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

Medicines Development for Global Health

Status and phase: Completed; Phase 3

Conditions: Onchocerciasis

Treatments: Drug: Albendazole; Drug: Ivermectin; Drug: Moxidectin

Study type: Interventional

Funder types: Other

Identifiers

NCT04311671

MDGH-MOX-3002

Details and patient eligibility

About

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.

Enrollment: 12,997 patients

Sex: All

Ages: 4+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12,997 participants in 4 patient groups

Moxidectin

Experimental group

Description:

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

Treatment:

Drug: Moxidectin

Ivermectin

Active Comparator group

Description:

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

Treatment:

Drug: Ivermectin

Moxidectin with concomitant Albendazole

Experimental group

Description:

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

Treatment:

Drug: Moxidectin

Drug: Albendazole

Ivermectin with concomitant Albendazole

Active Comparator group

Description:

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

Treatment:

Drug: Ivermectin

Drug: Albendazole