Chronic Rhinosinusitis With Nasal PolypsPhase 4NCT06107101
th2 Modulation CRSwNP
A Phase 4 study testing Mepolizumab in people with Chronic Rhinosinusitis With Nasal Polyps, run by St. Paul's Sinus Centre at 1 site in Canada.
Trial summary
Chronic rhinosinusitis (CRS) is a condition of persistent sinonasal mucosal inflammation which affects 11.9% of the US population. Mepolizumab is newly approved to treat chronic rhinosinusitis with nasal polyps (CRSwNP, the spaces inside nose and head are swollen and inflamed) and acts booking interleukin-5 (IL-5) a… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Mepolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2024to 1 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be >=19 of age at the time of signing the informed consent form.
- Capable of giving signed informed consent.
- Treatment group:
- Bilateral Chronic Rhinosinusitis with Nasal Polyposis and Asthma
- Diagnosis consistent with EPOS 2020 b. Endoscopic Nasal Polyps Score (1-8) c. Asthma diagnosis based on: i. Consistent Clinical symptoms (History of wheeze, cough and breathlessness) ii. Reversible airflow obstruction (Spirometry)
- Eligibility for Mepolizumab therapy (Canada)
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- On waiting list for surgery with planned wait of >6 months
- Disease control group:
- Bilateral Chronic Rhinosinusitis without Nasal Polyposis, (only for the disease control group) oDiagnosis consistent with EPOS 2020
- Healthy controls:
- Participants >=19 of age and capable of giving signed informed consent
- Participants with no history of sinonasal or lower airway disease
Who cannot join
- Participants are excluded from the trial if any of the following criteria apply:
- Women who are pregnant, plan to become pregnant or breastfeed during the trial.
- Current participation in any other interventional treatment trials.
- Compliance: is unlikely to comply with trial visits based on investigator judgment.
- Secondary, or suspected secondary, cause of nasal polyposis:
- EGPA, positive MPO ANCA or circulating eosinophilia >10% total leukocytes
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- Known or suspected hereditary ciliary dysmotility (e.g: Cystic fibrosis, childhood-onset nasal polyposis)
- Diagnosed or suspected malignant or premalignant nasal disease (e.g: Schniderian Papilloma, unilateral nasal polyposis)
- Fungal rhinosinusitis (CT/Histology), positive Aspergillus skin prick testing and/or positive Aspergillus IgE RAST testing.
- Aspirin Exacerbated Respiratory Disease/Salicylate allergy
- Known hypersensitivity or significant allergies to monoclonal antibodies.
- Malignant neoplasm within 5 years (from screening) excluding basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterine cervix treated locally and without metastatic disease for 3 years.
- A history of a primary immunodeficiency.
- Active bleeding disorders, and/or inability to support interruption to anticoagulant or anti-platelet therapies for nasal biopsy.
- Severe nasal deformity precluding endoscopic assessment/biopsy of postnasal space
- Severe heart failure (New York Heart Association Class IV) or other severe, uncontrolled cardiac disease.
- Have a history of a major organ transplant or hematopoietic stem cell/marrow transplant.
- Have an acute or chronic infection (excluding that related to CRS) requiring management as follows:
- Currently on any treatment for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria
- Hospitalisation solely for treatment of proven infection requiring parenteral (IV or IM) antibiotics (antibacterial, antiviral, antifungal, or anti-parasitic agents) within 60 days of Day 1.
- Proven severe infection requiring outpatient treatment with parenteral (IV or IM) antibiotics (antibacterial, antiviral, antifungal, or anti-parasitic agents) within 60 days of Day 1. Prophylactic anti-infective treatment is allowed.
- Known positive human immunodeficiency virus (HIV) status.
- Known positive Hepatitis B (HB) or Hepatitis C status.
- Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to asthma which, in the opinion of the principal investigator, could confound the results of the trial or put the participant at undue risk.
