Better Options for Lymphatic Filariasis Treatment

NCT07159373 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: MDGH-MOX-3003
• Study Type: interventional
• Target: 5,100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if mass drug administration with moxidectin in combination with diethylcarbamazine, and albendazole (MoxDA) can treat lymphatic filariasis, scabies and strongyloidiasis in children and adults living in communities where these diseases are common. The main questions it aims to answer are:

1. 1.Does MoxDA clear infection in people with lymphatic filariasis ?
2. 2.Does MoxDA cause any medical problems in infected and uninfected people?
3. 3.Be tested to see if they are infected with the parasites that cause lymphatic filariasis, scabies and strongyloidiasis
4. 4.Take 3 single doses of MoxDA or IDA, 12 months apart
5. 5.Visit their village centre once or twice in the 1 week after each treatment for safety checkups

Conditions

Lymphatic Filariasis; Scabies; Strongyloidiasis

Keywords

Moxidectin; Ivermectin; Mass drug administration; Lymphatic filariasis; Scabies; Strongyloidiasis; Cluster-randomized; Diethylcarbamazine; Albendazole

Outcome Measures

Primary Outcomes (2)

• Proportion of microfilariae (Mf)-positive participants at Baseline who are Mf-negative at Month 12 following treatment with MoxDA or IDA

  Lymphatic filariasis (LF) Mf measured by ultrafiltration

  12 months post-treatment

• Incidence and severity of adverse events

  Frequency, type, and severity of adverse events reported by treatment group

  7 days, 12 months and 24 months post-treatment

Secondary Outcomes (11)

• Proportion of Mf-positive participants at Baseline who are Mf-negative at Month 24 following treatment with MoxDA or IDA

  24 months post-treatment

• Mean Mf density and mean change from Baseline at Months 12 and 24 following treatment with MoxDA or IDA in participants who are Mf-positive at Baseline

  12 and 24 months post-treatment

• Proportion of participants who are circulating filarial antigen (CFA)-positive at baseline who become CFA-negative at Months 12 and/or 24 following treatment with MoxDA or IDA

  12 and 24 months post-treatment

• Change in community prevalence of LF, as measured by Mf, at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessments between Months 12 and 24

  12 and 24 months post-treatment

• Change in community prevalence of LF, as measured by CFA, at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthl

  12 and 24 months post-treatment

Study Arms (2)

MoxDA

EXPERIMENTAL

Moxidectin + diethylcarbamazine + albendazole

Drug: MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole

IDA

ACTIVE COMPARATOR

Ivermectin + diethylcarbamazine + albendazole

Drug: IDA - Ivermectin + DEC + albendazole

Interventions

MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole DRUG

Mass drug administration with moxidectin co-administered with DEC and albendazole (MoxDA). Participants who are ineligible to receive moxidectin will be offered modified treatment options: 1. Children aged ≥ 2 years but \< 4 years - DEC, albendazole, and permethrin 5% cream 2. Participants who have a severe illness, a known or suspected allergy to ivermectin, moxidectin, DEC or albendazole, are pregnant or breastfeeding a baby up to 7 days of age, or are under 2 years of age - permethrin 5% cream (unless allergic)

MoxDA

IDA - Ivermectin + DEC + albendazole DRUG

Mass drug administration with ivermectin co-administered with DEC and albendazole (IDA). Participants who are ineligible to receive moxidectin will be offered modified treatment options: 1. Children aged \< 2 years or weight \< 15 kg - DEC, albendazole, and permethrin 5% cream 2. Participants who have a severe illness, a known or suspected allergy to ivermectin, moxidectin, DEC or albendazole, are pregnant or breastfeeding a baby up to 7 days of age, or are under 2 years of age - permethrin 5% cream (unless allergic)

IDA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent.
• Resident in one of the study locations.

You may not qualify if:

• Participants are ineligible to receive the treatment regimen allocated to their village if they meet any of the following criteria:
• Severe illness (any illness that is severe enough to interfere with activities of daily living);
• Known or suspected allergy to ivermectin, moxidectin, diethylcarbamazine or albendazole;
• Pregnant;
• Breastfeeding a baby within 7 days of birth;
• Age \< 4 years for villages randomised to moxidectin, diethylcarbamazine, and albendazole (MoxDA); or
• Age \< 2 years or weight \< 15 kg for villages randomized to ivermectin, diethylcarbamazine and albendazole (IDA).

Sponsors & Collaborators

• Medicines Development for Global Health: lead
• Murdoch Childrens Research Institute: collaborator
• Kirby Institute: collaborator

Study Sites (1)

Ministry of Health and Medical Services Fiji

Suva, Fiji

Location

MeSH Terms

Conditions

Elephantiasis, Filarial; Scabies; Strongyloidiasis

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Rhabditida Infections

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label trial of mass drug administration with two treatment arms cluster-randomized 1:1 by village and stratified by island.

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 8, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

FI (1)