Postmenopausal Women With OsteoporosisPhase 3NCT04757376
A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
A Phase 3 study testing CT-P41 and US-licensed Prolia in people with Postmenopausal Women With Osteoporosis, run by Celltrion at 20 sites in 4 countries.
Trial summary
This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Postmenopausal Women With Osteoporosis
- What is being tested?
- CT-P41 and US-licensed Prolia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 479 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 17 Jun 2021to 16 Nov 2023
- Phase
- Phase 3
- 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 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women, 50 to 80 years of age, both inclusive.
- Body weight between 40.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
- Postmenopausal
- Bone mineral density T-score ≤ - 2.5 and ≥ - 4.0 at the lumbar spine (L1 to L4) as assessed by the central imaging vendor based on dual-energy X-ray absorptiometry(DXA) scan.
- Patients must have at least 3 vertebrae considered evaluable at the lumbar spine (L1 to L4) and at least 1 hip considered evaluable by DXA scan assessed by the central imaging vendor. Patients with unilateral metal in hips that would be allowed for the other side of 1 evaluable hip are included.
- Patient with albumin-adjusted total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) at Screening.
Who cannot join
- Patient previously received denosumab, any other monoclonal antibodies, or biologic agents for osteoporosis
- Patient confirmed or suspected with infection of COVID-19 at Screening, or has contact with COVID-19 patient within 14 days from Screening
- Patient with history and/or presence of one severe or > 2 moderate vertebral fractures as determined by central reading of lateral spine X-ray
- Patient with history and/or presence of hip fracture
- Patient with history and/or presence of hyperparathyroidism or hypoparathyroidism, irrespective of current controlled or uncontrolled status
- Patient with current hyperthyroidism (unless well controlled on stable antithyroid therapy)
- Patient with current hypothyroidism (unless well controlled on stable thyroid replacement therapy)
- Patient with history and/or presence of bone disease and metabolic disease (except for osteoporosis) that may interfere with the interpretation of the results
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
Poland10 sites
NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik
Bialystok, Podlaskie Voivodeship, 15-351
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, Pomeranian Voivodeship, 81-537
Krakowskie Centrum Medyczne
Krakow, Lesser Poland Voivodeship, 31-501
MCM Krakow - PRATIA - PPDS
Krakow, 30-510
SOMED CR Sp. z o.o. Sp. Komandytowa - Lodz
Lódz, Lódzkie, 90-368
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, 60-702
Centrum Medyczne Poznan - PRATIA - PPDS
Skórzewo, Greater Poland Voivodeship, 60-185
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, Masovian Voivodeship, 01-192
SOMED CR Sp. z o.o. Sp. Komandytowa - Warszawa
Warsaw, Masovian Voivodeship, 01-737
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-381
Estonia4 sites
KLV Arstikabinet
Pärnu, 80010
Center For Clinical And Basic Research
Tallinn, Harju, 10128
East Tallinn Central Hospital-Ravi 18
Tallinn, Harju, 11312
Clinical Research Centre Ltd
Tartu, Tartu, 50106
Ukraine4 sites
AES - AS - Medical Center of Edelweiss Medics LLC
Kyiv, 02002
Clinic of SI Institute of Gerontology n.a. D.F.Chebotaryov of NAMS of Ukraine
Kyiv, 04114
AES - AS - Medical Center of Medbud - Clinic LLC
Kyiv
Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov
Vinnytsia, 21029
Latvia2 sites
Health Center Association, Medical Center Liepaja
Liepāja, 3401
Health Center 4-117 K. Barona Str
Riga, 1012
About this study
Official title: A Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis
Read the detailed description
This is a double-blind, randomized, active-controlled, Phase 3 study to evaluate the efficacy, PK, PD, and safety including immunogenicity of CT-P41 compared with US-licensed Prolia in postmenopausal women with osteoporosis. All patients will also receive daily supplementation containing at least 1,000 mg of elemental calcium and at least 400 IU vitamin D from randomization to EOS visit and the data will be collected via patient's diary.
- Conditions
- Postmenopausal Women With Osteoporosis
- Being tested
- CT-P41, US-licensed Prolia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P41Biological
60 mg/mL single dose, Solution for injection in PFS
US-licensed ProliaBiological
60 mg/mL single dose, Solution for injection in PFS
| Study group | Role | What they receive |
|---|---|---|
| CT-P41 | Experimental | 60 mg/mL single dose administration, Solution for injection in prefilled syringe(PFS) Receives: Biological: CT-P41 |
| US-licensed Prolia | Active comparator | 60 mg/mL single dose administration, Solution for injection in PFS Receives: Biological: US-licensed Prolia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 - Full Analysis Set (FAS)
Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA) and assessments of the lumbar spine (L1 to L4) were performed at a central imaging vendor. To evaluate the difference between 2 groups in the primary efficacy endpoint, the percent change from baseline in BMD for lumbar spine (L1 to L4) by DXA at Week 52 was analyzed using an analysis of covariance (ANCOVA) model coupled with multiple imputation assuming the data to be missing at random (MAR).
Measured: baseline (screening), Week 52 predose
Secondary outcomes (13)
Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 52 - FAS
Bone mineral density was assessed by DXA and assessments of the lumbar spine (L1 to L4), total hip, and femoral neck were performed at a central imaging vendor.
Measured: baseline (screening), Week 52 predose
Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 78 - FAS-TP II Subset
Bone mineral density was assessed by DXA and assessments of the lumbar spine (L1 to L4), total hip, and femoral neck BMD were performed at a central imaging vendor.
Measured: baseline (screening), Week 78
Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP I - FAS
Efficacy analysis of new vertebral fractures included only vertebral fractures occurring from T4 to L4 and confirmed by the central imaging vendor. A new vertebral fracture was defined as an increase of ≥1 grade in any vertebra from T4 to L4 that was normal at screening.
The nonvertebral fractures endpoint included fractures other than those of the vertebrae, excluding the skull, facial bones, mandible, metacarpals, and phalanges (fingers or toes) since they are not associated with decreased BMD, and excluded pathologic fractures and those associated with severe trauma acquired from a fall (from a height higher than a stool, chair, or first rung of a ladder) or otherwise. Only nonvertebral fractures confirmed by the central imaging vendor were included in the efficacy analysis.
The fractures occurring at the site of femur neck, femur intertrochanter, or femur subtrochanter were considered as a hip fracture.
Measured: up to Week 52 predose
Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP II - FAS-TP II Subset
Efficacy analysis of new vertebral fractures included only vertebral fractures occurring from T4 to L4 and confirmed by the central imaging vendor. A new vertebral fracture was defined as an increase of ≥1 grade in any vertebra from T4 to L4 that was normal at screening.
The nonvertebral fractures endpoint included fractures other than those of the vertebrae, excluding the skull, facial bones, mandible, metacarpals, and phalanges (fingers or toes) since they are not associated with decreased BMD, and excluded pathologic fractures and those associated with severe trauma acquired from a fall (from a height higher than a stool, chair, or first rung of a ladder) or otherwise. Only nonvertebral fractures confirmed by the central imaging vendor were included in the efficacy analysis.
The fractures occurring at the site of femur neck, femur intertrochanter, or femur subtrochanter were considered as a hip fracture.
Measured: from Week 52 to Week 78
Trough Serum Concentration (Ctrough) of Denosumab at Weeks 0 and 26 - Pharmacokinetic (PK) Set
The Ctrough, a concentration before the next study drug administration, was calculated by non-compartmental analysis method from the concentration-time data. All serum concentrations below the lower limit of quantification (LLoQ) was set to 0 in the descriptive summaries of PK parameter estimation. In TP I, the Ctrough of denosumab at Weeks 0 and 26 was assessed as the serum concentration at Weeks 26 and 52 before the study drug administration, respectively.
Measured: Week 0 Day 1 predose, Week 26 predose
Ctrough of Denosumab at Week 52 - PK-TP II Subset
The Ctrough, a concentration before the next study drug administration, was calculated by non-compartmental analysis method from the concentration-time data. All serum concentrations below the LLoQ was set to 0 in the descriptive summaries of PK parameter estimation. In TP II, the Ctrough of denosumab at Week 52 was assessed as the serum concentration at Week 78.
Measured: Week 52
Maximum Serum Concentration (Cmax) of Denosumab After First Dose - PK Set
Cmax was calculated by non-compartmental analysis method from the concentration-time data. All serum concentrations below the LLoQ was set to 0 in the descriptive summaries of PK parameter estimation.
Measured: from baseline (Week 0 Day 1 predose) to Week 26 predose
Percent Change From Baseline for Serum Concentration of Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Weeks 26 and 52 - Pharmacodynamic (PD) Set
Serum concentration below the LLoQ was set to the LLoQ. The percent change from baseline for serum concentration at each visit was calculated as ([Result at each visit - Result at Baseline] / Result at Baseline) × 100.
Measured: Baseline (Week 0 Day 1 predose), Weeks 26 and 52 (predose)
Percent Change From Baseline for Serum Concentration of s-CTX at Week 78 - PD-TP II Subset
Serum concentration below the LLoQ was set to the LLoQ. The percent change from baseline for serum concentration at each visit was calculated as ([Result at each visit - Result at Baseline] / Result at Baseline) × 100.
Measured: Baseline (Week 0 Day 1 predose), Week 78
Percent Change From Baseline for Serum Concentration of Procollagen Type 1 N-terminal Propeptide (P1NP) at Weeks 26 and 52 - PD Set
Serum concentration below the LLoQ was set to the LLoQ. The percent change from baseline for serum concentration at each visit was calculated as ([Result at each visit - Result at Baseline] / Result at Baseline) × 100.
Measured: Baseline (Week 0 Day 1 predose), Weeks 26 and 52 (predose)
Percent Change From Baseline for Serum Concentration of P1NP at Week 78 - PD-TP II Subset
Serum concentration below the LLoQ was set to the LLoQ. The percent change from baseline for serum concentration was calculated as ([Result at each visit - Result at Baseline] / Result at Baseline) × 100.
Measured: Baseline (Week 0 Day 1 predose), Week 78
Number of Participants With at Least 1 Anti-drug Antibodies (ADA)/Neutralizing Antibodies (NAb) Result After the First Study Drug Administration of TP I - Safety Set
Samples that were positive in the ADA confirmatory assay were analyzed further to conduct a NAb assessment. The test outcomes for the screening assay were 'Positive' or 'Negative'. The number of patients with at least one ADA/NAb positive result after the first study drug administration of each treatment period including scheduled and unscheduled visits (Treatment Period I: Week 0 / Treatment Period II: Week 52) regardless of their ADA status at baseline were presented.
Measured: up to Week 52 predose
Number of Participants With at Least 1 ADA/NAb Result After the First Study Drug Administration of TP II - Safety-TP II Subset
Samples that were positive in the ADA confirmatory assay were analyzed further to conduct a NAb assessment. The test outcomes for the screening assay were 'Positive' or 'Negative'. The number of patients with at least one ADA/NAb positive result after the first study drug administration of each treatment period including scheduled and unscheduled visits (Treatment Period I: Week 0 / Treatment Period II: Week 52) regardless of their ADA status at baseline were presented.
Measured: from Week 52 to Week 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start17 Jun 2021
- Primary completion18 May 2023
- Study completion16 Nov 2023
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 Postmenopausal Women With OsteoporosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757376
- Sponsor's protocol ID
- CT-P41 3.1
- Other IDs
- 2020-005974-91
- Status last verified
- May 2024
- First submitted
- 12 Feb 2021
- Last updated
- 14 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT04757376
- Acronym / sponsor ID
- CT-P41 3.1
- Conditions
- Postmenopausal Women With Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis
Detailed description
This is a double-blind, randomized, active-controlled, Phase 3 study to evaluate the efficacy, PK, PD, and safety including immunogenicity of CT-P41 compared with US-licensed Prolia in postmenopausal women with osteoporosis. All patients will also receive daily supplementation containing at least 1,000 mg of elemental calcium and at least 400 IU vitamin D from randomization to EOS visit and the data will be collected via patient's diary.
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 |
|---|---|---|
| CT-P41 | Experimental | Biological: CT-P4160 mg/mL single dose administration, Solution for injection in prefilled syringe(PFS) |
| US-licensed Prolia | Active comparator | Biological: US-licensed Prolia60 mg/mL single dose administration, Solution for injection in PFS |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women, 50 to 80 years of age, both inclusive.
- Body weight between 40.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
- Postmenopausal
- Bone mineral density T-score ≤ - 2.5 and ≥ - 4.0 at the lumbar spine (L1 to L4) as assessed by the central imaging vendor based on dual-energy X-ray absorptiometry(DXA) scan.
- Patients must have at least 3 vertebrae considered evaluable at the lumbar spine (L1 to L4) and at least 1 hip considered evaluable by DXA scan assessed by the central imaging vendor. Patients with unilateral metal in hips that would be allowed for the other side of 1 evaluable hip are included.
Key exclusion criteria (8 listed)
- Patient previously received denosumab, any other monoclonal antibodies, or biologic agents for osteoporosis
- Patient confirmed or suspected with infection of COVID-19 at Screening, or has contact with COVID-19 patient within 14 days from Screening
- Patient with history and/or presence of one severe or > 2 moderate vertebral fractures as determined by central reading of lateral spine X-ray
- Patient with history and/or presence of hip fracture
- Patient with history and/or presence of hyperparathyroidism or hypoparathyroidism, irrespective of current controlled or uncontrolled status
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 |
|---|---|---|
| CT-P4160 mg/mL single dose, Solution for injection in PFS | Biological | CT-P41 |
| US-licensed Prolia60 mg/mL single dose, Solution for injection in PFS | Biological | US-licensed Prolia |
Primary outcome
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 - Full Analysis Set (FAS)
Time frame: baseline (screening), Week 52 predose
Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA) and assessments of the lumbar spine (L1 to L4) were performed at a central imaging vendor. To evaluate the difference between 2 groups in the primary efficacy endpoint, the percent change from baseline in BMD for lumbar spine (L1 to L4) by DXA at Week 52 was analyzed using an analysis of covariance (ANCOVA) model coupled with multiple imputation assuming the data to be missing at random (MAR).
13 secondary outcomes
Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 52 - FAS
Time frame: baseline (screening), Week 52 predose
Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 78 - FAS-TP II Subset
Time frame: baseline (screening), Week 78
Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP I - FAS
Time frame: up to Week 52 predose
Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP II - FAS-TP II Subset
Time frame: from Week 52 to Week 78
Trough Serum Concentration (Ctrough) of Denosumab at Weeks 0 and 26 - Pharmacokinetic (PK) Set
Time frame: Week 0 Day 1 predose, Week 26 predose
Ctrough of Denosumab at Week 52 - PK-TP II Subset
Time frame: Week 52
Maximum Serum Concentration (Cmax) of Denosumab After First Dose - PK Set
Time frame: from baseline (Week 0 Day 1 predose) to Week 26 predose
Percent Change From Baseline for Serum Concentration of Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Weeks 26 and 52 - Pharmacodynamic (PD) Set
Time frame: Baseline (Week 0 Day 1 predose), Weeks 26 and 52 (predose)
Percent Change From Baseline for Serum Concentration of s-CTX at Week 78 - PD-TP II Subset
Time frame: Baseline (Week 0 Day 1 predose), Week 78
Percent Change From Baseline for Serum Concentration of Procollagen Type 1 N-terminal Propeptide (P1NP) at Weeks 26 and 52 - PD Set
Time frame: Baseline (Week 0 Day 1 predose), Weeks 26 and 52 (predose)
Percent Change From Baseline for Serum Concentration of P1NP at Week 78 - PD-TP II Subset
Time frame: Baseline (Week 0 Day 1 predose), Week 78
Number of Participants With at Least 1 Anti-drug Antibodies (ADA)/Neutralizing Antibodies (NAb) Result After the First Study Drug Administration of TP I - Safety Set
Time frame: up to Week 52 predose
Number of Participants With at Least 1 ADA/NAb Result After the First Study Drug Administration of TP II - Safety-TP II Subset
Time frame: from Week 52 to Week 78
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CT-P41 and US-licensed Prolia in people with Postmenopausal Women With Osteoporosis, run by Celltrion at 20 sites in 4 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 6 inclusion and 8 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 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Poland, Estonia, Ukraine, Latvia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 May 2024). 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?
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 - Full Analysis Set (FAS) (time frame: baseline (screening), Week 52 predose). 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 14 Jun 2024; AzTrials last refreshed its copy on 30 Oct 2026.