EGPA - Eosinophilic Granulomatosis With PolyangiitisPhase 4BEOMICSNCT07343661
Beyond EOsinophils: proteoMICS to Identify Potential Biomarker of Organ Damage and Response to MEPOLIZUMAB in EGPA
A Phase 4 study testing Mepolizumab 100 MG Injection [Nucala] and Mepolizumab 300 mg in people with EGPA - Eosinophilic Granulomatosis With Polyangiitis and Severe Asthma, run by Azienda Ospedaliero Universitaria di Cagliari at 1 site in Italy.
Trial summary
Aim of the study is to identify potential biomarkers, through a proteomic approach, which could be used to evaluate organ damage and predict the response to mepolizumab in a cohort of patients affected by EGPA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGPA - Eosinophilic Granulomatosis With Polyangiitis, Severe Asthma, Eosinophilic Asthma
- What is being tested?
- Mepolizumab 100 MG Injection [Nucala] and Mepolizumab 300 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 17 Oct 2025to 30 Sep 2028
- Phase
- Phase 4
- 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
- Informed Consent: Prior to start any study related activities, participants must be able and willing to provide written informed consent;
- Participants must have a current clinical diagnosis of asthma or EGPA;
- Physician decision to initiate treatment with mepolizumab.
- Patient has to be in treatment with medium-high dose ICS plus an additional controller in the least 6 months before screening and, if on OCS therapy, a stable dosage of prednisone (or equivalent dose of other steroids) in the 4 weeks before screening will be allowed. The above-indicated treatment has to be maintained by the patient all along the study.
- Adults aged 18 years or over.
Who cannot join
- Asthmatic patients receiving other biological treatment
- Participation in an interventional clinical trial in which the treatment regimen and/or monitoring is dictated by a protocol during the previous 12 months.
- Pregnant and breastfeeding woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Beyond Eosinophils: Proteomics to Identify Potential Biomarkers of Organ Damage and Response to MEPOLIZUMAB in EGPA
Aim of the study is to identify potential biomarkers, through a proteomic approach, which could be used to evaluate organ damage and predict the response to mepolizumab in a cohort of patients affected by EGPA. Proteomic analyses will be performed using a proteomic platform, based on a nano-HPLC- couplet to an high resolution ESI-MS device, on three types of biological matrices: blood, saliva and sputum samples in both EGPA and severe asthmatic patients (as controls) at baseline and at different time points after starting treatment with mepolizumab, an anti-IL-5 drug, in order to cluster patients and to analyze the effect of the therapy during treatment, assessing the disease progression on three key aspects: lung function and symptoms control, vasculitis and neuropathy. Plasma analysis will provide an overview of quantitative/qualitative proteomic variations at systemic level after drug administration; however, a less invasive procedure is often sufficient and would improve trial recruitment. On this regard, saliva is a biological fluid well suitable to be used in proteomic investigations for suggestion of potential disease biomarkers and includes various potential advantages compared with blood sample collection such as lower overall cost, lower infection risk, increased patient convenience, acceptability, compliance and uptake. Moreover, the protein composition of the human saliva includes both specific proteins of the oral cavity and proteins common to other tissues and bodily fluids, so saliva prognostic and diagnostic role is particularly interesting. Consequently, the plan is to compare the proteomic results of the non-invasive saliva testing to that of blood examination.
These data may be a further step to untangle the mechanisms of the disease and to characterize treatment's response, in the contest of a phenotype/endotype asthma management.
Read the detailed description
The investigators plan to collect blood, salivary and sputum samples in both EGPA and severe asthmatic patients (as controls) at baseline and at different timepoints after starting treatment with mepolizumab, an anti-IL-5 drug, in order to cluster patients and to analyse the effect of the therapy during treatment and assess the disease progression on three key aspects of the disease: lung function and symptoms control, vasculitis and neuropathy.
untangle the mechanisms of the disease and to characterize response to treatment, in the context of a phenotype/endotype asthma and EGPA management.
- Being tested
- Mepolizumab 100 MG Injection [Nucala], Mepolizumab 300 mg
- Keywords
- EGPA, severe asthma, eosinophilic asthma
- Medical subject headings
- Churg-Strauss Syndrome, Asthma, Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepolizumab 100 MG Injection [Nucala]Drug
collect blood, salivary and sputum samples in both EGPA and severe asthmatic patients (as controls) at baseline and at different timepoints after starting treatment with mepolizumab, an anti-IL-5 drug, in order to cluster patients and to analyse the effect of the therapy during treatment and assess the disease progression on three key aspects of the disease: lung function and symptoms control, vasculitis and neuropathy.
Mepolizumab 300 mgDrug
collect blood, salivary and sputum samples in both EGPA and severe asthmatic patients (as controls) at baseline and at different timepoints after starting treatment with mepolizumab, an anti-IL-5 drug, in order to cluster patients and to analyse the effect of the therapy during treatment and assess the disease progression on three key aspects of the disease: lung function and symptoms control, vasculitis and neuropathy.
| Study group | Role | What they receive |
|---|---|---|
| EGPA with predominant ENT/asthmatic phenotype | Experimental | Mepolizumab treatment Receives: Drug: Mepolizumab 300 mg |
| EGPA with vasculitic phenotype | Experimental | immunosuppressive drugs (CYC, AZA, MTX) and/or Mepolizumab Receives: Drug: Mepolizumab 300 mg |
| severe eosinophilic asthma | Active comparator | before and after Mepolizumab treatment Receives: Drug: Mepolizumab 100 MG Injection [Nucala] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva, sputum, and plasma proteomic profile of EGPA patients
Obtain a proteomic profile of EGPA patients and severe asthmatic patients from blood, saliva and sputum.
Analyse the samples after starting anti IL - 5 treatment ( mepolizumab ) and evaluate the possible disease modifying effect of the mepoliumab on vas
Measured: From the data to the enrollment until the end of the study, up to 52 weeks.
Secondary outcomes (1)
If it is possible to predict the response to treatment by analyzing the proteomic profile of the patients.
untangle the mechanisms of the disease and to characterize response to treatment, in the context of a phenotype/endotype asthma and EGPA management
Measured: From date of randomization until the date of first documented progression, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start17 Oct 2025
- Primary completion17 Oct 2026 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for EGPA - Eosinophilic Granulomatosis With PolyangiitisStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- According to the patients' groups evaluated in other publications with a robust statistical method and sample size calculation performed by the team, a sample of 90 patients can be considered sufficient to allow the realization of the study. The investigators plan to enroll 90 patients followed in Allergy and Clinical Immunology Centers divided into three groups: * 30 patients with EGPA with predominant ENT/asthmatic phenotype (longitudinal sampling before and after Mepolizumab treatment) * 30 patients with EGPA with vasculitic phenotype before and after immunosuppressive drugs (CYC, AZA, MTX) and/or Mepolizumab. * 30 patients with a diagnosis of severe eosinophilic asthma (longitudinal sampling before and after Mepolizumab treatment)
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria di Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulia Costanzo, Azienda Ospedaliero Universitaria di Cagliari
- Investigators
- STEFANO DEL GIACCO, MD, Principal investigator, AZIENDA OSPEDALIERA UNIVERSITARIA CAGLIARI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343661
- Sponsor's protocol ID
- 14918-219771
- Other IDs
- GSK IIS Study 14918-219771
- Acronym
- BEOMICS
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: PRIVACY
Publications
Steinfeld J, Bradford ES, Brown J, Mallett S, Yancey SW, Akuthota P, Cid MC, Gleich GJ, Jayne D, Khoury P, Langford CA, Merkel PA, Moosig F, Specks U, Weller PF, Wechsler ME. Evaluation of clinical benefit from treatment with mepolizumab for patients with eosinophilic granulomatosis with polyangiitis. J Allergy Clin Immunol. 2019 Jun;143(6):2170-2177. doi: 10.1016/j.jaci.2018.11.041. Epub 2018 Dec 19.
PubMed 30578883Wechsler ME, Akuthota P, Jayne D, Khoury P, Klion A, Langford CA, Merkel PA, Moosig F, Specks U, Cid MC, Luqmani R, Brown J, Mallett S, Philipson R, Yancey SW, Steinfeld J, Weller PF, Gleich GJ; EGPA Mepolizumab Study Team. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2017 May 18;376(20):1921-1932. doi: 10.1056/NEJMoa1702079.
PubMed 28514601Kahn JE, Grandpeix-Guyodo C, Marroun I, Catherinot E, Mellot F, Roufosse F, Bletry O. Sustained response to mepolizumab in refractory Churg-Strauss syndrome. J Allergy Clin Immunol. 2010 Jan;125(1):267-70. doi: 10.1016/j.jaci.2009.10.014. No abstract available.
PubMed 20109753Puechal X, Pagnoux C, Baron G, Lifermann F, Geffray L, Quemeneur T, Saraux JL, Wislez M, Cottin V, Ruivard M, Limal N, Aouba A, Bonnotte B, Neel A, Agard C, Cohen P, Terrier B, Le Jeunne C, Mouthon L, Ravaud P, Guillevin L; French Vasculitis Study Group investigators. Non-severe eosinophilic granulomatosis with polyangiitis: long-term outcomes after remission-induction trial. Rheumatology (Oxford). 2019 Dec 1;58(12):2107-2116. doi: 10.1093/rheumatology/kez139.
PubMed 31056661Samson M, Puechal X, Devilliers H, Ribi C, Cohen P, Stern M, Pagnoux C, Mouthon L, Guillevin L; French Vasculitis Study Group. Long-term outcomes of 118 patients with eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) enrolled in two prospective trials. J Autoimmun. 2013 Jun;43:60-9. doi: 10.1016/j.jaut.2013.03.003. Epub 2013 Apr 13.
PubMed 23590801Jennette JC, Falk RJ, Bacon PA, Basu N, Cid MC, Ferrario F, Flores-Suarez LF, Gross WL, Guillevin L, Hagen EC, Hoffman GS, Jayne DR, Kallenberg CG, Lamprecht P, Langford CA, Luqmani RA, Mahr AD, Matteson EL, Merkel PA, Ozen S, Pusey CD, Rasmussen N, Rees AJ, Scott DG, Specks U, Stone JH, Takahashi K, Watts RA. 2012 revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides. Arthritis Rheum. 2013 Jan;65(1):1-11. doi: 10.1002/art.37715. No abstract available.
PubMed 23045170
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Eosinophils: Proteomics to Identify Potential Biomarkers of Organ Damage and Response to MEPOLIZUMAB in EGPA
- ClinicalTrials.gov ID
- NCT07343661
- Acronym / sponsor ID
- BEOMICS / 14918-219771
- Keywords
- EGPA, severe asthma, eosinophilic asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria di CagliariUniversity, hospital or other
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 17 Oct 2026 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 15 Jan 2026 (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.
Aim of the study is to identify potential biomarkers, through a proteomic approach, which could be used to evaluate organ damage and predict the response to mepolizumab in a cohort of patients affected by EGPA. Proteomic analyses will be performed using a proteomic platform, based on a nano-HPLC- couplet to an high resolution ESI-MS device, on three types of biological matrices: blood, saliva and sputum samples in both EGPA and severe asthmatic patients (as controls) at baseline and at different time points after starting treatment with mepolizumab, an anti-IL-5 drug, in order to cluster patients and to analyze the effect of the therapy during treatment, assessing the disease progression on three key aspects: lung function and symptoms control, vasculitis and neuropathy. Plasma analysis will provide an overview of quantitative/qualitative proteomic variations at systemic level after drug administration; however, a less invasive procedure is often sufficient and would improve trial recruitment. On this regard, saliva is a biological fluid well suitable to be used in proteomic investigations for suggestion of potential disease biomarkers and includes various potential advantages compared with blood sample collection such as lower overall cost, lower infection risk, increased patient convenience, acceptability, compliance and uptake. Moreover, the protein composition of the human saliva includes both specific proteins of the oral cavity and proteins common to other tissues and bodily fluids, so saliva prognostic and diagnostic role is particularly interesting. Consequently, the plan is to compare the proteomic results of the non-invasive saliva testing to that of blood examination.
