Clinical trial NCT05875441: Efficacy and Safety Study of Moxidectin in Adults With Scabies
Official title: A Phase 2, Placebo-controlled, Double-blind, Randomized, Dose Ranging, Efficacy and Safety Study of Orally Administered Moxidectin in Adults With Scabies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scabies
Keywords: Moxidectin
Oral
Lead sponsor: Medicines Development for Global Health
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo-controlled, double-blind, randomized, dose ranging study. Four cohorts of 50 subjects per cohort are planned. Subjects will be randomized 1:1:1:1 to receive Moxidectin 8mg, Moxidectin 16mg, Moxidectin 32mg or Placebo as a single oral dose.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of index subjects achieving complete cure (Efficacy)
timeFrame: 28 Days
measure: Incidence and severity of Treatment Emergent Adverse Event (Safety)
timeFrame: 84 Days
Secondary outcomes:
Other outcomes:
measure: 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.
timeFrame: 28 Days
measure: 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.
timeFrame: 28 Days
Locations:
city: Los Angeles
country: United States
facility: LA Universal Research Center, Inc
state: California
city: Miami
country: United States
facility: Evolution Clinical Trials
state: Florida
city: Miami
country: United States
facility: Advanced Care and Clinical Trials, LLC
state: Florida
city: Miami
country: United States
facility: Medical Research of Westchester, Inc
state: Florida
city: Tampa
country: United States
facility: Affinity Clinical Research LLC
state: Florida
city: Santo Domingo Oeste
country: Dominican Republic
facility: Instituto Dermatologico Dominicano y Cirugia de Piel
state: Santo Domingo
city: San Salvador
country: El Salvador
facility: Vargas Clinic
city: San Pedro Sula
country: Honduras
facility: Hospital y Clinica Bendana
state: Cortes
city: San Pedro Sula
country: Honduras
facility: Derclinic
state: Cortez
Study officials:
affiliation: Advance Care and Clinical Trials
name: Richard L Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital y Clinica Bendana
name: Jorge Lopez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Dermatologico Dominicano y Cirugia de Pie
name: Daisy Blanco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Affinity Clinical Research Services
name: Jorge Castillo Molina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Derclinic
name: Patricia A Zuniga Munoz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vargas Clinic
name: Laura B Vargas Rivas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Evolution Clinical Trials
name: Gilberto Perez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Research of Westchester, Inc
name: Armando Pineda-Velez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: LA Universal Research Center, Inc
name: Bruce Torkan, MD
role: PRINCIPAL_INVESTIGATOR
References: