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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

12997 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2024-09-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Onchocerciasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Moxidectin

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

Group Type EXPERIMENTAL

Moxidectin

Intervention Type DRUG

2 mg tablets, encapsulated for blinding

Ivermectin

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

Group Type ACTIVE_COMPARATOR

Ivermectin

Intervention Type DRUG

3 mg tablets, encapsulated for blinding

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

Group Type EXPERIMENTAL

Moxidectin

Intervention Type DRUG

2 mg tablets, encapsulated for blinding

Albendazole

Intervention Type DRUG

400 mg tablets

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

Group Type ACTIVE_COMPARATOR

Ivermectin

Intervention Type DRUG

3 mg tablets, encapsulated for blinding

Albendazole

Intervention Type DRUG

400 mg tablets

Interventions

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Moxidectin

2 mg tablets, encapsulated for blinding

Intervention Type DRUG

Ivermectin

3 mg tablets, encapsulated for blinding

Intervention Type DRUG

Albendazole

400 mg tablets

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes