Moxidectin for LF, Cote d'Ivoire (DOLF)

NCT04410406 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 202005076
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether moxidectin (Mox) will be more effective than ivermectin (IVM) when used in single-dose combination therapies for lymphatic filariasis (LF).

Conditions

Lymphatic Filariasis

Keywords

moxidectin; ivermectin

Outcome Measures

Primary Outcomes (2)

• Clearance of Microfilaremia (IA vs. MoxA)

  The proportion of participants in IA and MoxA study arms with complete clearance of W. bancrofti microfilaremia at 12 months after treatment.

  12 months

• Clearance of Microfilaremia (IDA vs. MoxDA)

  The proportion of participants in IDA and MoxDA study arms with complete clearance of W. bancrofti microfilaremia at 24 months after treatment.

  24 months

Secondary Outcomes (6)

• Clearance of Microfilaremia

  6, 12, 24, & 36 months

• Change in Mf Counts

  Assessed at Baseline, 6, 12, & 24 months; Reported at 12 and 24 months

• Reduction in Circulating Filarial Antigen (CFA) Counts

  Assessed at Baseline, 6, 12, & 24 months; 12 and 24 months reported

• Inactivation of Adult Worm Nests in Male Participants Only

  6, 12, & 24 months

• Frequency and Severity of AEs

  From baseline treatment to 7 days post-treatment

Study Arms (4)

IA (Ivermectin + Albendazole)

ACTIVE COMPARATOR

Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.

Drug: Ivermectin; Drug: Albendazole

MoxA (Moxidectin + Albendazole)

ACTIVE COMPARATOR

Participants will receive one oral dose of Mox 8 mg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxA at the same dosage.

Drug: Albendazole; Drug: Moxidectin

IDA (Ivermectin + Diethylcarbamazine + Albendazole)

ACTIVE COMPARATOR

Participants will receive one oral dose of IVM 200 µg/kg + Diethylcarbamazine (DEC) 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with IDA at the same dosage.

Drug: Ivermectin; Drug: Diethylcarbamazine; Drug: Albendazole

MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)

ACTIVE COMPARATOR

Participants will receive one oral dose of Mox 8 mg + DEC 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxDA at the same dosage.

Drug: Diethylcarbamazine; Drug: Albendazole; Drug: Moxidectin

Interventions

Ivermectin DRUG

Ivermectin (IVM) 200 µg/kg

Also known as: Stromectol

IA (Ivermectin + Albendazole); IDA (Ivermectin + Diethylcarbamazine + Albendazole)

Diethylcarbamazine DRUG

Diethylcarbamazine (DEC) 6mg/kg

Also known as: Diethylcarbamazine citrate, Hetrazan

IDA (Ivermectin + Diethylcarbamazine + Albendazole); MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)

Albendazole DRUG

Albendazole (ABZ) 400 mg

IA (Ivermectin + Albendazole); IDA (Ivermectin + Diethylcarbamazine + Albendazole); MoxA (Moxidectin + Albendazole); MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)

Moxidectin DRUG

Moxidectin (Mox) 8 mg

MoxA (Moxidectin + Albendazole); MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Male or female, aged 18-70 years
• In good general health as evidenced by medical history
• Peripheral night blood W. bancrofti Mf levels ≥40 Mf/mL
• No history of taking antifilarial medications in past 12 months
• Resident of the study area with no plans to change residence in the next 36 months
• For women of childbearing potential, willing to use appropriate method of contraception for one month following each treatment

You may not qualify if:

• Pregnancy or currently breastfeeding
• Known allergic reactions to any of the study medications
• Evidence of severe or systemic comorbidities (aside from features of filarial disease), as judged by the principal investigator
• Baseline biochemical abnormalities, as indicated by AST, ALT, or creatinine \> 2 times the upper limit of normal
• Evidence of urinary tract infection as indicated by 3+ nitrites on dipstick (individuals with 1+ or 2+ nitrites will not be excluded) or underlying chronic kidney disease as indicated by 3+ protein or 3+ blood on urine dipstick exam
• Hgb \< 7 gm/dL (any such individuals will be referred to the local health center for evaluation and treatment)
• Positive skin snip for onchocerciasis

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Case Western Reserve University: collaborator
• Centre Suisse de Recherches Scientifiques en Cote d'Ivoire: collaborator

Study Sites (1)

Regional Hospital of Agboville, Southern Cote d'Ivoire

Agboville, Côte d’Ivoire

Location

Related Publications (29)

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• Chhonker YS, Sleightholm RL, Murry DJ. Bioanalytical method development and validation of moxidectin in plasma by LC-MS/MS: Application to in vitro metabolism. Biomed Chromatogr. 2019 Feb;33(2):e4389. doi: 10.1002/bmc.4389. Epub 2018 Oct 30.

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• Hertz MI, Nana-Djeunga H, Kamgno J, Jelil Njouendou A, Chawa Chunda V, Wanji S, Rush A, Fischer PU, Weil GJ, Budge PJ. Identification and characterization of Loa loa antigens responsible for cross-reactivity with rapid diagnostic tests for lymphatic filariasis. PLoS Negl Trop Dis. 2018 Nov 16;12(11):e0006963. doi: 10.1371/journal.pntd.0006963. eCollection 2018 Nov.

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• Koudou GB, Bjerum CM, Ouattara FA, Gabo TP, Goss CW, Lew D, Dje NN, King CL, Fischer PU, Weil GJ, Budge PJ. Moxidectin combination therapies for lymphatic filariasis: an open-label, observer-masked, randomised controlled trial. Lancet Infect Dis. 2025 Oct;25(10):1075-1083. doi: 10.1016/S1473-3099(25)00111-2. Epub 2025 May 6.

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• Bjerum CM, Koudou BG, Ouattara AF, Lew D, Goss CW, Gabo PT, King CL, Fischer PU, Weil GJ, Budge PJ. Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Cote d'Ivoire: A randomized controlled superiority study. PLoS Negl Trop Dis. 2023 Sep 18;17(9):e0011633. doi: 10.1371/journal.pntd.0011633. eCollection 2023 Sep.

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• Chhonker YS, Bjerum C, Bala V, Ouattara AF, Koudou BG, Gabo TP, Alshehri A, Meite A, Fischer PU, Weil GJ, King CL, Budge PJ, Murry DJ. Pharmacokinetics of Moxidectin combined with Albendazole or Albendazole plus Diethylcarbamazine for Bancroftian Filariasis. PLoS Negl Trop Dis. 2023 Aug 24;17(8):e0011567. doi: 10.1371/journal.pntd.0011567. eCollection 2023 Aug.

  PMID: 37616301 DERIVED

Related Links

• First new treatment for river blindness approved by U.S. FDA in 20 years 2018 \[cited 2018 June 27\].

MeSH Terms

Conditions

Elephantiasis, Filarial

Interventions

Ivermectin; Diethylcarbamazine; Albendazole; moxidectin

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

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Philip Budge
• Organization: Washington University

pbudge@wustl.edu

3147475532

Study Officials

• Philip Budge, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Catherine Bjerum, MD, MPH

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• Toki Pascal Gabo, MD

  Regional Hospital of Agboville, Southern Cote d'Ivoire

  PRINCIPAL INVESTIGATOR

• Benjamin Koudou, PhD

  Regional Hospital of Agboville, Southern Cote d'Ivoire

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Recognizing that number and appearance of tablets received in each study arm will be noticeably different, this study will not be completely masked to participants or care providers. To minimize bias, administration of study medications will be performed by a staff member with no role in assessing AEs. AE assessments and all other outcome measures will be assessed by observers masked to the treatment assignment as best as possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This trial is a single-site, Phase III, randomized, open-label, masked-observer superiority trial with four treatment arms (IA, MoxA, IDA, and MoxDA). Block randomization by gender will be used to assign treatment arms.

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: August 20, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 29, 2026
• Results First Posted: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CÔ (1)