Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole

A Randomized, Double Blind, Parallel Group Clinical Trial to Evaluate the Safety of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Treatment With Albendazole

The purpose of this phase 3b study is to determine the safety of a single dose of moxidectin, compared to a single dose of ivermectin, in individuals living in onchocerciasis endemic areas and in individuals living in onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity receiving concomitant albendazole.

Study Overview

• Status: Completed
• Conditions: Onchocerciasis
• Intervention / Treatment: Drug: Albendazole; Drug: Moxidectin; Drug: Ivermectin

• Study Type: Interventional
• Enrollment (Actual): 12979
• Phase: Phase 3

Contacts and Locations

Study Locations

• Côte d’Ivoire
  • Abidjan, Côte d’Ivoire
    • Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire
• Democratic Republic of the Congo
  • Ituri
    • Rethy, Ituri, Democratic Republic of the Congo
      • Centre de Recherche pour les Maladies Tropicales Negligees

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Provision of written informed consent, or assent with parental or guardian written consent*
2. Known O. volvulus skin microfilariae density ≥0 microfilariae/mg skin (participants ≥12 years of age only).
3. Living in an onchocerciasis endemic area.
4. Age ≥4 years
5. All female participants of childbearing potential must commit to the use of a reliable method of birth control until 3 months after administration of investigational product (Month 3). * Expression of 'deliberate objection' will be the basis for assessing assent of children aged ≥ 4 to <6 years

Exclusion Criteria:

1. Pregnant or breast-feeding.
2. Any concurrent condition that, in the opinion of the Investigator, would preclude evaluation of response to treatment or would pose undue risk to the participant's health.
3. Has received ivermectin or oral diethylcarbamazine (DEC) within 30 days of Baseline.
4. Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration.
5. Known or suspected allergy to ivermectin or moxidectin or their excipients and, in areas with high levels of LF co-endemicity, known or suspected allergy to albendazole and its excipients.
6. Self-reported planned or ongoing activities within the study period that would make it unlikely that the participant will be available for follow-up examinations.
7. Infection with Loa loa.
8. Height <90 cm.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moxidectin; In onchocerciasis endemic areas: Moxidectin 8 mg per oral on Day 0	Drug: Moxidectin; 2 mg tablets, encapsulated for blinding
Active Comparator: Ivermectin; In onchocerciasis endemic areas: Ivermectin treatment with approximately 150 µg/kg per oral determined based on height on Day 0	Drug: Ivermectin; 3 mg tablets, encapsulated for blinding
Experimental: Moxidectin with concomitant Albendazole; In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Moxidectin 8 mg per oral with concomitant albendazole 400 mg per oral on Day 0	Drug: Albendazole; 400 mg tablets; Drug: Moxidectin; 2 mg tablets, encapsulated for blinding
Active Comparator: Ivermectin with concomitant Albendazole; In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Ivermectin treatment with approximately 150 microgram/kilogram (μg/kg) per oral determined based on height with concomitant albendazole 400 mg per oral on Day 0	Drug: Albendazole; 400 mg tablets; Drug: Ivermectin; 3 mg tablets, encapsulated for blinding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and Severity of Treatment Emergent Adverse Events	Participant incidence rates of treatment emergent adverse events following a single dose of moxidectin versus a single dose of ivermectin will be assessed separately by endemic area. Treatment emergent adverse events may also be pooled across both endemic areas (pooled monotherapy and combination therapies separately for moxidectin and ivermectin), provided a qualitative assessment shows they are similar enough to enable the interpretation of the pooled analysis.	Up to 3 months

Collaborators and Investigators

• Sponsor: Medicines Development for Global Health
• Investigators: Principal Investigator: Benjamin Koudou, PhD, Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire; Principal Investigator: Tony Ukety, MD, DO, MPH, Centre De Recherche en Maladies Tropicales De L'ituri

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): September 27, 2024
• Study Completion (Actual): September 27, 2024

Study Registration Dates

• First Submitted: March 14, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Skin Diseases; Skin Diseases, Infectious; Spirurida Infections; Secernentea Infections; Nematode Infections; Skin Diseases, Parasitic; Helminthiasis; Filariasis; Skin and Connective Tissue Diseases; Onchocerciasis; Organic Chemicals; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Acids, Acyclic; Carboxylic Acids; Macrolides; Lactones; Polyketides; Carbamates; Ivermectin; Albendazole; moxidectin
• Other Study ID Numbers: MDGH-MOX-3002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data in the form of data listings and SDTM and ADaM datasets may be available for sharing on application to the Sponsor.
• IPD Sharing Time Frame: Data will become available 12 months after publication.
• IPD Sharing Access Criteria: Provision of a methodologically sound and relevant proposal detailing the intended use of the data and relevant ethics approval for the proposed analysis, as applicable.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• 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.: No