Eosinophilic Granulomatosis With PolyangiitisPhase 3OCEANNCT05263934
Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA)
A Phase 3 study testing Depemokimab and Mepolizumab in people with Eosinophilic Granulomatosis With Polyangiitis, run by GlaxoSmithKline at 63 sites in 18 countries.
Trial summary
This study aims to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory EGPA receiving SoC therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Granulomatosis With Polyangiitis
- What is being tested?
- Depemokimab and Mepolizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 63 sitesin 18 countries
- Study dates
- 14 Jul 2022to 27 Oct 2026
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant (male or female) must be 18 years of age or older at the time of signing the informed consent.
- Participants who are >=40 kilogram at Screening Visit 1.
- Participants with a documented diagnosis of EGPA for at least 6 months based on the history or presence of: asthma plus eosinophilia defined as >1.0*10^9/Liter (L) and/or >10 percentage (%) of leucocytes plus at least 2 of the following additional features of EGPA: a biopsy showing histopathological evidence of eosinophilic vasculitis, or perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation, neuropathy, mono or poly (motor deficit or nerve conduction abnormality), pulmonary infiltrates, non-fixed, sino-nasal abnormality, cardiomyopathy (established by echocardiography or magnetic resonance imaging), glomerulonephritis (hematuria, red cell casts, proteinuria), alveolar hemorrhage (by bronchoalveolar lavage), palpable purpura, anti-neutrophil cytoplasmic antibodies positive Myeloperoxidase or Proteinase 3.
- History of relapsing OR refractory disease.
- Participants must be on a stable dose of oral prednisolone or prednisone of >=7.5 mg/day (but not >50 mg/day) or equivalent for at least 4 weeks prior to Baseline (Visit 2).
- If participants receiving immunosuppressive therapy (excluding cyclophosphamide) the dosage must be stable for the 4 weeks prior to Baseline (Visit 2) and during the study.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of non-childbearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%.
- Capable of giving signed informed consent
Who cannot join
- Participants diagnosed with granulomatosis with polyangiitis; previously known as Wegener's granulomatosis or microscopic polyangiitis.
- Participants with organ-threatening EGPA as per EULAR criteria,
- Imminently life-threatening EGPA disease within 3 months prior to Screening (Visit 1).
- A current malignancy or previous history of cancer in remission for less than 12 months prior to Screening.
- Participants with alanine aminotransferase >2*upper limit of normal (ULN) or if participant is on background methotrexate or azathioprine >3*ULN, aspartate aminotransferase >2*ULN or if participant is on background methotrexate or azathioprine >3*ULN, alkaline phosphatase >=2.0*ULN, total bilirubin >1.5*ULN (isolated bilirubin >1.5*ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%), Cirrhosis or current unstable liver or biliary disease per investigator assessment.
- Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment.
Show all 16Show fewer
- Participants who have known, pre-existing, clinically significant system abnormalities that are not associated with EGPA and are uncontrolled with standard treatment.
- Clinically significant abnormality in the hematological, biochemical or urinalysis screen at Visit 1.
- Chronic or ongoing active infectious disease requiring systemic treatment.
- Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening Visit 1.
- A known immunodeficiency (e.g., human immunodeficiency virus [HIV]).
- Participants that, according to the investigator's medical judgment, are likely to have active coronavirus disease 2019 (COVID-19) infection. Participants with known COVID-19 positive contacts within the past 14 days must be excluded for at least 14 days following the exposure during which the participant must remain symptom-free.
- Participants with a known allergy or intolerance to a monoclonal antibody or biologic therapy or any of the excipients of the investigational products.
- Participants who have a previous documented failure with anti-Interleukin-5 /Interleukin-5 receptor therapy (e.g., mepolizumab, reslizumab, benralizumab). Participants who have received monoclonal antibodies (mAb) and who have not undergone the required washout periods, prior to Visit 1.
- Participants receiving any of the following: Oral corticosteroids: Participant requires an oral corticosteroid dose of >50 mg/day prednisolone/prednisone in the 4-week period prior to Baseline (Visit 2), Intravenous (IV), intramuscular or subcutaneous (SC) corticosteroids in the 4-week period prior to Baseline (Visit 2), Omalizumab within 130 days prior to Screening (Visit 1), Cyclophosphamide (CYC): oral CYC within 4 weeks prior to Baseline (Visit 2) and IV CYC within 3 weeks prior to Baseline (Visit 2), if their total white blood cells is >=4*10^9/L (measured using the local laboratory if necessary), Rituximab within 12 months prior to Screening (Visit 1); in addition, the Participant must have shown recovery of peripheral B-cell count to within the normal range, Tezepelumab and Dupilumab with a washout period of 5 half-lives prior to Screening Visit 1, IV or SC immunoglobulin within 6 months prior to Screening (Visit 1); For China and Japan only within 12 weeks prior to Screening (Visit 1), Interferon-alpha within 6 months prior to Screening Visit 1, Anti-tumor necrosis factor therapy within 12 weeks prior to Screening Visit 1, Anti-CD52 (alemtuzumab) within 6 months prior to Screening Visit 1.
