Safety and Efficacy of IDA for Onchocerciasis

NCT04188301 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 201910085
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

This DOLF study will investigate the safety and effectiveness of IDA treatment 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

Keywords

ophthalmology

Outcome Measures

Primary Outcomes (3)

• Rates of Severe Adverse Events (SAEs) Across Study Arms

  Rates of severe adverse events (grade 3 or higher) following 1-day or 3-day triple drug treatment will be compared against those of the comparator regimen of 1 day of IVM/ALB.

  Within 7 days following end of treatment

• Percentage of Worms Killed Across Study Arms

  The effect of three treatment regimens for killing adult female O. volvulus worms will be compared based on the percentage of all adult female worms in nodules that are alive with embryos in the uterus 18 months after treatment.

  18 months following treatment.

• Percentage of Worms Sterilized Across Study Arms

  The effect of three treatment regimens for sterilizing adult female O. volvulus worms will be compared based on the percentage of all adult female worms that are fertile in the nodules 18 months after treatment.

  18 months following treatment.

Secondary Outcomes (5)

• Rates of SAEs by Treatment Group in Those With Intraocular Microfilariae Just Prior to Treatment With IDA

  within 7 days following end of treatment

• Rates of Ocular Adverse Events (Any Grade) by Treatment Group

  within 3 months of treatment with IDA

• Effectiveness of Killing Adult Female Worms

  18 months following treatment

• Effectiveness of Clearing Microfilariae From Skin by Skin Snips

  Baseline, 3 months, 12 months, & 18 months following treatment.

• Effectiveness for Preventing Reappearance of Microfilariae in the Skin by Skin Snips

  Baseline, 12 months, and 18 months following treatment

Study Arms (3)

IVM + ALB

ACTIVE COMPARATOR

Single dose of oral IVM (150 µg/kg) plus ALB (400 mg)

Drug: IVM w/ ALB

IDA x 1 dose

EXPERIMENTAL

Single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)

Drug: Single dose of IDA

IDA x 3 doses

EXPERIMENTAL

Once daily for 3 days oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)

Drug: Three daily doses of IDA

Interventions

IVM w/ ALB DRUG

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

Also known as: IA

IVM + ALB

Single dose of IDA DRUG

Participants will be given a single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)

Also known as: IVM/DEC/ALB (x1)

IDA x 1 dose

Three daily doses of IDA DRUG

Participants will be given one daily dose for 3 days of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)

Also known as: IVM/DEC/ALB (x3)

IDA x 3 doses

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women who were previously enrolled in the preceding Part I study (Protocol ID#201804116) and residing in the study area
• Must have at least palpable subcutaneous nodule (onchocercoma)
• Participants with baseline skin Mf counts less than or equal to 3 Mf/mg at the time of enrollment into the Part I study (Protocol ID#201804116)

You may not qualify if:

• Pregnant and breastfeeding mothers within 1 month of giving birth
• Any cataract of any type preventing clear visualization of fundus or imaging on Optical Coherence Tomography (OCT).
• Intraocular pressure (IOP) greater than or equal to 25 by Goldmann tonometry .12
• Retinal Detachment or Retinal Break
• Acute ocular infection (i.e., Viral conjunctivitis, corneal ulcer, endophthalmitis)
• Optic Atrophy with visual field defect reproducible on confrontation visual field testing..
• Exam consistent with Herpes Simplex Virus eye infection
• Homonymous hemianopsia, quadrantanopsia, 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 patient
• Severe Tremor, blepharospasm, or other voluntary or involuntary motor condition that prevents ability to examine patient with slit lamp, OCT, gonioscopy, IOP measurement, fundus photography, and Frequency doubling technology perimetry.
• Cognitive impairment sufficient to prevent ability to understand and perform Visual Acuity Test with 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
• History of uveitis not associated with onchocercal disease

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Case Western Reserve University: collaborator
• University of Health and Allied Sciences: collaborator

Study Sites (1)

University of Health and Allied Sciences

Hohoe, Ghana

Location

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MeSH Terms

Conditions

Onchocerciasis

Interventions

Albumins

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

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Pause on clinical trial operations between March 2020 - June 2020 due to the COVID-19 pandemic. Decreased health and viability of the adult female worm population in participants may have reduced the study's ability to detect a significant macrofilaricidal effect of IDA. Study enrolled participants with light/moderate infections, which greatly decreased the risk of SAEs occurring. Future studies to assess tolerability of IDA would need to be conducted with higher infection rates.

Results Point of Contact

• Title: Dr. Gary Weil
• Organization: Washington University in St. Louis

gary.j.weil@wustl.edu

3144547787

Study Officials

• Gary Weil, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Christopher King, MD, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• Nicholas Opoku, MB, CHB, MSC

  University of Health and Allied Sciences, Hohoe, Ghana

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Participants will be split into two strata - those without ocular Mf detected six months after ivermectin pretreatment in the Part I preceding study AND without ocular Mf detected at baseline in the part II study will be in stratum 1. Those participants with ocular Mf detected 6 months after ivermectin pretreatment in the preceding study OR with ocular Mf detected at the baseline exam for this study will be in stratum 2. Stratum 1 will be enrolled first, followed by stratum 2. Members of each stratum will be evenly randomized into one of three treatment arms: 1. IVM + ALB - Single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB) 2. IDA x 1 dose - Single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) 3. IDA x 3 doses -Once daily for 3 days oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 5, 2019
• Study Start: December 6, 2019
• Primary Completion: March 14, 2022
• Study Completion: June 1, 2022
• Last Updated: June 4, 2024
• Results First Posted: May 10, 2023

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

GH (1)