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Emodepside Phase II Trial for Treatment of Onchocerciasis

NCT05180461 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 578

Last updated 2024-03-05

No results posted yet for this study

Summary

The trial evaluates safety, tolerability, pharmacodynamics, pharmacokinetics, dose-response, and efficacy of emodepside tablets, administrated as a range of dose regimens, in adults infected with Onchocerca Volvulus.

Conditions

  • Onchocerciasis

Interventions

DRUG

emodepside

emodepside tablet

DRUG

matching placebo of emodepside

emodepside matching placebo tablet

DRUG

ivermectin

ivermectin tablet (overencapsulated for blinding)

DRUG

matching placebo of ivermectin

matching placebo of overencapsulated ivermectin tablet

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Drugs for Neglected Diseases

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-30
Primary Completion
2026-09-18
Completion
2026-10-02

Countries

  • Democratic Republic of the Congo
  • Ghana

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05180461 on ClinicalTrials.gov