- Have a planned surgical procedure, laboratory abnormality, or condition that, in the opinion of the principal investigator, makes the participant unsuitable for the trial.
- Have received any monoclonal antibody therapy ever.
- Have received any investigational agent (that is not approved for sale in Canada) within 60 days of Day 1.
- Have previously undergone sinus surgery or nasal polypectomy
- Previous immunomodulatory therapy (excluding corticosteroids)
- Healthy controls exclusion criteria
- Have previously undergone sinus surgery or nasal polypectomy
- Have received any monoclonal antibody therapy (e.g., dupilumab, mepolizumab, omalizumab)
- Have known hypersensitivity or significant allergies to monoclonal antibodies
- Have a positive human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C status
- Have tumors in the nasal cavity
- Participants currently participating in other clinical trials
- Have severe, uncontrolled cardiac disease
- Have a history of a major organ transplant or hematopoietic stem cell/marrow transplant
- Have an acute or chronic infection that is not related to chronic rhinosinusitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effects of Th2 Modulation on the Generation and Persistence of Tissue Adaptive Immune Memory in Chronic Rhinosinusitis With Nasal Polyposis
Chronic rhinosinusitis (CRS) is a condition of persistent sinonasal mucosal inflammation which affects 11.9% of the US population. Mepolizumab is newly approved to treat chronic rhinosinusitis with nasal polyps (CRSwNP, the spaces inside nose and head are swollen and inflamed) and acts booking interleukin-5 (IL-5) a protein implicated in the inflammatory process. We aim to use Single-cell RNA sequencing (RNA-Seq, a method of genetically 'barcoding' cells to allow gene expression to be profiled at the level of individual cells) to study the effects of IL-5 blockade on the generation and maintenance of nasal adaptive immune responses, in CRS subjects.
Read the detailed description
Purpose:
CRS is a poorly understood disease with suboptimal therapeutic strategies and a high disease burden. Adaptive immunity in the form of Th2 polarized T cell responses and B cell IgE class switching, and plasma cell infiltration, are a core component of eosinophilic CRS and asthma, yet our understanding of adaptive immunity in CRS remains limited. Modulating the Th2 response, through IL-5 blockade, leads to mixed results for CRSwNP patients. There are a number of patients who achieve improved asthma control with IL-5 blockade therapies that fail to see the same improvements in their nasal disease, outlining the currently limited understanding of factors involved in disease activity, disease endotypes, and the effects of modulating the Th2 response in this tissue environment. Improved understanding of nasal tissue immunity modulation by IL-5 blockade at a cellular level is an essential step towards appropriate patient selection and development of new targeted therapeutics. Single-cell transcriptomics is powerful tool for characterizing tissue immune landscapes and functional variations, has as yet been poorly utilized beyond studies of nasal epithelium in CRS
Hypothesis
- IL-5 blockade stimulates increased activity of nasal tissue T cells > peripheral blood T cells, and promotes increased tissue T cell Th2 polarization
- IL-5 blockade stimulates increased B cell germinal center activity in nasal secondary and tertiary lymphoid structures, through increased Tfh-B cell interactions and increased maturation to tissue antibody-secreting cells through BLIMP1 upregulation in Germinal Centre B cells.
Objectives
- Characterise the local mucosal B cell response in tertiary (nasal) and secondary (postnasal space) lymphoid organs in CRSwNP, compared with circulating immunity, through visualization and modeling of germinal center activity, cellular support for germinal center activity and assessment of B cell clonal selection, class-switching, fate, and somatic hypermutation using single-cell transcriptomics, single-cell BCR (B- cell receptor) sequencing and spatial resolution through confocal microscopy.
- Use single-cell transcriptomics and VDJ (variable, diversity, and joining) repertoire analysis to characterize the effects of Th2 modulation, through IL-5 blockade, on the formation and maintenance of nasal T and B cell adaptive immune memory.
