Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis

• Moxidectin (Drug): 2mg tablets, encapsulated for blinding
• Ivermectin (Drug): 3mg tablets, encapsulated for blinding

Primary outcomes

• Proportion of moxidectin annual and biannual recipients with sustained microfilarial response at month 12 [Up to 12 months]: Proportion of recipients with zero Onchocerca volvulus microfilariae/mg skin at all post-treatment timepoints to month 12
• Incidence and severity of adverse events [Up to 36 months]: Incidence and severity of adverse events, vital signs and liver function tests

Secondary outcomes

• Proportion of participants in all dose groups with sustained microfilariae response [6 months, 12 months, 18 months, 24 months, 30 months, 36 months]: Proportion of participants with zero Onchocerca volvulus microfilariae/mg skin
• Sustained ocular microfilariae response in all dose groups [6 months, 12 months, 18 months, 24 months, 30 months, 36 months]: 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
• Skin microfilarial density in all dose groups [6 months, 12 months, 18 months, 24 months, 30 months, 36 months]: Mean, median and percentage reduction Onchocerca volvulus microfilariae/mg skin from baseline
• Ocular microfilariae response in all dose groups [6 months, 12 months, 18 months, 24 months, 30 months, 36 months]: 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
• Mean skin microfilariae density at each post-Screening assessment [6 months, 12 months, 18 months, 24 months, 30 months, 36 months]: Mean and mean change from baseline of Onchocerca volvulus microfilariae/mg skin

Other outcomes

• Signs and symptoms of onchocerciasis in all dose groups [6 months, 12 months, 18 months, 24 months, 30 months, 36 months]: Proportion of participants with signs and symptoms of onchocerciasis with these signs and symptoms at baseline.
• Viability and fertility of male and female macrofilariae in all dose groups [36 months]: Histopathological assessment of male and female macrofilariae excised from participants with palpable nodules

Sex: All, ages: 12 Years to any

Inclusion Criteria:

* Provision of written informed consent, or assent with parental or guardian written consent.
* Mean ≥ 10 O. volvulus microfilariae/mg skin, determined by four skin snips
* Living in a village selected for the study.
* Age ≥ 12 years.
* All female participants of childbearing potential must commit to the use of a reliable method of birth control for the duration of treatment and until 3 months after completion of dosing with investigational product.

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, oral diethylcarbamazine (DEC) or doxycycline (for > 2 weeks) within 6 months of Baseline.
* Has received treatment with an investigational agent within the last 30 days (or 5 half-lives, whichever is longer) prior to Baseline.
* Known or suspected allergy to ivermectin or moxidectin or their excipients.
* Self-reported planned or ongoing activities within the study period that would make it unlikely that a participant will be available for all planned treatment rounds and follow-up examinations.
* Weight > 88 kg.
* Infection with Loa loa.

• Study Protocol and Statistical Analysis Plan (PDF, 2023-01-12)

• Tony Ukety, MD, DO, MPH, Principal investigator, Centre de Recherche en Maladies Tropicales de l'Ituri