Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (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 is Cohort A1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 in participants with uncomplicated Plasmodium falciparum malaria.

Study Overview

• Status: Completed
• Conditions: Uncomplicated Plasmodium Falciparum Malaria
• Intervention / Treatment: Drug: INE963

Detailed Description

The Cohort A1 of this Platfom study (NCT05750628) is an open-label, randomized, multi-arm monotherapy part evaluating a single oral administration of an anti-malarial agent (INE963) at 3 parallel dose levels followed by optional adaptive sequential dose level(s).

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• Burkina Faso
  • Banfora, Burkina Faso
    • Novartis Investigative Site
• Côte d’Ivoire
  • Azaguié, Côte d’Ivoire, BP 173
    • Novartis Investigative Site
• Gabon
  • Lambaréné, Gabon, BP 242
    • Novartis Investigative Site
• Ghana
  • Navrongo, Ghana, VWJ6+8WF
    • Novartis Investigative Site
• Kenya
  • Kisumu, Kenya, 40100
    • Novartis Investigative Site
• Uganda
  • Kampala, Uganda
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and female patients ≥18 years of age at screening.
2. Patients must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 5,000 to 150,000 asexual parasite count/μl of blood for P. falciparum
3. Patients must weigh between 40 kg and 90 kg.
4. Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.

Exclusion Criteria:

1. 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
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. 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.

6. 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A1: INE963 Dose Level 1	Drug: INE963; Administered via oral INE963
Experimental: Cohort A1: INE963 Dose Level 2	Drug: INE963; Administered via oral INE963
Experimental: Cohort A1: INE963 Dose Level 3	Drug: INE963; Administered via oral INE963
Experimental: Cohort A1: INE963 Dose Level 4	Drug: INE963; Administered via oral INE963

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parasite clearance time (PCT)	To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in participants with uncomplicated P. falciparum malaria. PCT is defined as the time from the first positive blood slide at inclusion to the time of the first negative slide followed by two consecutive slides.	up to Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCR-corrected and uncorrected ACPR	To assess the 28-day cure rate of an anti malarial agent administered orally as monotherapy 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 monotherapy.	Day 22
Area under the concentration-time curve from time zero to infinity (AUCinf)	To characterize PK of the anti-malarial agent administered orally as monotherapy.	Day 22
Maximum observed concentration (Cmax)	To characterize PK of the anti-malarial agent administered orally as monotherapy.	Day 22
Time to reach maximum observed concentration (Tmax)	To characterize PK of the anti-malarial agent administered orally as monotherapy.	Day 22
Elimination half-life (T1/2)	To characterize PK of the anti-malarial agent administered orally as monotherapy.	Day 22
Total body clearance (CL/F)	To characterize PK of the anti-malarial agent administered orally as monotherapy.	Day 22
Apparent volume of distribution (V/F)	To characterize PK of the anti-malarial agent administered orally as monotherapy.	Day 22
Area under the concentration-time curve (AUC0-t)	To characterize PK of the anti-malarial agent administered orally as monotherapy.	Day 22

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): February 21, 2025

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: October 1, 2025

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; INE963
• Other Study ID Numbers: CADPT13A12201_A1

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