- Localize nasal sources of pro-inflammatory signaling in CRSwNP in the presence of IL-5 blockade, using single-cell transcriptomics, confocal microscopy, and nasal cytokine analysis.
- Compare nasal pro-inflammatory cell subsets with paired peripheral blood samples by single cell transcriptomics, to correlate activity with biomarker candidates.
Research design
The proposed study is a prospective experimental medicine study using IL-5 blockade as a way of investigating the effects of Th2 modulation on the generation of local tissue adaptive immunity in CRSwNP. Participants will be classified in:
- Treatment group:20 subjects with CRSwNP and asthma that will start Mepolizumab treatment
- Disease control group: 10 subjects with CRSsNP without asthma that will not start Mepolizumab and will continue their standard of care treatment.
- Control group: 10 healthy subjects without any sinuses disease
This study involves three study visits for the Treatment arm (Baseline, weeks 6, and 30), two visits for disease control subjects, and one (Baseline) visit for Healthy control subjects.
Participants on study medication will receive 100mg of mepolizumab every 4 weeks subcutaneously.
Treatment Arm:
CRSwNP (NPS 1-8) and asthma undergoing IL-5 blockade (Mepolizumab)
- Week 0: Recruitment, screening, and initiating standard-of-care therapy
- Nasal and blood samples Week 6 - Pre-Mepolizumab commencement (Pre-treatment) Week 30 - After Mepolizumab commencement (On treatment)
Control Arm:
- Diseased Control: CRSsNP without asthma
- Week 0: Recruitment, screening, and initiating standard-of care therapy
- Nasal and blood samples Week 6 - After 6 weeks standard of care therapy
- Healthy control • Week 0: Recruitment and screening, Nasal and blood samples
Statistical analysis Single cell RNA sequencing data Sequenced data will be aligned with CellRanger v7.0. The resulting output files will be processed using a standard filtering and QC pipeline in Scanpy. The batch correction will be performed using scVI, and Leiden clustering will be performed. Cluster labels will be assigned using canonical marker genes and published gene signatures, with validation using a published dataset of sorted immune cells via the SingleR package. The downstream analysis will include, but not be limited to, gene set expression analysis (GSEA) of Hallmark and Gene Ontology genesets, differential abundance testing, weighted gene co-expression network analysis, and imputation of cell-cell interaction using CellphoneDB. TCR analysis will be performed using Scirpy, and BCR analysis with the Dandelion, and Immcantation suites
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Mepolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabDrug
100mg of mepolizumab every 4 weeks subcutaneously for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 20 subjects with CRSwNP and asthma that will start Mepolizumab treatment Receives: Drug: Mepolizumab |
| Disease control group | No intervention | 10 subjects with CRSsNP without asthma that will not start Mepolizumab and will continue their standard of care treatment. |
| Control group | No intervention | 10 healthy subjects without any sinuses disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotyping nasal response to Mepolizumab
Clinical response vs standard of care change in Endoscopic Nasal Polyp Score
Measured: week 30
Endotyping nasal response to Mepolizumab
Clinical response vs standard of care change in SNOT-22 score
Measured: week 30
Endotyping nasal response to Mepolizumab
Clinical response vs standard of care change in degree os eosinophil depletion
Measured: week 30
Nasal immune endotyping
Comparison of Circulating B cells, Pre-IL-5 subjects, CRSsNP subjects, Healthy controls, Nasal vs NALT
Measured: week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies 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
- * Treatment group:20 subjects with CRSwNP and asthma that will start Mepolizumab treatment * Disease control group: 10 subjects with CRSsNP without asthma that will not start Mepolizumab and will continue their standard of care treatment. * Control group: 10 healthy subjects without any sinus disease
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Paul's Sinus Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Andrew Thamboo, MD, St. Paul's Sinus Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107101
- Sponsor's protocol ID
- H23-01777
- Status last verified
- Apr 2024
- First submitted
- 24 Oct 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Th2 Modulation on the Generation and Persistence of Tissue Adaptive Immune Memory in Chronic Rhinosinusitis With Nasal Polyposis
- ClinicalTrials.gov ID
- NCT06107101
- Acronym / sponsor ID
- H23-01777
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. Paul's Sinus CentreUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 30 Oct 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.
