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NCT04546633: KALUMI
Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria
Phase 2 trial testing KAF156 in Uncomplicated Plasmodium Falciparum Malaria in 295 participants. Completed in 28 August 2024.
13 August 2024
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 295 |
| Start date | 16 February 2021 |
| Primary completion | 13 August 2024 |
| Estimated completion | 28 August 2024 |
| Sites | 9 locations across Mali, Burkina Faso, Gabon, Democratic Republic of the Congo, Côte d’Ivoire |
Drugs / interventions tested
- KAF156 — full drug profile →
- LUM-SDF — full drug profile →
- Coartem (LUMEFANTRINE) — full drug profile →
Conditions studied
- Uncomplicated Plasmodium Falciparum Malaria — all drugs for Uncomplicated Plasmodium Falciparum Malaria →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
Adults 6 Months to 17, any sex, with Uncomplicated Plasmodium Falciparum Malaria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Ganaplacide (KAF156) plus lumefantrine solid dispersion formulation combination for uncomplicated Plasmodium falciparum malaria: an open-label, multicentre, parallel-group, randomised, controlled, phase 2 trial.
Ogutu B, Yeka A, Kusemererwa S, Thompson R, et al · · 2023 · cited 34× · PMID 37327809 · DOI 10.1016/s1473-3099(23)00209-8 -
Genomic and Genetic Approaches to Studying Antimalarial Drug Resistance and Plasmodium Biology.
Okombo J, Kanai M, Deni I, Fidock DA. · · 2021 · cited 19× · PMID 33715941 · DOI 10.1016/j.pt.2021.02.007 -
Scoping Review of Antimalarial Drug Candidates in Phase I and II Drug Development.
Abd-Rahman AN, Zaloumis S, McCarthy JS, Simpson JA, et al · · 2022 · cited 15× · PMID 34843390 · DOI 10.1128/aac.01659-21 -
Pharmacokinetics of Ganaplacide and Lumefantrine in Adults, Adolescents, and Children with Plasmodium falciparum Malaria Treated with Ganaplacide Plus Lumefantrine Solid Dispersion Formulation: Analysis of Data from a Multinational Phase 2 Study.
Sangana R, Ogutu B, Yeka A, Kusemererwa S, et al · · 2025 · cited 6× · PMID 39344281 · DOI 10.1002/jcph.6138
Verify or expand the search:
- PubMed search for NCT04546633
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of KAF156
Trials testing the same drug.
- NCT03167242 — Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparu · Phase 2 · completed
- NCT04072302 — Safety and Causal Prophylactic Efficacy of KAF156 in a Controlled Human Malaria Challenge Model · Phase 1 · completed
Other recruiting trials for Uncomplicated Plasmodium Falciparum Malaria
Currently open trials in the same condition.
- NCT05951595 — A Study to Find Out if a Combination of 3 Medicines for the Treatment of Malaria Works as Well and is as Safe and Tolera · Phase 3 · recruiting
- NCT05750628 — Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Fal · Phase 2 · recruiting
- NCT05764746 — Triple Artemisinin-based Combination Therapy for Delaying Drug Resistance Development - a Randomized Clinical Trial · Phase 2, PHASE3 · recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04546633 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 25 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04546633.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing