A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the Efficacy and Safety of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 582
- 试验地点
- 33
- 主要终点
- The Percentage of Participants Who Achieve Effective Treatment at Week 52
研究概览
简要总结
Phase 2 study to examine how the study drug works and its side effects in subjects with toenail fungus.
详细描述
A phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to investigate the efficacy and safety of 4 dose regimens of ORAL albaconazole in subjects with distal subungual onychomycosis. Subjects will take oral study drug for up to 36 weeks and then will be followed for an additional 16 weeks to determine if the study drug was efficacious. Subjects will have routine blood draws and other safety assessments during the study, as well as regular assessments of their toenail fungus
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject aged 18 to 75 years.
- •Diagnosis with distal subungual onychomycosis of the toenails that affects at least one great toe (target toenail).
- •Subject is willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed.
- •Subject is able to complete the study, comply with study instructions, and take study product orally.
- •Sexually active non-lactating females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product and up to the first menses 60 days following the last dose of study product.
- •Women of childbearing potential must have a negative pregnancy test at enrollment.
- •Subject has screening laboratory parameters and ECG within the normal ranges unless considered to be not clinically relevant by the principal investigator.
排除标准
- •Subjects with any of the following conditions or characteristics will be excluded from study enrollment (ie, will not receive study product):
- •Subject has received an investigational drug within 4 weeks of the first dose of study product, or who are scheduled to receive an investigational drug other than the study product during the study.
- •Subject has participated in a clinical trial for the systemic treatment of onychomycosis of the toenails within 6 months prior to the first dose of study product.
- •Subject is receiving any drugs that are known substrates of the 3A4 isozyme of cytochrome P450 (CYP3A4) with QT prolongation potential or any of the concomitant medications listed under prohibited medication section.
- •Subject has a history of known or suspected intolerance to albaconazole or the formulation excipients, or to azole antifungal drugs in general.
- •Subject has previously participated in a clinical study with albaconazole.
- •Subject is not prepared to give up use of any nail cosmetic products for the duration of the study.
- •Subject has any known immunodeficiency or history of malignancy in the last 4 years, excluding nonmelanoma skin cancer.
- •Subject has any known liver disease or a history of liver toxicity with other drugs.
- •Subject is currently suffering from any disease or condition, that could include abnormal laboratory tests, and/or who are currently using medication which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk.
- •Subject has psoriasis, lichen planus, or other abnormalities that could result in a clinically abnormal toenail.
- •Subject has a history of any condition that could possibly affect absorption of drug (eg, gastrectomy), uncontrolled diabetes, clinically significant peripheral vascular disease or peripheral circulatory impairment, or has had any major illness within 30 days prior to the screening examination.
- •Subject has a history of drug, prescription medicine, or alcohol abuse within the past 2 years.
- •Female subjects who are pregnant, trying to become pregnant, or lactating.
- •Employees of Investigator/clinical research organization (CRO) or Stiefel Laboratories, Inc., or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.
研究组 & 干预措施
Albaconazole 100mg
Albaconazole for 36 weeks
干预措施: Albaconazole 100mg (Drug)
Albaconazole 200mg
Albaconazole for 36 weeks
干预措施: Albaconazole 200mg (Drug)
Albaconazole 400mg
Albaconazole for 36 weeks
干预措施: Albaconazole 400mg (Drug)
Albaconazole 400mg 24 weeks, Placebo 12 weeks
Albaconazole for 24 weeks, Placebo for 12 weeks
干预措施: Albaconazole 400mg (Drug)
Albaconazole 400mg 24 weeks, Placebo 12 weeks
Albaconazole for 24 weeks, Placebo for 12 weeks
干预措施: Placebo 400 mg (Drug)
Placebo 400 mg
Placebo for 36 weeks
干预措施: Placebo 400 mg (Drug)
结局指标
主要结局
The Percentage of Participants Who Achieve Effective Treatment at Week 52
时间窗: Week 52
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Effective treatment was defined as a mycological cure and clear or almost clear nail (distal subungual hyperkeratosis and/or onycholysis leaving less than 10% of nail plate effected). Comparisons were carried out in a sequential step-down fashion, combined with the Holm procedure at step 2. P-value was based on a sequential step-down combined with the Holm procedure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
次要结局
- The Percentage of Participants Who Achieve Complete Cure at Week 52(Week 52)
- Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52(Baseline (Week 0/Day 1 or before) and up to Week 52)
- The Percentage of Participants Who Achieve Clinical Cure at Week 52(Week 52)
- The Percentage of Participants Who Achieve Mycological Cure at Week 52(Week 52)
- The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52(Week 52)