Dose-finding study of moxidectin for the treatment of scabies

A Phase II, randomized, double-blind, parallel group dose finding study of single oral doses of moxidectin in adults with scabies

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001775-37-FR

Enrollment

Registered

2019-07-16

Start date

2019-09-20

Completion date

Unknown

Last updated

2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scabies (infection with Sarcoptes scabiei) MedDRA version: 20.1 Level: LLT Classification code 10039511 Term: Scabies System Organ Class: 100000004862

Interventions

Trade Name: Moxidectin Product Name: Moxidectin Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged = 18 years. 2. Provision of written informed consent. 3. Parasitologically confirmed active Sarcoptes scabiei infestation, defined as the presence of at least two lesions (which may include burrows), each containing at least one live (internal and/or external structures discernable) adult Sarcoptes scabiei mite observed by Reflectance Confocal Microscopy (RCM). 4. Agree to the use of reliable contraceptive measures if female or male partner of a female of child-bearing potential from Screening until 6 months after treatment with study drug. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

Exclusion criteria: 1. History of chronic or recurring dermatologic disease (other than scabies) that could interfere with the diagnosis and/or subsequent clinical assessment of scabies. 2. Diagnosis of crusted/Norwegian scabies. 3. Received any treatment for scabies within 7 days of Screening, including but not limited to permethrin, ivermectin, benzyl benzoate, lindane, crotamiton, malathion, and/or tea tree oil. 4. 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 would put the subject at increased risk from participating in the study or confound study evaluations. 5. Poor venous access. 6. Received an investigational agent within 28 days of Screening (or 5 half-lives of the investigational agent, whichever is longer). 7. Clinically relevant abnormal findings in vital signs, 12-lead electrocardiogram (ECG), or physical examination at Screening and/or Baseline in the opinion of the Investigator. 8. Clinically relevant laboratory abnormalities at Screening, including: a. alanine aminotransferase or aspartate aminotransferase > 2.5 x upper limit of reference range; b. creatinine > 2.0 milligrams per deciliter (mg/dL); c. hemoglobin 2.0 x upper limit of reference range. 9. Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin. 10. Use of systemic steroids within 14 days of Screening, or history of prolonged use of systemic and/or high-dose inhaled corticosteroids. 11. Subjects with known or suspected Loa loa coinfection. 12. Received a vaccination within 28 days of Baseline. 13. Difficulty swallowing tablets. 14. Pregnant or breastfeeding, or planning to become pregnant. 15. Known or suspected alcohol or illicit substance abuse. 16. Unwilling, unlikely or unable to comply with all protocol specified assessments. 17. Previous enrolment and treatment with moxidectin in this study.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objectives of the trial are to identify an optimal dose of moxidectin for the treatment of scabies and evaluate the safety of moxidectin in adults infected with scabies;Secondary Objective: The secondary objective of the trial is to characterize the plasma pharmacokinetics of moxidectin in adults infected with scabies.;Primary end point(s): Efficacy will be determined by death of the mites, defined as the degradation (loss of internal and/or external anatomic structures) of the adult mite observed by reflectance confocal microscopy (RCM). Safety will be assessed by the incidence and severity of adverse event (AEs), physical examinations, measurement of vital signs and laboratory safety parameters.;Timepoint(s) of evaluation of this end point: Efficacy as determined by observation with RCM will be assessed at Hours 4, 8, 24, 48 and 72 and Days 7, 14 and 28 in not less than two lesions nominated pre-treatment. Safety (incidence and severity of adverse events, physical examinations and measurement of vital signs) will be assessed up to and including Week 12, and laboratory safety parameters up to and including Day 28.	—

Measure

Time frame

Main Objective: The primary objectives of the trial are to identify an optimal dose of moxidectin for the treatment of scabies and evaluate the safety of moxidectin in adults infected with scabies;Secondary Objective: The secondary objective of the trial is to characterize the plasma pharmacokinetics of moxidectin in adults infected with scabies.;Primary end point(s): Efficacy will be determined by death of the mites, defined as the degradation (loss of internal and/or external anatomic structures) of the adult mite observed by reflectance confocal microscopy (RCM). Safety will be assessed by the incidence and severity of adverse event (AEs), physical examinations, measurement of vital signs and laboratory safety parameters.;Timepoint(s) of evaluation of this end point: Efficacy as determined by observation with RCM will be assessed at Hours 4, 8, 24, 48 and 72 and Days 7, 14 and 28 in not less than two lesions nominated pre-treatment. Safety (incidence and severity of adverse events, physical examinations and measurement of vital signs) will be assessed up to and including Week 12, and laboratory safety parameters up to and including Day 28.

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Secondary

Measure	Time frame
Secondary end point(s): Key exposure metrics for moxidectin including area under the concentration time curve (AUC) and maximum plasma concentration (Cmax), will be determined by non-compartmental analysis of moxidectin pharmacokinetic parameters or other methods as appropriate.;Timepoint(s) of evaluation of this end point: The plasma concentration of moxidectin will be assessed at Hours 4, 8, 24, 48 and 72 and Days 7, 14 and 28.	—

Measure

Time frame

Secondary end point(s): Key exposure metrics for moxidectin including area under the concentration time curve (AUC) and maximum plasma concentration (Cmax), will be determined by non-compartmental analysis of moxidectin pharmacokinetic parameters or other methods as appropriate.;Timepoint(s) of evaluation of this end point: The plasma concentration of moxidectin will be assessed at Hours 4, 8, 24, 48 and 72 and Days 7, 14 and 28.

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Countries

Australia, Austria, France

Contacts

Public ContactVictoria Ryg-Cornejo

Medicines Development Limited (trading as Medicines Development for Global Health)

MDGH-MOX-2001@medicinesdevelopment.com+61396296111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026