Sickle Cell AnemiaPhase 2NCT02961218
Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia
A Phase 2 study testing ACZ885 in people with Sickle Cell Anemia, run by Novartis Pharmaceuticals at 15 sites in 7 countries.
Trial summary
The study assesses the efficacy, safety and tolerability of ACZ885 (canakinumab) in pediatric and young adult patients with sickle cell anemia (SCA). Read more about this study
- Who is it for?
- Ages 8 to 20 years
- Conditions the study is for
- Sickle Cell Anemia
- What is being tested?
- ACZ885
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 15 sitesin 7 countries
- Study dates
- 5 Apr 2017to 27 Apr 2020
- 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 8 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female subjects ages 8-20 years of age (both inclusive) diagnosed with sickle cell anemia (HbSS) or sickle beta0 thalassemia (documented by family studies, or analysis of either hemoglobin or DNA).
- Patient's written informed consent from those ≥18 years of age must be obtained before any assessment is performed. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients < 18 years of age.
- Detectable baseline of background or episodic pain measured by daily e-diary over 1 to 2 weeks during screening period as defined below: Average daily pain score ≥ 1 cm without analgesic use over a period of at least 7 days and/or, At least one episode of pain requiring analgesic use during a period of up to 14 days.
- History of ≥2 vaso-occlusive pain episodes in the past year, as defined as pain with no other, non-sickle cell identifiable cause that requires analgesia and interferes with the patient's normal daily routine.
Who cannot join
- History of known hypersensitivity to canakinumab.
- Ongoing or treatment with the past 3 months with red blood cell transfusion therapy, or have evidence of iron overload requiring chelation therapy.
- Transcranial Doppler ultrasound in the past year or at screening in patients with an accessible transtemporal window, demonstrating velocity in middle or anterior cerebral or internal carotid artery ≥200 cm/sec.
- Administration of any other blood products within 3 weeks of screening visit.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
15 sites in 7 countries.
15 sites in 7 countries
United Kingdom5 sites
Novartis Investigative Site
London, E1 1BB
Novartis Investigative Site
London, NW1 2BU
Novartis Investigative Site
London, SE1 7EH
Novartis Investigative Site
London, SE5 9RS
Novartis Investigative Site
Wolverhampton, Staffordshire, WS11 5XY
United States3 sites
Novartis Investigative Site
Atlanta, Georgia, 30329
Novartis Investigative Site
Augusta, Georgia, 30912
Novartis Investigative Site
Greenville, North Carolina, 27834
Turkey (Türkiye)3 sites
Novartis Investigative Site
Adana, 01330
Novartis Investigative Site
Ankara, 06100
Novartis Investigative Site
Mersin, 33343
South Africa1 site
Novartis Investigative Site
Johannesburg, Guateng, 2193
About this study
Official title: A Multiple-dose, Subject- and Investigator-blinded, Placebo-controlled, Parallel Design Study to Assess the Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia
The study assesses the efficacy, safety and tolerability of ACZ885 (canakinumab) in pediatric and young adult patients with sickle cell anemia (SCA).
Read the detailed description
This was an ambulatory-based 24-week study followed by an additional 24-week open label phase. It was a subject- and investigator-blinded, randomized, placebo-controlled, parallel group, non-confirmatory study to assess the clinical efficacy of ACZ885 administered s.c. in six injections given 28 days apart (in each phase of the study).
Pediatric and young adult subjects diagnosed with sickle cell anemia (SCA) were planned to be randomized to either ACZ885 treatment or placebo treatment in a 1:1 ratio,.
For each subject, there was a maximum 28-day screening period that included recording of daily pain frequency and intensity by e-diary for at least 1 week. Subjects who met the eligibility criteria at screening underwent evaluation of baseline clinical and biomarker assessments prior to first dose administration.
On Day 1, monthly s.c. dosing with ACZ885 started at 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects. Subjects in the placebo treatment arm were injected with placebo in a like manner. All subjects returned to the study centers for safety checks on a monthly basis when they received treatment with either ACZ885 or placebo.
The final blinded dosing was given on Week 20, followed by blinded clinical assessments at Week 24. Subjects from both study arms were then offered optional, open label monthly dosing of ACZ885 for an additional 24 weeks (Weeks 24-48) with clinical outcome assessment.
Subjects returned for the end of study (EOS) visit at Week 56. For subjects who chose not to participate in the optional, open label portion of the study, or for those stopping treatment early for any other reason, an EOS visit occurred approximately 8 weeks after last dose received.
After enrollment of 49 subjects, Novartis decided to terminate the study early due to strategic reasons not related to safety and decided that no additional enrollment was needed in order to interpret the study objectives.
- Conditions
- Sickle Cell Anemia
- Being tested
- ACZ885, Placebo
- Keywords
- Sickle cell disease, hemoglobinopathy, pediatric
- Medical subject headings
- Anemia, Sickle Cell, Hemoglobinopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACZ885Drug
Also called Canakinumab
Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects
PlaceboDrug
Monthly doses of placebo to match the administered dose of canakinumab s.c.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects Receives: Drug: Placebo |
| ACZ885 | Experimental | Monthly doses of 300 mg (4 mg/kg for patients ≤ 40 kg) canakinumab s.c. Receives: Drug: ACZ885 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline of 4- Week Average Daily Pain Measured by Visual Analog Score (VAS) Over the Period of Week 8 to 12
Visual analog scale (VAS) was used to record severity. Pediatric and young adult participants rated their daily sickle cell associated pain intensity once each day in the evening using an 11-point numerical rating scale from 0 to 10 with higher ratings associated with more intense pain (0 = no pain, 10 = worst pain). For each subject, there was a maximum 28-day screening period that included recording of daily pain intensity by e-diary for at least 1 week. The average daily pain results in the screening period were used to derive the baseline value. The average over week 8 to 12 was calculated and the change from baseline in the average daily pain VAS was analyzed using a Bayesian model for repeated measures.
Measured: Baseline (upto 28 days prior to start of treatment), Week 8 to 12
Secondary outcomes (14)
Change From Baseline of Average Daily Pain VAS Over 4 Weeks Intervals up to Week 24
Visual analog scale (VAS) was used to record severity. Pediatric and young adult participants rated their daily sickle cell associated pain intensity once each day in the evening using an 11-point numerical rating scale from 0 to 10 with higher ratings associated with more intense pain (0 = no pain, 10 = worst pain). The average of 4 weeks interval up to week 24 was calculated.
Measured: Baseline (upto 28 days prior to start of treatment), Week 0 to 4, Week 4 to 8, Week 8 to 12, Week 12 to 16, Week 16 to 20 and Week 20 to 24
Change in the Concentration of High Sensitivity C-Reactive Protein (hsCRP) From Baseline to Week 12
hs-CRP is a biomarker that represents the inflammation process.
Measured: Baseline, Week 12
Change in the Concentration of White Blood Cell (WBC) Count From Baseline to Week 12
WBC count was used as a laboratory marker to determine the effect of the drug
Measured: Baseline, Week 12
Change in the Concentration of Absolute Count of Neutrophils From Baseline to Week 12
Absolute count of neutrophils was measured as a laboratory marker to determine the effect of the drug
Measured: Baseline, Week 12
Change in the Concentration of Absolute Count of Blood Monocytes From Baseline to Week 12
Absolute count of blood monocytes was measured as a laboratory marker to determine the effect of the drug.
Measured: Baseline, Week 12
Change in the Concentration of Hemoglobin From Baseline to Week 12
Hemoglobin was used as a hemolysis marker to determine the effect of the drug.
Measured: Baseline, Week 12
Change in the Reticulocyte Count From Baseline to Week 12
Reticulocyte count was used as a hemolysis marker to determine the effect of the drug
Measured: Baseline, Week 12
Change in the Concentration of Bilirubin From Baseline to Week 12
Bilirubin was used as a hemolysis marker to determine the effect of the drug
Measured: Baseline, Week 12
Change in the Concentration of Lactate Dehydrogenase (LDH) From Baseline to Week 12
LDH was used as a hemolysis marker to determine the effect of the drug
Measured: Baseline, Week 12
Change in the Concentration of Haptoglobin From Baseline to Week 12
Haptoglobin was used as a hemolysis marker to determine the effect of the drug
Measured: Baseline, Week 12
Change in the Concentration of Oxygen Percent Saturation (SAO2) From Baseline to Week 12
SAO2 was used as a hemolysis marker to determine the effect of the drug
Measured: Baseline, Week 12
Number of Days Absent From School or Work Due to Pain as Recorded by E-diary
The number of SCA-related days absent from school or work were derived from eDiary records.
Measured: up to Week 24
Number of Acute Blood Transfusions Per Patient by Study Period - Double-blind Period
The occurrence of acute blood transfusions was summarized as the proportion of subjects who received at least one acute blood transfusion and the event rate of acute blood transfusions per subject, by study period, group and reason of transfusion.
Measured: 12 weeks
Mean Serum Concentration After Repeated Dosing of ACZ885
PK samples were collected at Baseline, Week 4, 12, 20 and 24. Mean and standard deviation of the ACZ885 concentration was reported. Only those participants available at the specified time points were analyzed
Measured: Baseline, Week 4, 12, 20 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study start5 Apr 2017
- Primary completion27 Jun 2019
- Study completion27 Apr 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell AnemiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 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
- NCT02961218
- Sponsor's protocol ID
- CACZ885X2206
- Status last verified
- Dec 2025
- First submitted
- 20 Oct 2016
- Last updated
- 13 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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
Publications
Rees DC, Kilinc Y, Unal S, Dampier C, Pace BS, Kaya B, Trompeter S, Odame I, Mahlangu J, Unal S, Brent J, Grosse R, Fuh BR, Inusa BPD, Koren A, Leblebisatan G, Levin C, McNamara E, Meiser K, Hom D, Oliver SJ. A randomized, placebo-controlled, double-blind trial of canakinumab in children and young adults with sickle cell anemia. Blood. 2022 Apr 28;139(17):2642-2652. doi: 10.1182/blood.2021013674.
PubMed 35226723
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-dose, Subject- and Investigator-blinded, Placebo-controlled, Parallel Design Study to Assess the Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia
- ClinicalTrials.gov ID
- NCT02961218
- Acronym / sponsor ID
- CACZ885X2206
- Conditions
- Sickle Cell Anemia
- Keywords
- Sickle cell disease, hemoglobinopathy, pediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 10 Nov 2016 (estimated)
- Results
- Posted 17 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study assesses the efficacy, safety and tolerability of ACZ885 (canakinumab) in pediatric and young adult patients with sickle cell anemia (SCA).
Detailed description
This was an ambulatory-based 24-week study followed by an additional 24-week open label phase. It was a subject- and investigator-blinded, randomized, placebo-controlled, parallel group, non-confirmatory study to assess the clinical efficacy of ACZ885 administered s.c. in six injections given 28 days apart (in each phase of the study).
Pediatric and young adult subjects diagnosed with sickle cell anemia (SCA) were planned to be randomized to either ACZ885 treatment or placebo treatment in a 1:1 ratio,.
For each subject, there was a maximum 28-day screening period that included recording of daily pain frequency and intensity by e-diary for at least 1 week. Subjects who met the eligibility criteria at screening underwent evaluation of baseline clinical and biomarker assessments prior to first dose administration.
On Day 1, monthly s.c. dosing with ACZ885 started at 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects. Subjects in the placebo treatment arm were injected with placebo in a like manner. All subjects returned to the study centers for safety checks on a monthly basis when they received treatment with either ACZ885 or placebo.
The final blinded dosing was given on Week 20, followed by blinded clinical assessments at Week 24. Subjects from both study arms were then offered optional, open label monthly dosing of ACZ885 for an additional 24 weeks (Weeks 24-48) with clinical outcome assessment.
Subjects returned for the end of study (EOS) visit at Week 56. For subjects who chose not to participate in the optional, open label portion of the study, or for those stopping treatment early for any other reason, an EOS visit occurred approximately 8 weeks after last dose received.
After enrollment of 49 subjects, Novartis decided to terminate the study early due to strategic reasons not related to safety and decided that no additional enrollment was needed in order to interpret the study objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMonthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects |
| ACZ885 | Experimental | Drug: ACZ885Monthly doses of 300 mg (4 mg/kg for patients ≤ 40 kg) canakinumab s.c. |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male and female subjects ages 8-20 years of age (both inclusive) diagnosed with sickle cell anemia (HbSS) or sickle beta0 thalassemia (documented by family studies, or analysis of either hemoglobin or DNA).
- Patient's written informed consent from those ≥18 years of age must be obtained before any assessment is performed. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients < 18 years of age.
- Detectable baseline of background or episodic pain measured by daily e-diary over 1 to 2 weeks during screening period as defined below: Average daily pain score ≥ 1 cm without analgesic use over a period of at least 7 days and/or, At least one episode of pain requiring analgesic use during a period of up to 14 days.
- History of ≥2 vaso-occlusive pain episodes in the past year, as defined as pain with no other, non-sickle cell identifiable cause that requires analgesia and interferes with the patient's normal daily routine.
