A Phase 2 interventional study of Ivermectin w/ Albendazole and Ivermectin + Diethylcarbamazine + Albendazole in Onchocercal Subcutaneous Nodule, Onchocerciasis and Onchocerciasis, Ocular, sponsored by Washington University School of Medicine. Active, not recruiting at 1 site in Liberia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment
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.
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.
35 studies on the registry are indexed under Onchocerciasis; 7 are open to participants now.
This study's planned enrollment of 300 is above the median of 216 across 26 interventional studies indexed under Onchocerciasis.
Browse Onchocerciasis studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose of oral Ivermectin (150 µg/kg) plus Albendazole (400 mg)
Drug: Ivermectin w/ Albendazole
Dose of oral Ivermectin (150 µg/kg), Diethylcarbamazine (6 mg/kg) and Albendazole (400 mg)
Drug: Ivermectin + Diethylcarbamazine + Albendazole
Dose of oral Moxidectin (8mg) plus Albendazole (400 mg)
Drug: Moxidectin + Albendazole
Dose of oral Moxidectin (8mg), Diethylcarbamazine (6 mg/kg) and Albendazole (400 mg)
Drug: Moxidectin + Diethylcarbamazine + Albendazole
Participants will be given a dose of oral Ivermectin (IVM) (150 µg/kg) plus Albendazole (ALB) (400 mg)
Also known as: IA
Drug pages: Ivermectin · Diethylcarbamazine · Albendazole
Participants will be given a dose of oral Ivermectin (IVM) (150 µg/kg), Diethylcarbamazine (DEC) (6 mg/kg) and Albendazole (ALB) (400 mg)
Also known as: IDA
Drug pages: Moxidectin · Albendazole
Participants will be given a dose of oral Moxidectin (Mox) (8 mg) plus Albendazole (ALB) (400 mg)
Also known as: MoxA
Drug pages: Moxidectin · Diethylcarbamazine · Albendazole
Participants will be given a dose of oral Moxidectin (Mox) (8 mg), Diethylcarbamazine (DEC) (6 mg/kg) and Albendazole (ALB) (400 mg)
Also known as: MoxDA
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").
Time frame: 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").
Time frame: 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.
Time frame: 24 months
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.
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
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 Months
Percentage of nodules with microfilaria in tissue
The percentage of nodules with microfilariae in nodule tissue (outside of worms)
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 24 Months
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Dataset will be shared through Washington University School of Medicine Becker Library at the time of publication.
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ivermectin · Diethylcarbamazine · Albendazole · Moxidectin
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