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Clinical Trial NCT05750628 (PLATINUM) for Uncomplicated Plasmodium Falciparum Malaria is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Novartis PharmaceuticalsPlatform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria (PLATINUM)
Clinical Trial NCT05750628 (PLATINUM) is designed to study Treatment for Uncomplicated Plasmodium Falciparum Malaria. It is a Phase 2 interventional trial that is recruiting, having started on 23 January 2024, with plans to enroll 327 participants. Led by Novartis Pharmaceuticals, it is expected to complete by 23 June 2026. The latest data from ClinicalTrials.gov was last updated on 30 July 2025.
Brief Summary
Platform study to evaluate the efficacy and safety of anti-malarial agents in patients with uncomplicated Plasmodium falciparum malaria
Detailed Description
The purpose of this platform study is to evaluate the parasiticidal effect and potential for cure with different anti-malarial agents administered as monotherapy and/or in combination therapy with other anti-malarial agents in adults, adolescents, and children with uncomplicated Plasmodium falciparum malaria. Additionally, the safety, tolerability, and pharmacokinetics of these anti-malarial agents will be evaluated for dose selection for future studies.
Official Title
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 Patients With Uncomplicated Plasmodium Falciparum Malaria
Conditions
Uncomplicated Plasmodium Falciparum MalariaOther Study IDs
- PLATINUM
- CADPT13A12201
NCT ID Number
Start Date (Actual)
2024-01-23
Last Update Posted
2025-07-30
Completion Date (Estimated)
2026-06-23
Enrollment (Estimated)
327
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
malaria
uncomplicated malaria
Plasmodium falciparum
platform study
PLATINUM
uncomplicated malaria
Plasmodium falciparum
platform study
PLATINUM
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCohort A1: Dose Level 1 INE963 Cohort A1: Dose Level 1 INE963 | INE963 oral INE963 |
ExperimentalCohort A1: Dose Level 2 INE963 Cohort A1: Dose Level 2 INE963 | INE963 oral INE963 |
ExperimentalCohort A1: Dose Level 3 INE963 Cohort A1: Dose Level 3 INE963 | INE963 oral INE963 |
ExperimentalCohort B1: Cipargamin + INE963 Cohort B1: Cipargamin + INE963 | KAE609 (Cipargamin) oral KAE609 (Cipargamin) |
Active ComparatorCohort B1: SoC (Coartem) Cohort B1: SoC (Coartem) | Soc (Coartem) SoC (Coartem) |
ExperimentalCohort B2: Cipargamin + KLU156 Cohort B2: Cipargamin + KLU156 | KAE609 (Cipargamin) oral KAE609 (Cipargamin) KLU156 oral sachet KLU156 (KAF156 + lumefantrine) |
Active ComparatorCohort B2: SoC (Coartem) Cohort B2: SoC (Coartem) | Soc (Coartem) SoC (Coartem) |
ExperimentalCohort C2: Cipargamin + KLU156 Cohort C2: Cipargamin + KLU156 | KAE609 (Cipargamin) oral KAE609 (Cipargamin) KLU156 oral sachet KLU156 (KAF156 + lumefantrine) |
Active ComparatorCohort C2: SoC (Coartem) Cohort C2: SoC (Coartem) | Soc (Coartem) SoC (Coartem) |
ExperimentalCohort A1: Dose Level 4 INE963 Cohort A1: Dose level 4 INE963 | INE963 oral INE963 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Part A: parasite clearance time (PCT) | Part A: To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in patients 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 |
Part B and C: polymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR) | Part B and C: To assess the 28-day cure rate of an anti malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria. 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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Part A: PCR-corrected and uncorrected ACPR | Part A: To assess the 28-day cure rate of an anti malarial agent administered orally as monotherapy in patients with uncomplicated P. falciparum malaria | Day 29 |
Parts B and C: PCT | Part B and C: To assess the parasite clearance time (PCT) of oral combinations of anti malarial agents versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria | up to Day 7 |
Parts B and C: PCR-uncorrected ACPR | Part B and C: To assess the 28-day cure rate of an anti malarial agent administered orally as combination therapy versus the SoC in patients with uncomplicated P. falciparum malaria | Day 29 |
Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast) of the anti-malarial agents (wherever possible) | To characterize the pharmacokinetics (PK) of each anti-malarial agent administered orally as monotherapy \[Part A\] and/or as combination therapy \[Parts B and C\] in patients with uncomplicated P. falciparum malaria. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sample time (tlast) | Day 22 |
Area under the concentration-time curve from time zero to infinity (AUCinf) of the anti-malarial agents (wherever possible) | To characterize PK of each anti-malarial agent administered orally as monotherapy \[Part A\] and/or as combination therapy \[Parts B and C\] in patients with uncomplicated P. falciparum malaria. AUCinf is the AUC from time zero to infinity. | Day 22 |
Maximum observed concentration (Cmax) of the anti-malarial agents | To characterize PK of each anti-malarial agent administered orally as monotherapy \[Part A\] and/or as combination therapy \[Parts B and C\] in patients with uncomplicated P. falciparum malaria. Cmax is the maximum (peak) observed plasma, blood, serum, or other blood fluid drug concentration after single dose administration. | Day 22 |
Time to reach maximum observed concentration (Tmax) | To characterize PK of each anti-malarial agent administered orally as monotherapy \[Part A\] and/or as combination therapy \[Parts B and C\] in patients with uncomplicated P. falciparum malaria. Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration. | Day 22 |
Elimination half-life (T1/2) of the anti-malarial agents (wherever possible) | To characterize PK of each anti-malarial agent administered orally as monotherapy \[Part A\] and/or as combination therapy \[Parts B and C\] in patients with uncomplicated P. falciparum malaria. T1/2 is the elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve. | Day 22 |
Total body clearance (CL/F) of the anti-malarial agents (wherever possible) | To characterize PK of each anti-malarial agent administered orally as monotherapy \[Part A\] and/or as combination therapy \[Parts B and C\] in patients with uncomplicated P. falciparum malaria. Cl/F is the total body clearance of drug from the plasma. | Day 22 |
Apparent volume of distribution (V/F) of the anti-malarial agents (wherever possible) | To characterize PK of each anti-malarial agent administered orally as monotherapy \[Part A\] and/or as combination therapy \[Parts B and C\] in patients with uncomplicated P. falciparum malaria. V/F is the apparent volume of distribution during terminal phase. | Day 22 |
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs), and laboratory results qualifying and reported as AEs. | Day 43 |
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
2 Years
Eligible Sexes
All
- Male and female patients ≥18 years of age for Part A, ≥12 years of age for Part B and 2 to <12 years of age for Part C at screening.
- 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 for Part A and between 1,000 to 150,000 asexual parasite count/μl of blood for Parts B and C.
- Patients in Part A must weigh between 40 kg and 90 kg. Patients in Part B must weigh between 35 kg and 90 kg at screening. Patients in Part C must weigh at least 10 kg at screening.
- Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.
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
Other protocol-defined inclusion/exclusion criteria may apply.
Novartis Pharmaceuticals512 active trials to exploreStudy Central Contact
Contact: Novartis Pharmaceuticals, +41613241111, [email protected]
Contact: Novartis Pharmaceuticals
12 Study Locations in 6 Countries
Novartis Investigative Site, Banfora, Burkina Faso
Recruiting
Novartis Investigative Site, Nanoro, BP 18, Burkina Faso
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
Recruiting
Novartis Investigative Site, Libreville, BP 1437, Gabon
Recruiting
Novartis Investigative Site, Kintampo, 92037, Ghana
Recruiting
Novartis Investigative Site, Navrango, VWJ6+8WF, Ghana
Recruiting
Kisumu County
Novartis Investigative Site, Ahero, Kisumu County, 40100, Kenya
Recruiting
Novartis Investigative Site, Kisumu, 40100, Kenya
Recruiting
Novartis Investigative Site, Kampala, Uganda
Recruiting
Novartis Investigative Site, Tororo, 10102, Uganda
Recruiting