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 Overview
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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.

Official Title
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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

Conditions
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Onchocerciasis

Intervention / Treatment
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* Drug: Moxidectin
* Drug: Ivermectin
* Drug: Albendazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxidectin<br>In onchocerciasis endemic areas: Moxidectin 8 mg per oral on Day 0 | Drug: Moxidectin<br>* 2 mg tablets, encapsulated for blinding<br>|
| Active Comparator: Ivermectin<br>In onchocerciasis endemic areas: Ivermectin treatment with approximately 150 µg/kg per oral determined based on height on Day 0 | Drug: Ivermectin<br>* 3 mg tablets, encapsulated for blinding<br>|
| Experimental: Moxidectin with concomitant Albendazole<br>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<br>* 2 mg tablets, encapsulated for blinding<br>Drug: Albendazole<br>* 400 mg tablets<br>|
| Active Comparator: Ivermectin with concomitant Albendazole<br>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<br>* 3 mg tablets, encapsulated for blinding<br>Drug: Albendazole<br>* 400 mg tablets<br>|

What is the study measuring?
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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 |