Chronic Rhinosinusitis With Nasal PolypsPhase 4ISS-RESMEPONCT05902325
Identifying Predictors Of Response To Mepolizumab In CRSwNP
A Phase 4 study testing Mepolizumab 100 MG Injection in people with Chronic Rhinosinusitis With Nasal Polyps, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The investigators propose a real-world study to assess the mechanism of action of long-lasting response to mepolizumab in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) and identify clinically useful predictors of response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Mepolizumab 100 MG Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 3 Oct 2023to 31 Dec 2026
- 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
- Bilateral NP, as diagnosed by endoscopy or historical CT scan
- At least one NP surgery* within the last 10 years.
- Severe NP symptoms consistent with a need for surgery (obstruction VAS symptom score>5, overall, VAS symptom score >7, endoscopic bilateral NP score ≥4 [with a score ≥2 in each nasal cavity]).
- Ongoing treatment with INCS (via spray or intranasal liquid steroid wash/douching) for ≥4 weeks prior to screening
- ≥2 of the following CRS symptoms for at least 12 weeks:
- Nasal blockage/obstruction/congestion
Show all 9Show fewer
- Nasal discharge (anterior/posterior nasal drip)
- Facial pain/pressure
- Reduction or loss of sense of smell
Who cannot join
- If as a result of a medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study.
- Cystic fibrosis
- Eosinophilic granulomatosis with polyangiitis (also known as Churg Strauss syndrome), Young's, Kartagener's or dyskinetic ciliary syndromes
- Antrochoanal polyps
- Nasal septal deviation occluding one nostril
- Acute sinusitis or upper respiratory tract infection (URTI) at screening or 2 weeks prior to screening
Show all 21Show fewer
- Ongoing rhinitis medicamentosa (rebound or chemical-induced rhinitis)
- Participants who have undergone any intranasal and/or sinus surgery (for example polypectomy, balloon dilatation or nasal stent insertion) within 6 months prior to V1
- Participants where NP surgery is contraindicated in the opinion of the Investigator
- Participants with a known medical history of HIV infection.
- Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1.
- Participants who are currently receiving or have received within 3 months (or 5 half-lives - whatever is the longest) prior to the screening visit, radiotherapy, or investigational medications/therapies.
- Participants with a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. Aspirin-sensitive participants are acceptable.
- Participants with a history of allergic reaction to anti-IL-5 or other monoclonal antibody therapy.
- Use of systemic corticosteroids (including oral corticosteroids) within 4 weeks prior to screening or planned use of such medications during the double-blind period
- Treatments with biological or immunosuppressive treatment (other than Xolair) treatment within 5 terminal phase half-lives of Visit 1
- Omalizumab (Xolair) treatment in the 130 days prior to Visit 1
- Commencement or change of dose of allergen immunotherapy within the previous 3 months.
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. Contraceptive use will be required with a double barrier method or documented effective surgical sterilization.
- Immunocompromised subjects from disease or medication, other than oral corticosteroids.
- Women of childbearing potential (WOCBP) will be included with measures to prevent accidental exposure to IMP by using double barrier contraception and pregnancy test prior to injection.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
About this study
Official title: Identifying Predictors Of Long-Lasting Response To Mepolizumab In CRSwNP: Is The Disease-Modifying Role Secondary To Restored Anti-Viral Activity Or Enhanced Epithelial Regeneration?
The investigators propose a real-world study to assess the mechanism of action of long-lasting response to mepolizumab in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) and identify clinically useful predictors of response.
Mepolizumab is a monoclonal antibody targeting IL-5 and is approved for use in asthma and CRSwNP. In clinical studies, 12 months of treatment with mepolizumab improved signs and symptoms of CRSwNP and reduced the need for surgery. While several biologic medications targeting facets of the Type 2 mechanism are currently indicated for chronic rhinosinusitis with nasal polyps mepolizumab alone appears capable of modifying the disease's biological behaviour and producing long-standing improvements after the cessation of treatment. In the mepolizumab for CRSwNP regulatory trial (SYNAPSE), a subset of patients experienced dramatic and long-lasting, which is over 48 months after cessation of administration of the investigational medicinal product (IMP) in our experience. This has been partially captured in a follow-on study to the registration trail, which showed that a subset of patients followed for 24 weeks after cessation of biologic therapy (with continued use of mometasone furoate) demonstrated persistent improvements over baseline.
Read more
However, the mechanism of the long-lasting effect in a subset of patients is not well understood, and it is impossible currently to identify patients who will derive this maximal benefit. The mechanism for the prolonged improvements in CRSwNP seen in certain patients with mepolizumab remains to be established but suggests that effects beyond eosinophil trafficking are implicated.
The investigators believe that mepolizumab has IL-5-mediated pleiotropic effects which contribute to disease modification with effects extending beyond eosinophil activation and trafficking. This may include the following primary or secondary effects:
- Improving epithelial barrier function ii) Altering mast cell dynamics iii) Reversing epigenetic modifications iv) Altering the immune response to better clear pathogenic bacteria or viruses.
Read the detailed description
Study Rationale:
The investigators propose an ambitious research program to investigate the underlying mechanism of action of the prolonged responses to treatment with mepolizumab in patients with CRSwNP seen in the SYNAPSE trial. In addition, the investigators seek to establish the link between viral disease and eosinophilia, based upon a concept of viral interference with immunologic response inspired by findings from the COVID-19 pandemic.
Study Design:
In this monocentric prospective cohort study, two seasoned investigators will assess the disease-modifying effects of mepolizumab on CRSwNP. This study aims to identify in a ''real-world'' setting the mechanisms underpinning the prolonged response to mepolizumab and identify biomarkers predictive of prolonged response. Thirty-six patients with CRSwNP unresponsive to medical and surgical treatment will be treated with twelve months of mepolizumab in an unblinded and nonrandomized fashion (open-label).
The response will be assessed with usual clinical parameters, including sino-nasal endoscopy. The mechanism of response will be explored in depth before and 6 months after the beginning of treatment with a multiomic approach. The long-term effect will be assessed by clinical assessment only.
- Determine the mechanism of action of mepolizumab in CRSwNP with multiomics. The investigators will explore the critical mechanisms that contribute to transcription patterns in diseased tissue in a cell-type-specific perspective and explore whether viral infection contributes to CRS. Simultaneous profiling of gene expression and open chromatin from the same cell will be used to capture epigenetic modifications in identified cell clusters by RNA-seq combined with an assay for transposase-accessible chromatin (Chromium Single-Cell Multiome ATAC + Gene expression, 10X Genomics).
- Confirm improved epithelial regeneration and repair following mepolizumab treatment via in vitro functional assessment of epithelial capacity for regeneration. Using in vitro wound healing models, the investigators will evaluate the proliferation and cell migration of PEC from patients' nasal polyp biopsy prior to and 6 months after the beginning of treatment. Each time point will be assessed in triplicate on petri (3 wells/ patient) along with cultures on Lab-Tek chamber slides for immunofluorescence assays. Functional assessment of the capacity of tissue repair will be assessed by the speed of repair following standardized injury. Immunofluorescence will assess the markers of the epithelium (tubulin, cadherin, vimentin etc.) and epithelial function (tight junction, zonula occludens, integrins etc.) and by the presence of proliferation markers (Ki-67) at the wound site.
- Identify associated epigenetic marks of response which can serve as potential biomarkers of the responder population. As described above, epigenetic modulation of the genome will be assessed at the single-cell level in multiomic profiling. In order to restrict epigenetic profiling to epigenetic modifications which may have a use as biomarkers, DNA methylation profiling will be performed by DNA MethylationEPIC Beadchip to identify putative biomarkers of response to treatment and identify methylation-related regulatory mechanisms.
- Characterise the impact of mepolizumab on viruses by defining a library of viruses present in CRSwNP and comparing their levels pre- and post-treatment with mepolizumab. The investigators will perform sequenced-based profiling using deep sequencing technologies (Illumina high-throughput RNA sequencing) to reveal candidate viral pathogens using an existing pre-COVID biobank of CRSwNP tissue in our institution to define the type of viruses present in CRSwNP. Similarly, viruses will be assessed in the population undergoing treatment with mepolizumab to assess whether treatment influences viral burden and specific viruses.
- Identify epigenetic marks associated with the presence of different viruses which can serve as markers of prior viral infection.
The investigators will investigate the specific association between viruses and epigenetic marks with the integrative analysis of the resulting data using epigenomics and transcriptomics methods.
There will be a follow-up of patients over 12 months.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Mepolizumab 100 MG Injection
- Keywords
- CRSwNP, Epigenetic, Virus, Multiomics, Mepolizumab
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepolizumab 100 MG InjectionDrug
Also called Nucala
Patients will receive Mepolizumab 100mg SC once every 4 weeks for 48 weeks (twelve injections, no placebo) at the hospital. The IMP will be administered following clinic procedures and blood collection. Patients will be monitored at the study site for at least 30 minutes after injections for signs of hypersensitivity reaction. Subcutaneous injection sites should be alternated among the 4 quadrants of the abdomen (avoiding navel and waist areas) or the upper arms. Background therapy will be assured with mometasone furoate nasal spray (200µg BID) daily throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Mepolizumab 100mg injection | Experimental | Mepolizumab 100mg SC once every 4 weeks for 48 weeks (twelve injections) Receives: Drug: Mepolizumab 100 MG Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent clinical response to mepolizumab after cessation off mepoluzimab treatment
Percentage (%) of participants demonstrating persistent clinical response to mepolizumab following cessation of treatment will be defined as persistence of improvement in Nasal Polyp size greater than 1 six months after cessation of a twelve-month treatment course of mepoluzimab.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start3 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with severe recurrent CRSwNP will receive Mepolizumab 100mg SC once every 4 weeks for 48 weeks (twelve injections, no placebo) at the hospital.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Yvon Desrosiers, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902325
- Sponsor's protocol ID
- 2024-11343
- Acronym
- ISS-RESMEPO
- Status last verified
- Aug 2026
- First submitted
- 11 May 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Milavetz BI, Balakrishnan L. Viral epigenetics. Methods Mol Biol. 2015;1238:569-96. doi: 10.1007/978-1-4939-1804-1_30.
PubMed 25421681Jiao J, Wang C, Zhang L. Epithelial physical barrier defects in chronic rhinosinusitis. Expert Rev Clin Immunol. 2019 Jun;15(6):679-688. doi: 10.1080/1744666X.2019.1601556. Epub 2019 Apr 9.
PubMed 30925220Kim JY, Kim DK, Yu MS, Cha MJ, Yu SL, Kang J. Role of epigenetics in the pathogenesis of chronic rhinosinusitis with nasal polyps. Mol Med Rep. 2018 Jan;17(1):1219-1227. doi: 10.3892/mmr.2017.8001. Epub 2017 Nov 7.
PubMed 29115522
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Predictors Of Long-Lasting Response To Mepolizumab In CRSwNP: Is The Disease-Modifying Role Secondary To Restored Anti-Viral Activity Or Enhanced Epithelial Regeneration?
- ClinicalTrials.gov ID
- NCT05902325
- Acronym / sponsor ID
- ISS-RESMEPO / 2024-11343
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Keywords
- CRSwNP, Epigenetic, Virus, Multiomics, Mepolizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jun 2023 (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.
The investigators propose a real-world study to assess the mechanism of action of long-lasting response to mepolizumab in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) and identify clinically useful predictors of response.
Mepolizumab is a monoclonal antibody targeting IL-5 and is approved for use in asthma and CRSwNP. In clinical studies, 12 months of treatment with mepolizumab improved signs and symptoms of CRSwNP and reduced the need for surgery. While several biologic medications targeting facets of the Type 2 mechanism are currently indicated for chronic rhinosinusitis with nasal polyps mepolizumab alone appears capable of modifying the disease's biological behaviour and producing long-standing improvements after the cessation of treatment. In the mepolizumab for CRSwNP regulatory trial (SYNAPSE), a subset of patients experienced dramatic and long-lasting, which is over 48 months after cessation of administration of the investigational medicinal product (IMP) in our experience. This has been partially captured in a follow-on study to the registration trail, which showed that a subset of patients followed for 24 weeks after cessation of biologic therapy (with continued use of mometasone furoate) demonstrated persistent improvements over baseline.
However, the mechanism of the long-lasting effect in a subset of patients is not well understood, and it is impossible currently to identify patients who will derive this maximal benefit. The mechanism for the prolonged improvements in CRSwNP seen in certain patients with mepolizumab remains to be established but suggests that effects beyond eosinophil trafficking are implicated.
The investigators believe that mepolizumab has IL-5-mediated pleiotropic effects which contribute to disease modification with effects extending beyond eosinophil activation and trafficking. This may include the following primary or secondary effects:
- Improving epithelial barrier function ii) Altering mast cell dynamics iii) Reversing epigenetic modifications iv) Altering the immune response to better clear pathogenic bacteria or viruses.
Detailed description
Study Rationale:
The investigators propose an ambitious research program to investigate the underlying mechanism of action of the prolonged responses to treatment with mepolizumab in patients with CRSwNP seen in the SYNAPSE trial. In addition, the investigators seek to establish the link between viral disease and eosinophilia, based upon a concept of viral interference with immunologic response inspired by findings from the COVID-19 pandemic.
Study Design:
In this monocentric prospective cohort study, two seasoned investigators will assess the disease-modifying effects of mepolizumab on CRSwNP. This study aims to identify in a ''real-world'' setting the mechanisms underpinning the prolonged response to mepolizumab and identify biomarkers predictive of prolonged response. Thirty-six patients with CRSwNP unresponsive to medical and surgical treatment will be treated with twelve months of mepolizumab in an unblinded and nonrandomized fashion (open-label).
The response will be assessed with usual clinical parameters, including sino-nasal endoscopy. The mechanism of response will be explored in depth before and 6 months after the beginning of treatment with a multiomic approach. The long-term effect will be assessed by clinical assessment only.
- Determine the mechanism of action of mepolizumab in CRSwNP with multiomics. The investigators will explore the critical mechanisms that contribute to transcription patterns in diseased tissue in a cell-type-specific perspective and explore whether viral infection contributes to CRS. Simultaneous profiling of gene expression and open chromatin from the same cell will be used to capture epigenetic modifications in identified cell clusters by RNA-seq combined with an assay for transposase-accessible chromatin (Chromium Single-Cell Multiome ATAC + Gene expression, 10X Genomics).
- Confirm improved epithelial regeneration and repair following mepolizumab treatment via in vitro functional assessment of epithelial capacity for regeneration. Using in vitro wound healing models, the investigators will evaluate the proliferation and cell migration of PEC from patients' nasal polyp biopsy prior to and 6 months after the beginning of treatment. Each time point will be assessed in triplicate on petri (3 wells/ patient) along with cultures on Lab-Tek chamber slides for immunofluorescence assays. Functional assessment of the capacity of tissue repair will be assessed by the speed of repair following standardized injury. Immunofluorescence will assess the markers of the epithelium (tubulin, cadherin, vimentin etc.) and epithelial function (tight junction, zonula occludens, integrins etc.) and by the presence of proliferation markers (Ki-67) at the wound site.
- Identify associated epigenetic marks of response which can serve as potential biomarkers of the responder population. As described above, epigenetic modulation of the genome will be assessed at the single-cell level in multiomic profiling. In order to restrict epigenetic profiling to epigenetic modifications which may have a use as biomarkers, DNA methylation profiling will be performed by DNA MethylationEPIC Beadchip to identify putative biomarkers of response to treatment and identify methylation-related regulatory mechanisms.
