Efficacy, Safety and Tolerability of KLU156 in Adults and Children ≥ 5 kg Body Weight With Uncomplicated P. Falciparum Malaria

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,720

Participants

Timeline

Start Date

March 7, 2024

Primary Completion Date

June 27, 2025

Study Completion Date

August 8, 2027

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.

Trial Locations (34)

2300

Novartis Investigative Site, Siaya

5004

Novartis Investigative Site, Tanga

8003

Novartis Investigative Site, Niamey

10102

Novartis Investigative Site, Tororo

40102

Novartis Investigative Site, Kombewa

70100

Novartis Investigative Site, Nchelenge

71769

Novartis Investigative Site, Ndola

92037

Novartis Investigative Site, Kintampo

751003

Novartis Investigative Site, Bhubaneswar

Unknown

Novartis Investigative Site, Banfora

Novartis Investigative Site, Kimpese

Novartis Investigative Site, Kisantu

Novartis Investigative Site, Commune de La Kenya Lubumbashi

Novartis Investigative Site, Kenge

Novartis Investigative Site, Masi-Manimba

Novartis Investigative Site, Sotouba

Novartis Investigative Site, Rubavu

Novartis Investigative Site, Rusizi

Novartis Investigative Site, Bagamoyo

Novartis Investigative Site, Korogwe Tanga

01

Novartis Investigative Site, Bobo-Dioulasso

BP 18

Novartis Investigative Site, Nanoro

11 BP 218

Novartis Investigative Site, Ouagadougou

06 BP 10248

Novartis Investigative Site, Sabou

13BP972

Novartis Investigative Site, Abidjan

BP 154

Novartis Investigative Site, Agboville

BP 173

Novartis Investigative Site, Azaguié

BP 242

Novartis Investigative Site, Lambaréné

BP 1437

Novartis Investigative Site, Libreville

VWJ6+8WF

Novartis Investigative Site, Navrango

00200

Novartis Investigative Site, Nairobi

00114

Novartis Investigative Site, Gicumbi District Rwamiko

0000

Novartis Investigative Site, Kigali

BP 4560

Novartis Investigative Site, Kigali

Sponsors
All Listed Sponsors
collaborator

MMV, EDCTP, WANECAM

UNKNOWN

lead

Novartis Pharmaceuticals

INDUSTRY