Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria (KALUMI)

A Phase 2 Interventional, Multicenter, Randomized, Open-label Study in Three Age-descending Cohorts to Evaluate Efficacy, Safety and Tolerability of KAF156 and Lumefantrine-SDF Combination in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in a Pediatric Population

This study aimed 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.

Study Overview

• Status: Completed
• Conditions: Uncomplicated Plasmodium Falciparum Malaria
• Intervention / Treatment: Drug: KAF156; Drug: LUM-SDF; Drug: Coartem

Detailed Description

This Phase 2 study aimed to evaluate the efficacy, safety and tolerability of the investigational drug KAF156 and a Solid Dispersion Formulation of lumefantrine (LUM-SDF) when administered in combination in pediatric patients 6 months to < 18 years of age with uncomplicated Plasmodium falciparum malaria. In addition, pharmacokinetics (PK) of the drug combination was also evaluated.

There were three age-descending cohorts in the study: Run-in Cohort (12 years to < 18 years), Cohort 1 (2 years to < 12 years) and Cohort 2 (6 months to < 2 years). The rationale for separated cohorts 1 and 2 was to allow enrolment of the youngest patients (cohort 2) after safety and exposure review of older patients in cohort 1. Given the age-independent symptoms of acute malaria, and to increase statistical power, for all outcomes measures the cohorts 1 and 2 were pooled (cohort 1/2). This new study first explored the effect of food on lumefantrine and KAF156 pharmacokinetics (PK) in patients 12 to < 18 years old with malaria caused by P. falciparum. Based on the data from the Run-in Cohort, recommendation on dose, dosing regimen, dosage administration (with food) and duration were provided before younger patients in Cohorts 1 and 2 were dosed with KAF156/LUM-SDF. Then, efficacy, safety, tolerability and PK of the combination of KAF156/LUM-SDF in comparison with Coartem®(Artemether/Lumefantrine) were evaluated in younger patients, in pooled Cohort 1/2.

• Study Type: Interventional
• Enrollment (Actual): 295
• Phase: Phase 2

Contacts and Locations

Study Locations

• Burkina Faso
  • Banfora, Burkina Faso
    • Novartis Investigative Site
  • Bobo-Dioulasso, Burkina Faso, 01
    • Novartis Investigative Site
  • Ouagadougou, Burkina Faso
    • Novartis Investigative Site
  • Sabou, Burkina Faso, 06 BP 10248
    • Novartis Investigative Site
• Côte d’Ivoire
  • Abidjan, Côte d’Ivoire, 13BP972
    • Novartis Investigative Site
• Gabon
  • Lambaréné, Gabon, BP 242
    • Novartis Investigative Site
• Mali
  • Kati, Mali
    • Novartis Investigative Site
  • Sotouba, Mali
    • Novartis Investigative Site
• Republic of the Congo
  • Du Haut Katanga
    • Lubumbashi, Du Haut Katanga, Republic of the Congo, 7010
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. In run-in cohort: Male and female patients 12 to < 18 years of age, with a body weight

   • 35.0 kg In Cohort 1: Male and female patients 2 to < 12 years of age, with a body weight ≥ 10.0 kg In Cohort 2: Male and female patients 6 months to < 2 years of age, with a body weight
   • 5.0 kg
2. Microscopic confirmation of P. falciparum by Giemsa-stained thick and thin films
3. P. falciparum parasitemia of ≥ 1,000 and ≤ 150,000 parasites/μL at the time of prescreening for the Run-in Cohort; and P. falciparum parasitemia of ≥ 1,500 and ≤ 150,000 parasites/μL at the time of pre-screening for Cohorts 1 and 2
4. Axillary temperature ≥ 37.5 ºC or oral/tympanic/rectal temperature ≥ 38.0 ºC; or history of fever during the previous 24 hours (at least documented verbally)
5. Written informed consent has been obtained from parent / legal guardian before any assessment is performed. If the parent/legal guardian is unable to read and write, then a witnessed consent according to local ethical standards is permitted. Patients who are capable of providing assent, must provide assent with parental/legal guardian consent or as per local ethical guidelines
6. The patient and his/her parent/legal guardian is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned

Exclusion Criteria:

