Uncomplicated Plasmodium Falciparum MalariaPhase 2PLATINUMNCT05750628
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria
A Phase 2 study testing INE963, KAE609 (Cipargamin) and SoC (Coartem) in people with Uncomplicated Plasmodium Falciparum Malaria, run by Novartis Pharmaceuticals at 12 sites in 6 countries.
Trial summary
Platform study to evaluate the efficacy and safety of anti-malarial agents in patients with uncomplicated Plasmodium falciparum malaria Read more about this study
- Who is it for?
- Ages 2 to 100 years
- Conditions the study is for
- Uncomplicated Plasmodium Falciparum Malaria
- What is being tested?
- INE963, KAE609 (Cipargamin) and SoC (Coartem)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 23 Jan 2024to 23 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 2 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients ≥18 years of age for Part A, ≥12 years of age for Part B and 2 to <12 years of age for Part C at screening.
- Patients must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 5,000 to 150,000 asexual parasite count/μl of blood for P. falciparum for Part A and between 1,000 to 150,000 asexual parasite count/μl of blood for Parts B and C.
- Patients in Part A must weigh between 40 kg and 90 kg. Patients in Part B must weigh between 35 kg and 90 kg at screening. Patients in Part C must weigh at least 10 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
12 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
12 sites in 6 countries
Burkina Faso2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Banfora
- Recruiting
Novartis Investigative Site
Nanoro, BP 18
Côte d’Ivoire2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Abidjan, 13BP972
- Recruiting
Novartis Investigative Site
Azaguié, BP 173
Gabon2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Lambaréné, BP 242
- Recruiting
Novartis Investigative Site
Libreville, BP 1437
Ghana2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Kintampo, 92037
- Recruiting
Novartis Investigative Site
Navrango, VWJ6+8WF
Kenya2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Ahero, Kisumu County, 40100
- Recruiting
Novartis Investigative Site
Kisumu, 40100
Uganda2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Kampala
- Recruiting
Novartis Investigative Site
Tororo, 10102
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 Patients With Uncomplicated Plasmodium Falciparum Malaria
Platform study to evaluate the efficacy and safety of anti-malarial agents in patients with uncomplicated Plasmodium falciparum malaria
Read the detailed description
The purpose of this platform study is to evaluate the parasiticidal effect and potential for cure with different anti-malarial agents administered as monotherapy and/or in combination therapy with other anti-malarial agents in adults, adolescents, and children with uncomplicated Plasmodium falciparum malaria. Additionally, the safety, tolerability, and pharmacokinetics of these anti-malarial agents will be evaluated for dose selection for future studies.
- Being tested
- INE963, KAE609 (Cipargamin), SoC (Coartem), KLU156
- Keywords
- malaria, uncomplicated malaria, Plasmodium falciparum, platform study, PLATINUM
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INE963Drug
oral INE963
KAE609 (Cipargamin)Drug
oral KAE609 (Cipargamin)
SoC (Coartem)Drug
SoC (Coartem)
KLU156Drug
oral sachet KLU156 (KAF156 + lumefantrine)
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1: Dose Level 1 INE963 | Experimental | Cohort A1: Dose Level 1 INE963 Receives: Drug: INE963 |
| Cohort A1: Dose Level 2 INE963 | Experimental | Cohort A1: Dose Level 2 INE963 Receives: Drug: INE963 |
| Cohort A1: Dose Level 3 INE963 | Experimental | Cohort A1: Dose Level 3 INE963 Receives: Drug: INE963 |
| Cohort B1: Cipargamin + INE963 | Experimental | Cohort B1: Cipargamin + INE963 Receives: Drug: KAE609 (Cipargamin) |
| Cohort B1: SoC (Coartem) | Active comparator | Cohort B1: SoC (Coartem) Receives: Drug: SoC (Coartem) |
| Cohort B2: Cipargamin + KLU156 | Experimental | Cohort B2: Cipargamin + KLU156 Receives: Drug: KAE609 (Cipargamin); Drug: KLU156 |
| Cohort B2: SoC (Coartem) | Active comparator | Cohort B2: SoC (Coartem) Receives: Drug: SoC (Coartem) |
| Cohort C2: Cipargamin + KLU156 | Experimental | Cohort C2: Cipargamin + KLU156 Receives: Drug: KAE609 (Cipargamin); Drug: KLU156 |
| Cohort C2: SoC (Coartem) | Active comparator | Cohort C2: SoC (Coartem) Receives: Drug: SoC (Coartem) |
| Cohort A1: Dose Level 4 INE963 | Experimental | Cohort A1: Dose level 4 INE963 Receives: Drug: INE963 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: parasite clearance time (PCT)
Part A: To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in patients with uncomplicated P. falciparum malaria. PCT is defined as the time from the first positive blood slide at inclusion to the time of the first negative slide followed by two consecutive slides.
Measured: up to Day 7
Part B and C: polymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR)
Part B and C: To assess the 28-day cure rate of an anti malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria. ACPR is defined as the absence of parasitemia on Study Day 29 irrespective of axillary temperature, without previously meeting any of the criteria of Early Treatment Failure (ETF) or Late Clinical Failure (LCF) or Late Parasitological Failure (LPF).
Measured: Day 29
Secondary outcomes (11)
Part A: PCR-corrected and uncorrected ACPR
Part A: To assess the 28-day cure rate of an anti malarial agent administered orally as monotherapy in patients with uncomplicated P. falciparum malaria
Measured: Day 29
Parts B and C: PCT
Part B and C: To assess the parasite clearance time (PCT) of oral combinations of anti malarial agents versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria
Measured: up to Day 7
Parts B and C: PCR-uncorrected ACPR
Part B and C: To assess the 28-day cure rate of an anti malarial agent administered orally as combination therapy versus the SoC in patients with uncomplicated P. falciparum malaria
Measured: Day 29
Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast) of the anti-malarial agents (wherever possible)
To characterize the pharmacokinetics (PK) of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Parts B and C] in patients with uncomplicated P. falciparum malaria. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sample time (tlast)
Measured: Day 22
Area under the concentration-time curve from time zero to infinity (AUCinf) of the anti-malarial agents (wherever possible)
To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Parts B and C] in patients with uncomplicated P. falciparum malaria. AUCinf is the AUC from time zero to infinity.
Measured: Day 22
Maximum observed concentration (Cmax) of the anti-malarial agents
To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Parts B and C] in patients with uncomplicated P. falciparum malaria. Cmax is the maximum (peak) observed plasma, blood, serum, or other blood fluid drug concentration after single dose administration.
Measured: Day 22
Time to reach maximum observed concentration (Tmax)
To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Parts B and C] in patients with uncomplicated P. falciparum malaria. Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration.
Measured: Day 22
Elimination half-life (T1/2) of the anti-malarial agents (wherever possible)
To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Parts B and C] in patients with uncomplicated P. falciparum malaria. T1/2 is the elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve.
Measured: Day 22
Total body clearance (CL/F) of the anti-malarial agents (wherever possible)
To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Parts B and C] in patients with uncomplicated P. falciparum malaria. Cl/F is the total body clearance of drug from the plasma.
Measured: Day 22
Apparent volume of distribution (V/F) of the anti-malarial agents (wherever possible)
To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Parts B and C] in patients with uncomplicated P. falciparum malaria. V/F is the apparent volume of distribution during terminal phase.
Measured: Day 22
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs), and laboratory results qualifying and reported as AEs.
Measured: Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start23 Jan 2024
- Primary completion9 Jun 2026 (estimated)
- Study completion23 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 327 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750628
- Sponsor's protocol ID
- CADPT13A12201
- Acronym
- PLATINUM
- Status last verified
- Jul 2025
- First submitted
- 17 Feb 2023
- Last updated
- 30 Jul 2025
- Results posted
- No
- 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 30 Jul 2025. 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 Patients With Uncomplicated Plasmodium Falciparum Malaria
- ClinicalTrials.gov ID
- NCT05750628
- Acronym / sponsor ID
- PLATINUM / CADPT13A12201
- Keywords
- malaria, uncomplicated malaria, Plasmodium falciparum, platform study, PLATINUM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 327 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 9 Jun 2026 (estimated)
- Study completion
- 23 Jun 2026 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Platform study to evaluate the efficacy and safety of anti-malarial agents in patients with uncomplicated Plasmodium falciparum malaria
Detailed description
The purpose of this platform study is to evaluate the parasiticidal effect and potential for cure with different anti-malarial agents administered as monotherapy and/or in combination therapy with other anti-malarial agents in adults, adolescents, and children with uncomplicated Plasmodium falciparum malaria. Additionally, the safety, tolerability, and pharmacokinetics of these anti-malarial agents will be evaluated for dose selection for future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort A1: Dose Level 1 INE963 | Experimental | Drug: INE963Cohort A1: Dose Level 1 INE963 |
| Cohort A1: Dose Level 2 INE963 | Experimental | Drug: INE963Cohort A1: Dose Level 2 INE963 |
| Cohort A1: Dose Level 3 INE963 | Experimental | Drug: INE963Cohort A1: Dose Level 3 INE963 |
| Cohort B1: Cipargamin + INE963 | Experimental | Drug: KAE609 (Cipargamin)Cohort B1: Cipargamin + INE963 |
| Cohort B1: SoC (Coartem) | Active comparator | Drug: SoC (Coartem)Cohort B1: SoC (Coartem) |
| Cohort B2: Cipargamin + KLU156 | Experimental | Drug: KAE609 (Cipargamin), Drug: KLU156Cohort B2: Cipargamin + KLU156 |
| Cohort B2: SoC (Coartem) | Active comparator | Drug: SoC (Coartem)Cohort B2: SoC (Coartem) |
| Cohort C2: Cipargamin + KLU156 | Experimental | Drug: KAE609 (Cipargamin), Drug: KLU156Cohort C2: Cipargamin + KLU156 |
| Cohort C2: SoC (Coartem) | Active comparator | Drug: SoC (Coartem)Cohort C2: SoC (Coartem) |
| Cohort A1: Dose Level 4 INE963 | Experimental | Drug: INE963Cohort A1: Dose level 4 INE963 |
Who may qualify
- Ages
- 2 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients ≥18 years of age for Part A, ≥12 years of age for Part B and 2 to <12 years of age for Part C at screening.
- Patients must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 5,000 to 150,000 asexual parasite count/μl of blood for P. falciparum for Part A and between 1,000 to 150,000 asexual parasite count/μl of blood for Parts B and C.
- Patients in Part A must weigh between 40 kg and 90 kg. Patients in Part B must weigh between 35 kg and 90 kg at screening. Patients in Part C must weigh at least 10 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 |
|---|---|---|
| INE963oral INE963 | Drug | Cohort A1: Dose Level 1 INE963, Cohort A1: Dose Level 2 INE963, Cohort A1: Dose Level 3 INE963, Cohort A1: Dose Level 4 INE963 |
| KAE609 (Cipargamin)oral KAE609 (Cipargamin) | Drug | Cohort B1: Cipargamin + INE963, Cohort B2: Cipargamin + KLU156, Cohort C2: Cipargamin + KLU156 |
| SoC (Coartem)SoC (Coartem) | Drug | Cohort B1: SoC (Coartem), Cohort B2: SoC (Coartem), Cohort C2: SoC (Coartem) |
| KLU156oral sachet KLU156 (KAF156 + lumefantrine) | Drug | Cohort B2: Cipargamin + KLU156, Cohort C2: Cipargamin + KLU156 |
Primary outcome
Part A: parasite clearance time (PCT)
Time frame: up to Day 7
Part A: To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in patients with uncomplicated P. falciparum malaria. PCT is defined as the time from the first positive blood slide at inclusion to the time of the first negative slide followed by two consecutive slides.
Part B and C: polymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR)
Time frame: Day 29
Part B and C: To assess the 28-day cure rate of an anti malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria. ACPR is defined as the absence of parasitemia on Study Day 29 irrespective of axillary temperature, without previously meeting any of the criteria of Early Treatment Failure (ETF) or Late Clinical Failure (LCF) or Late Parasitological Failure (LPF).
11 secondary outcomes
Part A: PCR-corrected and uncorrected ACPR
Time frame: Day 29
Parts B and C: PCT
Time frame: up to Day 7
Parts B and C: PCR-uncorrected ACPR
Time frame: Day 29
Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast) of the anti-malarial agents (wherever possible)
Time frame: Day 22
Area under the concentration-time curve from time zero to infinity (AUCinf) of the anti-malarial agents (wherever possible)
Time frame: Day 22
Maximum observed concentration (Cmax) of the anti-malarial agents
Time frame: Day 22
Time to reach maximum observed concentration (Tmax)
Time frame: Day 22
Elimination half-life (T1/2) of the anti-malarial agents (wherever possible)
Time frame: Day 22
Total body clearance (CL/F) of the anti-malarial agents (wherever possible)
Time frame: Day 22
Apparent volume of distribution (V/F) of the anti-malarial agents (wherever possible)
Time frame: Day 22
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 43
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- 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.
Novartis Pharmaceuticals contact
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INE963, KAE609 (Cipargamin) and SoC (Coartem) in people with Uncomplicated Plasmodium Falciparum Malaria, run by Novartis Pharmaceuticals at 12 sites in 6 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: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Burkina Faso, Côte d’Ivoire, Gabon, Ghana, Kenya and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: parasite clearance time (PCT) (time frame: up to Day 7). The study lists 2 primary outcomes in all. 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 30 Jul 2025.