Chronic rhinosinusitis (CRS) is a condition of persistent sinonasal mucosal inflammation which affects 11.9% of the US population. Mepolizumab is newly approved to treat chronic rhinosinusitis with nasal polyps (CRSwNP, the spaces inside nose and head are swollen and inflamed) and acts booking interleukin-5 (IL-5) a protein implicated in the inflammatory process. We aim to use Single-cell RNA sequencing (RNA-Seq, a method of genetically 'barcoding' cells to allow gene expression to be profiled at the level of individual cells) to study the effects of IL-5 blockade on the generation and maintenance of nasal adaptive immune responses, in CRS subjects.
Detailed description
Purpose:
CRS is a poorly understood disease with suboptimal therapeutic strategies and a high disease burden. Adaptive immunity in the form of Th2 polarized T cell responses and B cell IgE class switching, and plasma cell infiltration, are a core component of eosinophilic CRS and asthma, yet our understanding of adaptive immunity in CRS remains limited. Modulating the Th2 response, through IL-5 blockade, leads to mixed results for CRSwNP patients. There are a number of patients who achieve improved asthma control with IL-5 blockade therapies that fail to see the same improvements in their nasal disease, outlining the currently limited understanding of factors involved in disease activity, disease endotypes, and the effects of modulating the Th2 response in this tissue environment. Improved understanding of nasal tissue immunity modulation by IL-5 blockade at a cellular level is an essential step towards appropriate patient selection and development of new targeted therapeutics. Single-cell transcriptomics is powerful tool for characterizing tissue immune landscapes and functional variations, has as yet been poorly utilized beyond studies of nasal epithelium in CRS
Hypothesis
- IL-5 blockade stimulates increased activity of nasal tissue T cells > peripheral blood T cells, and promotes increased tissue T cell Th2 polarization
- IL-5 blockade stimulates increased B cell germinal center activity in nasal secondary and tertiary lymphoid structures, through increased Tfh-B cell interactions and increased maturation to tissue antibody-secreting cells through BLIMP1 upregulation in Germinal Centre B cells.
Objectives
- Characterise the local mucosal B cell response in tertiary (nasal) and secondary (postnasal space) lymphoid organs in CRSwNP, compared with circulating immunity, through visualization and modeling of germinal center activity, cellular support for germinal center activity and assessment of B cell clonal selection, class-switching, fate, and somatic hypermutation using single-cell transcriptomics, single-cell BCR (B- cell receptor) sequencing and spatial resolution through confocal microscopy.
- Use single-cell transcriptomics and VDJ (variable, diversity, and joining) repertoire analysis to characterize the effects of Th2 modulation, through IL-5 blockade, on the formation and maintenance of nasal T and B cell adaptive immune memory.
- Localize nasal sources of pro-inflammatory signaling in CRSwNP in the presence of IL-5 blockade, using single-cell transcriptomics, confocal microscopy, and nasal cytokine analysis.
- Compare nasal pro-inflammatory cell subsets with paired peripheral blood samples by single cell transcriptomics, to correlate activity with biomarker candidates.
Research design
The proposed study is a prospective experimental medicine study using IL-5 blockade as a way of investigating the effects of Th2 modulation on the generation of local tissue adaptive immunity in CRSwNP. Participants will be classified in:
- Treatment group:20 subjects with CRSwNP and asthma that will start Mepolizumab treatment
- Disease control group: 10 subjects with CRSsNP without asthma that will not start Mepolizumab and will continue their standard of care treatment.
