Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B1)

NCT07811882 | Completed Phase 2

• 2 other identifiers: CADPT13A12201_B12022-004197-27
• Study Type: interventional
• Target: 95
• Locations: 7 countries
• Sites: 13

Brief Summary

This is Cohort B1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 + Cipargamin 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 B1: Cipargamin + INE963

EXPERIMENTAL

Cohort B1: Cipargamin + INE963

Drug: KAE609 (Cipargamin); Drug: INE963

Cohort B1: SoC (Artemether 80 mg + lumefantrine 480 mg)

ACTIVE COMPARATOR

Cohort B1: SoC (Artemether 80 mg + lumefantrine 480 mg)

Drug: SoC (Coartem)

Interventions

KAE609 (Cipargamin) DRUG

oral KAE609 (Cipargamin)

Also known as: KAE609

Cohort B1: Cipargamin + INE963

SoC (Coartem) DRUG

SoC (Coartem)

Cohort B1: SoC (Artemether 80 mg + lumefantrine 480 mg)

INE963 DRUG

oral INE963

Cohort B1: Cipargamin + INE963

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 (13)

Novartis Investigative Site

Banfora, Burkina Faso

Location

Novartis Investigative Site

Nanoro, BP 18, Burkina Faso

Location

Novartis Investigative Site

Abidjan, 13BP972, Côte d’Ivoire

Location

Novartis Investigative Site

Azaguié, BP 173, Côte d’Ivoire

Location

Novartis Investigative Site

Lambaréné, BP 242, Gabon

Location

Novartis Investigative Site

Libreville, BP 1437, Gabon

Location

Novartis Investigative Site

Kintampo, 92037, Ghana

Location

Novartis Investigative Site

Navrongo, VWJ6+8WF, Ghana

Location

Novartis Investigative Site

Ahero, 40100, Kenya

Location

Novartis Investigative Site

Kisumu, 40100, Kenya

Location

Novartis Investigative Site

Kigali, BP 4560, Rwanda

Location

Novartis Investigative Site

Kampala, 101, Uganda

Location

Novartis Investigative Site

Tororo, 10102, Uganda

Location

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

NITD 609; Artemether, Lumefantrine Drug Combination; INE963

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

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: September 4, 2026
• First Posted: September 10, 2026
• Study Start: October 10, 2025
• Primary Completion: June 17, 2026
• Study Completion: July 1, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

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