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

NCT04311671 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: MDGH-MOX-3002
• Study Type: interventional
• Target: 12,979
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Onchocerciasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Moxidectin

EXPERIMENTAL

In onchocerciasis endemic areas: Moxidectin 8 mg per oral on Day 0

Drug: Moxidectin

Ivermectin

ACTIVE COMPARATOR

In onchocerciasis endemic areas: Ivermectin treatment with approximately 150 µg/kg per oral determined based on height on Day 0

Drug: Ivermectin

Moxidectin with concomitant Albendazole

EXPERIMENTAL

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: Moxidectin; Drug: Albendazole

Ivermectin with concomitant Albendazole

ACTIVE COMPARATOR

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: Ivermectin; Drug: Albendazole

Interventions

Moxidectin DRUG

2 mg tablets, encapsulated for blinding

Moxidectin; Moxidectin with concomitant Albendazole

Ivermectin DRUG

3 mg tablets, encapsulated for blinding

Ivermectin; Ivermectin with concomitant Albendazole

Albendazole DRUG

400 mg tablets

Ivermectin with concomitant Albendazole; Moxidectin with concomitant Albendazole

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent, or assent with parental or guardian written consent\*
• Known O. volvulus skin microfilariae density ≥0 microfilariae/mg skin (participants ≥12 years of age only).
• Living in an onchocerciasis endemic area.
• Age ≥4 years
• 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

You may not qualify if:

• Pregnant or breast-feeding.
• 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.
• Has received ivermectin or oral diethylcarbamazine (DEC) within 30 days of Baseline.
• Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration.
• 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.
• 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.
• Infection with Loa loa.
• Height \<90 cm.

Sponsors & Collaborators

• Medicines Development for Global Health: lead

Study Sites (2)

Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire

Abidjan, Côte d’Ivoire

Location

Centre de Recherche pour les Maladies Tropicales Negligees

Rethy, Ituri, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Onchocerciasis

Interventions

moxidectin; Ivermectin; Albendazole

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

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Amanda Handley
• Organization: Medicines Development for Global Health

ahandley@mdgh.com

+61 (0)438 367 239

Study Officials

• Tony Ukety, MD, DO, MPH

  Centre de Recherche en Maladies Tropicales de l'Ituri

  PRINCIPAL INVESTIGATOR

• Benjamin Koudou, PhD

  Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2020
• First Posted: March 17, 2020
• Study Start: May 3, 2021
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: March 3, 2026
• Results First Posted: February 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available 12 months after publication.
• 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.

Locations

CÔ (1); DE (1)