A Phase 2, Placebo-controlled, Double-blind, Randomized, Dose Ranging, Efficacy and Safety Study of Orally Administered Moxidectin in Adults With Scabies.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 17
- 主要终点
- Proportion of index subjects achieving complete cure (Efficacy)
研究概览
简要总结
Moxidectin is not approved to treat scabies in humans. The effective dose of moxidectin to treat scabies is not known. This study aims to assess the efficacy of a single administration of 8 mg, 16 mg, or 32 mg moxidectin per oral in achieving Scabies Complete Cure at Day 28. This study also aims to assess the safety of three strengths of single moxidectin doses in adults with scabies.
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)
盲法说明
Double blinded. Subjects will be randomized to one of the treatment arm by Interactive Response Technology at 1:1:1:1
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
- •Aged 18 years or older.
- •Provided written informed consent.
- •Diagnosis of active scabies infestation confirmed by the presence of clinical signs and symptoms (evidence of burrows or typical inflammatory/noninflammatory lesions and pruritus) and either microscopic confirmation of scabies mite(s), ova or scybala by skin scraping or dermoscopy.
- •All female subjects of childbearing potential must agree to the use of a highly effective method of birth control until 16 weeks after administration of Investigational Product (IP).
排除标准
- •Diagnosis of crusted/Norwegian scabies or scabies presentation that, in the opinion of the Investigator, would require treatment with more than one standard of care treatment for scabies (e.g., scabies requiring concurrent topical and oral treatment).
- •History of chronic or recurrent dermatologic disease or skin conditions other than scabies that could interfere with the diagnosis of scabies and evaluation of cure.
- •Received any treatment with one or more scabicides within the 28 days prior to Screening, or between Screening and Baseline, including but not limited to permethrin, ivermectin, benzyl benzoate, sulfur, lindane, crotamiton, malathion, tea tree oil or spinosad.
- •Body mass index > 35 kg/m
- •Creatinine clearance < 30 mL/min (using Cockcroft-Gault equation).
- •Both total bilirubin >1.5 x upper limit of normal (ULN) and AST > ULN.
- •Abnormal and clinically relevant findings in hematology or biochemistry assessments at Screening, or in vital signs, 12-lead ECG, or physical examination at Screening and/or Baseline, that in the opinion of the Investigator would put the subjects at increased risk from participating in the study, confound study evaluations, or may interfere with study conduct.
- •Presence of any other clinically relevant condition, including infection, immunological disorder, malignant disease, and/or other underlying condition or circumstance at Screening or Baseline that in the opinion of the Investigator would put the subjects at increased risk from participating in the study, confound study evaluations, or interfere with the study conduct.
- •Use of topical steroids, systemic or high-dose inhaled corticosteroids (>500 µg per day of fluticasone propionate or equivalent for adults), or other immunomodulators within 14 days of Baseline.
- •Requiring ongoing treatment with, or received within 5 half-lives before Screening, any of the following medications that are clinical BCRP inhibitors: curcurmin (turmeric) supplements, cyclosporine A, darolutamide, eltrombopag, febuxostat, fostamatinib, rolapitant and teriflunomide.
- •Received an investigational agent within 28 days of Screening (or 5 half-lives of the investigational agent, whichever is longer).
- •Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin or ivermectin.
- •Known or suspected hypersensitivity to any of the components in permethrin 5% cream, to any synthetic pyrethroid or pyrethrin, or to the components of spinosad 0.9% topical suspension.
- •Known, suspected or at risk of Loa loa coinfection.
- •Difficulty swallowing tablets or capsules.
- •Pregnant or breastfeeding or planning to become pregnant from Screening until 16 weeks after treatment with IP.
- •Known or suspected alcohol or illicit substance abuse.
- •Unwilling, unlikely or unable to comply with all protocol specified assessments.
- •Previous enrolment in this study.
- •Previous moxidectin exposure within 6 months (5 half-lives) from Baseline.
- •Has household members who refuse or are unable to receive permethrin 5% cream treatment for scabies.
研究组 & 干预措施
Placebo
16 Placebo capsules will be administered as a single dose on Day 0.
干预措施: Placebo (Drug)
Moxidectin 16mg
Moxidectin 16 mg (over encapsulated) will be administered as a single dose on Day 0. Each subject will receive the same number of capsules made up of moxidectin 2 mg over encapsulated tablets and placebo capsules to maintain the blind.
干预措施: Moxidectin Oral Product (Drug)
Moxidectin 8mg
Moxidectin 8 mg (over encapsulated) will be administered as a single dose on Day 0. Each subject will receive the same number of capsules made up of moxidectin 2 mg over encapsulated tablets and placebo capsules to maintain the blind.
干预措施: Moxidectin Oral Product (Drug)
Moxidectin 32mg
Moxidectin 32 mg (over encapsulated) will be administered as a single dose on Day 0.
干预措施: Moxidectin Oral Product (Drug)
结局指标
主要结局
Proportion of index subjects achieving complete cure (Efficacy)
时间窗: 28 Days
Proportion of index subjects achieving Complete Cure at Day 28. Complete Cure is defined as demonstration of both: 1. Clinical cure: all signs and symptoms have completely resolved, including burrows, inflammatory/noninflammatory lesions and pruritus. And 2. Microscopic or dermatoscopic cure demonstrating the absence of mites, eggs, and/or scybala, and negative dermoscopy for burrows.
Incidence and severity of Treatment Emergent Adverse Event (Safety)
时间窗: 84 Days
Incidence and severity of Treatment Emergent Adverse Event (TEAEs), Incidence of serious TEAEs and Incidence of TEAEs leading to study withdrawal and/or death.
Percentage of Index Subjects Achieving Complete Cure (Efficacy)
时间窗: 28 Days
Complete Cure is defined as demonstration of both: 1. Clinical cure: all signs and symptoms have completely resolved, including burrows, inflammatory/noninflammatory lesions and pruritus. And 2. Microscopic or dermatoscopic cure demonstrating the absence of mites, eggs, and/or scybala, and negative dermoscopy for burrows.
Incidence and Severity of Treatment Emergent Adverse Event (Safety)
时间窗: Day 0 to Week 16 inclusive.
Incidence and severity of Treatment Emergent Adverse Event (TEAEs), Incidence of serious TEAEs and Incidence of TEAEs leading to study withdrawal and/or death. The analysis of adverse events (AEs) was focused on treatment emergent adverse events (TEAEs), defined as AEs that started, or worsened, on or after the start of the administration of IP.
次要结局
未报告次要终点