MedTrace Logo

Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria

NCT05842954 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1720

Last updated 2026-01-27

No results posted yet for this study

Summary

This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ≥ 10 kg of body weight suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection).

In the Extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure (ETF), who did not experience any study treatment-related SAE (Serious Adverse Event) previously and who gave informed consent to participate in the Extension phase.

Conditions

  • Uncomplicated Plasmodium Falciparum Malaria

Interventions

DRUG

KLU156

Oral use. KLU156 (400/480 mg) is the dose for patients with a bodyweight ≥ 35kg. Patients \< 35kg will take a fraction of the dose according to weight group as defined in the protocol.

DRUG

Coartem

Oral use. Dosing will be selected based on patient's body weight as per product's label.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2025-06-27
Completion
2025-11-25

Countries

  • Burkina Faso
  • Côte d’Ivoire
  • Democratic Republic of the Congo
  • Gabon
  • Ghana
  • Kenya
  • Mali
  • Niger
  • Rwanda
  • Tanzania
  • Uganda
  • Zambia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05842954 on ClinicalTrials.gov