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

NCT03876262 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: MDGH-MOX-3001
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

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.

Conditions

Onchocerciasis

Outcome Measures

Primary Outcomes (2)

• Proportion of moxidectin annual and biannual recipients with sustained microfilarial response at month 12

  Proportion of recipients with zero Onchocerca volvulus microfilariae/mg skin at all post-treatment timepoints to month 12

  Up to 12 months

• Incidence and severity of adverse events

  Incidence and severity of adverse events, vital signs and liver function tests

  Up to 36 months

Secondary Outcomes (5)

• 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

Other Outcomes (2)

• Signs and symptoms of onchocerciasis in all dose groups

  6 months, 12 months, 18 months, 24 months, 30 months, 36 months

• Viability and fertility of male and female macrofilariae in all dose groups

  36 months

Study Arms (4)

Annual Moxidectin

EXPERIMENTAL

Moxidectin 8mg per oral, administered annually for 24 months

Drug: Moxidectin

Biannual Moxidectin

EXPERIMENTAL

Moxidectin 8mg per oral, administered biannually for 24 months

Drug: Moxidectin

Annual Ivermectin

ACTIVE COMPARATOR

Ivermectin (approximately) 150 micrograms/kg per oral, administered annually for 24 months

Drug: Ivermectin

Biannual Ivermectin

EXPERIMENTAL

Ivermectin (approximately) 150 micrograms/kg per oral, administered biannually for 24 months

Drug: Ivermectin

Interventions

Moxidectin DRUG

2mg tablets, encapsulated for blinding

Annual Moxidectin; Biannual Moxidectin

Ivermectin DRUG

3mg tablets, encapsulated for blinding

Annual Ivermectin; Biannual Ivermectin

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medicines Development for Global Health: lead

Study Sites (1)

Centre de Recherche pour les Maladies Tropicales Negligees

Rethy, Ituri, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Onchocerciasis

Interventions

moxidectin; Ivermectin

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Tony Ukety, MD, DO, MPH

  Centre de Recherche en Maladies Tropicales de l'Ituri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to four groups: annual ivermectin; annual moxidectin; biannual ivermectin; or biannual moxidectin

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 15, 2019
• Study Start: May 3, 2021
• Primary Completion: July 31, 2024
• Study Completion: January 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

DE (1)