Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2) (PLATINUM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Uncomplicated Plasmodium Falciparum Malaria
• Intervention / Treatment: Drug: KAE609; Drug: KLU156; Drug: SoC (Coartem)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +1 888 669 6682; Email: novartis.email@novartis.com

Study Locations

• Burkina Faso
  • Banfora, Burkina Faso
    • Recruiting
    • Novartis Investigative Site
  • Nanoro, Burkina Faso, BP 18
    • Not yet recruiting
    • Novartis Investigative Site
• Côte d’Ivoire
  • Abidjan, Côte d’Ivoire, 13BP972
    • Recruiting
    • Novartis Investigative Site
  • Azaguié, Côte d’Ivoire, BP 173
    • Recruiting
    • Novartis Investigative Site
• Gabon
  • Lambaréné, Gabon, BP 242
    • Not yet recruiting
    • Novartis Investigative Site
  • Libreville, Gabon, BP 1437
    • Not yet recruiting
    • Novartis Investigative Site
• Ghana
  • Kintampo, Ghana, 92037
    • Not yet recruiting
    • Novartis Investigative Site
  • Navrongo, Ghana, VWJ6+8WF
    • Not yet recruiting
    • Novartis Investigative Site
• Kenya
  • Ahero, Kenya, 40100
    • Not yet recruiting
    • Novartis Investigative Site
  • Kisumu, Kenya, 40100
    • Not yet recruiting
    • Novartis Investigative Site
• Rwanda
  • Kigali, Rwanda, BP 4560
    • Recruiting
    • Novartis Investigative Site
• Uganda
  • Kampala, Uganda, 101
    • Not yet recruiting
    • Novartis Investigative Site
  • Tororo, Uganda, 10102
    • Not yet recruiting
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort C2: KLU156 + KAE609; KLU156 + KAE609 was administered orally with light meal.	Drug: KAE609; oral capsules administered in combination with KLU156; Other Names: Cipargamin; Drug: KLU156; oral sachet formulation (KAF156+LUM-SDF) administered in combination with cipargamin (KAE609); Other Names: ganaplacide + lumefantrine solid dispersion formulation
Active Comparator: Cohort C2: SoC (Artemether + lumefantrine); Artemether + lumefantrine was administered orally as per label.	Drug: SoC (Coartem); Standard of Care; Other Names: Coartem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR)	ACPR is defined as the absence of parasitemia on Study Day 29 irrespective of axillary temperature, without previously meeting any of the criteria of Early Treatment Failure (ETF) or Late Clinical Failure (LCF) or Late Parasitological Failure (LPF).	Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parasite clearance time (PCT)	To assess the parasite clearance time (PCT) of oral anti malarial agent versus the standard of care (SoC) in participants with uncomplicated P. falciparum malaria	up to Day 7
PCR-uncorrected ACPR	To assess the 28-day cure rate of an anti malarial agent administered orally as combination therapy versus the SoC in participants with uncomplicated P. falciparum malaria.	Day 29
Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)	To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.	Day 8
Maximum observed concentration (Cmax)	To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.	Day 8
Time to reach maximum observed concentration (Tmax)	To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.	Day 8
Elimination half-life (T1/2)	To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.	Day 8
Total body clearance (CL/F)	To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.	Day 8
Apparent volume of distribution (V/F)	To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.	Day 8
Area under the concentration-time curve from time zero to infinity (AUCinf)	To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.	Day 8
Area under the concentration-time curve (AUC0-t)	To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.	Day 8

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2026
• Primary Completion (Estimated): February 4, 2027
• Study Completion (Estimated): February 18, 2027

Study Registration Dates

• First Submitted: September 4, 2026
• First Submitted That Met QC Criteria: September 4, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 4, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Plasmodium falciparum; platform study; uncomplicated malaria; PLATINUM; single dose cure malaria
• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Infections; Protozoan Infections; Parasitic Diseases; Malaria; Malaria, Falciparum; Organic Chemicals; Pharmaceutical Preparations; Hydrocarbons; Hydrocarbons, Cyclic; Terpenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Inorganic Chemicals; Drug Combinations; Reactive Oxygen Species; Free Radicals; Artemether; Artemisinins; Lumefantrine; Fluorenes; Sesquiterpenes; Artemether, Lumefantrine Drug Combination; NITD 609; ganaplacide
• Other Study ID Numbers: CADPT13A12201_C2; 2022-004197-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No