Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis

NCT06070116 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 202307136
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Onchocerciasis; Onchocerciasis, Ocular; Onchocerca Infection; Tropical Disease; Onchocercal Subcutaneous Nodule

Outcome Measures

Primary Outcomes (3)

• 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").

  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").

  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.

  24 months

Secondary Outcomes (13)

• Rates of adverse events grade 3 or higher by Ivermectin treatment group, that occur within 7 days of treatment

  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

  Baseline to 7 days after first treatment.

• Rates of adverse events grade 3 or higher in participants with ocular MF in Ivermectin treatment groups.

  Baseline to 7 days after first treatment.

• Rates of adverse events grade 3 or higher in participants with ocular MF in Moxidectin treatment groups.

  Baseline to 7 days after first treatment.

• Rates of ocular adverse events (any grade) by Ivermectin treatment group

  Baseline to 7 days after first treatment.

Study Arms (4)

Ivermectin + Albendazole (IA)

ACTIVE COMPARATOR

Dose of oral Ivermectin (150 µg/kg) plus Albendazole (400 mg)

Drug: Ivermectin w/ Albendazole

Ivermectin + Diethylcarbamazine + Albendazole (IDA)

EXPERIMENTAL

Dose of oral Ivermectin (150 µg/kg), Diethylcarbamazine (6 mg/kg) and Albendazole (400 mg)

Drug: Ivermectin + Diethylcarbamazine + Albendazole

Moxidectin + Albendazole (MoxA)

EXPERIMENTAL

Dose of oral Moxidectin (8mg) plus Albendazole (400 mg)

Drug: Moxidectin + Albendazole

Moxidectin+ Diethylcarbamazine + Albendazole (MoxDA)

EXPERIMENTAL

Dose of oral Moxidectin (8mg), Diethylcarbamazine (6 mg/kg) and Albendazole (400 mg)

Drug: Moxidectin + Diethylcarbamazine + Albendazole

Interventions

Ivermectin w/ Albendazole DRUG

Participants will be given a dose of oral Ivermectin (IVM) (150 µg/kg) plus Albendazole (ALB) (400 mg)

Also known as: IA

Ivermectin + Albendazole (IA)

Ivermectin + Diethylcarbamazine + Albendazole DRUG

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

Ivermectin + Diethylcarbamazine + Albendazole (IDA)

Moxidectin + Albendazole DRUG

Participants will be given a dose of oral Moxidectin (Mox) (8 mg) plus Albendazole (ALB) (400 mg)

Also known as: MoxA

Moxidectin + Albendazole (MoxA)

Moxidectin + Diethylcarbamazine + Albendazole DRUG

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

Moxidectin+ Diethylcarbamazine + Albendazole (MoxDA)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• Any cataract that prevents clear visualization of fundus or imaging by OCT.
• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Public Health Institute of Liberia: collaborator

Study Sites (1)

Bong County Hospital

Bong Town, Bong County, Liberia

Location

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MeSH Terms

Conditions

Onchocerciasis; Onchocerciasis, Ocular

Interventions

Albendazole; Ivermectin; Diethylcarbamazine; moxidectin

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Eye Infections, Parasitic; Vector Borne Diseases; Eye Infections; Eye Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Polyketides; Lactones; Piperazines; Heterocyclic Compounds, 1-Ring

Study Officials

• Peter Fischer, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Patrick Kpanyen, PhD

  National Public Health Institute of Liberia

  PRINCIPAL INVESTIGATOR

• Gary Weil, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: While this is an open label study and there is no placebo treatment group, all efforts will be made to ensure that that medical/technical staff assessing skin Mf, adverse events (AEs) and ophthalmological findings will be unaware of initial baseline skin and ocular Mf findings and treatment arm as best as possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: October 6, 2023
• Study Start: April 5, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Dataset will be shared through Washington University School of Medicine Becker Library at the time of publication.

Locations

LI (1)