These data may be a further step to untangle the mechanisms of the disease and to characterize treatment's response, in the contest of a phenotype/endotype asthma management.
Detailed description
The investigators plan to collect blood, salivary and sputum samples in both EGPA and severe asthmatic patients (as controls) at baseline and at different timepoints after starting treatment with mepolizumab, an anti-IL-5 drug, in order to cluster patients and to analyse the effect of the therapy during treatment and assess the disease progression on three key aspects of the disease: lung function and symptoms control, vasculitis and neuropathy.
untangle the mechanisms of the disease and to characterize response to treatment, in the context of a phenotype/endotype asthma and EGPA management.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- According to the patients' groups evaluated in other publications with a robust statistical method and sample size calculation performed by the team, a sample of 90 patients can be considered sufficient to allow the realization of the study. The investigators plan to enroll 90 patients followed in Allergy and Clinical Immunology Centers divided into three groups: * 30 patients with EGPA with predominant ENT/asthmatic phenotype (longitudinal sampling before and after Mepolizumab treatment) * 30 patients with EGPA with vasculitic phenotype before and after immunosuppressive drugs (CYC, AZA, MTX) and/or Mepolizumab. * 30 patients with a diagnosis of severe eosinophilic asthma (longitudinal sampling before and after Mepolizumab treatment)
| Arm | Type | Receives |
|---|---|---|
| EGPA with predominant ENT/asthmatic phenotype | Experimental | Drug: Mepolizumab 300 mgMepolizumab treatment |
| EGPA with vasculitic phenotype | Experimental | Drug: Mepolizumab 300 mgimmunosuppressive drugs (CYC, AZA, MTX) and/or Mepolizumab |
| severe eosinophilic asthma | Active comparator | Drug: Mepolizumab 100 MG Injection [Nucala]before and after Mepolizumab treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed Consent: Prior to start any study related activities, participants must be able and willing to provide written informed consent;
- Participants must have a current clinical diagnosis of asthma or EGPA;
- Physician decision to initiate treatment with mepolizumab.
- Patient has to be in treatment with medium-high dose ICS plus an additional controller in the least 6 months before screening and, if on OCS therapy, a stable dosage of prednisone (or equivalent dose of other steroids) in the 4 weeks before screening will be allowed. The above-indicated treatment has to be maintained by the patient all along the study.
- Adults aged 18 years or over.
Key exclusion criteria (3 listed)
- Asthmatic patients receiving other biological treatment
- Participation in an interventional clinical trial in which the treatment regimen and/or monitoring is dictated by a protocol during the previous 12 months.
- Pregnant and breastfeeding woman
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 |
|---|---|---|
| Mepolizumab 100 MG Injection [Nucala]collect blood, salivary and sputum samples in both EGPA and severe asthmatic patients (as controls) at baseline and at different timepoints after starting treatment with mepolizumab, an anti-IL-5 drug, in order to cluster patients and to analyse the effect of the therapy during treatment and assess the disease progression on three key aspects of the disease: lung function and symptoms control, vasculitis and neuropathy. | Drug | severe eosinophilic asthma |
| Mepolizumab 300 mgcollect blood, salivary and sputum samples in both EGPA and severe asthmatic patients (as controls) at baseline and at different timepoints after starting treatment with mepolizumab, an anti-IL-5 drug, in order to cluster patients and to analyse the effect of the therapy during treatment and assess the disease progression on three key aspects of the disease: lung function and symptoms control, vasculitis and neuropathy. | Drug | EGPA with predominant ENT/asthmatic phenotype, EGPA with vasculitic phenotype |
Primary outcome
Saliva, sputum, and plasma proteomic profile of EGPA patients
Time frame: From the data to the enrollment until the end of the study, up to 52 weeks.
Obtain a proteomic profile of EGPA patients and severe asthmatic patients from blood, saliva and sputum. Analyse the samples after starting anti IL - 5 treatment ( mepolizumab ) and evaluate the possible disease modifying effect of the mepoliumab on vas
1 secondary outcome
If it is possible to predict the response to treatment by analyzing the proteomic profile of the patients.
