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ENROLLING_BY_INVITATIONPHASE3

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

NCT06736691•Swiss Tropical & Public Health Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or non-pregnant (confirmed by a negative serum pregnancy test) and non-breastfeeding female participants aged 12 years and older.
•2. T. trichiura as a single infection or co-infection with hookworm and/or A. lumbricoides, confirmed by presence of T. trichiura eggs assessed by Kato-Katz thick smears from two stool samples (infection intensity defined as number of eggs per gram of stool (EPG): (1) light (1-999 EPG), (2) moderate to heavy (≥1000 EPG).
•3. A minimum infection intensity of 24 eggs per gram of stool at baseline and at least two positive slides out of the four slides assessed at baseline.
•4. Written informed consent signed by the participant and/or legally authorized representative(s) according to the participant's age as established per local regulations. In addition, participant's assent is required as applicable by local laws and regulations for adolescents of 12-17 years of age.
•5. Women of childbearing potential must agree to use an effective, culturally appropriate contraceptive measure from at least 28 days prior to first dosage for hormonal contraceptives only and for non-hormonal contraceptive measures from screening Visit 2 until End of Study Visit.

Exclusion Criteria

•1. Presence of any systemic illnesses, renal and/or hepatic impairment, any other acute or chronic health conditions or congenital disorders which, in the opinion of the Investigator, would make the participant unsuitable for participation in a clinical study or may interfere with the efficacy, safety, and/or pharmacokinetic (PK) evaluation of the study drug.
•2. Any of the following:
•1. Platelet \<75,000/mm3
•2. Alanine Aminotransferase (ALT) or Serum Glutamic Pyruvic Transaminase (SGPT) \>3x upper limit of normal (ULN)
•3. Total bilirubin \>2xULN
•4. Estimated Glomerular Filtration Rate (eGFR) \<90 ml/min/1.73 m2 (adolescents) or estimated creatinine clearance (CrCl) \<90 ml/min (adults)
•3. Treatment with the following anthelminthic drugs: albendazole, mebendazole, ivermectin, within 28 days before the first dose of study intervention or planned before End of Study Visit.
•4. Use of sensitive CYP3A4 substrates within 14 days before the start of the first study intervention and until at least 14 days after the last administration of study intervention (detailed list of prohibited medication is provided in Section 6.5.1).
•5. Treatment with metronidazole within 2 days before the first dose of study intervention or planned before 24 hours after last administration of study intervention.
•6. Previous assignment to a study intervention for another study planned to be administered during the period the participant is enrolled in this study (from date of informed consent to last follow-up).
+1 more criteria

Locations (1)

Public Health Laboratory - Ivo de Carneri (PHL-IdC)

Chake Chake, Tanzania

Key Dates

Start Date

November 25, 2025

Primary Completion Date

May 1, 2026

Completion Date

July 1, 2026

Last Updated

January 7, 2026

Enrollment

315

ESTIMATED participants

Conditions

Trichuris Trichiura; InfectionHookworm InfectionAscaris Lumbricoides Infection

Interventions

emodepside (BAY 44-4400)

DRUG

matching placebo of emodepside

DRUG

Mebendazole

DRUG

similar placebo to mebendazole

DRUG

Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant

NCT01385189

Hookworm InfectionHookworm Disease

View study

COMPLETEDPHASE2

Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm

NCT05538767

Hookworm Infections

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COMPLETEDPHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant

Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm

Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm

Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education

Safety and Immunogenicity of the Na-APR-1 Hookworm Vaccine in Healthy Adults

Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana