NCT07235033

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This was 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) was 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

Interventions

Type	Name	Description
DRUG	KAE609	oral capsules administered in combination with KLU156
DRUG	SoC (Coartem)	Standard of Care
DRUG	KLU156	oral sachet formulation (KAF156+LUM-SDF) administered in combination with cipargamin (KAE609)

Timeline

• Start date: 2024-01-23
• Primary completion: 2025-03-05
• Completion: 2025-03-19
• First posted: 2025-11-19
• Last updated: 2026-03-13
• Results posted: 2026-03-13

Locations

3 sites across 3 countries: Côte d’Ivoire, Gabon, Kenya