- Participants with QT interval corrected for heart rate according to Fridericia's formula (QTcF) >=450 milliseconds (msec) or QTcF >=480 msec for participants with Bundle Branch Block in the 12-lead ECG central over-read from at Screening Visit 1.
Trial locations and contacts
63 sites in 18 countries.
63 sites in 18 countries
Italy10 sites
GSK Investigational Site
Bari, 70124
GSK Investigational Site
Brescia, 25123
GSK Investigational Site
Florence, 50134
GSK Investigational Site
Milan, 20132
GSK Investigational Site
Milan, 20162
GSK Investigational Site
Pavia, 27100
GSK Investigational Site
Pisa, 56126
GSK Investigational Site
Roma, 00128
GSK Investigational Site
Torrette AN, 60126
GSK Investigational Site
Treviso, 31100
China8 sites
GSK Investigational Site
Beijing, 100005
GSK Investigational Site
Guangzhou, 510163
GSK Investigational Site
Hefei, 230001
GSK Investigational Site
Nanjing, 210006
GSK Investigational Site
Qingdao, 266071
GSK Investigational Site
Shanghai, 200032
GSK Investigational Site
Shenzhen, 518020
GSK Investigational Site
Wenzhou, 325000
United States6 sites
GSK Investigational Site
Charlotte, North Carolina, 28211
GSK Investigational Site
Denver, Colorado, 80206
GSK Investigational Site
Gainesville, Florida, 32610
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
Pittsburgh, Pennsylvania, 15261
GSK Investigational Site
Rochester, Minnesota, 55905
Japan5 sites
GSK Investigational Site
Kanagawa, 247-8533
GSK Investigational Site
Kanagawa, 252-0392
GSK Investigational Site
Saitama, 350-8550
GSK Investigational Site
Tokyo, 162-8666
GSK Investigational Site
Tokyo, 181-8611
South Korea5 sites
GSK Investigational Site
Gwangju, 61469
GSK Investigational Site
Seoul, 05505
GSK Investigational Site
Seoul, 06351
GSK Investigational Site
Seoul, 06591
GSK Investigational Site
Seoul, 3080
Spain5 sites
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Granada, 18014
GSK Investigational Site
Pamplona, 31008
GSK Investigational Site
Zaragoza, 50009
France3 sites
GSK Investigational Site
La Roche-sur-Yon, 85925
GSK Investigational Site
Nantes, 44093
GSK Investigational Site
Paris, 75014
Poland3 sites
GSK Investigational Site
Gdansk, 80-952
GSK Investigational Site
Lodz, 90-153
GSK Investigational Site
Warsaw, 01-138
United Kingdom3 sites
GSK Investigational Site
Birmingham, B15 2GW
GSK Investigational Site
Cambridge, CB2 2QQ
GSK Investigational Site
London, SE1 7EH
Argentina2 sites
GSK Investigational Site
La Plata, B1900
GSK Investigational Site
San Miguel de Tucumán, T4000
Brazil2 sites
GSK Investigational Site
Santo André, 09060-870
GSK Investigational Site
São Paulo, 4023900
Canada2 sites
GSK Investigational Site
Toronto, Ontario, M5T 3A9
GSK Investigational Site
Toronto, Ontario, M5T 3L9
Germany2 sites
GSK Investigational Site
Freiburg im Breisgau, 79106
GSK Investigational Site
Minden, 32429
Netherlands2 sites
GSK Investigational Site
Groningen, 9713 GZ
GSK Investigational Site
Leiden, 2333 ZA
Portugal2 sites
GSK Investigational Site
Lisbon, 1649-035
GSK Investigational Site
Porto, 4099-001
About this study
Official title: A 52-week, Randomized, Double-blind, Double-dummy, Parallel-group, Multi-centre, Non-inferiority Study to Investigate the Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) Receiving Standard of Care (SoC) Therapy
This study aims to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory EGPA receiving SoC therapy.
- Being tested
- Depemokimab, Mepolizumab, Placebo matching mepolizumab, Placebo matching depemokimab
- Keywords
- Depemokimab, Mepolizumab, Eosinophilic Granulomatosis with Polyangiitis
- Medical subject headings
- Churg-Strauss Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepemokimabBiological
Depemokimab will be administered
MepolizumabBiological
Mepolizumab will be administered
Placebo matching mepolizumabDrug
Placebo matching to mepolizumab will be administered.
