Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases

NCT07145736 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: KirbyI
• Study Type: interventional
• Target: 52,000
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial compares two treatments - ivermectin and moxidectin - to learn which is better at reducing the proportion of people with onchocerciasis (river blindness) when given through mass drug administration (MDA) in Angola. Both drugs are approved by the United States Food and Drug Administration (FDA) to treat this disease. The study also explores how these treatments affect other infections common in the region, including intestinal worms (soil-transmitted helminths) and scabies. The trial aims to answer the following key questions:

• How do moxidectin and ivermectin compare in reducing the prevalence (how common the disease is) and intensity (amount of parasites per person) of onchocerciasis in the community?
• Do the treatments differ in their effect on the prevalence and intensity of soil-transmitted helminths and the prevalence of scabies?
• Does moxidectin reduce transmission of onchocerciasis more effectively than ivermectin, based on genetic testing of parasites in people and lab testing of the blackflies that carry the infection?
• How many more years of treatment would be needed to reach elimination with each drug, based on mathematical disease modelling?
• How do communities feel about receiving moxidectin versus ivermectin, and what factors help or make it harder to carry out MDA programs with moxidectin versus ivermectin? The study takes place in Bié Province, Angola, and involves 20 groups of villages randomly assigned to receive either moxidectin or ivermectin once a year for four years. Prior to every round of MDA, researchers will collect skin, stool and blood samples from a sample of the people living in the study area. We believe the results will help guide global policy on the use of moxidectin in efforts to eliminate onchocerciasis and control related diseases.

Conditions

Onchocerciasis; Ascaris Lumbricoides Infection; Trichuris Trichiura; Infection; Hookworm Infections; Scabies

Outcome Measures

Primary Outcomes (1)

• Prevalence of Onchocerca volvulus microfilariae

  Prevalence of O. volvulus microfilariae at 36 months in skin snips, the marker most likely to show change in the shorter term as demonstrated by the therapeutic trials

  36 months after the first intervention

Secondary Outcomes (15)

• Prevalence of O. volvulus microfilaria/mg skin

  12, 24 and 36 months after the first intervention

• Microfilariae density (mean, median)

  12, 24 and 36 months after the first intervention

• Prevalence of nodules

  12, 24 and 36 months after the first intervention

• Prevalence of onchocerciasis skin disease

  12, 24 and 36 months after the first intervention

• Proportion of black flies with infective O. volvulus larvae

  12, 24 and 36 months after the first intervention

Study Arms (2)

Moxidectin

EXPERIMENTAL

Single oral dose of moxidectin treatment 8 mg (4 tablets of 2 mg of moxidectin), once per year

Drug: Moxidectin

Ivermectin

ACTIVE COMPARATOR

Single oral dose of ivermectin treatment with approximately 150 µg/kg determined based on height (between 1 and 4 tablets of 3 mg of ivermectin), once per year

Drug: Ivermectin

Interventions

Moxidectin DRUG

2 mg tablets

Moxidectin

Ivermectin DRUG

3 mg tablets

Ivermectin

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female children and adults
• Residents in the villages selected for MDA treatment

You may not qualify if:

• Arm 1 (ivermectin): children under the age of 5 and/or under 90 cm of height
• Arm 2 (moxidectin): children under the age of 12 years (who will receive ivermectin if they are at least 90 cm in height/5 years of age and above).
• Arm 1 (ivermectin): Women breast-feeding babies under 45 days of age
• Arm 2 (moxidectin): All breastfeeding women (who will be offered ivermectin if their infants is at least 45 days old)
• Know allergy to ivermectin or moxidectin
• Attending other clinical trials during the study
• Pregnant
• Arm 2 (moxidectin): Women planning to become pregnant in the 3 months post-treatment
• Refusal to receive one or both study drugs, i.e. participants in villages allocated to receive moxidectin who refuse to receive moxidectin will be given the option to receive ivermectin; if they refuse to receive both drugs they will be excluded from the MDA altogether
• Has an illness that makes them too sick or weak to get out of bed
• Currently hospitalized

Sponsors & Collaborators

• Kirby Institute: lead
• Emory University: collaborator
• La Trobe University: collaborator
• Murdoch Childrens Research Institute: collaborator
• Medicines Development for Global Health: collaborator
• University of Melbourne: collaborator
• Swiss Tropical & Public Health Institute: collaborator
• University of Ottawa: collaborator
• The Mentor Initiative: collaborator
• Erasmus Medical Center: collaborator
• Ministry of Health, Angola: collaborator
• The END Fund: collaborator
• Center for Research on Filariasis and Other Tropical Diseases, Cameroon: collaborator
• World Health Organization: collaborator

Study Sites (1)

Villages in Andulo and Nharea Municipalities

Andulo, Bíe Province, Angola

RECRUITING

MeSH Terms

Conditions

Onchocerciasis; Trichuriasis; Hookworm Infections; Scabies

Interventions

moxidectin; Ivermectin

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Enoplida Infections; Adenophorea Infections; Strongylida Infections; Mite Infestations; Ectoparasitic Infestations

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Susana V Nery, PhD

  Kirby Institute, University of New South Wales, Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susana V Nery, PhD

CONTACT

+61467076047; snery@kirby.unsw.edu.au

Marta S Palmeirim, PhD

CONTACT

+351916563622; mpalmeirim@kirby.unsw.edu.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Clusters of villages are assigned to either ivermectin or moxidectin in parallel for the duration of the study.

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

AN (1)