Efficacy and Safety Study of Moxidectin in Adults With Scabies

Scabies Clinical Trial

Official title:

A Phase 2, Placebo-controlled, Double-blind, Randomized, Dose Ranging, Efficacy and Safety Study of Orally Administered Moxidectin in Adults With Scabies.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875441
• Other study ID #: MDGH-MOX-2002
• Status: Recruiting
• Phase: Phase 2
• Start date: November 23, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2023
• Source: Medicines Development for Global Health
• Contact: Vidya Uprety
• Phone: +61(0)3 9912 2427
• Email: vidya.uprety[@]medicinesdevelopment.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged 18 years or older.

2. Provided written informed consent.

3. 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.

4. 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).

Exclusion Criteria:

1. 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).

2. 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.

3. 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.

4. Body mass index > 35 kg/m2.

5. Creatinine clearance < 30 mL/min (using Cockcroft-Gault equation).

6. Both total bilirubin >1.5 x upper limit of normal (ULN) and AST > ULN.

7. 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.

8. 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.

9. 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.

10. 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.

11. Received an investigational agent within 28 days of Screening (or 5 half-lives of the investigational agent, whichever is longer).

12. Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin or ivermectin.

13. 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.

14. Known, suspected or at risk of Loa loa coinfection.

15. Difficulty swallowing tablets or capsules.

16. Pregnant or breastfeeding or planning to become pregnant from Screening until 16 weeks after treatment with IP.

17. Known or suspected alcohol or illicit substance abuse.

18. Unwilling, unlikely or unable to comply with all protocol specified assessments.

19. Previous enrolment in this study.

20. Previous moxidectin exposure within 6 months (5 half-lives) from Baseline.

21. Has household members who refuse or are unable to receive permethrin 5% cream treatment for scabies.

Related Conditions & MeSH terms

• Scabies

Intervention

Drug:
• Moxidectin Oral Product
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose with placebo capsules to match as required
• Moxidectin Oral Product
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose with placebo capsules to match as required
• Moxidectin Oral Product
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose.
• Placebo
16 placebo capsules will be administered as a single dose.

Locations

Country	Name	City	State
Dominican Republic	Instituto Dermatologico Dominicano y Cirugia de Piel	Santo Domingo Oeste	Santo Domingo
Honduras	Hospital y Clinica Bendana	San Pedro Sula	Cortes
Puerto Rico	CAIMED Center Ponce Medical School Foundation Inc	Ponce
United States	West Houston Clinical Research Service	Houston	Texas
United States	Advanced Care and Clinical Trials, LLC	Miami	Florida
United States	Paddington Testing Company, Inc	Philadelphia	Pennsylvania
United States	Affinity Clinical Research LLC	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medicines Development for Global Health

Countries where clinical trial is conducted

United States,  Dominican Republic,  Honduras,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of index subjects achieving clinical cure without microscopic or dermatoscopic cure, assessed by skin examination to confirm all signs of scabies have completely resolved.	The proportion of index subjects demonstrating clinical cure without microscopic or dermatoscopic cure at Day 28.	28 Days
Other	Proportion of index subjects achieving microscopic or dermatoscopic cure without clinical cure. Microscopic or dermatoscopic cure is assessed by demonstrating the absence of scabies mites, eggs, and/or scybala, and negative dermoscopy for burrows.	The proportion of index subjects demonstrating microscopic or dermatoscopic cure without clinical cure at Day 28.	28 Days
Primary	Proportion of index subjects achieving complete cure (Efficacy)	Proportion of index subjects achieving Complete Cure at Day 28. Complete Cure is defined as demonstration of both: Clinical cure: all signs and symptoms have completely resolved, including burrows, inflammatory/noninflammatory lesions and pruritus. And; Microscopic or dermatoscopic cure demonstrating the absence of mites, eggs, and/or scybala, and negative dermoscopy for burrows.	28 Days
Primary	Incidence and severity of Treatment Emergent Adverse Event (Safety)	Incidence and severity of Treatment Emergent Adverse Event (TEAEs), Incidence of serious TEAEs and Incidence of TEAEs leading to study withdrawal and/or death.	84 Days