A 3- to 5-day Clinical Trial of Levamisole in Loiasis Infected Subjects

NCT06252961 | Recruiting Phase 2 DMC

• 1 other identifier: Protocole128
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to evaluate the safety and efficacy of a 3- and 5-day course of levamisole (2.5 mg/kg) in management of loiasis microfilaremia.

Conditions

Loiasis

Keywords

Onchocerciasis; Filariasis; Levamisole

Outcome Measures

Primary Outcomes (1)

• Tolerance of multiple doses of levamisole 2.5 mg/kg in individuals with Loa loa microfilaremia

  The proportions of adverse reactions and severe adverse reactions between the three arms of study will be compared, as well as between each interventional arm versus placebo, using appropriate comparative tests A multivariate analysis may be envisaged to assess the influence of age, gender and the presence or absence of M. perstans on the proportion of AEs

  During the treatment (5 days) and 2 weeks after

Secondary Outcomes (1)

• Efficacy of multiple doses of levamisole 2.5 mg/kg on Loa loa microfilaremia

  From Day 3 after the first dose to Day 30 after the first dose

Study Arms (3)

Levamisole 3 days

EXPERIMENTAL

Participants randomized in this arm will receive 3 days of levamisole 2.5mg/kg, followed by 2 days of placebo

Drug: Levamisole 3 days

Levamisole 5 days

EXPERIMENTAL

Participants randomized in this arm will receive a 5-day course of levamisole 2.5mg/kg

Drug: Levamisole 5 days

Placebo

PLACEBO COMPARATOR

Participants randomized in this arm will receive 5 days of placebo

Drug: Placebo

Interventions

Levamisole 3 days DRUG

Levamisole for 3 days (2,5 mg/kg) then placebo for 2 days

Levamisole 3 days

Levamisole 5 days DRUG

Levamisole for 5 days (2,5 mg/kg)

Levamisole 5 days

Placebo DRUG

Placebo for 5 days

Placebo

Eligibility Criteria

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

You may qualify if:

• Consent informed, written, signed and dated
• Women or men aged 18 to 65 years inclusive
• Carrier of L. loa microfilaremia
• Body weight ≥ 40 kg in women and ≥ 45 kg in men; and less than 90 kg
• In good health, as determined by medical questionnaire and general clinical examination
• Absence of acute or chronic infection :

You may not qualify if:

• Participation in any study other than a purely observational study, within the 4 weeks preceding this study (determined by the theoretical date of the first administration of levamisole or placebo)
• Any vaccination within 4 weeks previous to this study
• Infection requiring treatment in the 10 days previous to this study, as determined by the anamnesis during the medical interview (e.g. pulmonary infection , digestive or skin infection; with or without antibiotic treatment)
• Treatment with clozapine, phenothiazines, sulfasalazine, carbamazepine, synthetic antithyroid drugs, ticlopidine, cimetidine, and gold salts: whether it was long-term treatment, or treatment given as a single dose 10 days before the start of treatment for the clinical trial (precaution with regard to the risk of agranulocytosis of immuno-allergic or toxic origin)
• Known immunosuppressive pathology (by self-report)
• Past or present history of neurological (including epilepsy) or neuropsychiatric disease
• History of agranulocytosis
• Use of cocaine or other drugs of abuse in the 72 hours preceding administration of the trial treatment, as determined by history during the medical interview
• Any condition, in the opinion of the investigator, that exposes the subject to undue risk
• Known intolerance to levamisole
• Subjects who donated blood in the previous 8 weeks to study entry, with a standard volume (\> 500 mL)
• Ivermectin and/or levamisole taken in the last six months; and/or mebendazole or albendazole taken in the last month
• Pregnant and/or breast-feeding women

Sponsors & Collaborators

• Programme National de Lutte contre l'Onchocercose, Republic of the Congo: lead
• Institut de Recherche pour le Developpement: collaborator

Study Sites (2)

Supervisor

Sibiti, Komono, Republic of the Congo

RECRUITING

General Supervisor

Sibiti, Mokassi, Republic of the Congo

RECRUITING

Related Publications (1)

• Chesnais CB, Hemilembolo MC, Sahm BA, Toutin F, Djeutassong E, Nga-Elomo N, Cuer B, Ntsiba-N'Goulou MA, Pakat M, Pion SDS, Missamou F, Boussinesq M, Campillo JT. Safety and efficacy of 3- and 5-day regimens of levamisole in loiasis: a randomized, placebo-controlled, double-blind clinical trial. Nat Commun. 2025 Jul 4;16(1):6191. doi: 10.1038/s41467-025-61479-6.

  PMID: 40615414 DERIVED

MeSH Terms

Conditions

Loiasis; Onchocerciasis; Filariasis

Interventions

Levamisole

Condition Hierarchy (Ancestors)

Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jéremy CAMPILLO, PharmD PhD

  Institut de Recherche pour le Développement (IRD)

  STUDY DIRECTOR

• François MISSAMOU, MD

  Programme National de Lutte contre l'Onchocercose (PNLO)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jéremy CAMPILLO, PharmD PhD

CONTACT

+33 4 67 41 61 52; jeremy.campillo@ird.fr

Bachiratou SAHM

CONTACT

bachiratou.sahm@ird.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A 3-group, randomized, double-blind, parallel clinical trial: * Levamisole 2.5 mg for 3 days (followed by 2 days placebo), * Levamisole 2.5 mg for 5 days, * Placebo for 5 days.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 12, 2024
• Study Start: June 21, 2024
• Primary Completion: September 18, 2024
• Study Completion: February 1, 2026
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

RE (2)