- Control group: 10 healthy subjects without any sinuses disease
This study involves three study visits for the Treatment arm (Baseline, weeks 6, and 30), two visits for disease control subjects, and one (Baseline) visit for Healthy control subjects.
Participants on study medication will receive 100mg of mepolizumab every 4 weeks subcutaneously.
Treatment Arm:
CRSwNP (NPS 1-8) and asthma undergoing IL-5 blockade (Mepolizumab)
- Week 0: Recruitment, screening, and initiating standard-of-care therapy
- Nasal and blood samples Week 6 - Pre-Mepolizumab commencement (Pre-treatment) Week 30 - After Mepolizumab commencement (On treatment)
Control Arm:
- Diseased Control: CRSsNP without asthma
- Week 0: Recruitment, screening, and initiating standard-of care therapy
- Nasal and blood samples Week 6 - After 6 weeks standard of care therapy
- Healthy control • Week 0: Recruitment and screening, Nasal and blood samples
Statistical analysis Single cell RNA sequencing data Sequenced data will be aligned with CellRanger v7.0. The resulting output files will be processed using a standard filtering and QC pipeline in Scanpy. The batch correction will be performed using scVI, and Leiden clustering will be performed. Cluster labels will be assigned using canonical marker genes and published gene signatures, with validation using a published dataset of sorted immune cells via the SingleR package. The downstream analysis will include, but not be limited to, gene set expression analysis (GSEA) of Hallmark and Gene Ontology genesets, differential abundance testing, weighted gene co-expression network analysis, and imputation of cell-cell interaction using CellphoneDB. TCR analysis will be performed using Scirpy, and BCR analysis with the Dandelion, and Immcantation suites
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- * Treatment group:20 subjects with CRSwNP and asthma that will start Mepolizumab treatment * Disease control group: 10 subjects with CRSsNP without asthma that will not start Mepolizumab and will continue their standard of care treatment. * Control group: 10 healthy subjects without any sinus disease
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Mepolizumab20 subjects with CRSwNP and asthma that will start Mepolizumab treatment |
| Disease control group | No intervention | –10 subjects with CRSsNP without asthma that will not start Mepolizumab and will continue their standard of care treatment. |
| Control group | No intervention | –10 healthy subjects without any sinuses disease |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants must be >=19 of age at the time of signing the informed consent form.
- Capable of giving signed informed consent.
- Treatment group:
- Disease control group:
- Participants >=19 of age and capable of giving signed informed consent
Key exclusion criteria (39 listed)
- Participants are excluded from the trial if any of the following criteria apply:
- Healthy controls exclusion criteria
- Have previously undergone sinus surgery or nasal polypectomy
- Have received any monoclonal antibody therapy (e.g., dupilumab, mepolizumab, omalizumab)
- Have known hypersensitivity or significant allergies to monoclonal antibodies
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 |
|---|---|---|
| Mepolizumab100mg of mepolizumab every 4 weeks subcutaneously for 6 months | Drug | Treatment |
Primary outcome
Endotyping nasal response to Mepolizumab
Time frame: week 30
Clinical response vs standard of care change in Endoscopic Nasal Polyp Score
Endotyping nasal response to Mepolizumab
Time frame: week 30
Clinical response vs standard of care change in SNOT-22 score
Endotyping nasal response to Mepolizumab
Time frame: week 30
Clinical response vs standard of care change in degree os eosinophil depletion
Nasal immune endotyping
Time frame: week 30
Comparison of Circulating B cells, Pre-IL-5 subjects, CRSsNP subjects, Healthy controls, Nasal vs NALT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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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.
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 in people with Chronic Rhinosinusitis With Nasal Polyps, run by St. Paul's Sinus Centre 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 12 inclusion and 39 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. 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?
Results are not available in the source record.
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?
Endotyping nasal response to Mepolizumab (time frame: week 30). The study lists 4 primary outcomes in all. 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 17 Apr 2024.