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

Phase 3

Completed

• Conditions: Onchocerciasis
• Interventions: Drug: Ivermectin; Drug: Moxidectin; Drug: Albendazole

• Registration Number: NCT04311671
• Lead Sponsor: Medicines Development for Global Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-14
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-17
• Study Start: 2021-05-03
• Primary Completion: 2024-09-27
• Study Completion: 2024-09-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12997

Inclusion Criteria

1. Provision of written informed consent, or assent with parental or guardian written consent*
2. Known O. volvulus skin microfilariae density ≥0 microfilariae/mg skin (participants ≥12 years of age only).
3. Living in an onchocerciasis endemic area.
4. Age ≥4 years
5. 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

1. Pregnant or breast-feeding.
2. 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.
3. Has received ivermectin or oral diethylcarbamazine (DEC) within 30 days of Baseline.
4. Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration.
5. 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.
6. 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.
7. Infection with Loa loa.
8. Height <90 cm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivermectin	Ivermectin	In onchocerciasis endemic areas: Ivermectin treatment with approximately 150 µg/kg per oral determined based on height on Day 0
Moxidectin with concomitant Albendazole	Moxidectin	In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Moxidectin 8 mg per oral with concomitant albendazole 400 mg per oral on Day 0
Moxidectin	Moxidectin	In onchocerciasis endemic areas: Moxidectin 8 mg per oral on Day 0
Moxidectin with concomitant Albendazole	Albendazole	In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Moxidectin 8 mg per oral with concomitant albendazole 400 mg per oral on Day 0
Ivermectin with concomitant Albendazole	Ivermectin	In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Ivermectin treatment with approximately 150 microgram/kilogram (μg/kg) per oral determined based on height with concomitant albendazole 400 mg per oral on Day 0
Ivermectin with concomitant Albendazole	Albendazole	In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Ivermectin treatment with approximately 150 microgram/kilogram (μg/kg) per oral determined based on height with concomitant albendazole 400 mg per oral on Day 0

Primary Outcome Measures

Name	Time	Method
Incidence and severity of treatment emergent adverse events	Up to 3 months	Participant incidence rates of treatment emergent adverse events following a single dose of moxidectin versus a single dose of ivermectin will be assessed separately by endemic area. Treatment emergent adverse events may also be pooled across both endemic areas (pooled monotherapy and combination therapies separately for moxidectin and ivermectin), provided a qualitative assessment shows they are similar enough to enable the interpretation of the pooled analysis.

Trial Locations

Locations (2)

Centre de Recherche pour les Maladies Tropicales Negligees; 🇨🇩 Rethy, Ituri, Congo, The Democratic Republic of the

Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire; 🇨🇮 Abidjan, Côte D'Ivoire