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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Annual Moxidectin | Experimental | Moxidectin 8mg per oral, administered annually for 24 months |
|
| Biannual Moxidectin | Experimental | Moxidectin 8mg per oral, administered biannually for 24 months |
|
| Annual Ivermectin | Active Comparator | Ivermectin (approximately) 150 micrograms/kg per oral, administered annually for 24 months |
|
| Biannual Ivermectin | Experimental | Ivermectin (approximately) 150 micrograms/kg per oral, administered biannually for 24 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxidectin | Drug | 2mg tablets, encapsulated for blinding |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 12 months |
| Incidence and severity of adverse events | Incidence and severity of adverse events, vital signs and liver function tests | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants in all dose groups with sustained microfilariae response | Proportion of participants with zero Onchocerca volvulus microfilariae/mg skin | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months |
| Sustained ocular microfilariae response in all dose groups |
| Measure | Description | Time Frame |
|---|---|---|
| Signs and symptoms of onchocerciasis in all dose groups | Proportion of participants with signs and symptoms of onchocerciasis with these signs and symptoms at baseline. | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months |
| Viability and fertility of male and female macrofilariae in all dose groups |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tony Ukety, MD, DO, MPH | Centre de Recherche en Maladies Tropicales de l'Ituri | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche pour les Maladies Tropicales Negligees | Rethy | Ituri | Democratic Republic of the Congo |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 12, 2023 | Jul 19, 2023 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D009855 | Onchocerciasis |
| ID | Term |
|---|---|
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
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| ID | Term |
|---|---|
| C027837 | moxidectin |
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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Participants will be assigned to four groups: annual ivermectin; annual moxidectin; biannual ivermectin; or biannual moxidectin
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| Ivermectin | Drug | 3mg tablets, encapsulated for blinding |
|
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 |
| 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 | 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 | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months |
| Mean skin microfilariae density at each post-Screening assessment | Mean and mean change from baseline of Onchocerca volvulus microfilariae/mg skin | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months |
Histopathological assessment of male and female macrofilariae excised from participants with palpable nodules |
| 36 months |
| D006373 |
| Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D012876 | Skin Diseases, Parasitic |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |