Onchocercal Subcutaneous NodulePhase 2NCT06070116

Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis

A Phase 2 study testing Ivermectin w/ Albendazole, Ivermectin + Diethylcarbamazine + Albendazole and Moxidectin + Albendazole in people with Onchocercal Subcutaneous Nodule and Onchocerciasis, run by Washington University School of Medicine at 1 site in Liberia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This study will investigate the safety and effectiveness of combination regimens in persons with onchocerciasis when it is administered after pre-treatment with ivermectin to clear or greatly reduce microfilariae from the skin and eyes. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Onchocercal Subcutaneous Nodule, Onchocerciasis, Onchocerciasis, Ocular
What is being tested?: Ivermectin w/ Albendazole, Ivermectin + Diethylcarbamazine + Albendazole and Moxidectin + Albendazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteLiberia
Study dates: 5 Apr 2024to 1 Sep 2026
Phase: Phase 2
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult men and women, 18 years to 75 years old
Participants must have at least 1 palpable subcutaneous nodule (onchocercoma)
Participants with mean skin Mf counts ≥ 1 Mf/mg at the time of enrollment (prior to pretreatment)

Who cannot join

History of treatment with IVM or Mox less than six months prior to pretreatment with IVM.
Treatment with IVM or Mox outside of the study after the pre-treatment clearing dose before treatment with one of the four study treatments.
Pregnant or breastfeeding mothers.
Severe ocular disease at baseline (assessed just prior to the first study treatment, approximately 6-12 months after IVM pretreatment). Briefly, these conditions include severe uveitis, severe glaucoma, severe keratitis, and/or cataracts that interfere with visualization of the posterior segment of the eye. Details regarding ocular exclusion criteria are provided below. Individuals who are excluded with significant ocular disease will be referred for appropriate All ocular disease exclusion criteria apply to either eye. That is to say, participants will be excluded if any of the ocular exclusion criteria listed below are met for either eye. These exclusions are needed to reduce the risk of study treatments worsening severe pre-existing ocular disease. They also are needed to ensure that study staff will be able to adequately evaluate the posterior segment before and after treatment.
Any cataract that prevents clear visualization of fundus or imaging by OCT.
Severe retinal nerve fiber layer thinning of the optic nerve in the superior and inferior quadrant analysis by OCT with a corresponding visual field defect in the superior and inferior hemifield, and/or visual field loss within 5 degrees of fixation in at least one hemifield. Note: If OCT is not available, the following exclusion criteria will apply: vertical cup/disc ratio by fundoscopy greater than or equal to 0.80 with a corresponding visual field defect in the superior and inferior hemifield, and/or visual field loss within 5 degrees of fixation in at least one hemifield.

Show all 30Show fewer

Intraocular pressure (IOP) greater than or equal to 25 by Goldmann tonometry.
Retinal detachment or retinal break.
Acute ocular infection (i.e., viral conjunctivitis, corneal ulcer, endophthalmitis).
Optic atrophy with a reproducible visual field defect detected by confrontation visual field testing.
Exam consistent with Herpes simplex virus eye infection.
Homonymous hemianopsia, quadrantopsia, bitemporal hemianopsia, or central scotoma related to cerebral vascular disease by Automated Visual field testing and confrontation visual field testing.
Acute angle closure glaucoma.
Gonioscopy grade 0 (slit) limiting ability to safely dilate participant.
Severe tremor, blepharospasm, or other voluntary or involuntary motor condition that limits careful slit lamp examinations, OCT, gonioscopy, IOP measurement, fundus photography, and automated perimetry.
Cognitive impairment that limits participant's ability to understand and perform a Visual Acuity Test with a Tumbling E chart, confrontation visual field, slit lamp exam, or any other ocular exam component.
Optic nerve edema.
Active retinopathy or retinitis not attributable to onchocercal disease.
A history of uveitis not associated with onchocerciasis.
Any pre-existing chorioretinal scar or retinal degeneration and other significant retinal pathologies (foveomacular schisis, dystrophies, arterial macroaneurysms etc) involving the macula.
Severe ocular pain that the participant rates as 9 or 10 out of 10.
Best corrected or pinhole visual acuity worse than 6/60 (20/200).
Age-related macular degeneration (AMD).
>5 motile Mf in the anterior chamber in either eye at the time of secondary screening (6 months after pre-treatment with IVM).*
The presence of one or more Mf in the posterior segment of the eye (detected by any opthalmological test performed) at the time of treatment (at least six months after pre-treatment with IVM). *Note regarding exclusion criteria t and u: The cut-off of 5 Mf in either anterior chamber was suggested by external reviewers of our proposal to the Gates Foundation. These were experts in onchocerciasis selected by the Foundation. The reviews were anonymous, so we do not know their names. They also suggested that we exclude persons with any Mf in the posterior segment of the eye, and we have added that exclusion criterion to the protocol.
Significant comorbidities such as renal insufficiency (creatinine > 2 times the upper limit of normal), liver disease (jaundice or either AST or ALT greater than 2.5 times the upper limit of normal), or any other acute or chronic illness identified by study clinicians and investigators that interferes with the participant's ability to go to school or work or perform routine household chores.
Prior allergic or hypersensitivity reactions or intolerance to IVM, Mox, ALB, or DEC.
Evidence of severe or systemic comorbidities (aside from features of onchocerciasis), as judged by a study physician. Persons with baseline medical conditions that correspond to adverse event severity scores of grade 3 or higher will also be excluded.
Evidence of urinary tract infection as indicated by 3+ nitrites by dipstick (individuals with 1+ or 2+ nitrites will not be excluded) or underlying chronic kidney disease as indicated by 3+ protein or 3+ blood by dipstick. Persons with urinary tract infections can be enrolled after their infections are treated and cured.
Hgb <7 gm/dL; any such individuals will be referred to a local health center for evaluation and treatment).

Trial locations and contacts

1 site in 1 country.

Liberia1 site

Bong County Hospital
Bong Town, Bong County

Other trials in Liberia

About this study

Read the detailed description

The open label, randomized clinical trial studies the safety and efficacy of combination regimens for the treatment of onchocerciasis. Around 300 participants from Bong Mines, Liberia will be randomly assigned to one of four treatment groups after receiving Ivermectin pre-treatment: Ivermectin plus Albendazole (IA0, Ivermectin plus DEC plus Albendazole (IDA), Moxidectin plus albendazole (MoxA), or Moxidectin plus DEC plus Albendazole (MoxDA). Participants will be treated at baseline and 6 months after initial treatment.

Safety will be measured through extensive adverse event monitoring from baseline to 6 months.

Efficacy of the treatment will be measured at 24 months after the initial treatment by the proportion of all adult female worms that are fertile in the Onchocerca nodules and the percentage of participants without microfilaremia at 6, 18, and 24 months after the first treatment.

Conditions: Onchocercal Subcutaneous Nodule, Onchocerciasis, Onchocerciasis, Ocular, Onchocerca Infection, Tropical Disease
Being tested: Ivermectin w/ Albendazole, Ivermectin + Diethylcarbamazine + Albendazole, Moxidectin + Albendazole, Moxidectin + Diethylcarbamazine + Albendazole
Medical subject headings: Onchocerciasis, Onchocerciasis, Ocular

What participants receive

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

Ivermectin w/ AlbendazoleDrug
Also called IA
Participants will be given a dose of oral Ivermectin (IVM) (150 µg/kg) plus Albendazole (ALB) (400 mg)
Ivermectin + Diethylcarbamazine + AlbendazoleDrug
Also called IDA
Participants will be given a dose of oral Ivermectin (IVM) (150 µg/kg), Diethylcarbamazine (DEC) (6 mg/kg) and Albendazole (ALB) (400 mg)
Moxidectin + AlbendazoleDrug
Also called MoxA
Participants will be given a dose of oral Moxidectin (Mox) (8 mg) plus Albendazole (ALB) (400 mg)
Moxidectin + Diethylcarbamazine + AlbendazoleDrug
Also called MoxDA
Participants will be given a dose of oral Moxidectin (Mox) (8 mg), Diethylcarbamazine (DEC) (6 mg/kg) and Albendazole (ALB) (400 mg)

Study groups in NCT06070116
Study group	Role	What they receive
Ivermectin + Albendazole (IA)	Active comparator	Dose of oral Ivermectin (150 µg/kg) plus Albendazole (400 mg) Receives: Drug: Ivermectin w/ Albendazole
Ivermectin + Diethylcarbamazine + Albendazole (IDA)	Experimental	Dose of oral Ivermectin (150 µg/kg), Diethylcarbamazine (6 mg/kg) and Albendazole (400 mg) Receives: Drug: Ivermectin + Diethylcarbamazine + Albendazole
Moxidectin + Albendazole (MoxA)	Experimental	Dose of oral Moxidectin (8mg) plus Albendazole (400 mg) Receives: Drug: Moxidectin + Albendazole
Moxidectin+ Diethylcarbamazine + Albendazole (MoxDA)	Experimental	Dose of oral Moxidectin (8mg), Diethylcarbamazine (6 mg/kg) and Albendazole (400 mg) Receives: Drug: Moxidectin + Diethylcarbamazine + Albendazole

What is being measured

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

Rates and types of severe or serious adverse events within 6 months following Ivermectin treatments
Rates and types of severe or serious adverse events (grade 3 or higher) occurring within 6 months following combination treatment with DEC, ivermectin, and albendazole ("IDA") vs. the comparator regimen of ivermectin plus albendazole ("IA").
Measured: Baseline to 6 months
Rates and types of severe or serious adverse events within 6 months following Moxidectin treatments
Rates and types of severe or serious adverse events (grade 3 or higher) occurring within 6 months following combination treatment with DEC, moxidectin, and albendazole ("MoxDA") vs. the comparator regimen of moxidectin plus albendazole ("MoxA").
Measured: Baseline to 6 months
Proportion of all adult female worms that are fertile 24 months after first treatment
Proportion of all adult female worms in nodules that are fertile (i.e. with morulae or later developmental stages in the uterus) 24 months after the first treatment dose. The primary objective efficacy analysis will be restricted to comparisons between IA vs IDA and between MoxA vs. MoxDA, respectively.
Measured: 24 months

Secondary outcomes (13)

Rates of adverse events grade 3 or higher by Ivermectin treatment group, that occur within 7 days of treatment
Rates of adverse events grade 3 or higher by treatment group, that occur within 7 days of treatment. Comparison is made between IA vs IDA.
Measured: Baseline to 7 days after first treatment.
Rates of adverse events grade 3 or higher by Moxidectin treatment group, that occur within 7 days of treatment
Rates of adverse events grade 3 or higher by treatment group, that occur within 7 days of treatment. Comparison is made between MoxA vs MoxDA.
Measured: Baseline to 7 days after first treatment.
Rates of adverse events grade 3 or higher in participants with ocular MF in Ivermectin treatment groups.
Rates of adverse events grade 3 or higher that occur within 7 days of treatment in participants with detectable intraocular microfilariae just before the study treatment.
Measured: Baseline to 7 days after first treatment.
Rates of adverse events grade 3 or higher in participants with ocular MF in Moxidectin treatment groups.
Rates of adverse events grade 3 or higher that occur within 7 days of treatment in participants with detectable intraocular microfilariae just before the study treatment.
Measured: Baseline to 7 days after first treatment.
Rates of ocular adverse events (any grade) by Ivermectin treatment group
To compare rates of ocular adverse events (any grade) by treatment group that occur within 7 days of treatment. Comparison is between IA vs IDA.
Measured: Baseline to 7 days after first treatment.
Rates of ocular adverse events (any grade) by Moxidectin treatment groups
To compare rates of ocular adverse events (any grade) by treatment group that occur within 7 days of treatment. Comparison is between MoxA vs MoxDA.
Measured: Baseline to 7 days after first treatment.
Percentage of adult female worms in nodules that are alive
Percentage of adult female worms in nodules that are alive 24 months after the first round of study treatment.
Measured: 24 Months
Percentage of nodules with microfilaria in tissue
The percentage of nodules with microfilariae in nodule tissue (outside of worms)
Measured: 24 Months
Percentage of nodules that do not contain living adult worms
The percentage of nodules that do not contain any living adult female worms
Measured: 24 Months
Percentage of participants without microfiladermia after the first study treatment.
Percentage of participants without microfiladermia at 6, 18 and 24 months after the first study treatment.
Measured: 6, 18, and 24 Months
Percentage of participants with recurrence of microfilariae in the skin across treatment groups
Percentage of participants with recurrence of microfilariae in the skin at 18 and 24 months after the first study treatment (among persons who had complete Mf clearance 6 months after the first study treatment).
Measured: 18 and 24 Months
Microfilariae density in the skin across treatment groups
Mf density in the skin at 6, 18, and 24 months after the first study treatment.
Measured: 6, 8, and 24 Months
Percentage of nodules with fully or partially calcified worms
Percentage of nodules with fully or partially calcified worms 24 months after the first round of study treatment.
Measured: 24 Months

Timeline

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

5 Apr 20241 Sep 2026

First posted6 Oct 2023
Study start5 Apr 2024
Primary completion1 Sep 2026 (estimated)
Study completion1 Sep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (36)Papers the sponsor has linked to this study.
Other trials for Onchocercal Subcutaneous NoduleStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: IVM + ALB (IA) - Dose of oral IVM (150 µg/kg) plus ALB (400 mg) Mox + ALB (MoxA) - Dose of oral Mox (8mg tablets) plus ALB (400mg) IVM + DEC + ALB (IDA) - Dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) MOX + DEC + IVM (MoxDA) - Dose of oral Mox (8 mg), DEC (6 mg/kg) and ALB (400 mg)
Masking: None (open label)
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06070116
Sponsor's protocol ID: 202307136
Status last verified: Dec 2025
First submitted: 14 Sep 2023
Last updated: 18 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Datasets used for published results will be shared publicly through the Washington University School of Medicine Becker Library so that the broader scientific community can access it. Only de-identified data will be shared publicly.

Publications

Herricks JR, Hotez PJ, Wanga V, Coffeng LE, Haagsma JA, Basanez MG, Buckle G, Budke CM, Carabin H, Fevre EM, Furst T, Halasa YA, King CH, Murdoch ME, Ramaiah KD, Shepard DS, Stolk WA, Undurraga EA, Stanaway JD, Naghavi M, Murray CJL. The global burden of disease study 2013: What does it mean for the NTDs? PLoS Negl Trop Dis. 2017 Aug 3;11(8):e0005424. doi: 10.1371/journal.pntd.0005424. eCollection 2017 Aug. No abstract available.
PubMed 28771480
Taylor MJ, Awadzi K, Basanez MG, Biritwum N, Boakye D, Boatin B, Bockarie M, Churcher TS, Debrah A, Edwards G, Hoerauf A, Mand S, Matthews G, Osei-Atweneboana M, Prichard RK, Wanji S, Adjei O. Onchocerciasis Control: Vision for the Future from a Ghanian perspective. Parasit Vectors. 2009 Jan 21;2(1):7. doi: 10.1186/1756-3305-2-7.
PubMed 19154624
Zimmerman PA, Dadzie KY, De Sole G, Remme J, Alley ES, Unnasch TR. Onchocerca volvulus DNA probe classification correlates with epidemiologic patterns of blindness. J Infect Dis. 1992 May;165(5):964-8. doi: 10.1093/infdis/165.5.964.
PubMed 1569351
Fischer P, Kipp W, Bamuhiga J, Binta-Kahwa J, Kiefer A, Buttner DW. Parasitological and clinical characterization of Simulium neavei-transmitted onchocerciasis in western Uganda. Trop Med Parasitol. 1993 Dec;44(4):311-21.
PubMed 8134773
Dadzie KY, Bird AC, Awadzi K, Schulz-Key H, Gilles HM, Aziz MA. Ocular findings in a double-blind study of ivermectin versus diethylcarbamazine versus placebo in the treatment of onchocerciasis. Br J Ophthalmol. 1987 Feb;71(2):78-85. doi: 10.1136/bjo.71.2.78.
PubMed 3548811
Taylor HR. Onchocerciasis. Int Ophthalmol. 1990 May;14(3):189-94. doi: 10.1007/BF00158317.
PubMed 2188920
Bird AC, el-Sheikh H, Anderson J, Fuglsang H. Changes in visual function and in the posterior segment of the eye during treatment of onchocerciasis with diethylcarbamazine citrate. Br J Ophthalmol. 1980 Mar;64(3):191-200. doi: 10.1136/bjo.64.3.191.
PubMed 7387952
Duke BO. Human onchocerciasis--an overview of the disease. Acta Leiden. 1990;59(1-2):9-24.
PubMed 2198761
Braun G, McKechnie NM, Connor V, Gilbert CE, Engelbrecht F, Whitworth JA, Taylor DW. Immunological crossreactivity between a cloned antigen of Onchocerca volvulus and a component of the retinal pigment epithelium. J Exp Med. 1991 Jul 1;174(1):169-77. doi: 10.1084/jem.174.1.169.
PubMed 2056276
Chandrashekar R, Curtis KC, Weil GJ. Molecular characterization of a parasite antigen in sera from onchocerciasis patients that is immunologically cross-reactive with human keratin. J Infect Dis. 1995 Jun;171(6):1586-92. doi: 10.1093/infdis/171.6.1586.
PubMed 7539474
Chandrashekar R, Ogunrinade AF, Alvarez RM, Kale OO, Weil GJ. Circulating immune complex-associated parasite antigens in human onchocerciasis. J Infect Dis. 1990 Nov;162(5):1159-64. doi: 10.1093/infdis/162.5.1159.
PubMed 2230240
Johnson TP, Tyagi R, Lee PR, Lee MH, Johnson KR, Kowalak J, Elkahloun A, Medynets M, Hategan A, Kubofcik J, Sejvar J, Ratto J, Bunga S, Makumbi I, Aceng JR, Nutman TB, Dowell SF, Nath A. Nodding syndrome may be an autoimmune reaction to the parasitic worm Onchocerca volvulus. Sci Transl Med. 2017 Feb 15;9(377):eaaf6953. doi: 10.1126/scitranslmed.aaf6953.
PubMed 28202777
Kawabata M, Izui S, Anan S, Kondo S, Fukumoto S, Flores GZ, Kobayakawa T. Circulating immune complexes and their possible relevance to other immunological parameters in Guatemalan onchocerciasis. Int Arch Allergy Appl Immunol. 1983;72(2):128-33. doi: 10.1159/000234854.
PubMed 6874107
Semba RD, Murphy RP, Newland HS, Awadzi K, Greene BM, Taylor HR. Longitudinal study of lesions of the posterior segment in onchocerciasis. Ophthalmology. 1990 Oct;97(10):1334-41. doi: 10.1016/s0161-6420(90)32413-2.
PubMed 2243684
Banla M, Tchalim S, Karabou PK, Gantin RG, Agba AI, Kere-Banla A, Helling-Giese G, Heuschkel C, Schulz-Key H, Soboslay PT. Sustainable control of onchocerciasis: ocular pathology in onchocerciasis patients treated annually with ivermectin for 23 years: a cohort study. PLoS One. 2014 Jun 2;9(6):e98411. doi: 10.1371/journal.pone.0098411. eCollection 2014.
PubMed 24887413

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis
ClinicalTrials.gov ID: NCT06070116
Acronym / sponsor ID: 202307136
Conditions: Onchocercal Subcutaneous Nodule, Onchocerciasis, Onchocerciasis, Ocular, Onchocerca Infection, Tropical Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 300 participants (estimated)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: National Public Health Institute of Liberia
Study start: 5 Apr 2024 (actual)
Primary completion: 1 Sep 2026 (estimated)
Study completion: 1 Sep 2026 (estimated)
First posted: 6 Oct 2023 (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.

Detailed description

Safety will be measured through extensive adverse event monitoring from baseline to 6 months.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: IVM + ALB (IA) - Dose of oral IVM (150 µg/kg) plus ALB (400 mg) Mox + ALB (MoxA) - Dose of oral Mox (8mg tablets) plus ALB (400mg) IVM + DEC + ALB (IDA) - Dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) MOX + DEC + IVM (MoxDA) - Dose of oral Mox (8 mg), DEC (6 mg/kg) and ALB (400 mg)

Arm	Type	Receives
Ivermectin + Albendazole (IA)	Active comparator	Drug: Ivermectin w/ AlbendazoleDose of oral Ivermectin (150 µg/kg) plus Albendazole (400 mg)
Ivermectin + Diethylcarbamazine + Albendazole (IDA)	Experimental	Drug: Ivermectin + Diethylcarbamazine + AlbendazoleDose of oral Ivermectin (150 µg/kg), Diethylcarbamazine (6 mg/kg) and Albendazole (400 mg)
Moxidectin + Albendazole (MoxA)	Experimental	Drug: Moxidectin + AlbendazoleDose of oral Moxidectin (8mg) plus Albendazole (400 mg)
Moxidectin+ Diethylcarbamazine + Albendazole (MoxDA)	Experimental	Drug: Moxidectin + Diethylcarbamazine + AlbendazoleDose of oral Moxidectin (8mg), Diethylcarbamazine (6 mg/kg) and Albendazole (400 mg)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adult men and women, 18 years to 75 years old
Participants must have at least 1 palpable subcutaneous nodule (onchocercoma)
Participants with mean skin Mf counts ≥ 1 Mf/mg at the time of enrollment (prior to pretreatment)

Key exclusion criteria (30 listed)

History of treatment with IVM or Mox less than six months prior to pretreatment with IVM.
Treatment with IVM or Mox outside of the study after the pre-treatment clearing dose before treatment with one of the four study treatments.
Pregnant or breastfeeding mothers.
Severe ocular disease at baseline (assessed just prior to the first study treatment, approximately 6-12 months after IVM pretreatment). Briefly, these conditions include severe uveitis, severe glaucoma, severe keratitis, and/or cataracts that interfere with visualization of the posterior segment of the eye. Details regarding ocular exclusion criteria are provided below. Individuals who are excluded with significant ocular disease will be referred for appropriate All ocular disease exclusion criteria apply to either eye. That is to say, participants will be excluded if any of the ocular exclusion criteria listed below are met for either eye. These exclusions are needed to reduce the risk of study treatments worsening severe pre-existing ocular disease. They also are needed to ensure that study staff will be able to adequately evaluate the posterior segment before and after treatment.
Significant comorbidities such as renal insufficiency (creatinine > 2 times the upper limit of normal), liver disease (jaundice or either AST or ALT greater than 2.5 times the upper limit of normal), or any other acute or chronic illness identified by study clinicians and investigators that interferes with the participant's ability to go to school or work or perform routine household chores.

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
Ivermectin w/ AlbendazoleAlso: IAParticipants will be given a dose of oral Ivermectin (IVM) (150 µg/kg) plus Albendazole (ALB) (400 mg)	Drug	Ivermectin + Albendazole (IA)
Ivermectin + Diethylcarbamazine + AlbendazoleAlso: IDAParticipants will be given a dose of oral Ivermectin (IVM) (150 µg/kg), Diethylcarbamazine (DEC) (6 mg/kg) and Albendazole (ALB) (400 mg)	Drug	Ivermectin + Diethylcarbamazine + Albendazole (IDA)
Moxidectin + AlbendazoleAlso: MoxAParticipants will be given a dose of oral Moxidectin (Mox) (8 mg) plus Albendazole (ALB) (400 mg)	Drug	Moxidectin + Albendazole (MoxA)
Moxidectin + Diethylcarbamazine + AlbendazoleAlso: MoxDAParticipants will be given a dose of oral Moxidectin (Mox) (8 mg), Diethylcarbamazine (DEC) (6 mg/kg) and Albendazole (ALB) (400 mg)	Drug	Moxidectin+ Diethylcarbamazine + Albendazole (MoxDA)

