To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

Summary

Primary Objective: To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) was an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children. Secondary Objectives: * To evaluate the efficacy of OZ439/FQ: * To determine the incidence of recrudescence and re-infection. * To determine the time to relief of fever and parasite clearance. * To evaluate the safety and tolerability of OZ439/FQ in adults and children. * To characterize the pharmacokinetics of OZ439 in plasma, FQ and its active metabolite SSR97213 in blood. * To determine the blood/plasma ratio for FQ and SSR97213 in some participants at limited time points in selected sites.

Timeline

Start

2015-07-25

Primary completion

2019-09-23

Completion

2019-09-23

Outcome

Missed primary endpoint

Stopped: “All treatment arms met the futility criteria for efficacy during the pre-planned interim analysis, therefore the study was stopped.”

paper None of the treatment arms met the target efficacy criterion for PCR-adjusted ACPR at Day 28 (lower limit of 95% confidence interval [CI] > 90%). PMID 34011358 ↗

Publications

• Adoke Y, Zoleko-Manego R, Ouoba S, Tiono AB, Kaguthi G, Bonzela JE, Duong TT, Nahum A, Bouyou-Akotet M, Ogutu B, Ouedraogo A, Macintyre F, Jessel A, Laurijssens B, Cherkaoui-Rbati MH, Cantalloube C, Marrast AC, Bejuit R, White D, Wells TNC, Wartha F, Leroy D, Kibuuka A, Mombo-Ngoma G, Ouattara D, Mugenya I, Phuc BQ, Bohissou F, Mawili-Mboumba DP, Olewe F, Soulama I, Tinto H; FALCI Study Group. A randomized, double-blind, phase 2b study to investigate the efficacy, safety, tolerability and pharmacokinetics of a single-dose regimen of ferroquine with artefenomel in adults and children with uncomplicated Plasmodium falciparum malaria. Malar J. 2021 May 19;20(1):222. doi: 10.1186/s12936-021-03749-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Artefenomel	Small molecule	800 mg	Oral
Subject	Ferroquine	Small molecule	400 mg	Oral
Subject	Ferroquine	Small molecule	600 mg	Oral
Subject	Ferroquine	Small molecule	900 mg	Oral
Subject	Ferroquine	Small molecule	1200 mg	Oral

Indications