1. Mixed Plasmodium infections as per light microscopy results
2. Signs and symptoms of severe malaria according to WHO 2015 (see Section 16.4)
3. Significant, non-plasmodial co-infections including tuberculosis
4. Patients with concurrent febrile illnesses (e.g., typhoid fever, known or suspected COVID19)
5. Known relevant liver disease e.g. chronic hepatitis, cirrhosis, compensated or decompensated, history of hepatitis B or C, hepatitis B or A vaccination in last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis
6. Major congenital defects
7. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection or family history of congenital or hereditary immunodeficiency
8. Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior to recruitment. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed)
9. Repeated vomiting (defined as more than 3 times in the 24 hours prior to inclusion in the study) or severe diarrhea (defined as more than 3 watery stools in the 24 hours prior to inclusion in the study)
10. Active duodenal ulcer, ulcerative colitis, Crohn's disease, chronic (i.e., > 2 weeks) use of non-steroidal anti-inflammatory drugs (NSAIDs)
11. Clinically relevant abnormalities of electrolyte balance which require correction, e.g., hypokalemia, hypocalcemia or hypomagnesemia
12. Anemia (hemoglobin level <7 g/dL)

13. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs (e.g., HIV patients on ART therapy or TB patients on treatment), or which may jeopardize the patient in case of participation in the study. The investigator should make this determination in consideration of the patient's medical history and/or clinical or laboratory evidence of any of the following:

    • 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
14. Resting QT interval corrected by Fridericia's formula (QTcF) > 450 ms at screening
15. Creatinine > 2 x ULN in the absence of dehydration. In case of dehydration, creatinine should be < 2 x ULN after oral/parenteral rehydration
16. Any severe disease condition which might prohibit participation in this study
17. Known chronic underlying disease such as sickle cell disease, and severe cardiac, renal, or hepatic impairment
18. Known active or uncontrolled thyroid disease
19. Inability to swallow oral medication (in tablet and/or liquid form)
20. Patients with prior antimalarial therapy or antibiotics with antimalarial activity within minimum of their five (5) plasma half-lives (or within 4 weeks of screening if half-life is unknown)
21. Use of other investigational drugs within 30 days of dosing or until the expected pharmacodynamic effect has returned to baseline, whichever is longer
22. Patients taking medications prohibited by the protocol
23. Previous participation in any malaria vaccine study or received malaria vaccine in any other circumstance within 3 months of dosing
24. History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc interval, such as history of symptomatic cardiac arrhythmias, clinically relevant bradycardia or severe heart disease
25. Use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of study

26. History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes

    For the Run-in Cohort only:

27. Pregnant or nursing (lactating) patients

28. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of investigational drug. Basic contraception methods include:

    • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
    • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
    • Male sterilization (at least 6 m prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient
    • Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps).

    Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug. Women are considered not of child bearing potential if they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.

    For Cohorts 1 and 2 only:

29. Patients of child bearing potential, defined as all girls post first menarche (except for Run-in Cohort)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Run-in - KAF156 and LUM-SDF QD for 2 days in fasted condition; KAF156 and LUM-SDF QD (once daily) for 2 days in fasted condition	Drug: KAF156; Provided as 100 mg tablets, to be taken QD 2 or 3 Days in combination with LUM-SDF, dose is based on body weight; Drug: LUM-SDF; Provided as 120 mg or 240 mg powder in sachet, to be taken QD 2 or 3 Days in combination with KAF156, dose is based on body weight; Other Names: Lumefantrine Solid Dispersion Formulation
Experimental: Run-in - KAF156 and LUM-SDF QD for 2 days in fed condition; KAF156 and LUM-SDF QD (once daily) for 2 days in fed condition	Drug: KAF156; Provided as 100 mg tablets, to be taken QD 2 or 3 Days in combination with LUM-SDF, dose is based on body weight; Drug: LUM-SDF; Provided as 120 mg or 240 mg powder in sachet, to be taken QD 2 or 3 Days in combination with KAF156, dose is based on body weight; Other Names: Lumefantrine Solid Dispersion Formulation
Experimental: Cohort 1/2 - KAF156 and LUM-SDF QD (once daily) in 3-day dose regimen; KAF156 and LUM-SDF QD (once daily) in 3-day dose regimen. It was administered with a light meal and the full dose was adjusted based on patient´s body weight.	Drug: KAF156; Provided as 100 mg tablets, to be taken QD 2 or 3 Days in combination with LUM-SDF, dose is based on body weight; Drug: LUM-SDF; Provided as 120 mg or 240 mg powder in sachet, to be taken QD 2 or 3 Days in combination with KAF156, dose is based on body weight; Other Names: Lumefantrine Solid Dispersion Formulation
Active Comparator: Cohort 1/2 - Coartem® BID (twice a day) for 3 days; Coartem® BID twice a day for 3 days (It was administered with a light meal and doses were based on patient's body weight as per product label).	Drug: Coartem; Coartem® (Artemether/Lumefantrine dispersible tablets 20/120mg in blister pack) (for Cohorts 1 and 2), dose is based on body weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) - Cohorts 1 and 2 Pooled	PCR-corrected ACPR, defined as the absence of parasitemia(PS), was evaluated on Day29. Microscopic species identification was confirmed and determined by PCR genotyping methods to establish malaria recrudescence/reinfection.A participant was considered as PCR corrected ACPR at Day29 if the participant did not meet any of the criteria of early treatment failure (up to Day4), late clinical failure(Day5 to Day29) or late parasitological failure(Day8 to Day29), and had absence of PS on Day29 irrespective of axillary temperature unless the presence of PS after 7days(Day8 or later) was due to reinfection based on PCR genotyping.A presence of PS after 7days of treatment initiation was considered as a reinfection only if the PS was clear before Day8 and none of the parasite strain(s) detected on Day8 or later match with the parasite strain at baseline based on PCR genotyping.Given the age-independent symptoms of acute malaria, and to increase statistical power,the cohorts 1 and 2 were pooled.	Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCR-corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR)	PCR-corrected ACPR, defined as the absence of parasitemia, was evaluated. Microscopic species identification was confirmed and determined by polymerase chain reaction (PCR) genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and had absence of parasitemia on Days 15, 29 or 43 irrespective of axillary temperature unless the presence of parasitemia after 7 days was due to reinfection based on PCR. A presence of parasitemia after 7 days of treatment initiation was considered as a reinfection only if the parasitemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).	Corrected ACPR: Day 15, Day 43; Uncorrected ACPR: Day 15, Day 29 and Day 43
PCR-corrected Adequate Clinical and Parasitological Response (ACPR) - Run-in Cohort	PCR-corrected ACPR, defined as the absence of parasitemia, was evaluated on Day 29. Microscopic species identification was confirmed and determined by polymerase chain reaction (PCR) genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR corrected ACPR at Day 29 if the participant did not meet any of the criteria of early treatment failure (ETF) (up to Day 4), late clinical failure (LCF) (Day 5 to Day 29) or late parasitological failure (LPF) (Day 8 to Day 29), and had absence of parasitaemia on Day 29 irrespective of axillary temperature unless the presence of parasitaemia after 7 days (Day 8 or later) was due to reinfection based on PCR genotyping. A presence of parasitaemia after 7 days of treatment initiation was considered as a reinfection only if the parasitaemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later match with the parasite strain at baseline based on PCR genotyping.	Day 29
Parasite Clearance Time (PCT)	PCT is defined as time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. PCT is based on uncorrected parasite counts. PCT was calculated using the Kaplan-Meier method. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).	up to 43 days
Fever Clearance Times (FCT)	FCT is defined as time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours. FCT was calculated using the Kaplan-Meier method. Participants who received any antimalarial medication (including rescue medication) before fever clearance are censored at the first use of antimalarial medication. Participants without fever clearance are censored at the time of last fever assessment. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).	up to 43 days
Percentage Early Treatment Failure (ETF)	Participants were defined as early treatment failures (ETFs) if they developed danger signs or severe malaria on Day 2, Day 3, or Day 4 in the presence of parasitemia, parasitemia on Day 3 with a count higher than the Day 1 count irrespective of axillary temperature, parasitemia on Day 4 with axillary temperature ≥ 37.5°C, or parasitemia on Day 4 with a count equal to or more than 25% of the count on Day 1. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).	From Day 1 to Day 4
Percentage Late Clinical Failure (LCF)	Participants were defined as late clinical failures (LCFs) if they developed danger signs or severe malaria on any day from Day 5 to Day 43 in the presence of parasitemia without previously meeting any of the criteria of ETF, or if they had parasitemia and an axillary temperature of ≥ 37.5°C on any day from Day 5 to Day 43 without previously meeting any of the criteria of ETF. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).	Day 5 to Day 43
Percentage Late Parasitological Failure (LPF)	Participants were defined as late parasitological failures (LPFs) if they had parasitemia on any day from Day 8 to Day 43 and an axillary temperature < 37.5°C without previously meeting any of the criteria of ETF or LCF. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).	Day 8 to Day 43
Number of Participants With Recrudescence Events	Recrudescence is defined as appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at baseline. Recrudescence had to be confirmed by PCR analysis. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).	Day 15, Day 29 and Day 43
Number of Participants With New Infections Events	New infection is defined as appearance of asexual parasites after clearance of initial infection with a genotype different from those parasites present at baseline. New infection had to be confirmed by PCR analysis. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).	Day 15, Day 29 and Day 43
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).	Adverse events were reported from first dose of study treatment until end of study treatment up to a maximum duration of approximately 43 days.
KAF156 and Lumefantrine (LUM) Cmax	Cmax is the maximum observed plasma concentration following drug administration. PK parameters are calculated from plasma concentration-time data using non-compartmental methods. Analyte KAF156 is not applicable for Artemether80mg/LUM480mg arm.	Run-in Cohort:Pre-dose,1,3,4,5,6,8,24,25,27,28,29,30,32,48,72,168 hours; Cohort 1 and 2 KAF400mg/LUM480mg-QDx3 6-12 years: 3,6,24,48,51,54,72,168 hours; 6 months -<6 years:24,48,51,54,72,168 hours;Cohort 1 and 2 Artemether80mg/LUM480mg:24,48,68,168 hours
KAF156 and Lumefantrine Area Under Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast)	AUC is the area under the plasma concentration-time curve. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The Artemether80mg/LUM480mg arms (standard of care) involved limited pharmacokinetic sampling at 24, 48, 68, and 168 hours following the first dose administration. In contrast, the KAF156 arms had a more extensive sampling, varying by age group, which included time points at 3, 6, 24, 48, 51, 54, 72, and 168 hours following first dose. Due to the limited sampling in the Artemether80mg/LUM480mg arms, it was not planned (per protocol) to calculate AUC values.	Run-in Cohort:Pre-dose,1,3,4,5,6,8,24,25,27,28,29,30,32,48,72,168 hours; Cohort 1 and 2 KAF400mg/LUM480mg-QDx3 6-12 years: 3,6,24,48,51,54,72,168 hours; 6 months -< 6 years: 24,48,51,54,72,168 hours.
KAF156 and Lumefantrine Time to Reach the Maximum Plasma Concentration After Drug Administration (Tmax)	Tmax is the time to reach maximum plasma concentration following drug administration. PK parameters are calculated from plasma concentration-time data using non-compartmental methods. The Artemether80mg/LUM480mg arms (standard of care) involved limited pharmacokinetic sampling at 24, 48, 68, and 168 hours following the first dose administration. In contrast, the KAF156 arm had a more extensive sampling, varying by age group, which included time points at 3, 6, 24, 48, 51, 54, 72, and 168 hours following first dose. PK samples for the Artemether80mg/LUM480mg arms were collected around the expected Tmax (at 68 hours, i.e., 8 hours after the last dose, based on the known Tmax of lumefantrine in Coartem) to determine Cmax values; in line with the protocol, separate Tmax values were not calculated.	Run-in Cohort:Pre-dose,1,3,4,5,6,8,24,25,27,28,29,30,32,48,72,168 hours; Cohort 1 and 2 KAF400mg/LUM480mg-QDx3 6-12 years: 3,6,24,48,51,54,72,168 hours; 6 months -< 6 years: 24,48,51,54,72,168 hours.
KAF156 and Lumefantrine Plasma Drug Concentration 168 Hours Post First Dose Administration (C168h)	C168h is the plasma concentration at 168h post first dose administration. PK parameters are calculated from plasma concentration-time data using non-compartmental methods. Analyte KAF156 is not applicable for Artemether80mg/LUM480mg arm.	at 168 hours