- Characterise the impact of mepolizumab on viruses by defining a library of viruses present in CRSwNP and comparing their levels pre- and post-treatment with mepolizumab. The investigators will perform sequenced-based profiling using deep sequencing technologies (Illumina high-throughput RNA sequencing) to reveal candidate viral pathogens using an existing pre-COVID biobank of CRSwNP tissue in our institution to define the type of viruses present in CRSwNP. Similarly, viruses will be assessed in the population undergoing treatment with mepolizumab to assess whether treatment influences viral burden and specific viruses.
- Identify epigenetic marks associated with the presence of different viruses which can serve as markers of prior viral infection.
The investigators will investigate the specific association between viruses and epigenetic marks with the integrative analysis of the resulting data using epigenomics and transcriptomics methods.
There will be a follow-up of patients over 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with severe recurrent CRSwNP will receive Mepolizumab 100mg SC once every 4 weeks for 48 weeks (twelve injections, no placebo) at the hospital.
| Arm | Type | Receives |
|---|---|---|
| Mepolizumab 100mg injection | Experimental | Drug: Mepolizumab 100 MG InjectionMepolizumab 100mg SC once every 4 weeks for 48 weeks (twelve injections) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Bilateral NP, as diagnosed by endoscopy or historical CT scan
- At least one NP surgery* within the last 10 years.
- Severe NP symptoms consistent with a need for surgery (obstruction VAS symptom score>5, overall, VAS symptom score >7, endoscopic bilateral NP score ≥4 [with a score ≥2 in each nasal cavity]).
- Ongoing treatment with INCS (via spray or intranasal liquid steroid wash/douching) for ≥4 weeks prior to screening
- ≥2 of the following CRS symptoms for at least 12 weeks:
Key exclusion criteria (21 listed)
- If as a result of a medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study.
- Cystic fibrosis
- Eosinophilic granulomatosis with polyangiitis (also known as Churg Strauss syndrome), Young's, Kartagener's or dyskinetic ciliary syndromes
- Antrochoanal polyps
- Nasal septal deviation occluding one nostril
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 InjectionAlso: NucalaPatients will receive Mepolizumab 100mg SC once every 4 weeks for 48 weeks (twelve injections, no placebo) at the hospital. The IMP will be administered following clinic procedures and blood collection. Patients will be monitored at the study site for at least 30 minutes after injections for signs of hypersensitivity reaction. Subcutaneous injection sites should be alternated among the 4 quadrants of the abdomen (avoiding navel and waist areas) or the upper arms. Background therapy will be assured with mometasone furoate nasal spray (200µg BID) daily throughout the study. | Drug | Mepolizumab 100mg injection |
Primary outcome
Persistent clinical response to mepolizumab after cessation off mepoluzimab treatment
Time frame: 18 months
Percentage (%) of participants demonstrating persistent clinical response to mepolizumab following cessation of treatment will be defined as persistence of improvement in Nasal Polyp size greater than 1 six months after cessation of a twelve-month treatment course of mepoluzimab.
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 31 Aug 2026.
- Background: PubMed 25421681Milavetz BI, Balakrishnan L. Viral epigenetics. Methods Mol Biol. 2015;1238:569-96. doi: 10.1007/978-1-4939-1804-1_30.
- Background: PubMed 30925220Jiao J, Wang C, Zhang L. Epithelial physical barrier defects in chronic rhinosinusitis. Expert Rev Clin Immunol. 2019 Jun;15(6):679-688. doi: 10.1080/1744666X.2019.1601556. Epub 2019 Apr 9.
- Background: PubMed 29115522Kim JY, Kim DK, Yu MS, Cha MJ, Yu SL, Kang J. Role of epigenetics in the pathogenesis of chronic rhinosinusitis with nasal polyps. Mol Med Rep. 2018 Jan;17(1):1219-1227. doi: 10.3892/mmr.2017.8001. Epub 2017 Nov 7.
- Individual participant dataSharing planned: No
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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.
Martin Yvon Desrosiers, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
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 in people with Chronic Rhinosinusitis With Nasal Polyps, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 9 inclusion and 21 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 31 Aug 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 Canada. 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?
Persistent clinical response to mepolizumab after cessation off mepoluzimab treatment (time frame: 18 months). 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 NCT05902325, which also lists 3 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 31 Aug 2026.