Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis

NCT06373835 | Completed Phase 2

• 1 other identifier: EMODEPSIDE_LAOS
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy, safety and pharmacokinetics of ascending dosages of emodepside and in comparison to ivermectin against Strongyloidiasis stercoralis in adults: randomized stage II seamless adaptive controlled trials

Conditions

Strongyloides Stercoralis Infection; Strongyloidiasis

Outcome Measures

Primary Outcomes (1)

• Cure rate (CR) of emodepside against Strongyloides stercoralis

  The CR will be calculated as the proportion of Strongyloides stercoralis larvae-positive participants at baseline who become larvae-negative after treatment.

  In the week between 14 and 21 days post-treatment

Secondary Outcomes (4)

• Safety and tolerability of the dose-dependent emodepside treatment regimes, and compared with ivermectin.

  Actively evaluated at 3 hours, 24 hours, 72 hours, and 14 days post-treatment

• Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis.

  In the week between 14 and 21 days post-treatment

• Exposure response of emodepside in adults

  Actively collected at 0 hours, 0.5 hours, 2.5 hours, 5 hours, 24 hours, 72 hours, and 14 days post-treatment

• Cure rate (CR) and egg reduction rate (ERR) with other soil-transmitted helminths (STH) and trematodes

  In the week between 14 and 21 days post-treatment

Study Arms (8)

Emodepside 5 mg

EXPERIMENTAL

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Drug: Emodepside

Emodepside 10 mg

EXPERIMENTAL

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Drug: Emodepside

Emodepside 15 mg

EXPERIMENTAL

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Drug: Emodepside

Emodepside 20 mg

EXPERIMENTAL

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Drug: Emodepside

Emodepside 25 mg

EXPERIMENTAL

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Drug: Emodepside

Emodepside 30 mg

EXPERIMENTAL

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Drug: Emodepside

Placebo

PLACEBO COMPARATOR

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Drug: Emodepside

Ivermectin 3 mg

ACTIVE COMPARATOR

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Drug: Emodepside

Interventions

Emodepside DRUG

5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin

Emodepside 10 mg; Emodepside 15 mg; Emodepside 20 mg; Emodepside 25 mg; Emodepside 30 mg; Emodepside 5 mg; Ivermectin 3 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent signed by the participant him/herself
• Males and females of age 18 or older
• Infected with S. stercoralis (positive by at least two Baermann assays on two different days and infection intensities of at least 0.75 LPG in the two stool samples.
• Agree to comply with the study procedures, including to be examined by a study physician at the beginning of the study and to provide three stool samples during the screening period (within a maximum of 10 days) and approximately three weeks after treatment (follow-up).
• Female participants of childbearing potential to ensure adequate contraception during the study period.

You may not qualify if:

• No written informed consent by individual.
• Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment.
• Recent history of acute or severe chronic disease, as assessed by a medical doctor or reported by the participant: Type 1 and/or 2 diabetes; Psychiatric disorders; Chronic heart, liver, or renal disease
• Prior treatment with anthelmintics (eg, diethylcarbamazine \[DEC\], suramin, ivermectin, mebendazole or albendazole) within 4 weeks before planned study drug administration.
• Actively participating in other clinical trials during the study.
• Positive pregnancy test or breastfeeding women and planning to become pregnant within three months of study drug administration.
• Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin within 4 weeks before planned study drug administration.
• Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir.
• Known allergy to study drugs or any of the ingredients

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• National Institute of Public Health, Vientiane, Laos: collaborator

Study Sites (1)

Lao Tropical and Public Health Institute

Vientiane, Laos

Location

Related Publications (1)

• Taylor L, Many S, Jeanguenat H, Hattendorf J, Sayasone S, Keiser J. Efficacy and safety of ascending doses of emodepside in comparison with ivermectin in adults infected with Strongyloides stercoralis in Laos: a phase 2a, dose-ranging, randomised, parallel-group, placebo-controlled, single-blind clinical trial. Lancet Infect Dis. 2025 Nov;25(11):1254-1264. doi: 10.1016/S1473-3099(25)00255-5. Epub 2025 Jun 25.

  PMID: 40580974 DERIVED

MeSH Terms

Conditions

Strongyloidiasis

Interventions

emodepside

Condition Hierarchy (Ancestors)

Rhabditida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 18, 2024
• Study Start: May 20, 2024
• Primary Completion: September 21, 2024
• Study Completion: September 21, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)