OnchocerciasisPhase 3NCT03876262
Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
A Phase 3 study testing Moxidectin and Ivermectin in people with Onchocerciasis, run by Medicines Development for Global Health at 1 site in Democratic Republic of the Congo.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Onchocerciasis
- What is being tested?
- Moxidectin and Ivermectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 3 May 2021to 1 Jan 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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, 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.
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Centre de Recherche pour les Maladies Tropicales Negligees
Rethy, Ituri
About this study
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
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.
- Conditions
- Onchocerciasis
- Being tested
- Moxidectin, Ivermectin
- Medical subject headings
- Onchocerciasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxidectinDrug
2mg tablets, encapsulated for blinding
IvermectinDrug
3mg tablets, encapsulated for blinding
| Study group | Role | What they receive |
|---|---|---|
| Annual Moxidectin | Experimental | Moxidectin 8mg per oral, administered annually for 24 months Receives: Drug: Moxidectin |
| Biannual Moxidectin | Experimental | Moxidectin 8mg per oral, administered biannually for 24 months Receives: Drug: Moxidectin |
| Annual Ivermectin | Active comparator | Ivermectin (approximately) 150 micrograms/kg per oral, administered annually for 24 months Receives: Drug: Ivermectin |
| Biannual Ivermectin | Experimental | Ivermectin (approximately) 150 micrograms/kg per oral, administered biannually for 24 months Receives: Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 12 months
Incidence and severity of adverse events
Incidence and severity of adverse events, vital signs and liver function tests
Measured: Up to 36 months
Secondary outcomes (5)
Proportion of participants in all dose groups with sustained microfilariae response
Proportion of participants with zero Onchocerca volvulus microfilariae/mg skin
Measured: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
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
Measured: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Skin microfilarial density in all dose groups
Mean, median and percentage reduction Onchocerca volvulus microfilariae/mg skin from baseline
Measured: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
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
Measured: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Mean skin microfilariae density at each post-Screening assessment
Mean and mean change from baseline of Onchocerca volvulus microfilariae/mg skin
Measured: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start3 May 2021
- Primary completion31 Jul 2024
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Participants will be assigned to four groups: annual ivermectin; annual moxidectin; biannual ivermectin; or biannual moxidectin
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines Development for Global Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tony Ukety, MD, DO, MPH, Principal investigator, Centre de Recherche en Maladies Tropicales de l'Ituri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876262
- Sponsor's protocol ID
- MDGH-MOX-3001
- Status last verified
- Dec 2025
- First submitted
- 11 Mar 2019
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03876262
- Acronym / sponsor ID
- MDGH-MOX-3001
- Conditions
- Onchocerciasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Medicines Development for Global HealthUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be assigned to four groups: annual ivermectin; annual moxidectin; biannual ivermectin; or biannual moxidectin
| Arm | Type | Receives |
|---|---|---|
| Annual Moxidectin | Experimental | Drug: MoxidectinMoxidectin 8mg per oral, administered annually for 24 months |
| Biannual Moxidectin | Experimental | Drug: MoxidectinMoxidectin 8mg per oral, administered biannually for 24 months |
| Annual Ivermectin | Active comparator | Drug: IvermectinIvermectin (approximately) 150 micrograms/kg per oral, administered annually for 24 months |
| Biannual Ivermectin | Experimental | Drug: IvermectinIvermectin (approximately) 150 micrograms/kg per oral, administered biannually for 24 months |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not 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.
- 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.
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, 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.
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 |
|---|---|---|
| Moxidectin2mg tablets, encapsulated for blinding | Drug | Annual Moxidectin, Biannual Moxidectin |
| Ivermectin3mg tablets, encapsulated for blinding | Drug | Annual Ivermectin, Biannual Ivermectin |
Primary outcome
Proportion of moxidectin annual and biannual recipients with sustained microfilarial response at month 12
Time frame: Up to 12 months
Proportion of recipients with zero Onchocerca volvulus microfilariae/mg skin at all post-treatment timepoints to month 12
Incidence and severity of adverse events
Time frame: Up to 36 months
Incidence and severity of adverse events, vital signs and liver function tests
5 secondary outcomes
Proportion of participants in all dose groups with sustained microfilariae response
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Sustained ocular microfilariae response in all dose groups
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Skin microfilarial density in all dose groups
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Ocular microfilariae response in all dose groups
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Mean skin microfilariae density at each post-Screening assessment
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moxidectin and Ivermectin in people with Onchocerciasis, run by Medicines Development for Global Health at 1 site in Democratic Republic of the Congo.
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: under way, not looking for participants, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of moxidectin annual and biannual recipients with sustained microfilarial response at month 12 (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2025.