Uncomplicated Plasmodium Falciparum MalariaPhase 2PLATINUMNCT07811908
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2)
A Phase 2 study testing KAE609, SoC (Coartem) and KLU156 in people with Uncomplicated Plasmodium Falciparum Malaria, run by Novartis Pharmaceuticals at 13 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Uncomplicated Plasmodium Falciparum Malaria
- What is being tested?
- KAE609, SoC (Coartem) and KLU156
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 12 Feb 2026to 18 Feb 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
13 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
13 sites in 7 countries
Burkina Faso2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Banfora
- Recruiting
Novartis Investigative Site
Nanoro, BP 18
Côte d’Ivoire2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Abidjan, 13BP972
- Recruiting
Novartis Investigative Site
Azaguié, BP 173
Gabon2 sites, 2 recruiting
- Not yet recruiting
Novartis Investigative Site
Lambaréné, BP 242
- Not yet recruiting
Novartis Investigative Site
Libreville, BP 1437
Ghana2 sites, 2 recruiting
- Not yet recruiting
Novartis Investigative Site
Kintampo, 92037
- Not yet recruiting
Novartis Investigative Site
Navrongo, VWJ6+8WF
Kenya2 sites, 2 recruiting
- Not yet recruiting
Novartis Investigative Site
Ahero, 40100
- Not yet recruiting
Novartis Investigative Site
Kisumu, 40100
Uganda2 sites, 2 recruiting
- Not yet recruiting
Novartis Investigative Site
Kampala, 101
- Not yet recruiting
Novartis Investigative Site
Tororo, 10102
Rwanda1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Kigali, BP 4560
About this study
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 Participants With Uncomplicated Plasmodium Falciparum Malaria
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.
Read the detailed description
The Cohort C2 of this Platfom study (NCT05750628) is the open-label, randomized, two-arm combination therapy evaluating a single oral dose of up to three anti-malarial agents as a loose combination vs. standard of care (SoC), Coartem in children aged 2 to <12 years.
- Being tested
- KAE609, SoC (Coartem), KLU156
- Keywords
- single dose cure malaria, uncomplicated malaria, Plasmodium falciparum, platform study, PLATINUM
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAE609Drug
Also called Cipargamin
oral capsules administered in combination with KLU156
SoC (Coartem)Drug
Also called Coartem
Standard of Care
KLU156Drug
Also called ganaplacide + lumefantrine solid dispersion formulation
oral sachet formulation (KAF156+LUM-SDF) administered in combination with cipargamin (KAE609)
| Study group | Role | What they receive |
|---|---|---|
| Cohort C2: KLU156 + KAE609 | Experimental | KLU156 + KAE609 was administered orally with light meal. Receives: Drug: KAE609; Drug: KLU156 |
| Cohort C2: SoC (Artemether + lumefantrine) | Active comparator | Artemether + lumefantrine was administered orally as per label. Receives: Drug: SoC (Coartem) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 29
Secondary outcomes (10)
Parasite clearance time (PCT)
To assess the parasite clearance time (PCT) of oral anti malarial agent versus the standard of care (SoC) in participants with uncomplicated P. falciparum malaria
Measured: up to Day 7
PCR-uncorrected ACPR
To assess the 28-day cure rate of an anti malarial agent administered orally as combination therapy versus the SoC in participants with uncomplicated P. falciparum malaria.
Measured: 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 combination therapy.
Measured: Day 8
Maximum observed concentration (Cmax)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Measured: Day 8
Time to reach maximum observed concentration (Tmax)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Measured: Day 8
Elimination half-life (T1/2)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Measured: Day 8
Total body clearance (CL/F)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Measured: Day 8
Apparent volume of distribution (V/F)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Measured: Day 8
Area under the concentration-time curve from time zero to infinity (AUCinf)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Measured: Day 8
Area under the concentration-time curve (AUC0-t)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start12 Feb 2026
- Primary completion4 Feb 2027 (estimated)
- Study completion18 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811908
- Sponsor's protocol ID
- CADPT13A12201_C2
- Other IDs
- 2022-004197-27
- Acronym
- PLATINUM
- Status last verified
- Oct 2026
- First submitted
- 4 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.