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

Primary Purpose

Onchocerciasis

Status

Active

Phase

Phase 3

Locations

Congo, The Democratic Republic of the

Study Type

Interventional

Intervention

Moxidectin

Ivermectin

About this trial

This is an interventional treatment trial for Onchocerciasis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Centre de Recherche pour les Maladies Tropicales Negligees

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Annual Moxidectin

Biannual Moxidectin

Annual Ivermectin

Biannual Ivermectin

Arm Description

Moxidectin 8mg per oral, administered annually for 24 months

Moxidectin 8mg per oral, administered biannually for 24 months

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

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

Outcomes

Primary Outcome Measures

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

Incidence and severity of adverse events

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

Secondary Outcome Measures

Proportion of participants in all dose groups with sustained microfilariae response

Proportion of participants with zero Onchocerca volvulus microfilariae/mg skin

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

Skin microfilarial density in all dose groups

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

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

Mean skin microfilariae density at each post-Screening assessment

Mean and mean change from baseline of Onchocerca volvulus microfilariae/mg skin

Full Information

NCT ID

NCT03876262

First Posted

March 11, 2019

Last Updated

August 3, 2023

Sponsor

Medicines Development for Global Health

1. Study Identification

Unique Protocol Identification Number

NCT03876262

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 3, 2021 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medicines Development for Global Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Onchocerciasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

323 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Annual Moxidectin

Arm Type

Experimental

Arm Description

Moxidectin 8mg per oral, administered annually for 24 months

Arm Title

Biannual Moxidectin

Arm Type

Experimental

Arm Description

Moxidectin 8mg per oral, administered biannually for 24 months

Arm Title

Annual Ivermectin

Arm Type

Active Comparator

Arm Description

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

Arm Title

Biannual Ivermectin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Moxidectin

Intervention Description

2mg tablets, encapsulated for blinding

Intervention Type

Drug

Intervention Name(s)

Ivermectin

Intervention Description

3mg tablets, encapsulated for blinding

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Up to 12 months

Title

Incidence and severity of adverse events

Description

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

Time Frame

Up to 36 months

Secondary Outcome Measure Information:

Title

Proportion of participants in all dose groups with sustained microfilariae response

Description

Proportion of participants with zero Onchocerca volvulus microfilariae/mg skin

Time Frame

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

Title

Sustained ocular microfilariae response in all dose groups

Description

Time Frame

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

Title

Skin microfilarial density in all dose groups

Description

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

Time Frame

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

Title

Ocular microfilariae response in all dose groups

Description

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

Time Frame

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

Title

Mean skin microfilariae density at each post-Screening assessment

Description

Mean and mean change from baseline of Onchocerca volvulus microfilariae/mg skin

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Signs and symptoms of onchocerciasis in all dose groups

Description

Proportion of participants with signs and symptoms of onchocerciasis with these signs and symptoms at baseline.

Time Frame

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

Title

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

Description

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

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tony Ukety, MD, DO, MPH

Organizational Affiliation

Centre de Recherche en Maladies Tropicales de l'Ituri

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre de Recherche pour les Maladies Tropicales Negligees

City

Rethy

State/Province

Ituri

Country

Congo, The Democratic Republic of the

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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