Ectonucleotide Pyrophosphatase/phosphodiesterase1 DeficiencyPhase 2NCT06739980

The ENABLE Study: Safety and Efficacy Study of INZ-701 in Patients With ENPP1 Deficiency

A Phase 2 study testing INZ-701 in people with Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency and Autosomal Recessive Hypophosphatemic Rickets, run by Inozyme Pharma.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The purpose of Study INZ701-108 (ENABLE) is to assess the safety and efficacy of INZ-701 in patients 1 year of age and older with ENPP1 Deficiency who have not previously received INZ-701 and are not eligible for existing Inozyme-sponsored clinical studies that are still open to enrollment. Read more about this study

Who is it for?: Ages 1 year and older
Conditions the study is for: Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets, Generalized Arterial Calcification of Infancy 1
What is being tested?: INZ-701
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 31 Jan 2025to 31 Mar 2028
Phase: Phase 2
Are there results?: None posted in the registry

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 1 year and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Individuals eligible to participate must meet all of the following inclusion criteria:
Provide written or electronic informed consent after the nature of the study has been explained, and prior to any research-related procedures, per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP)
Provide assent in accordance with local regulations, if <18 years of age
Male or female, ≥1 year of age
A confirmed postnatal molecular genetic diagnosis of ENPP1 Deficiency with biallelic variants (ie, homozygous or compound heterozygous) performed using assays that meet CE-marked requirements, or from a College of American Pathologists/Clinical Laboratory Improvement Amendments (CAP/CLIA) certified laboratory, or regional equivalent
Must have at least one of the following clinical signs and/or symptoms consistent with ENPP1 Deficiency:

Show all 20Show fewer

≥1 atraumatic vertebral fracture
≥2 fractures as an adult (eg, long bones, digits, vertebrae)
For participants <55 years of age, low bone mineral density measured at any of the following sites: lumbar spine, radius, and hip (DXA Z-score less than -1.5)
History of myocardial infarction, unstable angina, transient ischemic attack, or low cardiac output before the age of 40 years
Renal vascular hypertension or other evidence for vascular insufficiency/stenosis
History of rickets or bone deformity
Diagnosis of ossification of the posterior longitudinal ligament
Other clinical signs/symptoms, with approval by Inozyme
Fasting plasma PPi concentration of <1400 nM at Screening
Serum level of 25-hydroxyvitamin D (25[OH]D) ≥12 ng/mL at Screening (Participants may be rescreened after receiving cholecalciferol treatment.)
Women of childbearing potential (WOCBP, as defined in Clinical Trials Coordination Group [CTCG 2024]) must have a negative serum pregnancy test at Screening and must not be breastfeeding
Males who are sexually active must agree to use condoms from the period following first dose of INZ-701 through 30 days after the last dose of INZ-701
WOCBP and partners of fertile males who are WOCBP must be using or agree to use a highly effective form of contraception (as per CTCG 2024) from at least 1 month before the first dose of INZ-701 through 30 days after the last dose of INZ701 (greater than 5 half-lives of INZ-701)
In the opinion of the Investigator, able to complete all aspects of the study

Who cannot join

Individuals who meet any of the following exclusion criteria will not be eligible to participate:
In the opinion of the Investigator, presence of any clinically significant disease or laboratory abnormality not due to ENPP1 Deficiency that may confound interpretation of study results
Eligible for another Inozyme sponsored study of INZ-701 treatment that is open for enrollment
Receiving prohibited medications
Unable or unwilling to discontinue calcitriol or other active forms of vitamin D3 (or analogs) within 7 days prior to Day 1 and/or oral phosphate supplements within 36 hours prior to Day 1
Received previous treatment with INZ-701

Show all 9Show fewer

Concurrent participation in another interventional clinical study and/or has received an investigational drug within 5 half-lives or within 4 weeks prior to the first dose of INZ-701, whichever is longer
Pregnant, trying to become pregnant, or breastfeeding
Male participants trying to father a child

About this study

Official title: The ENABLE Study: An Open-Label, Long-Term Safety and Efficacy Study of INZ-701 in Patients With Ectonucleotide Pyrophosphatase/ Phosphodiesterase 1 (ENPP1) Deficiency

Read the detailed description

INZ-701 is an ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) enzyme replacement therapy in development for the treatment of the ultra-rare genetic disorder, ENPP1 Deficiency.

Study INZ701-108 (ENABLE) is an open-label study to assess the long-term safety and efficacy of INZ-701 in patients 1 year of age and older with ENPP1 Deficiency who have not previously received INZ-701 and are not eligible for an Inozyme-sponsored clinical study that is open to recruitment.

The study will consist of a 30-day Screening Period, followed by an open-label Treatment Period during which all participants will receive once-weekly subcutaneous (SC) doses of INZ-701 and continue treatment through 104 weeks. The dose will be determined by the participant's age and weight.

Conditions: Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets, Generalized Arterial Calcification of Infancy 1
Being tested: INZ-701
Keywords: Ectonucleotide Pyrophosphatase/Phosphodiesterase1 Deficiency, Hypopyrophosphatemia, ENPP1, Autosomal Recessive Hypophosphatemic Rickets Type 2, ARHR2, Generalized Arterial Calcification of Infancy, GACI
Medical subject headings: Hypophosphatemic Rickets, Autosomal Recessive, 1, Arterial calcification of infancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INZ-701Drug
Also called (rhENPP1-Fc).
Recombinant fusion protein that contains the extracellular domains of human ENPP1 coupled with an Fc fragment from an immunoglobulin gamma-1 (IgG1) antibody.

Study groups in NCT06739980
Study group	Role	What they receive
INZ-701	Experimental	INZ-701 will be administered by SC injection on a once-weekly basis as follows: * Study participants from 1 year to <18 years of age will receive a dose of 2.4 mg/kg * Study participants ≥18 years and: weighing <50 kg or >100 kg will receive a 1.8 mg/kg dose, OR weighing ≥50 and ≤100 kg will receive a 150 mg dose of INZ-701 Receives: Drug: INZ-701

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline in Plasma Inorganic Pyrophosphate (PPi) concentration through Week 52
For each subject, plasma PPi will be measured via a series of blood samples obtained throughout the study, comparing the subject's baseline value over time.
Measured: 52 weeks (Baseline through Week 52)

Secondary outcomes (21)

Change from Baseline in skeletal abnormalities as measured by the Radiographic Global Impression of Change (RGI-C) global score through Week 104 for patients 1 to <13 years
For each subject, skeletal abnormalities will be measured via RGI-C global scores obtained throughout the study, comparing the subject's baseline value over time.
Measured: 52 weeks (Baseline through Week 52)
Change from Baseline in Rickets Severity Score (RSS) total score through Week 104 (measured on all long bones with open growth plates in the knee or wrist) for patients 1 to <13 years
For each subject, rickets severity score will be measured on all long bones with open growth plates in knees or wrist obtained throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Change from Baseline in arterial calcification score based on low dose computed tomography (CT) through Week 104 for patients 1 to <18 years
For each subject, arterial calcification will be measured via low dose computed tomography obtained throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Change over time in serum biomarkers: Fibroblast growth factor 23 for patients >1 year
For each subject, various serum biomarkers will be measured via a series of blood samples obtained throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Change over time in serum biomarkers: Procollagen type 1 N-terminal propeptide for patients >1 year
For each subject, various serum biomarkers will be measured via a series of blood samples obtained throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Change over time in serum biomarkers: Bone-specific alkaline phosphatase for patients >1 year
For each subject, various serum biomarkers will be measured via a series of blood samples obtained throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Change over time in serum biomarkers: Carboxy terminal cross-linked telopeptide of type I collagen for patients >1 year
For each subject, various serum biomarkers will be measured via a series of blood samples obtained throughout the study, comparing the subject's baseline value over time
Measured: 104 weeks (Baseline through Week 104)
Change from Baseline in growth parameters (body weight expressed as Z-score) through Week 104 for patients 1 to <13 years
For each subject, growth parameters will be measured throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Change over time in serum biomarkers: Serum phosphate for patients >1 year
For each subject, various serum biomarkers will be measured via a series of blood samples obtained throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Change from Baseline in growth parameters (height/length expressed as Z-score) through Week 104 for patients 1 to <13 years
For each subject, growth parameters will be measured throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Change from Baseline over time in growth velocity as measured by height over time through Week 104 for patients 1 to <13 years
For each subject, growth velocity will be measured via height throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Change from Baseline in lower extremity angle measurements from radiographic x-rays through Week 104 for patients 1 to <13 years
For each subject, lower extremity angle will be measured via radiograph x-rays throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Change from Baseline in audiometric outcomes as measured by hearing tests through Week 104 for patients 1 to <18 years
For each subject, audiometric outcomes will be measured via hearing tests throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Change from Baseline in 6 Minute Walk Test (6MWT) for patients >5 years
For each subject, 6-minute walk test will be measured and assessed throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Change in Baseline in bone mineral content and bone mineral density Z-score via dual X-ray absorptiometry (DXA) scan through Week 104 for patients ≥13 years
For each subject, bone mineral content and density will be measured via dual x-ray absorptiometry (DXA) throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Change from Baseline in age-appropriate motor performance-mobility assessments through Week 104 (Peabody Developmental Motor Scale - third edition [PDMS] for patients 1 to < 5 years
For each subject, motor performance-mobility assessments will be measured via the Developmental Motor Scale throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Patient Reported Outcomes (PROs) through Week 104 assessed via Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric - Cognitive Function, Fatigue, Pain Intensity, Pain Interference, Mobility) for patients 1 to <18 years
For each subject, quality of life PROs will be assessed throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
PROs through Week 104 (Patient-Reported Outcome Measurement Information System [PROMIS] Pediatric - Cognitive Function, Fatigue, Pain Intensity, Pain Interference, Physical Function) for patients >17 years
For each subject, quality of life PROs will be assessed throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
PROs through Week 104 (Clinical-, Caregiver-, and Patient-reported Global Impression of Change [CGI-C, CaGI-C, and PGI-C for patients >17 years
For each subject, PROs will be assessed throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Change from Baseline in bone histomorphometry as measured by bone biopsy through Week 104 for patients >17 years
For each subject, bone histomorphometry will be measured via bone biopsy throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)
Change from Baseline in pain visual analog VAS) score through Week 104 for patients >17 years
For each subject, pain will be measured via pain visual analog scale throughout the study, comparing the subject's baseline value over time.
Measured: 104 weeks (Baseline through Week 104)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 202531 Mar 2028

First posted18 Dec 2024
Study start31 Jan 2025 (estimated)
Primary completion31 Mar 2027 (estimated)
Study completion31 Mar 2028 (estimated)

Why it stopped: Study was not initiated as it is no longer consistent with the Sponsor's development plans.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ectonucleotide Pyrophosphatase/phosphodiesterase1 DeficiencyStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06739980
Sponsor's protocol ID: INZ701-108
Status last verified: Apr 2025
First submitted: 11 Dec 2024
Last updated: 1 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The ENABLE Study: An Open-Label, Long-Term Safety and Efficacy Study of INZ-701 in Patients With Ectonucleotide Pyrophosphatase/ Phosphodiesterase 1 (ENPP1) Deficiency
ClinicalTrials.gov ID: NCT06739980
Acronym / sponsor ID: INZ701-108
Conditions: Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets, Generalized Arterial Calcification of Infancy 1
Keywords: Ectonucleotide Pyrophosphatase/Phosphodiesterase1 Deficiency, Hypopyrophosphatemia, ENPP1, Autosomal Recessive Hypophosphatemic Rickets Type 2, ARHR2, Generalized Arterial Calcification of Infancy, GACI
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Study was not initiated as it is no longer consistent with the Sponsor's development plans.
Enrolment: 0 participants (actual)
Lead sponsor: Inozyme PharmaIndustry (pharma, biotech, devices)
Study start: 31 Jan 2025 (estimated)
Primary completion: 31 Mar 2027 (estimated)
Study completion: 31 Mar 2028 (estimated)
First posted: 18 Dec 2024 (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.

Detailed description

INZ-701 is an ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) enzyme replacement therapy in development for the treatment of the ultra-rare genetic disorder, ENPP1 Deficiency.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
INZ-701	Experimental	Drug: INZ-701INZ-701 will be administered by SC injection on a once-weekly basis as follows: * Study participants from 1 year to <18 years of age will receive a dose of 2.4 mg/kg * Study participants ≥18 years and: weighing <50 kg or >100 kg will receive a 1.8 mg/kg dose, OR weighing ≥50 and ≤100 kg will receive a 150 mg dose of INZ-701

Who may qualify

Ages: 1 year and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (20 listed)

Provide written or electronic informed consent after the nature of the study has been explained, and prior to any research-related procedures, per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP)
Provide assent in accordance with local regulations, if <18 years of age
Male or female, ≥1 year of age
A confirmed postnatal molecular genetic diagnosis of ENPP1 Deficiency with biallelic variants (ie, homozygous or compound heterozygous) performed using assays that meet CE-marked requirements, or from a College of American Pathologists/Clinical Laboratory Improvement Amendments (CAP/CLIA) certified laboratory, or regional equivalent
Must have at least one of the following clinical signs and/or symptoms consistent with ENPP1 Deficiency:

Key exclusion criteria (9 listed)

Individuals who meet any of the following exclusion criteria will not be eligible to participate:
In the opinion of the Investigator, presence of any clinically significant disease or laboratory abnormality not due to ENPP1 Deficiency that may confound interpretation of study results
Eligible for another Inozyme sponsored study of INZ-701 treatment that is open for enrollment
Receiving prohibited medications
Unable or unwilling to discontinue calcitriol or other active forms of vitamin D3 (or analogs) within 7 days prior to Day 1 and/or oral phosphate supplements within 36 hours prior to Day 1

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
INZ-701Also: (rhENPP1-Fc).Recombinant fusion protein that contains the extracellular domains of human ENPP1 coupled with an Fc fragment from an immunoglobulin gamma-1 (IgG1) antibody.	Drug	INZ-701

Primary outcome

Change from Baseline in Plasma Inorganic Pyrophosphate (PPi) concentration through Week 52
Time frame: 52 weeks (Baseline through Week 52)
For each subject, plasma PPi will be measured via a series of blood samples obtained throughout the study, comparing the subject's baseline value over time.