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Collaborators: European and Developing Countries Clinical Trials Partnership (EDCTP)
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Ogutu B, Yeka A, Kusemererwa S, Thompson R, Tinto H, Toure AO, Uthaisin C, Verma A, Kibuuka A, Lingani M, Lourenco C, Mombo-Ngoma G, Nduba V, N'Guessan TL, Nassa GJW, Nyantaro M, Tina LO, Singh PK, El Gaaloul M, Marrast AC, Chikoto H, Csermak K, Demin I, Mehta D, Pathan R, Risterucci C, Su G, Winnips C, Kaguthi G, Fofana B, Grobusch MP. Ganaplacide (KAF156) plus lumefantrine solid dispersion formulation combination for uncomplicated Plasmodium falciparum malaria: an open-label, multicentre, parallel-group, randomised, controlled, phase 2 trial. Lancet Infect Dis. 2023 Sep;23(9):1051-1061. doi: 10.1016/S1473-3099(23)00209-8. Epub 2023 Jun 13.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Actual): August 13, 2024
• Study Completion (Actual): August 28, 2024

Study Registration Dates

• First Submitted: September 5, 2020
• First Submitted That Met QC Criteria: September 5, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: children; Plasmodium falciparum malaria; KAF156; Lumefantrine Solid Dispersion Formulation; LUM-SDF
• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Infections; Protozoan Infections; Parasitic Diseases; Malaria; Malaria, Falciparum; Organic Chemicals; Pharmaceutical Preparations; Hydrocarbons; Hydrocarbons, Cyclic; Terpenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Inorganic Chemicals; Drug Combinations; Reactive Oxygen Species; Free Radicals; Artemether; Artemisinins; Lumefantrine; Fluorenes; Sesquiterpenes; Artemether, Lumefantrine Drug Combination; ganaplacide
• Other Study ID Numbers: CKAF156A2203; 2021-003583-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is commited to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No