Uncomplicated Plasmodium Falciparum MalariaPhase 2PLATINUMNCT07811882
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B1)
A Phase 2 study testing KAE609 (Cipargamin), SoC (Coartem) and INE963 in people with Uncomplicated Plasmodium Falciparum Malaria, run by Novartis Pharmaceuticals at 13 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Uncomplicated Plasmodium Falciparum Malaria
- What is being tested?
- KAE609 (Cipargamin), SoC (Coartem) and INE963
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 10 Oct 2025to 1 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
Burkina Faso2 sites
Novartis Investigative Site
Banfora
Novartis Investigative Site
Nanoro, BP 18
Côte d’Ivoire2 sites
Novartis Investigative Site
Abidjan, 13BP972
Novartis Investigative Site
Azaguié, BP 173
Gabon2 sites
Novartis Investigative Site
Lambaréné, BP 242
Novartis Investigative Site
Libreville, BP 1437
Ghana2 sites
Novartis Investigative Site
Kintampo, 92037
Novartis Investigative Site
Navrongo, VWJ6+8WF
Kenya2 sites
Novartis Investigative Site
Ahero, 40100
Novartis Investigative Site
Kisumu, 40100
Uganda2 sites
Novartis Investigative Site
Kampala, 101
Novartis Investigative Site
Tororo, 10102
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 is Cohort B1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 + Cipargamin in participants with uncomplicated Plasmodium falciparum malaria.
Read the detailed description
The Cohort B1 of this Platfom study (NCT05750628) is the open-label, randomized, two-arm combination therapy evaluating a dose of up to two anti-malarial agents as a loose combination vs. standard of care (SoC), Coartem in adult and adolescent participants.
- Being tested
- KAE609 (Cipargamin), SoC (Coartem), INE963
- 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.
KAE609 (Cipargamin)Drug
Also called KAE609
oral KAE609 (Cipargamin)
SoC (Coartem)Drug
SoC (Coartem)
INE963Drug
oral INE963
| Study group | Role | What they receive |
|---|---|---|
| Cohort B1: Cipargamin + INE963 | Experimental | Cohort B1: Cipargamin + INE963 Receives: 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) 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 start10 Oct 2025
- Primary completion17 Jun 2026
- Study completion1 Jul 2026
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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811882
- Sponsor's protocol ID
- CADPT13A12201_B1
- Other IDs
- 2022-004197-27
- Acronym
- PLATINUM
- Status last verified
- Aug 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07811882
- Acronym / sponsor ID
- PLATINUM / CADPT13A12201_B1
- Keywords
- single dose cure malaria, uncomplicated malaria, Plasmodium falciparum, platform study, PLATINUM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Cohort B1 of this Platfom study (NCT05750628) is the open-label, randomized, two-arm combination therapy evaluating a dose of up to two anti-malarial agents as a loose combination vs. standard of care (SoC), Coartem in adult and adolescent participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort B1: Cipargamin + INE963 | Experimental | Drug: KAE609 (Cipargamin), Drug: INE963Cohort B1: Cipargamin + INE963 |
| Cohort B1: SoC (Artemether 80 mg + lumefantrine 480 mg) | Active comparator | Drug: SoC (Coartem)Cohort B1: SoC (Artemether 80 mg + lumefantrine 480 mg) |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KAE609 (Cipargamin)Also: KAE609oral KAE609 (Cipargamin) | Drug | Cohort B1: Cipargamin + INE963 |
| SoC (Coartem)SoC (Coartem) | Drug | Cohort B1: SoC (Artemether 80 mg + lumefantrine 480 mg) |
| INE963oral INE963 | Drug | Cohort B1: Cipargamin + INE963 |
Primary outcome
Polymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR)
Time frame: Day 29
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).
10 secondary outcomes
Parasite clearance time (PCT)
Time frame: up to Day 7
PCR-uncorrected ACPR
Time frame: Day 29
Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)
Time frame: Day 8
Maximum observed concentration (Cmax)
Time frame: Day 8
Time to reach maximum observed concentration (Tmax)
Time frame: Day 8
Elimination half-life (T1/2)
Time frame: Day 8
Total body clearance (CL/F)
Time frame: Day 8
Apparent volume of distribution (V/F)
Time frame: Day 8
Area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: Day 8
Area under the concentration-time curve (AUC0-t)
Time frame: Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: 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.
Related trials for Uncomplicated Plasmodium Falciparum Malaria
RecruitingPhase 2
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2)
Uncomplicated Plasmodium Falciparum Malaria
Not yet recruitingObservational study
Ethiopian Antimalarial Therapeutic Efficacy Study 2026
Plasmodium Vivax Malaria Without Complication, Plasmodium Falciparum Malaria (Uncomplicated)
Not yet recruitingPhase 4
Study to Assess Safety and Clinical Responses With Coartem® Baby Dispersible Tablets in Paediatric Patients Weighing 2 to <5 kg With Uncomplicated Malaria
Malaria
Not yet recruitingPhase 2
A Phase 2A Study of a Novel Antimalarial Pyrrolidinamide in Adult Patients With Uncomplicated P. Falciparum Malaria
Malaria, Falciparum
RecruitingPhase 2
Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria
Malaria (Plasmodium Falciparum)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KAE609 (Cipargamin), SoC (Coartem) and INE963 in people with Uncomplicated Plasmodium Falciparum Malaria, run by Novartis Pharmaceuticals at 13 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Burkina Faso, Côte d’Ivoire, Gabon, Ghana, Kenya and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR) (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.