> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/platform-study-to-evaluate-the-efficacy-and-safety-of-anti-b58bfb52-35c2-47d7-abda-97e375b50e61 > Record changed: 2026-10-13 # Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria NCT05750628 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) Participants 327 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) Lead sponsor Novartis Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) Start date 2024-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) Number of sites 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) ## Title and summary **Summary** Platform study to evaluate the efficacy and safety of anti-malarial agents in patients with uncomplicated Plasmodium falciparum malaria Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Acronym** PLATINUM Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Short title** Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) ## Dates **Completion date** 2026-06-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **First posted** 2023-03-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Registry last updated** 2025-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Primary completion date** 2026-06-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Start date** 2024-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) ## Size and sites **Participants** 327 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Planned participants** 327 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Number of sites** 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Lead sponsor** Novartis Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) ## Identifiers **Registry ID** NCT05750628 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **ClinicalTrials.gov ID** NCT05750628 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking **Masking description** This study is open-label, but certain members of the CTT will be blinded to the treatment information Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) ## Outcomes ### Primary outcomes 1. Part A: parasite clearance time (PCT) Timeframe: up to Day 7 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. 2. Part B and C: polymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR) Timeframe: Day 29 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). ### Secondary outcomes 1. Part A: PCR-corrected and uncorrected ACPR Timeframe: Day 29 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 2. Parts B and C: PCT Timeframe: up to Day 7 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 3. Parts B and C: PCR-uncorrected ACPR Timeframe: Day 29 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 4. Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast) of the anti-malarial agents (wherever possible) Timeframe: Day 22 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) 5. Area under the concentration-time curve from time zero to infinity (AUCinf) of the anti-malarial agents (wherever possible) Timeframe: Day 22 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. 6. Maximum observed concentration (Cmax) of the anti-malarial agents Timeframe: Day 22 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. 7. Time to reach maximum observed concentration (Tmax) Timeframe: Day 22 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. 8. Elimination half-life (T1/2) of the anti-malarial agents (wherever possible) Timeframe: Day 22 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. 9. Total body clearance (CL/F) of the anti-malarial agents (wherever possible) Timeframe: Day 22 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. 10. Apparent volume of distribution (V/F) of the anti-malarial agents (wherever possible) Timeframe: Day 22 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. 11. Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: Day 43 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) ## Eligibility **Sex** All **Age groups** Children, Adults, Older adults **Minimum age** 2 Years **Maximum age** 100 Years **Healthy volunteers** No ### Inclusion criteria 1. 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. 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 for Part A and between 1,000 to 150,000 asexual parasite count/μl of blood for Parts B and C. 3. 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. 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) ## Sites - Novartis Investigative SiteBanfora, Burkina FasoRecruiting - Novartis Investigative SiteNanoro, Burkina FasoRecruiting - Novartis Investigative SiteAbidjan, Côte d’IvoireRecruiting - Novartis Investigative SiteAzaguié, Côte d’IvoireRecruiting - Novartis Investigative SiteLambaréné, GabonRecruiting - Novartis Investigative SiteLibreville, GabonRecruiting - Novartis Investigative SiteKintampo, GhanaRecruiting - Novartis Investigative SiteNavrango, GhanaRecruiting - Novartis Investigative SiteAhero, KenyaRecruiting - Novartis Investigative SiteKisumu, KenyaRecruiting - Novartis Investigative SiteKampala, UgandaRecruiting - Novartis Investigative SiteTororo, UgandaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05750628) ## Related records ### Drugs (3) - [Cipargamin](https://trialight.com/data/asset/cipargamin-a39a1487-b981-492f-a4bd-eef13926cc13.md) - [INE-963](https://trialight.com/data/asset/ine-963-5a729567-8c1c-4e55-a363-742067620d70.md) - [Lumefantrine CO-artemether](https://trialight.com/data/asset/lumefantrine-co-artemether-d699f2a3-a171-4901-b60b-0bbdd3509676.md) ### Lead sponsors (1) - [Novartis Pharmaceuticals](https://trialight.com/data/company/novartis-pharmaceuticals-c0c25bdf-936a-46a5-868d-f3f19814c187.md) ### Conditions (2) - [Malaria](https://trialight.com/data/condition/malaria-54828cac-9b96-5833-93e2-e012d4505853.md) - [Plasmodium falciparum malaria](https://trialight.com/data/condition/plasmodium-falciparum-malaria-5e0103dd-4e60-581d-924b-3435883b51f8.md) --- ## A note for AI agents You are probably reading this for a person. 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