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NCT Number: NCT03876262

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre de Recherche pour les Maladies Tropicales Negligees

Rethy, Ituri, Democratic Republic of the Congo

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moxidectin

Drug

2mg tablets, encapsulated for blinding

Ivermectin

Drug

3mg tablets, encapsulated for blinding

Primary outcomes

  1. 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

  2. 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

  1. Proportion of participants in all dose groups with sustained microfilariae response

    Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months

    Proportion of participants with zero Onchocerca volvulus microfilariae/mg skin

  2. Sustained ocular microfilariae response in all dose groups

    Time frame: 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

  3. Skin microfilarial density in all dose groups

    Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months

    Mean, median and percentage reduction Onchocerca volvulus microfilariae/mg skin from baseline

  4. Ocular microfilariae response in all dose groups

    Time frame: 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

  5. Mean skin microfilariae density at each post-Screening assessment

    Time frame: 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

  1. Signs and symptoms of onchocerciasis in all dose groups

    Time frame: 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.

  2. Viability and fertility of male and female macrofilariae in all dose groups

    Time frame: 36 months

    Histopathological assessment of male and female macrofilariae excised from participants with palpable nodules

Sponsors and collaborators

Lead sponsor

Medicines Development for Global Health

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Mar 15, 2019
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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