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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-30

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Trichuris Trichiura; Infection Hookworm Infection Ascaris Lumbricoides Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Sponsor staff, Site staff

Study Groups

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Emodepside

Group Type EXPERIMENTAL

emodepside (BAY 44-4400)

Intervention Type DRUG

Treatment with single dose of oral 15 mg emodepside

similar placebo to mebendazole

Intervention Type DRUG

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

Mebendazole

Group Type ACTIVE_COMPARATOR

Mebendazole 100 MG

Intervention Type DRUG

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

matching placebo of emodepside

Intervention Type DRUG

Treatment with single dose of oral emodepside matching placebo

Interventions

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emodepside (BAY 44-4400)

Treatment with single dose of oral 15 mg emodepside

Intervention Type DRUG

Mebendazole 100 MG

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

Intervention Type DRUG

similar placebo to mebendazole

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

Intervention Type DRUG

matching placebo of emodepside

Treatment with single dose of oral emodepside matching placebo

Intervention Type DRUG

Eligibility Criteria

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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No