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
Sponsored by
About this trial
This is an interventional treatment trial for Onchocerciasis
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.
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
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
No
Data Monitoring Committee
No
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
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
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
No
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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