Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria

Recruiting now · Phase 2

Conditions studied: Uncomplicated Plasmodium Falciparum Malaria

In brief

Platform study to evaluate the efficacy and safety of anti-malarial agents in patients with uncomplicated Plasmodium falciparum malaria

Key facts

Study ID

NCT05750628

Run by

Novartis Pharmaceuticals

People needed

327

Starts

2024-01-23

Expected to finish

2026-06-23

Last updated by the study team

2025-07-30

Who can join

Age: 2 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Banfora, Burkina Faso (enrolling)
• Novartis Investigative Site — Nanoro, Burkina Faso (enrolling)
• Novartis Investigative Site — Abidjan, Côte d’Ivoire (enrolling)
• Novartis Investigative Site — Azaguié, Côte d’Ivoire (enrolling)
• Novartis Investigative Site — Lambaréné, Gabon (enrolling)
• Novartis Investigative Site — Libreville, Gabon (enrolling)
• Novartis Investigative Site — Kintampo, Ghana (enrolling)
• Novartis Investigative Site — Navrango, Ghana (enrolling)
• Novartis Investigative Site — Ahero, Kisumu County, Kenya (enrolling)
• Novartis Investigative Site — Kisumu, Kenya (enrolling)
• Novartis Investigative Site — Kampala, Uganda (enrolling)
• Novartis Investigative Site — Tororo, Uganda (enrolling)

Full record on ClinicalTrials.gov

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