Last Update: Sep 10, 2026 A Multi-part, Multi-center PLATform Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Anti-malarial Agents Administered as Monotherapy and/or Combination Therapy IN Participants With Uncomplicated Plasmodium Falciparum Malaria ClinicalTrials.gov Identifier: [NCT07811908](https://clinicaltrials.gov/ct2/show/NCT07811908) Novartis Reference Number:CADPT13A12201\_C2 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description This was Cohort C2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria. The Cohort C2 of this Platfom study (NCT05750628) is the open-label, randomized, two-arm combination therapy evaluating a single oral dose of up to three anti-malarial agents as a loose combination vs. standard of care (SoC), Coartem in children aged 2 to \\<12 years. Condition Uncomplicated Plasmodium Falciparum Malaria Phase Phase2 Overall Status Recruiting Number of Participants120 Start Date Feb 12, 2026 Completion Date Feb 18, 2027 Gender All Age(s) 2 Years - 12 Years (Child) ## Interventions Drug ### KAE609 oral capsules administered in combination with KLU156 Drug ### KLU156 oral sachet formulation (KAF156+LUM-SDF) administered in combination with cipargamin (KAE609) Drug ### SoC (Coartem) Standard of Care ## Eligibility Criteria Inclusion Criteria: 1\. Male and female participants 2 to \\<12 years of age at screening. 2\. Participants must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 1,000 to 150,000 asexual parasite count/μl of blood for P. falciparum. 3\. Participants must weigh at least 10 kg at screening. Exclusion Criteria: 1\. Participants with signs and symptoms of severe/complicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening 2\. Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level \\< 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening 3\. Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of hepatitis B or C, hepatitis A or B vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis. Clinical or laboratory evidence of any of the following at screening: \* AST/ALT \\> 3 x the upper limit of normal range (ULN), regardless of the level of total bilirubin \* AST/ALT \\> 1.5 and ≤ 2 x ULN and total bilirubin is \\> ULN \* Total bilirubin \\> 2 x ULN, regardless of the level of AST/ALT 4\. Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening. 5\. History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as: \* Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker \* History of familial long QT syndrome or known family history of Torsades de Pointe. \* Resting heart rate (physical exam or 12 lead ECG) \\< 50 bpm Other protocol-defined inclusion/exclusion criteria may apply. Burkina Faso #### Novartis Investigative Site Recruiting Banfora,Burkina Faso Côte d’Ivoire #### Novartis Investigative Site Recruiting Abidjan,13bp972,Côte d’Ivoire #### Novartis Investigative Site Recruiting Azaguié,Bp 173,Côte d’Ivoire Rwanda #### Novartis Investigative Site Recruiting Kigali,Bp 4560,Rwanda ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: [](mailto:) #### Novartis Pharmaceuticals Phone: [ +1 888 669 6682]() Email: