Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2)

NCT07235033 | Completed Phase 2 Results DMC

• 1 other identifier: CADPT13A12201_B2
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 3

Brief Summary

This was Cohort B2 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 absence of parasitaemia (PS) on Study Day 29 regardless of axillary temperature, in patients who have not previously met any of the criteria of Early Treatment Failure (ETF), Late Clinical Failure (LCF), or Late Parasitological Failure (LPF). A patient was considered as PCR-corrected ACPR at Day 29 when the patient did not meet any of the criteria of ETF (up to Day 4), LCF (Day 5 to Day 29), or LPF (Day 8 to Day 29), and was absence of PS on Day 29, unless the presence of PS detected after 7 days (Day 8 or later) was due to reinfection. The presence of PS after 7 days of treatment initiation was considered as a reinfection only when the PS had cleared before Day 8, and none of the parasite strain(s) detected on or after Day 8 matched with the parasite strain at baseline.

  Day 29

Secondary Outcomes (11)

• Parasite Clearance Time (PCT)

  up to Day 7

• PCR Uncorrected Adequate Clinical and Parasitological Response (ACPR)

  Day 29

• Maximum Observed Plasma Concentration (Cmax)

  Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.

• Area Under Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24h)

  Pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours post dose.

Study Arms (2)

Cohort B2: KLU156 400/480 mg + KAE609 75 mg

EXPERIMENTAL

KLU156 \[(400 mg KAF156, 480 mg Lumefantrine (LUM)-solid dispersion formulation (SDF)\] + KAE609 75 mg was administered orally with light meal as a single dose.

Drug: KAE609; Drug: KLU156

Cohort B2: SoC (Artemether 80 mg + lumefantrine 480 mg)

ACTIVE COMPARATOR

Artemether 80 mg + lumefantrine 480 mg was administered twice a day for 3 days with a standard meal or drink rich in fat within 30 min of dosing, as per label.

Drug: SoC (Coartem)

Interventions

KAE609 DRUG

oral capsules administered in combination with KLU156

Also known as: Cipargamin

Cohort B2: KLU156 400/480 mg + KAE609 75 mg

SoC (Coartem) DRUG

Standard of Care

Also known as: Coartem

Cohort B2: SoC (Artemether 80 mg + lumefantrine 480 mg)

KLU156 DRUG

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

Also known as: ganaplacide + lumefantrine solid dispersion formulation

Cohort B2: KLU156 400/480 mg + KAE609 75 mg

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients ≥12 years of age at screening.
• Patients 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.
• Patients must weigh between 35 kg and 90 kg at screening.
• Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.

You may not qualify if:

• Patients 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.
• Pregnant or nursing (lactating) women, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of effective contraception, and sexually active patients not willing to practice effective contraception.
• 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 (3)

Novartis Investigative Site

Abidjan, 13BP972, Côte d’Ivoire

Location

Novartis Investigative Site

Libreville, BP 1437, Gabon

Location

Novartis Investigative Site

Ahero, 40100, Kenya

Location

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+ 1 862 778 8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study was 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: November 14, 2025
• First Posted: November 19, 2025
• Study Start: January 23, 2024
• Primary Completion: March 5, 2025
• Study Completion: March 19, 2025
• Last Updated: March 13, 2026
• Results First Posted: March 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

KE (1); GA (1); CÔ (1)