Placebo matching depemokimabDrug
Placebo matching to depemokimab will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving depemokimab+placebo matching mepolizumab | Experimental | Not described Receives: Biological: Depemokimab; Drug: Placebo matching mepolizumab |
| Participants receiving mepolizumab+placebo matching depemokimab | Active comparator | Not described Receives: Biological: Mepolizumab; Drug: Placebo matching depemokimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with remission (Birmingham Vasculitis Activity Score [BVAS] =0 and a dose of oral corticosteroid [OCS] less than or equal to [<=] 4 milligram [mg] per day)
Participants must be in remission at both Weeks 36 and 52.
Measured: Up to Week 52
Secondary outcomes (9)
Number of participants in each category of accrued duration of remission
Total accrued duration of remission is the accrued number of weeks where BVAS = 0 plus OCS dose <= 4 mg/day over the 52-week intervention period. The accrued duration was categorized into zero, >0 to <12 weeks, 12 to <24 weeks, 24 to <36 weeks or more than or equal to (>=) 36 weeks.
Measured: Up to Week 52
Number of participants with total accrued duration of remission
Total accrued duration of remission is the accrued number of weeks where BVAS = 0 plus OCS dose <= 4 mg/day over the 52-week intervention period.
Measured: Up to Week 52
Time to first EGPA relapse
The time to first EGPA relapse will be calculated from the date of first dose of study intervention and start date of the EGPA relapse.
Measured: Up to Week 52
Number of participants receiving in each category of mean OCS dose during the last 4 weeks of study treatment period (Weeks 49 to 52)
Number of participants receiving the mean OCS dose (categorized as 0, >0 to <=4, >4 to <=7.5 or >7.5 mg/day) will be assessed during the last 4 weeks of the study treatment period (Weeks 49 to 52).
Measured: Weeks 49 to 52
Number of participants achieving remission (BVAS = 0 and OCS <= 4 mg/day) within the first 24 weeks with continued remission until Week 52
Measured: Up to Week 52
Number of participants achieving remission using the European League against Rheumatism (EULAR) definition (BVAS = 0 and OCS <=7.5 mg/day) at Weeks 36 and 52
Measured: At Weeks 36 and 52
Number of participants in each category of accrued duration of remission according to the EULAR definition of remission (BVAS = 0 plus OCS <=7.5 mg/day) over 52-week intervention period
Total accrued duration of remission according to the EULAR definition of remission is the accrued number of weeks where BVAS = 0 plus OCS dose <=7.5 mg/day over the 52 week intervention period categorized as zero weeks; >0 to <12 weeks; 12 to <24 weeks; 24 to <36 weeks or >= 36 weeks.
Measured: Up to Week 52
Number of participants with total accrued duration of remission according to the EULAR definition of remission
Total accrued duration of remission according to the EULAR definition of remission is the accrued number of weeks where BVAS=0 plus OCS <=7.5 mg/day over the 52-week intervention period.
Measured: Up to Week 52
Number of participants with remission (BVAS=0 and OCS <=7.5 mg/day) within the first 24 weeks with continued remission until Week 52
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start14 Jul 2022
- Primary completion29 Sep 2026 (estimated)
- Study completion27 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Granulomatosis With PolyangiitisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will receive either depemokimab plus placebo matching mepolizumab or mepolizumab plus placebo matching depemokimab
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263934
- Sponsor's protocol ID
- 217102
- Other IDs
- 2023-510019-20-00, 2023
- Acronym
- OCEAN
- Status last verified
- Jul 2026
- First submitted
- 28 Feb 2022
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week, Randomized, Double-blind, Double-dummy, Parallel-group, Multi-centre, Non-inferiority Study to Investigate the Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) Receiving Standard of Care (SoC) Therapy
- ClinicalTrials.gov ID
- NCT05263934
- Acronym / sponsor ID
- OCEAN / 217102
- Keywords
- Depemokimab, Mepolizumab, Eosinophilic Granulomatosis with Polyangiitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 163 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 29 Sep 2026 (estimated)
- Study completion
- 27 Oct 2026 (estimated)
- First posted
- 3 Mar 2022 (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.
This study aims to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory EGPA receiving SoC therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will receive either depemokimab plus placebo matching mepolizumab or mepolizumab plus placebo matching depemokimab
| Arm | Type | Receives |
|---|---|---|
| Participants receiving depemokimab+placebo matching mepolizumab | Experimental | Biological: Depemokimab, Drug: Placebo matching mepolizumab |
| Participants receiving mepolizumab+placebo matching depemokimab | Active comparator | Biological: Mepolizumab, Drug: Placebo matching depemokimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant (male or female) must be 18 years of age or older at the time of signing the informed consent.
- Participants who are >=40 kilogram at Screening Visit 1.
- Participants with a documented diagnosis of EGPA for at least 6 months based on the history or presence of: asthma plus eosinophilia defined as >1.0*10^9/Liter (L) and/or >10 percentage (%) of leucocytes plus at least 2 of the following additional features of EGPA: a biopsy showing histopathological evidence of eosinophilic vasculitis, or perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation, neuropathy, mono or poly (motor deficit or nerve conduction abnormality), pulmonary infiltrates, non-fixed, sino-nasal abnormality, cardiomyopathy (established by echocardiography or magnetic resonance imaging), glomerulonephritis (hematuria, red cell casts, proteinuria), alveolar hemorrhage (by bronchoalveolar lavage), palpable purpura, anti-neutrophil cytoplasmic antibodies positive Myeloperoxidase or Proteinase 3.
- History of relapsing OR refractory disease.
- Participants must be on a stable dose of oral prednisolone or prednisone of >=7.5 mg/day (but not >50 mg/day) or equivalent for at least 4 weeks prior to Baseline (Visit 2).
Key exclusion criteria (16 listed)
- Participants diagnosed with granulomatosis with polyangiitis; previously known as Wegener's granulomatosis or microscopic polyangiitis.
- Participants with organ-threatening EGPA as per EULAR criteria,
- Imminently life-threatening EGPA disease within 3 months prior to Screening (Visit 1).
- A current malignancy or previous history of cancer in remission for less than 12 months prior to Screening.
- Participants with alanine aminotransferase >2*upper limit of normal (ULN) or if participant is on background methotrexate or azathioprine >3*ULN, aspartate aminotransferase >2*ULN or if participant is on background methotrexate or azathioprine >3*ULN, alkaline phosphatase >=2.0*ULN, total bilirubin >1.5*ULN (isolated bilirubin >1.5*ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%), Cirrhosis or current unstable liver or biliary disease per investigator assessment.
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 |
|---|---|---|
| DepemokimabDepemokimab will be administered | Biological | Participants receiving depemokimab+placebo matching mepolizumab |
| MepolizumabMepolizumab will be administered | Biological | Participants receiving mepolizumab+placebo matching depemokimab |
| Placebo matching mepolizumabPlacebo matching to mepolizumab will be administered. | Drug | Participants receiving depemokimab+placebo matching mepolizumab |
| Placebo matching depemokimabPlacebo matching to depemokimab will be administered. | Drug | Participants receiving mepolizumab+placebo matching depemokimab |
Primary outcome
Number of participants with remission (Birmingham Vasculitis Activity Score [BVAS] =0 and a dose of oral corticosteroid [OCS] less than or equal to [<=] 4 milligram [mg] per day)
Time frame: Up to Week 52
Participants must be in remission at both Weeks 36 and 52.
9 secondary outcomes
Number of participants in each category of accrued duration of remission
Time frame: Up to Week 52
Number of participants with total accrued duration of remission
Time frame: Up to Week 52
Time to first EGPA relapse
Time frame: Up to Week 52
Number of participants receiving in each category of mean OCS dose during the last 4 weeks of study treatment period (Weeks 49 to 52)
Time frame: Weeks 49 to 52
Number of participants achieving remission (BVAS = 0 and OCS <= 4 mg/day) within the first 24 weeks with continued remission until Week 52
Time frame: Up to Week 52
Number of participants achieving remission using the European League against Rheumatism (EULAR) definition (BVAS = 0 and OCS <=7.5 mg/day) at Weeks 36 and 52
Time frame: At Weeks 36 and 52
Number of participants in each category of accrued duration of remission according to the EULAR definition of remission (BVAS = 0 plus OCS <=7.5 mg/day) over 52-week intervention period
Time frame: Up to Week 52
Number of participants with total accrued duration of remission according to the EULAR definition of remission
Time frame: Up to Week 52
Number of participants with remission (BVAS=0 and OCS <=7.5 mg/day) within the first 24 weeks with continued remission until Week 52
Time frame: Up to Week 52
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 8 Jul 2026.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
63 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Depemokimab and Mepolizumab in people with Eosinophilic Granulomatosis With Polyangiitis, run by GlaxoSmithKline at 63 sites in 18 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 8 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in Italy, China, United States, Japan, South Korea and 13 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. 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?
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?
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?
Number of participants with remission (Birmingham Vasculitis Activity Score [BVAS] =0 and a dose of oral corticosteroid [OCS] less than or equal to [<=] 4 milligram [mg] per day) (time frame: Up to Week 52). 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 8 Jul 2026.