Time frame: From date of randomization until the date of first documented progression, assessed up to 24 months
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 15 Jan 2026.
- Background: PubMed 30578883Steinfeld J, Bradford ES, Brown J, Mallett S, Yancey SW, Akuthota P, Cid MC, Gleich GJ, Jayne D, Khoury P, Langford CA, Merkel PA, Moosig F, Specks U, Weller PF, Wechsler ME. Evaluation of clinical benefit from treatment with mepolizumab for patients with eosinophilic granulomatosis with polyangiitis. J Allergy Clin Immunol. 2019 Jun;143(6):2170-2177. doi: 10.1016/j.jaci.2018.11.041. Epub 2018 Dec 19.
- Background: PubMed 28514601Wechsler ME, Akuthota P, Jayne D, Khoury P, Klion A, Langford CA, Merkel PA, Moosig F, Specks U, Cid MC, Luqmani R, Brown J, Mallett S, Philipson R, Yancey SW, Steinfeld J, Weller PF, Gleich GJ; EGPA Mepolizumab Study Team. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2017 May 18;376(20):1921-1932. doi: 10.1056/NEJMoa1702079.
- Background: PubMed 20109753Kahn JE, Grandpeix-Guyodo C, Marroun I, Catherinot E, Mellot F, Roufosse F, Bletry O. Sustained response to mepolizumab in refractory Churg-Strauss syndrome. J Allergy Clin Immunol. 2010 Jan;125(1):267-70. doi: 10.1016/j.jaci.2009.10.014. No abstract available.
- Background: PubMed 31056661Puechal X, Pagnoux C, Baron G, Lifermann F, Geffray L, Quemeneur T, Saraux JL, Wislez M, Cottin V, Ruivard M, Limal N, Aouba A, Bonnotte B, Neel A, Agard C, Cohen P, Terrier B, Le Jeunne C, Mouthon L, Ravaud P, Guillevin L; French Vasculitis Study Group investigators. Non-severe eosinophilic granulomatosis with polyangiitis: long-term outcomes after remission-induction trial. Rheumatology (Oxford). 2019 Dec 1;58(12):2107-2116. doi: 10.1093/rheumatology/kez139.
- Background: PubMed 23590801Samson M, Puechal X, Devilliers H, Ribi C, Cohen P, Stern M, Pagnoux C, Mouthon L, Guillevin L; French Vasculitis Study Group. Long-term outcomes of 118 patients with eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) enrolled in two prospective trials. J Autoimmun. 2013 Jun;43:60-9. doi: 10.1016/j.jaut.2013.03.003. Epub 2013 Apr 13.
- Background: PubMed 23045170Jennette JC, Falk RJ, Bacon PA, Basu N, Cid MC, Ferrario F, Flores-Suarez LF, Gross WL, Guillevin L, Hagen EC, Hoffman GS, Jayne DR, Kallenberg CG, Lamprecht P, Langford CA, Luqmani RA, Mahr AD, Matteson EL, Merkel PA, Ozen S, Pusey CD, Rasmussen N, Rees AJ, Scott DG, Specks U, Stone JH, Takahashi K, Watts RA. 2012 revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides. Arthritis Rheum. 2013 Jan;65(1):1-11. doi: 10.1002/art.37715. No abstract available.
- Individual participant dataSharing planned: No. PRIVACY
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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.
STEFANO DEL GIACCO, MD principal investigator
AZIENDA OSPEDALIERA UNIVERSITARIA CAGLIARI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mepolizumab 100 MG Injection [Nucala] and Mepolizumab 300 mg in people with EGPA - Eosinophilic Granulomatosis With Polyangiitis and Severe Asthma, run by Azienda Ospedaliero Universitaria di Cagliari at 1 site in Italy.
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 5 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 15 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 1 site in Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Saliva, sputum, and plasma proteomic profile of EGPA patients (time frame: From the data to the enrollment until the end of the study, up to 52 weeks.). 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 NCT07343661, which also lists 6 linked publications.
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 15 Jan 2026.