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Phase 3 N=12,979 Randomized Quadruple-blind Treatment

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

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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