NCT06736691

Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections

A Phase III Single-center, Randomized, Double-blinded, Parallel-group, Active-controlled Study to Evaluate the Efficacy and Safety of a Single Dose of Emodepside Compared to Multiple Doses of Mebendazole in Adolescent and Adult Participants With Soil-transmitted Helminthiasis

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 315 (estimated)
• Sponsor: Swiss Tropical & Public Health Institute · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess the efficacy and safety of emodepside compared to mebendazole in adults and adolescents infected with T. trichiura, either as single infection or co-infections with hookworm and/or A. lumbricoides.

Conditions

• Trichuris Trichiura; Infection
• Hookworm Infection
• Ascaris Lumbricoides Infection

Interventions

Type	Name	Description
DRUG	emodepside (BAY 44-4400)	Treatment with single dose of oral 15 mg emodepside
DRUG	matching placebo of emodepside	Treatment with single dose of oral emodepside matching placebo
DRUG	Mebendazole	Treatment with 100 mg mebendazole orally administered b.i.d. for 3 days
DRUG	similar placebo to mebendazole	Treatment with mebendazole similar placebo orally administered b.i.d. for 3 days

Timeline

• Start date: 2025-11-25
• Primary completion: 2026-05-01
• Completion: 2026-07-01
• First posted: 2024-12-17
• Last updated: 2026-01-07

Locations

1 site across 1 country: Tanzania