Key exclusion criteria (5 listed)
- History of known hypersensitivity to canakinumab.
- Ongoing or treatment with the past 3 months with red blood cell transfusion therapy, or have evidence of iron overload requiring chelation therapy.
- Transcranial Doppler ultrasound in the past year or at screening in patients with an accessible transtemporal window, demonstrating velocity in middle or anterior cerebral or internal carotid artery ≥200 cm/sec.
- Administration of any other blood products within 3 weeks of screening visit.
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| ACZ885Also: CanakinumabMonthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects | Drug | ACZ885 |
| PlaceboMonthly doses of placebo to match the administered dose of canakinumab s.c. | Drug | Placebo |
Primary outcome
Change From Baseline of 4- Week Average Daily Pain Measured by Visual Analog Score (VAS) Over the Period of Week 8 to 12
Time frame: Baseline (upto 28 days prior to start of treatment), Week 8 to 12
Visual analog scale (VAS) was used to record severity. Pediatric and young adult participants rated their daily sickle cell associated pain intensity once each day in the evening using an 11-point numerical rating scale from 0 to 10 with higher ratings associated with more intense pain (0 = no pain, 10 = worst pain). For each subject, there was a maximum 28-day screening period that included recording of daily pain intensity by e-diary for at least 1 week. The average daily pain results in the screening period were used to derive the baseline value. The average over week 8 to 12 was calculated and the change from baseline in the average daily pain VAS was analyzed using a Bayesian model for repeated measures.
14 secondary outcomes
Change From Baseline of Average Daily Pain VAS Over 4 Weeks Intervals up to Week 24
Time frame: Baseline (upto 28 days prior to start of treatment), Week 0 to 4, Week 4 to 8, Week 8 to 12, Week 12 to 16, Week 16 to 20 and Week 20 to 24
Change in the Concentration of High Sensitivity C-Reactive Protein (hsCRP) From Baseline to Week 12
Time frame: Baseline, Week 12
Change in the Concentration of White Blood Cell (WBC) Count From Baseline to Week 12
Time frame: Baseline, Week 12
Change in the Concentration of Absolute Count of Neutrophils From Baseline to Week 12
Time frame: Baseline, Week 12
Change in the Concentration of Absolute Count of Blood Monocytes From Baseline to Week 12
Time frame: Baseline, Week 12
Change in the Concentration of Hemoglobin From Baseline to Week 12
Time frame: Baseline, Week 12
Change in the Reticulocyte Count From Baseline to Week 12
Time frame: Baseline, Week 12
Change in the Concentration of Bilirubin From Baseline to Week 12
Time frame: Baseline, Week 12
Change in the Concentration of Lactate Dehydrogenase (LDH) From Baseline to Week 12
Time frame: Baseline, Week 12
Change in the Concentration of Haptoglobin From Baseline to Week 12
Time frame: Baseline, Week 12
Change in the Concentration of Oxygen Percent Saturation (SAO2) From Baseline to Week 12
Time frame: Baseline, Week 12
Number of Days Absent From School or Work Due to Pain as Recorded by E-diary
Time frame: up to Week 24
Number of Acute Blood Transfusions Per Patient by Study Period - Double-blind Period
Time frame: 12 weeks
Mean Serum Concentration After Repeated Dosing of ACZ885
Time frame: Baseline, Week 4, 12, 20 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35226723Rees DC, Kilinc Y, Unal S, Dampier C, Pace BS, Kaya B, Trompeter S, Odame I, Mahlangu J, Unal S, Brent J, Grosse R, Fuh BR, Inusa BPD, Koren A, Leblebisatan G, Levin C, McNamara E, Meiser K, Hom D, Oliver SJ. A randomized, placebo-controlled, double-blind trial of canakinumab in children and young adults with sickle cell anemia. Blood. 2022 Apr 28;139(17):2642-2652. doi: 10.1182/blood.2021013674.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- A Pediatric Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- 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.
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACZ885 in people with Sickle Cell Anemia, run by Novartis Pharmaceuticals at 15 sites in 7 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 5 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 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom, United States, Turkey (Türkiye), Canada, Germany and 2 more countries. 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. Some participants in this study may receive a placebo. 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 17 Dec 2020). 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?
Change From Baseline of 4- Week Average Daily Pain Measured by Visual Analog Score (VAS) Over the Period of Week 8 to 12 (time frame: Baseline (upto 28 days prior to start of treatment), Week 8 to 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02961218, which also lists 1 linked publication.
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 13 Jan 2026.