Primary outcome

Rates and types of severe or serious adverse events within 6 months following Ivermectin treatments
Time frame: Baseline to 6 months
Rates and types of severe or serious adverse events (grade 3 or higher) occurring within 6 months following combination treatment with DEC, ivermectin, and albendazole ("IDA") vs. the comparator regimen of ivermectin plus albendazole ("IA").
Rates and types of severe or serious adverse events within 6 months following Moxidectin treatments
Time frame: Baseline to 6 months
Rates and types of severe or serious adverse events (grade 3 or higher) occurring within 6 months following combination treatment with DEC, moxidectin, and albendazole ("MoxDA") vs. the comparator regimen of moxidectin plus albendazole ("MoxA").
Proportion of all adult female worms that are fertile 24 months after first treatment
Time frame: 24 months
Proportion of all adult female worms in nodules that are fertile (i.e. with morulae or later developmental stages in the uterus) 24 months after the first treatment dose. The primary objective efficacy analysis will be restricted to comparisons between IA vs IDA and between MoxA vs. MoxDA, respectively.

13 secondary outcomes

Rates of adverse events grade 3 or higher by Ivermectin treatment group, that occur within 7 days of treatment
Time frame: Baseline to 7 days after first treatment.
Rates of adverse events grade 3 or higher by Moxidectin treatment group, that occur within 7 days of treatment
Time frame: Baseline to 7 days after first treatment.
Rates of adverse events grade 3 or higher in participants with ocular MF in Ivermectin treatment groups.
Time frame: Baseline to 7 days after first treatment.
Rates of adverse events grade 3 or higher in participants with ocular MF in Moxidectin treatment groups.
Time frame: Baseline to 7 days after first treatment.
Rates of ocular adverse events (any grade) by Ivermectin treatment group
Time frame: Baseline to 7 days after first treatment.
Rates of ocular adverse events (any grade) by Moxidectin treatment groups
Time frame: Baseline to 7 days after first treatment.
Percentage of adult female worms in nodules that are alive
Time frame: 24 Months
Percentage of nodules with microfilaria in tissue
Time frame: 24 Months
Percentage of nodules that do not contain living adult worms
Time frame: 24 Months
Percentage of participants without microfiladermia after the first study treatment.
Time frame: 6, 18, and 24 Months
Percentage of participants with recurrence of microfilariae in the skin across treatment groups
Time frame: 18 and 24 Months
Microfilariae density in the skin across treatment groups
Time frame: 6, 8, and 24 Months
Percentage of nodules with fully or partially calcified worms
Time frame: 24 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 18 Dec 2025.
Background: PubMed 28771480Herricks JR, Hotez PJ, Wanga V, Coffeng LE, Haagsma JA, Basanez MG, Buckle G, Budke CM, Carabin H, Fevre EM, Furst T, Halasa YA, King CH, Murdoch ME, Ramaiah KD, Shepard DS, Stolk WA, Undurraga EA, Stanaway JD, Naghavi M, Murray CJL. The global burden of disease study 2013: What does it mean for the NTDs? PLoS Negl Trop Dis. 2017 Aug 3;11(8):e0005424. doi: 10.1371/journal.pntd.0005424. eCollection 2017 Aug. No abstract available.
Background: PubMed 19154624Taylor MJ, Awadzi K, Basanez MG, Biritwum N, Boakye D, Boatin B, Bockarie M, Churcher TS, Debrah A, Edwards G, Hoerauf A, Mand S, Matthews G, Osei-Atweneboana M, Prichard RK, Wanji S, Adjei O. Onchocerciasis Control: Vision for the Future from a Ghanian perspective. Parasit Vectors. 2009 Jan 21;2(1):7. doi: 10.1186/1756-3305-2-7.
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Individual participant dataSharing planned: Yes. Datasets used for published results will be shared publicly through the Washington University School of Medicine Becker Library so that the broader scientific community can access it. Only de-identified data will be shared publicly.

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.

Peter Fischer, PhD principal investigator

Washington University School of Medicine

Patrick Kpanyen, PhD principal investigator

National Public Health Institute of Liberia

Gary Weil, MD principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 30 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 18 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 Liberia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Rates and types of severe or serious adverse events within 6 months following Ivermectin treatments (time frame: Baseline to 6 months). The study lists 3 primary outcomes in all. 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 NCT06070116, which also lists 36 linked publications.

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 18 Dec 2025.