Phase 3
N=12,979
Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole
Onchocerciasis
Bottom Line
View on ClinicalTrials.gov: NCT04311671 ↗Enrolled (actual)
12,979
Serious AEs
0.2%
Results posted
Feb 2026
Primary outcome: Primary: Incidence and Severity of Treatment Emergent Adverse Events — 346; 79; 1199; 288 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Moxidectin (Drug); Ivermectin (Drug); Albendazole (Drug)
- Age
- Pediatric, Adult, Older Adult · 4+ yrs
- Sex
- All
- Sponsor
- Medicines Development for Global Health
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Severity of Treatment Emergent Adverse Events |
346; 79; 1199; 288; 1545; 367 | — |
Summary
The purpose of this phase 3b study is to determine the safety of a single dose of moxidectin, compared to a single dose of ivermectin, in individuals living in onchocerciasis endemic areas and in individuals living in onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity receiving concomitant albendazole.
Eligibility Criteria
Inclusion Criteria
- Provision of written informed consent, or assent with parental or guardian written consent*
- Known O. volvulus skin microfilariae density ≥0 microfilariae/mg skin (participants ≥12 years of age only).
- Living in an onchocerciasis endemic area.
- Age ≥4 years
- All female participants of childbearing potential must commit to the use of a reliable method of birth control until 3 months after administration of investigational product (Month 3). * Expression of 'deliberate objection' will be the basis for assessing assent of children aged ≥ 4 to <6 years
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 or oral diethylcarbamazine (DEC) within 30 days of Baseline.
- Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration.
- Known or suspected allergy to ivermectin or moxidectin or their excipients and, in areas with high levels of LF co-endemicity, known or suspected allergy to albendazole and its excipients.
- Self-reported planned or ongoing activities within the study period that would make it unlikely that the participant will be available for follow-up examinations.
- Infection with Loa loa.
- Height <90 cm.
Data sourced from ClinicalTrials.gov (NCT04311671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.