A Phase 2, Randomized, Double-Blind, Parallel-Group Study to Assess the Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With Usual Type Vulvar Intraepithelial Neoplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacodynamics (HPV Viral Load Assessment)
研究概览
简要总结
To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001) in patients with usual type vulvar intraepithelial neoplasia (uVIN).
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 years
- •Biopsy proven uVIN, biopsies to have been taken within the last three months
- •Written informed consent to participate in the trial
- •At least one lesion that can be accurately measured (using RECIST criteria)
- •in at least one dimension with longest diameter ≥ 20mm
- •OR in two perpendicular dimensions that when multiplied together give a surface area of ≥ 120mm2 (e.g. 15mm x 8mm or 12mm x 10mm)
- •This is to ensure that 4x4mm biopsies can be performed on this lesion.
排除标准
- •Has any concomitant disease or significant medical conditions that would, in the opinion of the Investigator, potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical trial.
- •Clinically significant abnormalities, as judged by the Investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis) or ECG. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
- •Indication of a current active infectious disease of the vulva, other than HPV
- •Pregnant, breast feeding or trying to conceive
- •Active treatment for uVIN (i.e. surgical excision, lasertherapy, imiquimod, photodynamic therapy) within the previous month
- •Patients receiving immunosuppressive therapy
- •HIV positive or transplant patients
- •Any condition that in the opinion of the investigator could interfere with the conduct of the study
研究组 & 干预措施
Omiganan (CLS001)
CLS001 topical gel, 2.5%
干预措施: Omiganan (CLS001) topical gel (Drug)
Vehicle
Vehicle topical gel
干预措施: Vehicle topical gel (Drug)
结局指标
主要结局
Pharmacodynamics (HPV Viral Load Assessment)
时间窗: 24 Weeks
Assessment of target lesions by quantitative PCR including HPV genotyping in swabs and biopsies
Pharmacodynamics (Local Immunity Status)
时间窗: 24 Weeks
Histological changes in immune cells in the mucosa/submucosa
Clinical Assessment (Lesions by RECIST)
时间窗: 24 Weeks
Efficacy assessment of lesions by RECIST
Clinical Assessment (Sum of the longest diameter (SLD))
时间窗: 24 Weeks
Efficacy assessment of the sum of the longest diameter (SLD))
Clinical Assessment (Percent clearance of Lesions)
时间窗: 24 Weeks
Efficacy assessment of percent clearance of lesions
Clinical Assessment (Histology)
时间窗: 24 Weeks
Efficacy assessment of the histology (regression of uVIN to no dysplasia)
次要结局
- Safety and Tolerability (Adverse Events)(48 Weeks)
- Safety and Tolerability (Laboratory Safety Testing)(48 Weeks)
- Safety and Tolerability (12-Lead ECGs)(48 Weeks)
- Safety and Tolerability (Vital Signs)(48 Weeks)
- Pharmacokinetics (Area Under the Curve)(12 Weeks)
- Pharmacokinetics (Maximum Plasma Concentration)(12 Weeks)
- Pharmacokinetics (Tmax)(12 Weeks)