Dose-finding Study of Moxidectin for Treatment of Scabies

Scabies Clinical Trial

Official title:

A Phase II, Randomized, Double-blind, Parallel Group Dose Finding Study of Single Oral Doses of Moxidectin in Adults With Scabies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03905265
• Other study ID #: MDGH-MOX-2001
• Status: Completed
• Phase: Phase 2
• Start date: January 13, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: May 2022
• Source: Medicines Development for Global Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Scabies

Intervention

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

Locations

Country	Name	City	State
Australia	Royal Darwin Hospital	Darwin
Austria	Medizinischen Universität Wien	Vienna
France	Hopital Henri Mondor AP-HP	Créteil
France	CHU Nice Hopital Archet 2	Nice
France	CHU Saint-Etienne Hopital Nord	Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Medicines Development for Global Health

Countries where clinical trial is conducted

Australia,  Austria,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence and Severity of Scabies Signs and Symptoms	The incidence and severity of signs and symptoms of scabies infection will be explored using a clinician-reported scabies severity assessment.	28 days
Other	Severity of Pruritus	The severity of pruritus will be determined using the Numerical Rating Scale where 0="no itch" and 10="worst itch imaginable"	28 days
Primary	Mortality Rate for Adult Scabies Mites	Adult scabies mite death was based on the reflectance confocal microscopy (RCM) morphology assessment of 2 live adult scabies mites nominated pre-treatment (Baseline), hence overall number of units analyzed are different from the overall number of participants. For the outcome measure, the number of adult mites assessed at each timepoint is the sum of the number of adult mites from all participants in the analysis population for each dose. Therefore, mortality was assessed in 2 mites in the 2 mg group, 6 in the 8 mg group, 8 in the 20 mg group and 14 in the 32 mg group. Adult mite death was defined as the degradation (homogenization of internal structures and/or external anatomic structures, and increased reflectance) of the adult mite observed by RCM. The number of dead mites was assessed at Hours 4, 8, 24, 48 and 72, and Days 7, 14 and 28 compared to the baseline adult mites.	28 days
Primary	Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set)	No formal statistical analysis of AEs was undertaken. Adverse events reported in this Section refer to treatment emergent adverse events (TEAE), defined as AEs that started, or worsened, on or after the start of the administration of Investigational Product (Moxidectin). Moxidectin was generally well tolerated, with no treatment-related SAEs reported and no treatment emergent adverse event (TEAEs) leading to study withdrawal or resulting in death. Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term. Data up to and including the Day 28 assessment for each subject.	Day 0 to Day 28 inclusive
Primary	Number of Participants and Severity of Adverse Events	Number of participants with Adverse events reported in this Section refer to treatment emergent adverse events (TEAE), defined as AEs that started, or worsened, on or after the start of the administration of IP. Data up to and including the Day 28 assessment for each subject. The severity of adverse events were assessed using the Toxicity Grading Scale for Healthy Adult and Adolescent volunteers Enrolled in Preventive Vaccine Clinical Trials.	Day 0 to Day 28 inclusive
Secondary	Analysis of Moxidectin Plasma Concentrations	The final PK analysis dataset included a total of 240 evaluable PK samples from 22 subjects. All pre-dose samples were below the limit of quantitation (BQL).	Nominal time of PK sample collection was Pre-dose, 2hours (h), 3h, 4h, 8h, Day 1 (24h), Day 2 (48h), Day 3 (72h), Day 7 (168h), Day 14 (336h) and Day 28 (672h)
Secondary	Analysis of Moxidectin Maximum Plasma Concentrations (Cmax)	The final PK analysis dataset included a total of 240 evaluable PK samples from 22 subjects. All pre-dose samples were below the limit of quantitation (BQL).	Nominal time of PK sample collection was Pre-dose, 2hours (h), 3h, 4h, 8h, Day 1 (24h), Day 2 (48h), Day 3 (72h), Day 7 (168h), Day 14 (336h) and Day 28 (672h)