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

NCT06736691 | Enrolling By Invitation Phase 3

• 1 other identifier: P2810-23A
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Trichuris Trichiura; Infection; Hookworm Infection; Ascaris Lumbricoides Infection

Keywords

Trichuris trichiura; Ascaris lumbricoides; STH; Efficacy; Safety; Hookworm; Emodepside; Soil-transmitted helminths; Roundworm; Whipworm; Mebendazole

Outcome Measures

Primary Outcomes (1)

• Cured of T. trichiura infection

  Determined by negative Kato-Katz thick smears in two stool samples taken at the Test of Cure Visit

  Test of Cure Visit at 14 to 21 days after end of treatment

Secondary Outcomes (2)

• Cured of A. lumbricoides infection

  Test of Cure Visit at 14 to 21 days after end of treatment

• 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

Other Outcomes (3)

• Cured of hookworm infection

  Test of Cure Visit at 14 to 21 days after end of treatment

• Egg reduction of each species of STH (T. trichiura, A. lumbricoides and hookworm infection)

  Test of Cure Visit at 14 to 21 days after end of treatment

• Listing of individual plasma concentrations of emodepside

  Plasma concentrations at 3, 6, 21-48 hours and 14-21 days after the end of treatment

Study Arms (2)

Emodepside

EXPERIMENTAL

Drug: emodepside (BAY 44-4400); Drug: similar placebo to mebendazole

Mebendazole

ACTIVE COMPARATOR

Drug: matching placebo of emodepside; Drug: Mebendazole

Interventions

matching placebo of emodepside DRUG

Treatment with single dose of oral emodepside matching placebo

Mebendazole

similar placebo to mebendazole DRUG

Treatment with mebendazole similar placebo orally administered b.i.d. for 3 days

Emodepside

emodepside (BAY 44-4400) DRUG

Treatment with single dose of oral 15 mg emodepside

Emodepside

Mebendazole DRUG

Treatment with 100 mg mebendazole orally administered b.i.d. for 3 days

Mebendazole

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant (confirmed by a negative serum pregnancy test) and non-breastfeeding female participants aged 12 years and older.
• 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).
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• Any of the following:
• Platelet \<75,000/mm3
• Alanine Aminotransferase (ALT) or Serum Glutamic Pyruvic Transaminase (SGPT) \>3x upper limit of normal (ULN)
• Total bilirubin \>2xULN
• Estimated Glomerular Filtration Rate (eGFR) \<90 ml/min/1.73 m2 (adolescents) or estimated creatinine clearance (CrCl) \<90 ml/min (adults)
• 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.
• 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).
• Treatment with metronidazole within 2 days before the first dose of study intervention or planned before 24 hours after last administration of study intervention.
• 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).
• Known allergy/hypersensitivity to mebendazole and/or emodepside

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• Bayer: collaborator
• Public Health Laboratory Ivo de Carneri: collaborator
• Silicon Valley Community Foundation: collaborator

Study Sites (1)

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

Chake Chake, Tanzania

Location

Related Publications (2)

• Taylor L, Ahmada AA, Ali MS, Ali SM, Hattendorf J, Mohammed IS, Keiser J. Efficacy and safety of emodepside compared with albendazole in adolescents and adults with hookworm infection in Pemba Island, Tanzania: a double-blind, superiority, phase 2b, randomised controlled trial. Lancet. 2024 Aug 17;404(10453):683-691. doi: 10.1016/S0140-6736(24)01403-X.

  PMID: 39153818 BACKGROUND

• Mrimi EC, Welsche S, Ali SM, Hattendorf J, Keiser J. Emodepside for Trichuris trichiura and Hookworm Infection. N Engl J Med. 2023 May 18;388(20):1863-1875. doi: 10.1056/NEJMoa2212825.

  PMID: 37195942 BACKGROUND

MeSH Terms

Conditions

Trichuriasis; Hookworm Infections; Ancylostomiasis; Enterobiasis

Interventions

emodepside; Bay 44-4400; Mebendazole

Condition Hierarchy (Ancestors)

Enoplida Infections; Adenophorea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Strongylida Infections; Secernentea Infections; Oxyuriasis; Oxyurida Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jennifer Keiser, Professor

  Swiss Tropical & Public Health Institute

  STUDY DIRECTOR

• Said Mohammed Ali, MSc

  Public Health Laboratory Ivo de Carneri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff, Site staff,
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: November 25, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TA (1)