OnchocerciasisPhase 3NCT04311671

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

A Phase 3 study testing Moxidectin, Ivermectin and Albendazole in people with Onchocerciasis, run by Medicines Development for Global Health at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 4 years and olderHealthy volunteers can take part
Conditions the study is for: Onchocerciasis
What is being tested?: Moxidectin, Ivermectin and Albendazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12,979 participants
Where: 2 sitesin 2 countries
Study dates: 3 May 2021to 27 Sep 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Côte d’Ivoire1 site

Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire
Abidjan

Other trials in Côte d’Ivoire

Democratic Republic of the Congo1 site

Centre de Recherche pour les Maladies Tropicales Negligees
Rethy, Ituri

Other trials in Democratic Republic of the Congo

About this study

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

Conditions: Onchocerciasis
Being tested: Moxidectin, Ivermectin, Albendazole
Medical subject headings: Onchocerciasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MoxidectinDrug
2 mg tablets, encapsulated for blinding
IvermectinDrug
3 mg tablets, encapsulated for blinding
AlbendazoleDrug
400 mg tablets

Study groups in NCT04311671
Study group	Role	What they receive
Moxidectin	Experimental	In onchocerciasis endemic areas: Moxidectin 8 mg per oral on Day 0 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Ivermectin; Drug: Albendazole

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 202127 Sep 2024

First posted17 Mar 2020
Study start3 May 2021
Primary completion27 Sep 2024
Study completion27 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OnchocerciasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 12,979 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04311671
Sponsor's protocol ID: MDGH-MOX-3002
Status last verified: Dec 2025
First submitted: 14 Mar 2020
Last updated: 3 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
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Active, not recruitingPhase 3
Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
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Active, not recruitingPhase 2
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All Onchocerciasis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04311671
Acronym / sponsor ID: MDGH-MOX-3002
Conditions: Onchocerciasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 12,979 participants (actual)
Lead sponsor: Medicines Development for Global HealthUniversity, hospital or other
Study start: 3 May 2021 (actual)
Primary completion: 27 Sep 2024 (actual)
Study completion: 27 Sep 2024 (actual)
First posted: 17 Mar 2020 (actual)
Results: Posted 5 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Moxidectin	Experimental	Drug: MoxidectinIn onchocerciasis endemic areas: Moxidectin 8 mg per oral on Day 0
Ivermectin	Active comparator	Drug: IvermectinIn onchocerciasis endemic areas: Ivermectin treatment with approximately 150 µg/kg per oral determined based on height on Day 0
Moxidectin with concomitant Albendazole	Experimental	Drug: Moxidectin, Drug: AlbendazoleIn 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	Active comparator	Drug: Ivermectin, Drug: AlbendazoleIn 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

Who may qualify

Ages: 4 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Moxidectin2 mg tablets, encapsulated for blinding	Drug	Moxidectin, Moxidectin with concomitant Albendazole
Ivermectin3 mg tablets, encapsulated for blinding	Drug	Ivermectin, Ivermectin with concomitant Albendazole
Albendazole400 mg tablets	Drug	Ivermectin with concomitant Albendazole, Moxidectin with concomitant Albendazole

Primary outcome

Incidence and Severity of Treatment Emergent Adverse Events
Time frame: 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.

Results and safety

Results posted to the registry on 5 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Moxidectin	6,421	6,395
Ivermectin	1,605	1,592
Moxidectin Plus Albendazole	3,959	3,891
Ivermectin Plus Albendazole	994	977

Primary outcome: Incidence and Severity of Treatment Emergent Adverse Events

Time frame: Up to 3 months. Number. Unit: participants

Measure	Moxidectin n = 6421	Ivermectin n = 1605	Moxidectin Plus Albendazole n = 3959	Ivermectin Plus Albendazole n = 994	Moxidectin +/- Albendazole (Pooled) n = 10380	Ivermectin +/- Albendazole (Pooled) n = 2599
Number of Participants with one or more Treatment Emergent Adverse Events (TEAEs)	346	79	1199	288	1545	367
Number of Participants with one or more TEAEs defined as a Mazzotti Reaction	173	47	455	98	628	145
Number of Participants with Severe (Gr 3 or 4) TEAE	18	5	66	14	84	19
Number of Participants with TEAE defined as Serious	18	4	4	0	22	4
Number of participants with TEAE leading to Death	6	2	3	0	9	2
Number of Participants with a TEAE considered Related to Moxidectin or Ivermectin	189	50	576	128	765	178
Number of Participants with a Severe TEAE considered Related to Moxidectin or Ivermectin	0	0	0	0	0	0
Number of Participants with a TEAE considered Related to Albendazole	0	0	34	7	34	7

Population analysed: 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.

Adverse events

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.. Other adverse events reported at 0.1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moxidectin	18 of 6,421 (0.3%)	346 of 6,421 (5.4%)	6 of 6,421
Ivermectin	4 of 1,605 (0.2%)	79 of 1,605 (4.9%)	2 of 1,605
Moxidectin Plus Albendazole	4 of 3,959 (0.1%)	1,199 of 3,959 (30.3%)	3 of 3,959
Ivermectin Plus Albendazole	0 of 994 (0%)	288 of 994 (29%)	0 of 994
Moxidectin +/- Albendazole (Pooled)	22 of 10,380 (0.2%)	1,545 of 10,380 (14.9%)	9 of 10,380
Ivermectin +/- Albendazole (Pooled)	4 of 2,599 (0.2%)	367 of 2,599 (14.1%)	2 of 2,599

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

Related trials for Onchocerciasis

Active, not recruitingObservational study
Host Response to Infection and Treatment in Filarial Diseases
Filariasis, Helminthiasis
Recruiting
Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations
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Not yet recruiting
Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
Skin and Connective Tissue Diseases, Neglected Tropical Diseases
Active, not recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tony Ukety, MD, DO, MPH principal investigator

Centre de Recherche en Maladies Tropicales de l'Ituri

Benjamin Koudou, PhD principal investigator

Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Moxidectin, Ivermectin and Albendazole in people with Onchocerciasis, run by Medicines Development for Global Health at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Côte d’Ivoire, Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Severity of Treatment Emergent Adverse Events (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04311671.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.