Uncomplicated Plasmodium Falciparum MalariaPhase 2PLATINUMNCT07235033
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2)
A Phase 2 study testing KAE609, SoC (Coartem) and KLU156 in people with Uncomplicated Plasmodium Falciparum Malaria, run by Novartis Pharmaceuticals at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Uncomplicated Plasmodium Falciparum Malaria
- What is being tested?
- KAE609, SoC (Coartem) and KLU156
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 23 Jan 2024to 19 Mar 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients ≥12 years of age at screening.
- 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.
- Patients must weigh between 35 kg and 90 kg at screening.
- Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.
Who cannot join
- 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
- Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level < 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening
- 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
Show all 13Show fewer
- Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.
- 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.
- 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
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: 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
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.
Read the 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.
- Being tested
- KAE609, SoC (Coartem), KLU156
- Keywords
- single dose cure malaria, uncomplicated malaria, Plasmodium falciparum, platform study, PLATINUM
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAE609Drug
Also called Cipargamin
oral capsules administered in combination with KLU156
SoC (Coartem)Drug
Also called Coartem
Standard of Care
KLU156Drug
Also called ganaplacide + lumefantrine solid dispersion formulation
oral sachet formulation (KAF156+LUM-SDF) administered in combination with cipargamin (KAE609)
| Study group | Role | What they receive |
|---|---|---|
| Cohort B2: KLU156 400/480 mg + KAE609 75 mg | Experimental | KLU156 [(400 mg KAF156, 480 mg Lumefantrine (LUM)-solid dispersion formulation (SDF)] + KAE609 75 mg was administered orally with light meal as a single dose. Receives: Drug: KAE609; Drug: KLU156 |
| Cohort B2: SoC (Artemether 80 mg + lumefantrine 480 mg) | Active comparator | Artemether 80 mg + lumefantrine 480 mg was administered twice a day for 3 days with a standard meal or drink rich in fat within 30 min of dosing, as per label. Receives: Drug: SoC (Coartem) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polymerase Chain Reaction (PCR) Corrected Adequate Clinical and Parasitological Response (ACPR)
ACPR is defined as absence of parasitaemia (PS) on Study Day 29 regardless of axillary temperature, in patients who have not previously met any of the criteria of Early Treatment Failure (ETF), Late Clinical Failure (LCF), or Late Parasitological Failure (LPF). A patient was considered as PCR-corrected ACPR at Day 29 when the patient did not meet any of the criteria of ETF (up to Day 4), LCF (Day 5 to Day 29), or LPF (Day 8 to Day 29), and was absence of PS on Day 29, unless the presence of PS detected after 7 days (Day 8 or later) was due to reinfection. The presence of PS after 7 days of treatment initiation was considered as a reinfection only when the PS had cleared before Day 8, and none of the parasite strain(s) detected on or after Day 8 matched with the parasite strain at baseline.
Measured: Day 29
Secondary outcomes (11)
Parasite Clearance Time (PCT)
PCT is defined as time after administration of study drug until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. PCT was calculated using the Kaplan-Meier method.
Measured: up to Day 7
PCR Uncorrected Adequate Clinical and Parasitological Response (ACPR)
ACPR is defined as absence of parasitaemia (PS) on Study Day 29 regardless of axillary temperature, in patients who have not previously met any of the criteria of Early Treatment Failure (ETF), Late Clinical Failure (LCF), or Late Parasitological Failure (LPF). Treatment failures after 7 days due to reinfection were considered as failure for PCR- uncorrected analyses.
Measured: Day 29
Maximum Observed Plasma Concentration (Cmax)
Cmax is the maximum (peak) observed plasma concentration of the drug after dose administration. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method.
Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tmax is the time to reach maximum (peak) of the drug plasma concentration after single-dose administration (time). Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method.
Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.
Area Under Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24h)
The AUC from time zero to the 24-hour postdose sampling time. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method.
Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
Measured: Pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours post dose.
Area Under Plasma Concentration-time Curve From Time 0 to 48 Hours (AUC0-48h)
The AUC from time zero to the 48-hour postdose sampling time. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method.
Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.
Area Under Plasma Concentration-time Curve (AUClast)
AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of the drug. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method.
Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours post dose.
Area Under Plasma Concentration-time Curve (AUC[0-inf])
AUC[0-inf] is the area under the plasma concentration-time curve from time zero extrapolated to infinity. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method.
Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨. PK parameters derived from AUCinf (AUCinf, CL/F and Vz/F) cannot be reported for patients for whom the extrapolated area under the curve (AUCextrapolated) is more than 20%.
Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours post dose.
Terminal Elimination Half-life (T1/2)
T1/2 is the elimination half-life associated with the terminal slope. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method.
Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours post dose.
Apparent Clearance (CL/F)
CL/F is the apparent total body clearance of the drug from plasma following extravascular administration. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method.
Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨. PK parameters derived from AUCinf (AUCinf, CL/F and Vz/F) cannot be reported for patients for whom the extrapolated area under the curve (AUCextrapolated) is more than 20%.
Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.
Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F)
Vz/F is the apparent volume of distribution during terminal elimination phase following extravascular administration of the drug. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method.
Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨. PK parameters derived from AUCinf (AUCinf, CL/F and Vz/F) cannot be reported for patients for whom the extrapolated area under the curve (AUCextrapolated) is more than 20%.
Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start23 Jan 2024
- Primary completion5 Mar 2025
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uncomplicated Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235033
- Sponsor's protocol ID
- CADPT13A12201_B2
- Acronym
- PLATINUM
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2025
- Last updated
- 7 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed 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 review 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 availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07235033
- Acronym / sponsor ID
- PLATINUM / CADPT13A12201_B2
- Keywords
- single dose cure malaria, uncomplicated malaria, Plasmodium falciparum, platform study, PLATINUM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Posted 13 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort B2: KLU156 400/480 mg + KAE609 75 mg | Experimental | Drug: KAE609, Drug: KLU156KLU156 [(400 mg KAF156, 480 mg Lumefantrine (LUM)-solid dispersion formulation (SDF)] + KAE609 75 mg was administered orally with light meal as a single dose. |
| Cohort B2: SoC (Artemether 80 mg + lumefantrine 480 mg) | Active comparator | Drug: SoC (Coartem)Artemether 80 mg + lumefantrine 480 mg was administered twice a day for 3 days with a standard meal or drink rich in fat within 30 min of dosing, as per label. |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients ≥12 years of age at screening.
- 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.
- Patients must weigh between 35 kg and 90 kg at screening.
- Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.
Key exclusion criteria (13 listed)
- 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
- Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level < 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening
- 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:
- Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KAE609Also: Cipargaminoral capsules administered in combination with KLU156 | Drug | Cohort B2: KLU156 400/480 mg + KAE609 75 mg |
| SoC (Coartem)Also: CoartemStandard of Care | Drug | Cohort B2: SoC (Artemether 80 mg + lumefantrine 480 mg) |
| KLU156Also: ganaplacide + lumefantrine solid dispersion formulationoral sachet formulation (KAF156+LUM-SDF) administered in combination with cipargamin (KAE609) | Drug | Cohort B2: KLU156 400/480 mg + KAE609 75 mg |
Primary outcome
Polymerase Chain Reaction (PCR) Corrected Adequate Clinical and Parasitological Response (ACPR)
Time frame: Day 29
ACPR is defined as absence of parasitaemia (PS) on Study Day 29 regardless of axillary temperature, in patients who have not previously met any of the criteria of Early Treatment Failure (ETF), Late Clinical Failure (LCF), or Late Parasitological Failure (LPF). A patient was considered as PCR-corrected ACPR at Day 29 when the patient did not meet any of the criteria of ETF (up to Day 4), LCF (Day 5 to Day 29), or LPF (Day 8 to Day 29), and was absence of PS on Day 29, unless the presence of PS detected after 7 days (Day 8 or later) was due to reinfection. The presence of PS after 7 days of treatment initiation was considered as a reinfection only when the PS had cleared before Day 8, and none of the parasite strain(s) detected on or after Day 8 matched with the parasite strain at baseline.
11 secondary outcomes
Parasite Clearance Time (PCT)
Time frame: up to Day 7
PCR Uncorrected Adequate Clinical and Parasitological Response (ACPR)
Time frame: Day 29
Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.
Area Under Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24h)
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours post dose.
Area Under Plasma Concentration-time Curve From Time 0 to 48 Hours (AUC0-48h)
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.
Area Under Plasma Concentration-time Curve (AUClast)
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours post dose.
Area Under Plasma Concentration-time Curve (AUC[0-inf])
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours post dose.
Terminal Elimination Half-life (T1/2)
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours post dose.
Apparent Clearance (CL/F)
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.
Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F)
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Novartis is committed 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 review 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 availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KAE609, SoC (Coartem) and KLU156 in people with Uncomplicated Plasmodium Falciparum Malaria, run by Novartis Pharmaceuticals at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Côte d’Ivoire, Gabon, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polymerase Chain Reaction (PCR) Corrected Adequate Clinical and Parasitological Response (ACPR) (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.