Last updated: 07/16/2025 18:20:08
REALITI-N: Real World Benefit of Mepolizumab in Participants with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
GSK study ID
218955
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: REALITI-N: A Multinational, Observational Study to Evaluate the Real-World Effectiveness of Mepolizumab in Participants with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Trial description: This is a multinational study which has both retrospective and prospective phases to study effectiveness and improvements in Health-related Quality of Life (HRQoL) among adult participants with a confirmed diagnosis of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) over 12 months of mepolizumab use in a real-world setting. There will be three participant cohorts in this study which are: - Participants who are newly prescribed to mepolizumab (i.e., participants have not yet initiated mepolizumab prior to enrolment) for treatment of CRSwNP (prospective cohort); - Participants who have already initiated mepolizumab for treatment of CRSwNP more than 12 months prior to study enrolment, and have a Sino-Nasal Outcome Test (SNOT-22) score collected less than or equal to (=<) 30 days prior to and 12 months (+/-2 weeks) post-initiation of mepolizumab (Retrospective cohort). - Participants who have already initiated mepolizumab for treatment of CRSwNP fewer than two months prior to study enrolment and have a SNOT-22 score collected =<30 days prior to mepolizumab initiation (partially retrospective cohort). The primary purpose of the study is to evaluate the mean change in the SNOT-22 total score from baseline to 12 months whilst being treated with mepolizumab.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change from baseline in Sino-Nasal Outcome Test-22 (SNOT-22) total score
Timeframe: Baseline to month 12
Secondary outcomes:
Change from baseline in SNOT-22
Timeframe: Baseline, Month 3, and Month 6
Change from baseline in Visual Analogue Scale (VAS) score for smell dysfunction and nasal obstruction
Timeframe: Baseline, Month 3, Month 6, and Month 12
Percentage of participants who experienced Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)-related exacerbations
Timeframe: Baseline, Month 3, Month 6, and Month 12
Number of participants with CRSwNP exacerbation
Timeframe: Baseline, Month 3, Month 6, and Month 12
Time to first exacerbation
Timeframe: Baseline, Month 3, Month 6, and Month 12
Change from baseline in Nasal polyps (NP) score
Timeframe: Baseline to Month 12
Number of NP Surgeries
Timeframe: Baseline, Month 3, Month 6 and Month 12
Percentage of Participants that underwent NP-related surgery
Timeframe: Baseline, Month 3, Month 6 and Month 12
Percentage of Participants with incidence of surgery
Timeframe: Baseline, Month 3, Month 6 and Month 12
Percentage of Participants underwent polypectomy, full house surgery, reboot surgery, and DRAF III surgery
Timeframe: Baseline, Month 3, Month 6 and Month 12
Time to NP surgery
Timeframe: Baseline, Month 3, Month 6 and Month 12
Time to first NP surgery
Timeframe: Baseline, Month 3, Month 6 and Month 12
Number of NP surgeries and incidence rates
Timeframe: Baseline, Month 3, Month 6 and Month 12
Change from baseline in Oral corticosteroids (OCS) use
Timeframe: Baseline, Month 3, Month 6 and Month 12
Mean percentage reduction in OCS dose utilization from Baseline
Timeframe: Baseline, Month 3, Month 6 and Month 12
Percentage of Participants achieving OCS reduction and cessation
Timeframe: Baseline, Month 3, Month 6 and Month 12
Annualised rate of CRSwNP related Healthcare Resource Utilisation (HCRU)
Timeframe: Month 12 pre-dose to Month 12 (post-dose)
Change from baseline in Work Productivity and Activity Impairment – General Health (WPAI-GH) Score
Timeframe: Baseline, Month 3, Month 6 and Month 12
Change in dosing of mepolizumab utilisation
Timeframe: Baseline, Month 3, Month 6 and Month 12
Change in frequency of mepolizumab utilisation
Timeframe: Baseline, Month 3, Month 6 and Month 12
Percentage of participants with treatment interruptions
Timeframe: From Baseline up to Month 12
Percentage of Participants with treatment cessation
Timeframe: From Baseline up to Month 12
Time to mepolizumab cessation
Timeframe: From Baseline up to Month 12
Percentage of Participants using concomitant medications
Timeframe: From Baseline up to Month 12
Change in concomitant medication use
Timeframe: From Baseline up to Month 12
Interventions:
Not applicable
Enrollment:
667
Primary completion date:
2026-31-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Nasal Polyps
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
April 2024 to March 2026
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Greater than or equal to (>=) 18 years of age at initiation of mepolizumab.
- Participants with an investigator’s main diagnosis of CRSwNP confirmed by clinical criteria (including any imaging if performed) where CRSwNP is the main diagnosis indicated for use of mepolizumab per local labelling requirements.
- Participation in an interventional study that includes treatment with an investigational drug and/or treatment for CRSwNP at the same time as the index date (mepolizumab initiation)
- Prior participation in an interventional study that includes treatment with mepolizumab.
Inclusion and exclusion criteria
Inclusion criteria:
- Greater than or equal to (>=) 18 years of age at initiation of mepolizumab.
- Participants with an investigator’s main diagnosis of CRSwNP confirmed by clinical criteria (including any imaging if performed) where CRSwNP is the main diagnosis indicated for use of mepolizumab per local labelling requirements.
- Participants who have already initiated mepolizumab for treatment of CRSwNP more than 12 months prior to study enrolment and have a SNOT-22 score collected ≤30 days prior to mepolizumab initiation and 12 months (+/- 2 weeks) post-initiation (Retrospective Cohort).
- Participants who have already initiated mepolizumab for treatment of CRSwNP fewer than two months prior to study enrolment and have a SNOT-22 score collected ≤30 days prior to mepolizumab initiation (Partially Retrospective Cohort).
- Physician’s decision to prescribe mepolizumab for treatment of CRSwNP; Participant treatment-naïve at time of study enrolment (Prospective Cohort).
- Participant must be willing and able to provide voluntary informed consent (Prospective and partially retrospective cohort).
- Participants must be able to understand and complete study-related questionnaires. Participants must have access to a compatible device and internet access for electronic Participant-reported outcome (ePRO) completion and be willing and able to comply with ePRO data collection (Prospective and partially retrospective cohort).
Exclusion criteria:
- Participation in an interventional study that includes treatment with an investigational drug and/or treatment for CRSwNP at the same time as the index date (mepolizumab initiation)
- Prior participation in an interventional study that includes treatment with mepolizumab.
- Diagnosis of eosinophilic granulomatosis with polyangiitis, hyper-eosinophilic syndrome, cystic fibrosis, immunodeficiency, and primary ciliary dyskinesia, or any other condition that would make it difficult for the participant to fulfil the study criteria, per the investigator’s discretion.
- Prior use of another respiratory biologic (including but not limited to omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab) within six months of mepolizumab index date.
- Use of concomitant therapy with another respiratory biologic at the time of mepolizumab treatment.
- Three or more functional endoscopic sinus surgery (FESS) which includes anterior maxillectomy and/or ethmoidectomy and/or sphenoidotomy or 3 or more Endoscopic sinus surgery (ESS) with or without DRAF Iib or DRAF III.
- Pregnant or breastfeeding at the mepolizumab initiation (note: Participants who become pregnant during the study will not be excluded, provided they consent to continue with mepolizumab).
Trial location(s)
Location
GSK Investigational Site
Mandeville, LA, United States, 70471
Status
Recruitment Complete
Showing 1 - 6 of 104 Results
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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