Last updated: 11/21/2025 06:00:18

A Global Real-world Study of Participants with Chronic Rhinosinusitis (CRSwNP) Participants

GSK study ID
222422
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title:
Trial description: STRIDE-N is a global, non-interventional study observing how well a new medicine called Depemokimab works in real-life settings for adults with chronic rhinosinusitis with nasal polyps (CRSwNP). This condition causes long-term inflammation in the sinuses, leading to nasal blockages, loss of smell, and reduced quality of life. The study follows participants for up to 2 years after they start Depemokimab, without changing their usual care. It tracks symptoms, quality of life, work productivity, treatment satisfaction, and healthcare use. The goal is to understand how Depemokimab performs outside of clinical trials and how it affects participants’ daily lives.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Mean Change in Sino-Nasal Outcome Test (SNOT)-22 Total Score from. Baseline to Month 12

Timeframe: Baseline up to Month 12

Secondary outcomes:

Mean Change in SNOT-22 Total Score from. Baseline to Months 1, 3, 6, 12, 18 and 24

Timeframe: Baseline to Months 1, 3, 6, 12, 18 and 24

Percentage of Participants Achieving Improvement of greater than or equal to (>=) 8.9 (Minimal Clinically Important Difference) in SNOT-22 Total Score at Months 1, 3, 6, 12, 18, and 24

Timeframe: Baseline to Months 1, 3, 6, 12, 18 and 24

Percentage of Participants Achieving less than or equal to (<=) 20 (Minimal Clinically Important Difference) in SNOT-22 Total Score at Months 1, 3, 6, 12, 18, and 24

Timeframe: Baseline to Months 1, 3, 6, 12, 18 and 24

Percentage of Participants Achieving less than (<) 40 (Minimal Clinically Important Difference) in SNOT-22 Total Score at Months 1, 3, 6, 18, and 24

Timeframe: Baseline to Months 1, 3, 6, 12, 18 and 24

Mean Change from Baseline in Overall Symptom Score Using Visual Analogue Score (VAS) to Months 1, 3, 6, 12, 18, and 24

Timeframe: Baseline to Months 1, 3, 6, 12, 18 and 24

Mean Change from Baseline in Nasal Obstruction Score Using Verbal Rating Scale (VRS) to Months 1, 3, 6, 12, 18, and 24

Timeframe: Baseline to Months 1, 3, 6, 12, 18 and 24

Mean Change from Baseline in Symptom Score for Rhinorrhea Using VRS to Months 1, 3, 6, 12, 18, and 24

Timeframe: Baseline to Months 1, 3, 6, 12, 18 and 24

Mean Change from Baseline in Symptom Score for Loss of Smell Using VRS to Months 1, 3, 6, 12, 18, and 24

Timeframe: Baseline to Months 1, 3, 6, 12, 18 and 24

Percentage of Participants in each Demographic Category

Timeframe: Baseline

Percentage of Participants Categorized by Disease Characteristics

Timeframe: Baseline

Percentage of Participants with Comorbidities

Timeframe: Baseline

Percentage of Participants Categorized by the Type of Comorbidities

Timeframe: Baseline

Percentage of Participants with Prior Surgeries

Timeframe: Baseline

Percentage of Participants Categorized by the Number of Surgeries

Timeframe: Baseline

Percentage of Participants Categorized by the Type of Surgeries

Timeframe: Baseline

Percentage of Participants with Prior Treatment for CRSwNP

Timeframe: Baseline

Percentage of Participants categorized by the Type of Treatment for CRSwNP

Timeframe: Baseline

Percentage of Biologic-naïve Participants, Current and Former Biologic Experienced Participants

Timeframe: Baseline

Percentage of Participants Categorized by Use of Depe-Peri-Surgery

Timeframe: Baseline

Percentage of Participants not Receiving Intranasal corticosteroid (INC)

Timeframe: Baseline

Percentage of Participants Categorized by Reason for Switch or Discontinuation of CRSwNP Treatment

Timeframe: Baseline

Laboratory Assessments at Baseline

Timeframe: Baseline

Mean Change in Total VRS from Baseline to. Months 1, 3, 6, 12, 18, and 24

Timeframe: Baseline to Months 1, 3, 6, 12, 18, and 24

Number of Depemokimab Injections

Timeframe: Up to Month 24

Mean Time Difference Among Depemokimab Injections

Timeframe: Up to Month 24

Percentage of Participants with Depemokimab Treatment Interruptions or Discontinuation

Timeframe: Up to Month 24

Percentage of Participants with Treatment Switch from Depemokimab to Other Respiratory Biologics

Timeframe: Up to Month 24

Medication Possession Ratio

Timeframe: Up to Month 24

Percent Days Covered for Depemokimab Treatment

Timeframe: Up to Month 24

Median Time to Depemokimab Treatment Discontinuation

Timeframe: Up to Month 24

Median Time to Treatment Switch from Depemokimab to Another Biologic

Timeframe: Up to Month 24

Percentage of Participants Preferring the new Biologic Schedule at Baseline

Timeframe: Baseline

Percentage of Physicians satisfied with the new Biologic

Timeframe: Months 6, 12, 18 and 24

Mean Change in SF-12 Score from Baseline. to Months 3, 6, 12, 18, and 24

Timeframe: Baseline to Months 3, 6, 12, 18 and 24

Mean Change in 4-domains of Work Productivity and Activity Impairment (WPAI)-CRSwNP Score from Baseline to Months 3, 6, 12, 18, and 24

Timeframe: Baseline to Months 3, 6, 12, 18 and 24

Mean Change in EuroQol-5 Dimension (EQ-5D) Score from Baseline to Months 3, 6, 12, 18, and 24

