Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria
NCT ID: NCT05750628
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
327 participants
INTERVENTIONAL
2024-01-23
2026-06-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A1: Dose Level 1 INE963
Cohort A1: Dose Level 1 INE963
INE963
oral INE963
Cohort A1: Dose Level 2 INE963
Cohort A1: Dose Level 2 INE963
INE963
oral INE963
Cohort A1: Dose Level 3 INE963
Cohort A1: Dose Level 3 INE963
INE963
oral INE963
Cohort B1: Cipargamin + INE963
Cohort B1: Cipargamin + INE963
KAE609 (Cipargamin)
oral KAE609 (Cipargamin)
Cohort B1: SoC (Coartem)
Cohort B1: SoC (Coartem)
SoC (Coartem)
SoC (Coartem)
Cohort B2: Cipargamin + KLU156
Cohort B2: Cipargamin + KLU156
KAE609 (Cipargamin)
oral KAE609 (Cipargamin)
KLU156
oral sachet KLU156 (KAF156 + lumefantrine)
Cohort B2: SoC (Coartem)
Cohort B2: SoC (Coartem)
SoC (Coartem)
SoC (Coartem)
Cohort C2: Cipargamin + KLU156
Cohort C2: Cipargamin + KLU156
KAE609 (Cipargamin)
oral KAE609 (Cipargamin)
KLU156
oral sachet KLU156 (KAF156 + lumefantrine)
Cohort C2: SoC (Coartem)
Cohort C2: SoC (Coartem)
SoC (Coartem)
SoC (Coartem)
Cohort A1: Dose Level 4 INE963
Cohort A1: Dose level 4 INE963
INE963
oral INE963
Interventions
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INE963
oral INE963
KAE609 (Cipargamin)
oral KAE609 (Cipargamin)
SoC (Coartem)
SoC (Coartem)
KLU156
oral sachet KLU156 (KAF156 + lumefantrine)
Eligibility Criteria
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Inclusion Criteria
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
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
2 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Banfora, , Burkina Faso
Novartis Investigative Site
Nanoro, , Burkina Faso
Novartis Investigative Site
Abidjan, , Côte d’Ivoire
Novartis Investigative Site
Azaguié, , Côte d’Ivoire
Novartis Investigative Site
Lambaréné, , Gabon
Novartis Investigative Site
Libreville, , Gabon
Novartis Investigative Site
Kintampo, , Ghana
Novartis Investigative Site
Navrango, , Ghana
Novartis Investigative Site
Ahero, Kisumu County, Kenya
Novartis Investigative Site
Kisumu, , Kenya
Novartis Investigative Site
Kampala, , Uganda
Novartis Investigative Site
Tororo, , Uganda
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Other Identifiers
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CADPT13A12201
Identifier Type: -
Identifier Source: org_study_id
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