STRIDE-A: A Global Real-world Cohort of Participants Receiving Depemokimab for Treatment of Asthma
Trial overview
Annualized Rate of Clinically Significant Asthma Exacerbations (CSEs)
Timeframe: 12 months pre-exposure of Depemokimab and to 12 months post-initiation
Rate ratio of CSEs
Timeframe: 12 months pre-exposure of Depemokimab and to 12 months post-initiation
Proportion of Participants Classified as Responders
Timeframe: At 12-month pre-exposure and 6-, 18-, and 24-months post-exposure of Depemokimab
Annualized Rate of CSEs
Timeframe: At 12-month pre-exposure and 6-, 18-, and 24 months post-exposure of Depemokimab
Rate ratio of CSEs
Timeframe: AT 12-month pre-exposure and 6-, 18-, and 24-months post-exposure of Depemokimab
Mean Change from Baseline in Forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC), FEV1/FVC Ratio and Peak Expiratory Flow (PEF)
Timeframe: From Baseline and at 6-, 18-, and 24-months post-exposure of Depemokimab
Percentage of Participants with Improvement in FEV1
Timeframe: From Baseline and at 6-, 18-, and 24-months post-exposure of Depemokimab
Percentage of Participants categorized by Demographic Categories
Timeframe: Baseline up to 90 days prior to Depemokimab initiation
Percentage of Participants categorized by Disease Characteristics
Timeframe: Baseline up to 90 days prior to Depemokimab initiation
Percentage of Participants with Comorbidities and Type of Comorbidities
Timeframe: Baseline up to 90 days prior to Depemokimab initiation
Proportion of Participants with Prior NP related Surgeries, Including Number and Type of Surgeries
Timeframe: Baseline up to 90 days prior to Depemokimab initiation
Proportion of Participants with Prior Treatments
Timeframe: Baseline up to 90 days prior to Depemokimab initiation
Proportion of Biologic-naive Participants
Timeframe: Baseline up to 90 days prior to Depemokimab initiation
Proportion of Biologic-Experienced Participants
Timeframe: Baseline up to 90 days prior to Depemokimab initiation
Proportion of Type of Asthma Treatments
Timeframe: Baseline up to 90 days prior to Depemokimab initiation
Proportion of Participants with Reason for Treatment Discontinuation or Switch
Timeframe: Baseline up to 90 days prior to Depemokimab initiation
Mean Baseline Values of Laboratory Assessments (Blood Eosinophil, and Fractional Exhaled Nitric Oxide [FeNO])
Timeframe: Baseline up to 90 days prior to Depemokimab initiation
Percentage Mean Reduction in Systemic corticosteroids (SCS) Dose
Timeframe: Baseline to 6-, 12-, 18-, and 24-months post depemokimab initiation
Percentage Mean Reduction in SCS Frequency
Timeframe: Baseline to 6-, 12-, 18-, and 24-months post depemokimab initiation
Percentage Mean Reduction from Baseline in Achieving SCS Reduction and Discontinuation
Timeframe: Baseline to 6-, 12-, 18-, and 24-months post depemokimab initiation
Percentage of Participants who Remain SCS Free
Timeframe: Baseline to 6-, 12-, 18-, and 24-months post depemokimab initiation
Mean Change from Baseline in the Asthma Control Test (ACT) Score
Timeframe: Baseline to 1-, 3- 6-, 12-, 18-, and 24-months post depemokimab initiation
Mean Change from Baseline in the Asthma Control Questionnaire (ACQ)-5 Score
Timeframe: Baseline to 1-, 3- 6-, 12-, 18-, and 24-months post depemokimab initiation
Mean Change from Baseline in the Asthma Quality of Life Questionnaire (AQLQ)-12 Score
Timeframe: Baseline to 1-, 3- 6-, 12-, 18-, and 24-months post depemokimab initiation
Percentage of Participants Achieving Clinical Remission
Timeframe: Baseline to 12-, 18-, and 24-months post depemokimab initiation
Median Time to First Remission
Timeframe: Baseline to 12-, 18-, and 24-months post depemokimab initiation
Mean Change from Baseline in the 4-domains of Work Productivity and Activity Impairment (WPAI)-Asthma
Timeframe: Baseline to 3-, 6-, 12-, 18-, and 24-months post depemokimab initiation
Mean Change from Baseline in 12-item Short Form Health Survey (SF-12) score (Physical component summary [PCS] and Mental component summary [MCS])
Timeframe: Baseline to 3-, 6-, 12-, 18-, and 24-months post depemokimab initiation
Mean Change from Baseline in EuroQol-5 Dimension (EQ-5D) score
Timeframe: Baseline to 3-, 6-, 12-, 18-, and 24-months post depemokimab initiation
Mean Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Score
Timeframe: Baseline to 3-, 6-, 12-, 18-, and 24-months post depemokimab initiation
Number of Injections of Depemokimab
Timeframe: Baseline to 6-, 12-, 18-, and 24-months post depemokimab initiation
Mean Time Among Depemokimab Injections
Timeframe: Baseline to 6-, 12-, 18-, and 24-months post depemokimab initiation
Percentage of Participants with Treatment Interruptions/Discontinuation
Timeframe: Baseline to 6-, 12-, 18-, and 24-months post depemokimab initiation
Medication Possession Ratio
Timeframe: Baseline to 6-, 12-, 18-, and 24-months post depemokimab initiation
Proportion of days covered (Depemokimab)
Timeframe: Baseline to 6-, 12-, 18-, and 24-months post depemokimab initiation
Median Time to Treatment Discontinuation
Timeframe: Baseline to 6-, 12-, 18-, and 24-months post depemokimab initiation
Median Time to Treatment Switch to Another Biologic
Timeframe: Baseline to 6-, 12-, 18-, and 24-months post depemokimab initiation
Proportion of Participants on Respiratory Biologic since Diagnosis Prior to Depemokimab Initiation
Timeframe: Baseline to 6-, 12-, 18-, and 24-months post depemokimab initiation
Median Time on Another Respiratory Biologic Prior to Depemokimab Initiation
Timeframe: At Baseline
Proportion of Participants Preferring the new Biologic Schedule at Baseline
Timeframe: At Baseline
Percentage of Physician Satisfied the new Biologic Schedule at Month 12
Timeframe: At 12-month post depemokimab initiation
Annualized rates of asthma-related to asthma or not
Timeframe: 12-month pre-exposure to depemokimab and 12-, 18-, and 24-months post exposure period
Participation criteria
- Confirmed asthma diagnosis with health care provider’s decision to initiate treatment with depemokimab as per label
- Participants must be able and willing to provide voluntary informed consent for study participation
- Participants must be able and willing to provide voluntary informed consent for study participation
- Participants must be able to understand and complete study-related questionnaires
- Participants must have access to a compatible device (excluding countries where device will be provided to the participants) and internet access for electronic patient reported outcome (ePRO) completion and be willing and able to comply with ePRO data collection
- Participants must have 12 months medical history available prior to the index date Exclusion criteria:
- Have received depemokimab more than 14 days prior to enrolment (for regular sites) or, more than 30 days prior to enrolment (* for Spain and for remotely enrolled participants)
- Current or past (within the last 12 months) participation in an interventional clinical study that includes treatment for asthma with Type 2 inflammation 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 fulfil the study criteria per the study team’s discretion
- Have been prescribed depemokimab off-label
- Have not received a dose of depemokimab within 90 days after signing the informed consent form (ICF)
Confirmed asthma diagnosis with health care provider’s decision to initiate treatment with depemokimab as per label
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.