A Randomized, Double Blind, Parallel Trial in the Democratic Republic of Congo (DRC) Comparing the Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Treatment of Onchocerciasis
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 323
- Locations
- 1
- Primary Endpoint
- Proportion of moxidectin annual and biannual recipients with sustained microfilarial response at month 12
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Annual Moxidectin
Moxidectin 8mg per oral, administered annually for 24 months
Intervention: Moxidectin (Drug)
Biannual Moxidectin
Moxidectin 8mg per oral, administered biannually for 24 months
Intervention: Moxidectin (Drug)
Annual Ivermectin
Ivermectin (approximately) 150 micrograms/kg per oral, administered annually for 24 months
Intervention: Ivermectin (Drug)
Biannual Ivermectin
Ivermectin (approximately) 150 micrograms/kg per oral, administered biannually for 24 months
Intervention: Ivermectin (Drug)
Outcomes
Primary Outcomes
Proportion of moxidectin annual and biannual recipients with sustained microfilarial response at month 12
Time Frame: 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
Time Frame: 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)
- Sustained ocular microfilariae response in all dose groups(6 months, 12 months, 18 months, 24 months, 30 months, 36 months)
- Skin microfilarial density in all dose groups(6 months, 12 months, 18 months, 24 months, 30 months, 36 months)
- Ocular microfilariae response in all dose groups(6 months, 12 months, 18 months, 24 months, 30 months, 36 months)
- Mean skin microfilariae density at each post-Screening assessment(6 months, 12 months, 18 months, 24 months, 30 months, 36 months)