Dose-finding Study of Moxidectin for Treatment of Scabies

• ClinicalTrials.gov Identifier: NCT03905265
• Recruitment Status: Completed
• First Posted: April 5, 2019
• Last Update Posted: May 24, 2022
• Sponsor: Medicines Development for Global Health
• Information provided by (Responsible Party): Medicines Development for Global Health

Study Description

Brief Summary:

The effective dose of moxidectin to treat human scabies is not known. This study aims to provide proof of concept that a single dose of moxidectin is effective in eliminating the scabies parasite in humans and to enable the determination of an optimal dose of moxidectin for treatment of scabies for further clinical studies.

Condition or disease	Intervention/treatment	Phase
Scabies	Drug: Moxidectin Oral Product	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel, double blind, multicenter, randomized, pharmacokinetic/pharmacodynamic study. Three cohorts of six subjects per cohort are planned. Subjects will be randomized 1:1:1 to receive 2, 8 or 20 mg moxidectin as a single oral dose. An additional cohort of 36 mg may be initiated with a target sample size of 6 subjects.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: To maintain blinding to treatment allocation, all subjects will receive treatment with the same number of tablets, comprised of moxidectin 2 mg tablets and matched placebo (as required).
• Primary Purpose: Treatment
• Official Title: A Phase II, Randomized, Double-blind, Parallel Group Dose Finding Study of Single Oral Doses of Moxidectin in Adults With Scabies
• Actual Study Start Date: January 13, 2020
• Actual Primary Completion Date: February 28, 2022
• Actual Study Completion Date: February 28, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Moxidectin 2 mg; Moxidectin 2 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind.	Drug: Moxidectin Oral Product; The required number of moxidectin 2 mg oral tablets will be administered as a single dose with placebo to match as required
Experimental: Moxidectin 8 mg; Moxidectin 8 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind.	Drug: Moxidectin Oral Product; The required number of moxidectin 2 mg oral tablets will be administered as a single dose with placebo to match as required
Experimental: Moxidectin 20 mg; Moxidectin 20 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind.	Drug: Moxidectin Oral Product; The required number of moxidectin 2 mg oral tablets will be administered as a single dose with placebo to match as required
Experimental: Moxidectin 36 mg; Moxidectin 36 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind.	Drug: Moxidectin Oral Product; The required number of moxidectin 2 mg oral tablets will be administered as a single dose with placebo to match as required

Outcome Measures

Primary Outcome Measures :

1. Death of adult scabies mites [ Time Frame: 28 days ]
   Death of scabies mites in at least 2 target skin lesions nominated pre-treatment and observed by reflectance confocal microscopy between Baseline and Day 28
2. Incidence of adverse events [ Time Frame: 12 weeks ]
   Adverse events will be summarized by MedDRA preferred term.
3. Severity of adverse events [ Time Frame: 12 weeks ]
   The severity of adverse events will be assessed using the Toxicity Grading Scale for Healthy Adult and Adolescent volunteers Enrolled in Preventive Vaccine Clinical Trials.

Secondary Outcome Measures :

1. Analysis of moxidectin plasma concentrations [ Time Frame: 28 days ]
   Concentrations of moxidectin in plasma will be assessed by collection of plasma samples at pre-specified intervals after dosing with oral moxidectin. The concentration of moxidectin will be determined using a validated liquid chromatography-mass spectrometry(MS)/MS method.

Other Outcome Measures:

1. Incidence and severity of scabies signs and symptoms [ Time Frame: 28 days ]
   The incidence and severity of signs and symptoms of scabies infection will be explored using a clinician-reported scabies severity assessment.
2. Severity of pruritus [ Time Frame: 28 days ]
   The severity of pruritus will be determined using the Numerical Rating Scale where 0="no itch" and 10="worst itch imaginable"

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.
4. Agree to the use of reliable contraceptive measures if female or male partner of a female of child-bearing potential from Screening and until 6 months after treatment with study product.

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 or scabies that, in the opinion of the Investigator, would require treatment with more than one standard of care (e.g. scabies requiring concurrent topical and oral treatment).
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. Body Mass Index over 35 kg/m2.
8. 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.

9. Clinically relevant laboratory abnormalities at Screening, including:

   1. alanine aminotransferase or aspartate aminotransferase > 2.5 x upper limit of reference range;
   2. creatinine > 2.0 milligrams per deciliter (mg/dL);
   3. hemoglobin < 9.5 g/dL (female) or <10.5 g/dL (male);
   4. amylase > 2.0 x upper limit of reference range.
10. Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin.
11. Use of systemic steroids within 14 days of Screening, or history of prolonged use of systemic and/or high-dose inhaled corticosteroids, or use of topical steroids for 7 out of the 14 days prior to Screening.
12. Subjects with known or suspected Loa loa coinfection.
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.

Contacts and Locations

Locations

Australia

Royal Darwin Hospital

Darwin, Australia

Austria

Medizinischen Universität Wien

Vienna, Austria

France

Hopital Henri Mondor AP-HP

Créteil, France

CHU Nice Hopital Archet 2

Nice, France

CHU Saint-Etienne Hopital Nord

Saint-Priest-en-Jarez, France

Sponsors and Collaborators

Medicines Development for Global Health

More Information

• Responsible Party: Medicines Development for Global Health
• ClinicalTrials.gov Identifier: NCT03905265
• Other Study ID Numbers: MDGH-MOX-2001
• First Posted: April 5, 2019
• Last Update Posted: May 24, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Medicines Development for Global Health:

moxidectin; acaricide; oral

Additional relevant MeSH terms:

Scabies; Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Moxidectin; Anthelmintics; Antiparasitic Agents; Anti-Infective Agents; Antinematodal Agents