Timeframe: Baseline to Months 3, 6, 12, 18 and 24

Mean Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Score from Baseline to Months 3, 6, 12, 18, and 24

Timeframe: Baseline to Months 3, 6, 12, 18 and 24

Mean Change in University of Pennsylvania Smell Identification Test (UPSIT) Score from Baseline to Months 6, 12, 18, and 24

Timeframe: Baseline to Months 6, 12, 18 and 24

Mean Change in Sniffin’ Sticks Test Score from Baseline to Months 6, 12, 18, and 24

Timeframe: Baseline to Months 6, 12, 18 and 24

Mean Change in Nasal Polyps (NP) Score from Baseline to Months 6, 12, 18, and 24

Timeframe: Baseline to Months 6, 12, 18 and 24

Percentage of Participants with CRSwNP Exacerbations at Months 6, 12, 18, and 24

Timeframe: Months 6, 12, 18 and 24

Median Time to first CRSwNP Exacerbation

Timeframe: Up to Month 24

Incidence Rate of CRSwNP Exacerbation at Months 6, 12, 18, and 24

Timeframe: Months 6, 12, 18, and 24

Percentage of Participants in Remission at Months 12, 18, and 24

Timeframe: Months 12, 18, and 24

Median Time to Remission

Timeframe: Up to Month 24

Percent of NP Surgery

Timeframe: Up to Month 24

Percentage of Participants Categorized by the type of NP Surgery

Timeframe: Up to Month 24

Percentage of Participants Undergoing NP-related Surgery at Months 6, 12, 16 and 24

Timeframe: Months 6, 12, 16 and 24

Incidence Rate of NP Surgeries at Months 6, 12, 16 and 24

Timeframe: Months 6, 12, 16 and 24

Median Time to First NP Surgeries

Timeframe: Up to Month 24

Annualized Rates of CRSwNP-related Healthcare Resource Utilization (HCRU)

Timeframe: 12-months pre-exposure and the 12-, 18-, and 24 months post-exposure periods

Mean Change from Baseline in Systemic Corticosteroids (SCS) Use to Months 6, 12, 18 and 24

Timeframe: Baseline to Months 6, 12, 18, and 24

Percentage Reduction in SCS dose Utilization from Baseline to Months 6, 12, 18, and 24

Timeframe: Baseline to Months 6, 12, 18, and 24

Percentage of Participants Achieving SCS dose Reduction at Months 6, 12, 18, and 24

Timeframe: Months 6, 12, 18, and 24

Percentage of Participants Achieving SCS Cessation at Months 6, 12, 18, and 24

Timeframe: Months 6, 12, 18, and 24

Percentage of Participants SCS Free at Months 6, 12, 18, and 24

Timeframe: Months 6, 12, 18, and 24

Mean Change from Baseline in Lund Mackay Score from Months 12 and 24

Timeframe: Baseline to Months 12 and 24

Mean Change from Baseline in Blood Eosinophil Values from Months 6, 12, 18 and 24

Timeframe: Baseline to Months 6, 12, 18 and 24

Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2028-22-12
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
January 2026 to December 2028
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participants with a main diagnosis of CRSwNP per healthcare provider’s assessment
  • Healthcare provider’s decision to prescribe add-on depemokimab for treatment of CRSwNP prior to study enrollment as per routine clinical care and country-specific label
  • Have received depemokimab more than 14 days prior to enrollment (for regular sites) or more than 30 days prior to enrollment (*for Spain and for remotely-enrolled participants)
  • Current or past (within the last 12 months) participation in an interventional study that includes treatment with an investigational drug and/or treatment for CRSwNP
Inclusion and exclusion criteria
Inclusion criteria:
  • Participants with a main diagnosis of CRSwNP per healthcare provider’s assessment
  • Healthcare provider’s decision to prescribe add-on depemokimab for treatment of CRSwNP prior to study enrollment as per routine clinical care and country-specific label
  • Participants must be able and willing to provide voluntary informed consent
  • Participants must be able to understand and complete study-related questionnaires
  • Participants must have access to a compatible device (excluding China where device will be provided to the patients) and internet access for Electronic patient-reported outcome (ePRO) completion and be willing and able to comply with ePRO data collection
  • Participants with a main diagnosis of CRSwNP per healthcare provider’s assessment
  • Healthcare provider’s decision to prescribe add-on depemokimab for treatment of CRSwNP prior to study enrollment as per routine clinical care and country-specific label
  • Participants must be able and willing to provide voluntary informed consent
  • Participants must be able to understand and complete study-related questionnaires
  • Participants must have access to a compatible device (excluding China where device will be provided to the patients) and internet access for Electronic patient-reported outcome (ePRO) completion and be willing and able to comply with ePRO data collection
Exclusion criteria:
  • Have received depemokimab more than 14 days prior to enrollment (for regular sites) or more than 30 days prior to enrollment (*for Spain and for remotely-enrolled participants)
  • Current or past (within the last 12 months) participation in an interventional study that includes treatment with an investigational drug and/or treatment for CRSwNP
  • Participants who have previously been on depemokimab trial will not be excluded
  • Have any other condition that would make it difficult for the participant to fulfill the study criteria, per the study team’s discretion
  • Have been prescribed depemokimab off-label
  • Failure to provide a SNOT-22 pre-index baseline value (<=30 days prior to depemokimab initiation for regular sites). This applies only to participants enrolled at regular (on-site) sites. Remotely-enrolled participants in the United States of America (USA) are exempt

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Will be recruiting
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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