21 secondary outcomes

Change from Baseline in skeletal abnormalities as measured by the Radiographic Global Impression of Change (RGI-C) global score through Week 104 for patients 1 to <13 years
Time frame: 52 weeks (Baseline through Week 52)
Change from Baseline in Rickets Severity Score (RSS) total score through Week 104 (measured on all long bones with open growth plates in the knee or wrist) for patients 1 to <13 years
Time frame: 104 weeks (Baseline through Week 104)
Change from Baseline in arterial calcification score based on low dose computed tomography (CT) through Week 104 for patients 1 to <18 years
Time frame: 104 weeks (Baseline through Week 104)
Change over time in serum biomarkers: Fibroblast growth factor 23 for patients >1 year
Time frame: 104 weeks (Baseline through Week 104)
Change over time in serum biomarkers: Procollagen type 1 N-terminal propeptide for patients >1 year
Time frame: 104 weeks (Baseline through Week 104)
Change over time in serum biomarkers: Bone-specific alkaline phosphatase for patients >1 year
Time frame: 104 weeks (Baseline through Week 104)
Change over time in serum biomarkers: Carboxy terminal cross-linked telopeptide of type I collagen for patients >1 year
Time frame: 104 weeks (Baseline through Week 104)
Change from Baseline in growth parameters (body weight expressed as Z-score) through Week 104 for patients 1 to <13 years
Time frame: 104 weeks (Baseline through Week 104)
Change over time in serum biomarkers: Serum phosphate for patients >1 year
Time frame: 104 weeks (Baseline through Week 104)
Change from Baseline in growth parameters (height/length expressed as Z-score) through Week 104 for patients 1 to <13 years
Time frame: 104 weeks (Baseline through Week 104)
Change from Baseline over time in growth velocity as measured by height over time through Week 104 for patients 1 to <13 years
Time frame: 104 weeks (Baseline through Week 104)
Change from Baseline in lower extremity angle measurements from radiographic x-rays through Week 104 for patients 1 to <13 years
Time frame: 104 weeks (Baseline through Week 104)
Change from Baseline in audiometric outcomes as measured by hearing tests through Week 104 for patients 1 to <18 years
Time frame: 104 weeks (Baseline through Week 104)
Change from Baseline in 6 Minute Walk Test (6MWT) for patients >5 years
Time frame: 104 weeks (Baseline through Week 104)
Change in Baseline in bone mineral content and bone mineral density Z-score via dual X-ray absorptiometry (DXA) scan through Week 104 for patients ≥13 years
Time frame: 104 weeks (Baseline through Week 104)
Change from Baseline in age-appropriate motor performance-mobility assessments through Week 104 (Peabody Developmental Motor Scale - third edition [PDMS] for patients 1 to < 5 years
Time frame: 104 weeks (Baseline through Week 104)
Patient Reported Outcomes (PROs) through Week 104 assessed via Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric - Cognitive Function, Fatigue, Pain Intensity, Pain Interference, Mobility) for patients 1 to <18 years
Time frame: 104 weeks (Baseline through Week 104)
PROs through Week 104 (Patient-Reported Outcome Measurement Information System [PROMIS] Pediatric - Cognitive Function, Fatigue, Pain Intensity, Pain Interference, Physical Function) for patients >17 years
Time frame: 104 weeks (Baseline through Week 104)
PROs through Week 104 (Clinical-, Caregiver-, and Patient-reported Global Impression of Change [CGI-C, CaGI-C, and PGI-C for patients >17 years
Time frame: 104 weeks (Baseline through Week 104)
Change from Baseline in bone histomorphometry as measured by bone biopsy through Week 104 for patients >17 years
Time frame: 104 weeks (Baseline through Week 104)
Change from Baseline in pain visual analog VAS) score through Week 104 for patients >17 years
Time frame: 104 weeks (Baseline through Week 104)

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
Individual participant dataSharing planned: No

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.

Inozyme Pharma, Inc. study director

Inozyme Pharma, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INZ-701 in people with Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency and Autosomal Recessive Hypophosphatemic Rickets, run by Inozyme Pharma.

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 20 inclusion and 9 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: withdrawn, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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 in Plasma Inorganic Pyrophosphate (PPi) concentration through Week 52 (time frame: 52 weeks (Baseline through Week 52)). 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 NCT06739980.

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 1 May 2025.