Safety of a Single Dose of Moxidectin Compared With Iverm... | NCT04311671 | Trialant
NCT04311671
Sponsor
Medicines Development for Global Health
Status
Completed
Last Update Posted
Mar 3, 2026Actual
Enrollment
12,979Actual
Phase
Phase 3
Conditions
Onchocerciasis
Interventions
Moxidectin
Ivermectin
Albendazole
Countries
Côte d’Ivoire
Democratic Republic of the Congo
Protocol Section
Identification Module
NCT ID
NCT04311671
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MDGH-MOX-3002
Secondary IDs
Not provided
Brief Title
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
Official Title
A Randomized, Double Blind, Parallel Group Clinical Trial to Evaluate the Safety 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 Treatment With Albendazole
Acronym
Not provided
Organization
Medicines Development for Global HealthOTHER
Status Module
Record Verification Date
Dec 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 3, 2021Actual
Primary Completion Date
Sep 27, 2024Actual
Completion Date
Sep 27, 2024Actual
First Submitted Date
Mar 14, 2020
First Submission Date that Met QC Criteria
Mar 16, 2020
First Posted Date
Mar 17, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Dec 22, 2025
Results First Submitted that Met QC Criteria
Feb 3, 2026
Results First Posted Date
Feb 5, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 10, 2026
Last Update Posted Date
Mar 3, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Medicines Development for Global HealthOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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 provided
Conditions Module
Conditions
Onchocerciasis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
12,979Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Moxidectin
Experimental
In onchocerciasis endemic areas: Moxidectin 8 mg per oral on Day 0
Drug: Moxidectin
Ivermectin
Active Comparator
In onchocerciasis endemic areas: Ivermectin treatment with approximately 150 µg/kg per oral determined based on height on Day 0
Drug: Ivermectin
Moxidectin with concomitant Albendazole
Experimental
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
Drug: Moxidectin
Drug: Albendazole
Ivermectin with concomitant Albendazole
Active Comparator
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
Drug: Ivermectin
Drug: Albendazole
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Moxidectin
Drug
2 mg tablets, encapsulated for blinding
Moxidectin
Moxidectin with concomitant Albendazole
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence and Severity of Treatment Emergent Adverse Events
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.
Up to 3 months
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Provision of written informed consent, or assent with parental or guardian written consent*
Known O. volvulus skin microfilariae density ≥0 microfilariae/mg skin (participants ≥12 years of age only).
Living in an onchocerciasis endemic area.
Age ≥4 years
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:
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 or oral diethylcarbamazine (DEC) within 30 days of Baseline.
Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration.
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.
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.
Infection with Loa loa.
Height <90 cm.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
4 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Tony Ukety, MD, DO, MPH
Centre de Recherche en Maladies Tropicales de l'Ituri
Principal Investigator
Benjamin Koudou, PhD
Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire
Abidjan
Côte d’Ivoire
Centre de Recherche pour les Maladies Tropicales Negligees
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Deidentified individual participant data in the form of data listings and SDTM and ADaM datasets may be available for sharing on application to the Sponsor.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame
Data will become available 12 months after publication.
Access Criteria
Provision of a methodologically sound and relevant proposal detailing the intended use of the data and relevant ethics approval for the proposed analysis, as applicable.
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets.
Participants randomized in a blinded fashion to this group received treatment with a single dose of ivermectin of approximately 150mcg/kg, estimated by height, administered as 3mg ivermectin tablet-in-capsules plus placebo to match (total 4 capsules): Height 90-119cm (1 x 3mg); 120 to 139cm (2 x 3mg); 140 to 159cm (3 x 3mg); > 159cm (4 x 3mg) tablets in capsules. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in assessment of participants.
FG002
Moxidectin Plus Albendazole
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. All participants received a single Albendazole tablet 400mg as a single open label dose concurrently with moxidectin.
FG003
Ivermectin Plus Albendazole
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. All participants received a single Albendazole tablet 400mg as a single open label dose concurrently with ivermectin.
FG0006421 subjectsTreated population
FG0011605 subjectsTreated population
FG0023959 subjectsTreated population
FG003994 subjectsTreated population
COMPLETED
FG0006395 subjects
FG0011592 subjects
FG0023891 subjects
FG003977 subjects
NOT COMPLETED
FG00026 subjects
FG00113 subjects
FG00268 subjects
FG00317 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Moxidectin
In onchocerciasis endemic areas: Moxidectin 8 mg per oral on Day 0 for adults and children from 8 years, 4 mg for children 4 to < 8 years.
Moxidectin: 2 mg tablets, encapsulated for blinding
BG001
Ivermectin
In onchocerciasis endemic areas: Ivermectin treatment with approximately 150 µg/kg per oral determined based on height on Day 0
Ivermectin: 3 mg tablets, encapsulated for blinding
BG002
Moxidectin With Concomitant Albendazole
In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Moxidectin 8 mg per oral for adults and children from 8 years, 4 mg for children 4 to < 8 years, with concomitant albendazole 400 mg per oral on Day 0
Moxidectin: 2 mg tablets, encapsulated for blinding
Albendazole: 400 mg tablets
BG003
Ivermectin With Concomitant 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
Ivermectin: 3 mg tablets, encapsulated for blinding
Albendazole: 400 mg tablets
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006421
BG0011605
BG0023959
BG003994
BG00412979
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0006421
ParticipantsBG0011605
ParticipantsBG0023959
ParticipantsBG003
Age, Continuous
Mean
Full Range
years
Title
Denominators
Categories
ParticipantsBG0006421
ParticipantsBG0011605
ParticipantsBG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0006421
ParticipantsBG0011605
ParticipantsBG002
Race/Ethnicity, Customized
All participants were recruited from villages in rural areas of the Democratic Republic of Congo (Ituri province) and from the Akoupe region in Cote D'Ivoire. Only people of black African race were enrolled.
Number
participants
Title
Denominators
Categories
Race - Black African
ParticipantsBG0006421
ParticipantsBG0011605
ParticipantsBG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Congo, The Democratic Republic of the
ParticipantsBG0006421
ParticipantsBG0011605
ParticipantsBG002
Number of Participants with Onchocerca volvulus skin microfilariae (mf)
Assessment for presence of O. volvulus skin microfilariae in participants 12 years and older. Two (2) skin snips, one taken from each iliac crest, were collected prior to treatment by corneoscleral punch, processed in saline and the emerging microfilariae counted (if present). The results were then standardized to the number of microfilariae per milligram of skin
Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
Number
participants
Title
Denominators
Categories
Overall tested
ParticipantsBG0006271
ParticipantsBG001
Number of participants with LF antigenemia and/or microfilaremia
Assessment for presence of circulating lymphatic filarial antigen (CFA) was conducted using a semiquantitative rapid filarial test strip. A nocturnal venous blood sample was then collected for assessment of microfilaremia in participants with a CFA result greater than 0. This test was only conducted in the Cote D'Ivoire region where LF was was known to be endemic.
This assessment was only conducted in the Cote D'Ivoire region where LF was was known to be endemicand only in participants aged 12 years and older. Hence only participants in the Moxidectin plus Albendazole or the Ivermectin plus Albendazole arms have results for this measure
Number
participants
Title
Denominators
Categories
CFA Positive (Category 1-3) with or without microfilaremia
ParticipantsBG0000
ParticipantsBG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Incidence and Severity of Treatment Emergent Adverse Events
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.
Participants who received a single dose of moxidectin or ivermectin and participants who received a single dose of moxidectin or ivermectin with albendazole analyzed separately by endemic area and pooled.
Posted
Number
participants
Up to 3 months
ID
Title
Description
OG000
Moxidectin
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets.
OG001
Ivermectin
Participants randomized in a blinded fashion to this group received treatment with a single dose of ivermectin of approximately 150mcg/kg, estimated by height, administered as 3mg ivermectin tablet-in-capsules plus placebo to match (total 4 capsules): Height 90-119cm (1 x 3mg); 120 to 139cm (2 x 3mg); 140 to 159cm (3 x 3mg); > 159cm (4 x 3mg) tablets in capsules. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in assessment of participants.
OG002
Moxidectin Plus Albendazole
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. All participants received a single Albendazole tablet 400mg as a single open label dose concurrently with moxidectin.
OG003
Ivermectin Plus Albendazole
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. All participants received a single Albendazole tablet 400mg as a single open label dose concurrently with ivermectin.
OG004
Moxidectin +/- Albendazole (Pooled)
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. Participants received treatment with or without a single Albendazole tablet 400mg as a single open label dose concurrently with moxidectin, depending on LF-endemicity in the area
OG005
Ivermectin +/- Albendazole (Pooled)
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. Participants received treatment with or without a single Albendazole tablet 400mg as a single open label dose concurrently with ivermectin, depending on LF-endemicity in the area
Units
Counts
Participants
OG0006421
OG0011605
OG0023959
OG003
Title
Denominators
Categories
Number of Participants with one or more Treatment Emergent Adverse Events (TEAEs)
Title
Measurements
OG000346
OG00179
OG0021199
OG003
Time Frame
Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Description
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Moxidectin
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets.
6
6,421
18
6,421
346
6,421
EG001
Ivermectin
Participants randomized in a blinded fashion to this group received treatment with a single dose of ivermectin of approximately 150mcg/kg, estimated by height, administered as 3mg ivermectin tablet-in-capsules plus placebo to match (total 4 capsules): Height 90-119cm (1 x 3mg); 120 to 139cm (2 x 3mg); 140 to 159cm (3 x 3mg); > 159cm (4 x 3mg) tablets in capsules. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in assessment of participants.
2
1,605
4
1,605
79
1,605
EG002
Moxidectin Plus Albendazole
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. All participants received a single Albendazole tablet 400mg as a single open label dose concurrently with moxidectin.
3
3,959
4
3,959
1,199
3,959
EG003
Ivermectin Plus Albendazole
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. All participants received a single Albendazole tablet 400mg as a single open label dose concurrently with ivermectin.
0
994
0
994
288
994
EG004
Moxidectin +/- Albendazole (Pooled)
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. Participants received treatment with or without a single Albendazole tablet 400mg as a single open label dose concurrently with moxidectin, depending on LF-endemicity in the area
9
10,380
22
10,380
1,545
10,380
EG005
Ivermectin +/- Albendazole (Pooled)
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children < 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. Participants received treatment with or without a single Albendazole tablet 400mg as a single open label dose concurrently with ivermectin, depending on LF-endemicity in the area
The Sponsor requires that the study results be published in their entirety prior to a PI presenting, publishing or otherwise communicating study results for an individual site