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

NCT07811908 | Recruiting Phase 2

• 2 other identifiers: CADPT13A12201_C22022-004197-27
• Study Type: interventional
• Target: 120
• Locations: 7 countries
• Sites: 13

Brief Summary

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.

Conditions

Uncomplicated Plasmodium Falciparum Malaria

Keywords

single dose cure malaria; uncomplicated malaria; Plasmodium falciparum; platform study; PLATINUM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Parasite clearance time (PCT)

  up to Day 7

• PCR-uncorrected ACPR

  Day 29

• Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)

  Day 8

• Maximum observed concentration (Cmax)

  Day 8

• Time to reach maximum observed concentration (Tmax)

  Day 8

Study Arms (2)

Cohort C2: KLU156 + KAE609

EXPERIMENTAL

KLU156 + KAE609 was administered orally with light meal.

Drug: KAE609; Drug: KLU156

Cohort C2: SoC (Artemether + lumefantrine)

ACTIVE COMPARATOR

Artemether + lumefantrine was administered orally as per label.

Drug: SoC (Coartem)

Interventions

KAE609 DRUG

oral capsules administered in combination with KLU156

Also known as: Cipargamin

Cohort C2: KLU156 + KAE609

SoC (Coartem) DRUG

Standard of Care

Also known as: Coartem

Cohort C2: SoC (Artemether + lumefantrine)

KLU156 DRUG

oral sachet formulation (KAF156+LUM-SDF) administered in combination with cipargamin (KAE609)

Also known as: ganaplacide + lumefantrine solid dispersion formulation

Cohort C2: KLU156 + KAE609

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female participants 2 to \<12 years of age at screening.
• 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.
• Participants must weigh at least 10 kg at screening.

You may not qualify if:

• 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
• Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level \< 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening
• 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
• Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.
• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (13)

Novartis Investigative Site

Banfora, Burkina Faso

RECRUITING

Novartis Investigative Site

Nanoro, BP 18, Burkina Faso

NOT YET RECRUITING

Novartis Investigative Site

Abidjan, 13BP972, Côte d’Ivoire

RECRUITING

Novartis Investigative Site

Azaguié, BP 173, Côte d’Ivoire

RECRUITING

Novartis Investigative Site

Lambaréné, BP 242, Gabon

NOT YET RECRUITING

Novartis Investigative Site

Libreville, BP 1437, Gabon

NOT YET RECRUITING

Novartis Investigative Site

Kintampo, 92037, Ghana

NOT YET RECRUITING

Novartis Investigative Site

Navrongo, VWJ6+8WF, Ghana

NOT YET RECRUITING

Novartis Investigative Site

Ahero, 40100, Kenya

NOT YET RECRUITING

Novartis Investigative Site

Kisumu, 40100, Kenya

NOT YET RECRUITING

Novartis Investigative Site

Kigali, BP 4560, Rwanda

RECRUITING

Novartis Investigative Site

Kampala, 101, Uganda

NOT YET RECRUITING

Novartis Investigative Site

Tororo, 10102, Uganda

NOT YET RECRUITING

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

NITD 609; Artemether, Lumefantrine Drug Combination; ganaplacide

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+1 888 669 6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is open-label, but Core Clinical Team is blinded to treatment information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): February 4, 2027
• Study Completion (Estimated): February 18, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

GH (2); RW (1); BU (2); CÔ (2); KE (2); GA (2); UG (2)