Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2)

NCT ID: NCT07235033

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-23
• Study Completion Date: 2025-03-19

Brief Summary

This is Cohort B2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria

Detailed Description

The Cohort B2 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 adult and adolescent participants.

Conditions

Uncomplicated Plasmodium Falciparum Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort B2: KLU156 + cipargamin

Cohort B2: KLU156 + cipargamin

Group Type: EXPERIMENTAL

Cipargamin

Intervention Type: DRUG

oral capsules administered in combination with KLU156

KLU156

Intervention Type: DRUG

oral sachet formulation administered in combination with cipargamin

Cohort B2: SoC (Coartem)

Cohort B2: SoC (Coartem)

Group Type: ACTIVE_COMPARATOR

SoC (Coartem)

Intervention Type: DRUG

Standard of Care (Coartem)

Interventions

Cipargamin

oral capsules administered in combination with KLU156

Intervention Type: DRUG

SoC (Coartem)

Standard of Care (Coartem)

Intervention Type: DRUG

KLU156

oral sachet formulation administered in combination with cipargamin

Intervention Type: DRUG

Other Intervention Names

KAE609; ganaplacide + lumefantrine SDF

Eligibility Criteria

Inclusion Criteria

1. Male and female patients ≥12 years of age at screening.

2. 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.

3. Patients must weigh between 35 kg and 90 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novartis Investigative Site

Nanoro, , Burkina Faso

Novartis Investigative Site

Abidjan, , Côte d’Ivoire

Novartis Investigative Site

Libreville, , Gabon

Novartis Investigative Site

Kintampo, , Ghana

Novartis Investigative Site

Ahero, , Kenya

Novartis Investigative Site

Tororo, , Uganda

Countries

Burkina Faso; Côte d’Ivoire; Gabon; Ghana; Kenya; Uganda

Other Identifiers

CADPT13A12201_B2

Identifier Type: -

Identifier Source: org_study_id