The primary purpose of this phase 3b study is to determine the safety and efficacy of moxidectin administration twice a year, compared to once a year, in maintaining undetectable levels in skin of O. volvulus microfilaria in skin, the parasite that causes river blindness. Secondary purposes are to determine the effectiveness of moxidectin compared to ivermectin once or twice a year in maintaining undetectable levels, or reducing levels, of skin microfilaria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
323
2mg tablets, encapsulated for blinding
3mg tablets, encapsulated for blinding
Centre de Recherche pour les Maladies Tropicales Negligees
Rethy, Ituri, Democratic Republic of the Congo
Proportion of moxidectin annual and biannual recipients with sustained microfilarial response at month 12
Proportion of recipients with zero Onchocerca volvulus microfilariae/mg skin at all post-treatment timepoints to month 12
Time frame: Up to 12 months
Incidence and severity of adverse events
Incidence and severity of adverse events, vital signs and liver function tests
Time frame: Up to 36 months
Proportion of participants in all dose groups with sustained microfilariae response
Proportion of participants with zero Onchocerca volvulus microfilariae/mg skin
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Sustained ocular microfilariae response in all dose groups
Proportion of participants with 0 live O. volvulus microfilariae in the anterior chambers of the eyes at all post-Baseline assessments in those with liver ocular microfilariae before the first treatment
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Skin microfilarial density in all dose groups
Mean, median and percentage reduction Onchocerca volvulus microfilariae/mg skin from baseline
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Ocular microfilariae response in all dose groups
Proportion of participants in all dose groups with 0 Onchocerca volvulus microfilariae/mg skin and 0 live microfilariae in the anterior chambers of the eyes each timepoint
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
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Mean skin microfilariae density at each post-Screening assessment
Mean and mean change from baseline of Onchocerca volvulus microfilariae/mg skin
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months