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

Phase 3

Not yet recruiting

• Conditions: Trichuris Trichiura; Infection; Hookworm Infection; Ascaris Lumbricoides Infection
• Interventions: Drug: emodepside (BAY 44-4400); Drug: matching placebo of emodepside; Drug: similar placebo to mebendazole; Drug: Mebendazole

• Registration Number: NCT06736691
• Lead Sponsor: Swiss Tropical & Public Health Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10
• Study Start: 2025-05
• Primary Completion: 2025-09
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 315

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 <50,000/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. Concomitant use as well as use within 14 days before the start of the first study intervention of strong CYP3A4 inhibitors or inducers, strong P-gp inducers and sensitive CYP3A4 substrates (detailed list of prohibited medication is provided in Section 6.5.1).

5. Concomitant use of metronidazole from 2 days before the start of the first study intervention until 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).

7. Known allergy/hypersensitivity to mebendazole and/or emodepside

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emodepside	emodepside (BAY 44-4400)	-
Emodepside	similar placebo to mebendazole	-
Mebendazole	matching placebo of emodepside	-
Mebendazole	Mebendazole	-

Primary Outcome Measures

Name	Time	Method
Cured of T. trichiura infection	Test of Cure Visit at 14 to 21 days after end of treatment	Determined by negative Kato-Katz thick smears in two stool samples taken at the Test of Cure Visit

Secondary Outcome Measures

Name	Time	Method
Cured of A. lumbricoides infection	Test of Cure Visit at 14 to 21 days after end of treatment	Determined by negative Kato-Katz thick smears in two stool samples taken at the Test of Cure Visit. This endpoint is only applicable for the subgroup of participants co-infected with A. lumbricoides at baseline.
Occurrence of TEAEs	Adverse events that occur after the first dose of study intervention up to 21 days after the last dose of study intervention	Defined as any AE that occurred or worsened after the first dose of study intervention up to 21 days after the last dose of study intervention

Trial Locations

Locations (1)

Public Health Laboratory - Ivo de Carneri (PHL-IdC); 🇹🇿 Chake Chake, Tanzania