CLINICAL TRIALS PROFILE FOR KAF156

Clinical Trials for KAF156

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01753323 ↗	Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection	Completed	Novartis Pharmaceuticals	Phase 2	This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAF156 at 400 mg/day (Part 1) and single dosing with KAF156 at 800mg (Part 2)
NCT03167242 ↗	Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria	Completed	Medicines for Malaria Venture	Phase 2	This study aims to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in adult/adolescent and pediatric patients with uncomplicated P. falciparum malaria. There is unmet medical need for anti-malarial treatment with new mechanism of action to reduce probability of developing resistance, and for duration shorter than 3 days of treatment and/or reduced pill burden.
NCT03167242 ↗	Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria	Completed	Novartis Pharmaceuticals	Phase 2	This study aims to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in adult/adolescent and pediatric patients with uncomplicated P. falciparum malaria. There is unmet medical need for anti-malarial treatment with new mechanism of action to reduce probability of developing resistance, and for duration shorter than 3 days of treatment and/or reduced pill burden.
NCT04072302 ↗	Safety and Causal Prophylactic Efficacy of KAF156 in a Controlled Human Malaria Challenge Model	Completed	Novartis Pharmaceuticals	Phase 1	This study is designed to investigate the safety and causal prophylactic efficacy of KAF156 in healthy subjects using a controlled human malaria infection model.
NCT04546633 ↗	Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria	Recruiting	European and Developing Countries Clinical Trials Partnership (EDCTP)	Phase 2	This study aims to determine the efficacy, safety and tolerability of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in pediatric patients (6 months to < 18 years of age) with uncomplicated P. falciparum malaria. There is an unmet medical need for anti-malarial treatment with a new mechanism of action to reduce the probability of developing resistance, and for a duration shorter than 3 days of treatment and/or reduced pill burden.
NCT04546633 ↗	Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria	Recruiting	Novartis Pharmaceuticals	Phase 2	This study aims to determine the efficacy, safety and tolerability of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in pediatric patients (6 months to < 18 years of age) with uncomplicated P. falciparum malaria. There is an unmet medical need for anti-malarial treatment with a new mechanism of action to reduce the probability of developing resistance, and for a duration shorter than 3 days of treatment and/or reduced pill burden.

Clinical Trial Conditions for KAF156

Condition Name

Condition Name for
Intervention	Trials
Malaria	5
Uncomplicated Plasmodium Falciparum Malaria	2
Acute Uncomplicated Plasmodium Falciparum Malaria	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Malaria	8
Malaria, Falciparum	3
Body Weight	1
Malaria, Vivax	1

Clinical Trial Locations for KAF156

Trials by Country

Trials by Country for
Location	Trials
Burkina Faso	2
Mali	2
Vietnam	2
Thailand	2
Gabon	2

Trials by US State

Trials by US State for
Location	Trials
Washington	1

Clinical Trial Progress for KAF156

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	3
Phase 1	4

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Not yet recruiting	4
Completed	3
Recruiting	1

Clinical Trial Sponsors for KAF156

Sponsor Name

Sponsor Name for
Sponsor	Trials
Novartis Pharmaceuticals	8
Medicines for Malaria Venture	4
European and Developing Countries Clinical Trials Partnership (EDCTP)	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	8
Other	6