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

Onchocerciasis Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03876262
• Other study ID #: MDGH-MOX-3001
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 3, 2021
• Est. completion date: July 2026

Study information

• Verified date: August 2023
• Source: Medicines Development for Global Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 323
• Est. completion date: July 2026
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Onchocerciasis

Intervention

Drug:
• Moxidectin
2mg tablets, encapsulated for blinding
• Ivermectin
3mg tablets, encapsulated for blinding

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Centre de Recherche pour les Maladies Tropicales Negligees	Rethy	Ituri

Sponsors (1)

Lead Sponsor	Collaborator
Medicines Development for Global Health

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Signs and symptoms of onchocerciasis in all dose groups	Proportion of participants with signs and symptoms of onchocerciasis with these signs and symptoms at baseline.	6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Other	Viability and fertility of male and female macrofilariae in all dose groups	Histopathological assessment of male and female macrofilariae excised from participants with palpable nodules	36 months
Primary	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
Primary	Incidence and severity of adverse events	Incidence and severity of adverse events, vital signs and liver function tests	Up to 36 months
Secondary	Proportion of participants in all dose groups with sustained microfilariae response	Proportion of participants with zero Onchocerca volvulus microfilariae/mg skin	6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Secondary	Sustained ocular microfilariae response in all dose groups	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	6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Secondary	Skin microfilarial density in all dose groups	Mean, median and percentage reduction Onchocerca volvulus microfilariae/mg skin from baseline	6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Secondary	Ocular microfilariae response in all dose groups	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	6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Secondary	Mean skin microfilariae density at each post-Screening assessment	Mean and mean change from baseline of Onchocerca volvulus microfilariae/mg skin	6 months, 12 months, 18 months, 24 months, 30 months, 36 months