Assessment (IGA) score of ≥ 3
- •OLP Pain and Sensitivity Numerical Rating Scale (NRS) score of ≥ 3
- •Patients taking prescription oral steroid or rinse treatment(s) at the time of the Screening Visit agree to stop treatment for the duration of the trial and to undergo a 4-week washout period
- •Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the self-administered questionnaires
- •Willing to avoid live vaccines while enrolled in the trial
- •Patients of child-bearing potential must have a negative pregnancy test and agree to undergo pregnancy testing at each study visit. (unless patient has undergone a bilateral tubal ligation or hysterectomy and/or is post-menopausal as defined by the absence of menses for at least 12 months)
- •Patients of child-bearing potential and male participants with a female partner of child-bearing potential, agree to use a reliable method of contraception (condoms and/or oral contraceptives) for the duration of the trial and for 10 days thereafter
排除标准
- •Hyperkalemia
- •Chronic kidney disease
- •Long QT syndrome
- •History of oral cavity or oropharyngeal cancers
- •Active cancer
- •Uncontrolled hypertension (i.e., > 145 mm/Hg systolic or > 95 mmHg diastolic)
- •Patients who failed tacrolimus treatment for OLP in the past
- •Patient who is currently or has previously participated in another oral cavity therapeutic or device study within 3 months of screening and has not returned to baseline
- •History of oral cavity infection (bacterial, viral or fungal) within 3 months prior to screening
- •Pregnant or lactating
- •Active bleeding peptic ulcer disease
- •Known allergy to liposomes and/or egg yolk and/or tacrolimus
- •Evidence of renal impairment (creatinine > 2 × the upper limit of normal at Visit 1), hepatic impairment (AST or ALT > 3 × the upper limit of normal at Visit 1), clinically significant cardiovascular, respiratory, or psychiatric diseases per investigator's judgment
- •Patients currently taking magnesium and aluminum-hydroxide antacids or metoclopramide
- •Patients currently taking aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, and protease inhibitors
- •The presence of any clinically significant systemic disease or condition that in the opinion of the investigator would make the patient unsuitable for the study
研究组 & 干预措施
LP-10 0.25mg
0.25mg LP-10 / 10 mL twice daily oral rinse
干预措施: LP-10 (Liposomal Tacrolimus) (Drug)
LP-10 0.5 mg
0.5mg LP-10 / 10 mL twice daily oral rinse
干预措施: LP-10 (Liposomal Tacrolimus) (Drug)
LP-10 1.0 mg
1.0mg LP-10 / 10 mL twice daily oral rinse
干预措施: LP-10 (Liposomal Tacrolimus) (Drug)
结局指标
主要结局
To evaluate the safety of LP-10 in patients with oral lichen Planus
时间窗: over 4 weeks of treatment and 2 weeks of follow-up
Incidence and severity of treatment-emergent adverse events, changes in standard laboratory studies, whole-blood tacrolimus levels
次要结局
- To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus(at 4 weeks after first dose)