Onchocerciasis
Conditions
Brief summary
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.
Interventions
DRUGMoxidectin
2mg tablets, encapsulated for blinding
DRUGIvermectin
3mg tablets, encapsulated for blinding
Sponsors
Medicines Development for Global Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be assigned to four groups: annual ivermectin; annual moxidectin; biannual ivermectin; or biannual moxidectin
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events | Up to 36 months | Incidence and severity of adverse events, vital signs and liver function tests |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Democratic Republic of the Congo
Outcome results
None listed