A Randomized, Open-Label, Multicenter Study to Compare Efficacy, Safety and Tolerability of KLU156 with Coartem® in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Adults and Children ≥ 5 kg Body Weight Followed by an Extension Phase with Repeated KLU156 Treatment (KALUMA)

December 29, 2024 | Ongoing Project | Reading time: 7 min

Introduction
Kintampo Health Research Centre (KHRC) is carrying out this KALUMA drug trial, a three-year Phase 3 study that is testing how effective, safe, and tolerable a new drug, KLU156, is in comparison to Coatem, a widely used antimalarial treatment. This study, funded by Norvartis, will go a long way to help reduce malaria in children aged five and older.

Investigators

Dr. Samuel Harrison, Dr. Kwaku Poku Asante, Dr. Seyram Kaali, Dr. Felicia Serwah, Dr. Anthony Siibu.

Background

Malaria is one of the leading causes of death in Africa, with children under 5 years being the most at risk. The disease is caused by six types of Plasmodium parasites, with Plasmodium falciparum being responsible for most cases and the deadliest form. Over time, medicines like chloroquine have stopped working, and there are reports of resistance to the current malaria treatments.

This highlights the need for new medicines that are safe and effective in curing malaria to support its elimination. This study aims to find out if a new medicine, KLU156, a combination of ganaplacide (KAF156) and lumefantrine (lumefantrine-SDF) can safely and effectively treat malaria.

Objective
The objectives of the study include:

1. To check how well KLU156 works in treating adults and children weighing at least 5 kg and aged 2 months or older who have uncomplicated malaria caused by P. falciparum (with or without infection from other Plasmodium species).

2. To evaluate the safety and how well KLU156 is tolerated when used repeatedly over up to 2 years in adults and children weighing at least 5 kg and aged 2 months or older with uncomplicated malaria caused by P. falciparum (with or without other Plasmodium species).

Study Methodology

This study is being conducted in several African countries to compare the effectiveness and safety of two malaria treatments: KLU156 and Coartem. Participants who agree to join the study are randomly assigned to receive one of these treatments. The study has two parts: a core phase lasting 43 days and an optional extension phase lasting up to two years.

Around 1,500 male and female participants are expected to take part. The dose of the medication is based on the participant's body weight. People diagnosed with malaria after a confirmed test are invited to join the study, and the details are explained to them.

Once they agree, participants are taken to the study clinic, where they give their consent and go through screening. Those who pass screening are randomly assigned to one of the treatment groups.

Participants stay at the study clinic for four days for specific procedures and then return for scheduled outpatient visits until day 43, when they complete the core phase.

In the optional extension phase, participants who agree will be treated with KLU156 whenever they have confirmed malaria. This phase will assess the safety, tolerability, and effectiveness of repeated treatments with KLU156 over up to two years.

Expected Outcome
This study is expected to show that KLU156 is safe and works as well as, or better than, Coartem for treating uncomplicated malaria caused by P. falciparum (with or without other Plasmodium species) in adults and children weighing at least 5 kg and aged 2 months or older.

Funders: Novartis Pharma AG

Study Duration: Three (3) Years

Start Date: September 2024

End Date: June 2027