Last updated: 01/28/2026 11:50:14

STRIDE-A: A Global Real-world Cohort of Participants Receiving Depemokimab for Treatment of Asthma

GSK study ID
214579
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: Global Multicenter Observational Study to Prospectively Describe the Real-World Effectiveness of Depemokimab in Patients with Asthma with Type 2 Inflammation - STRIDE-A
Trial description: This global study observes how well Depemokimab, a new asthma drug, works in real-life settings for adults with severe Type 2 inflammation asthma. Approximately 650 adults newly prescribed Depemokimab are enrolled, with 12-month pre- and post-treatment exacerbation rates compared using clinical and patient-reported data collected over 24 months. The study also examines lung function, corticosteroid use, asthma control, quality of life, treatment adherence, and healthcare resource utilization to guide real-world practice.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Secondary outcomes:

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

Percentage of Participants with Prior Surgeries, Including Number and Type of Surgeries

Timeframe: Baseline up to 90 days prior to Depemokimab initiation

Percentage of Participants with Prior Asthma Treatments

Timeframe: Baseline up to 90 days prior to Depemokimab initiation

Percentage of Biologic-naive Participants

Timeframe: Baseline up to 90 days prior to Depemokimab initiation

Percentage of Biologic-Experienced Participants

Timeframe: Baseline up to 90 days prior to Depemokimab initiation

Percentage of Type of Asthma Treatments

Timeframe: Baseline up to 90 days prior to Depemokimab initiation

Percentage 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-Visual Analogue Score (EQ-5D VAS) 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

Number of Days Covered

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

Percentage of Participants on Respiratory Biologic 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: Baseline to 6-, 12-, 18-, and 24-months post depemokimab initiation

Percentage of Participants Preferring the new Biologic Schedule at Baseline

Timeframe: At Baseline

Percentage of Participants Satisfied the new Biologic Schedule at Months 6, 12, 18, and 24

Timeframe: Baseline to 6-, 12-, 18-, and 24-months post depemokimab initiation

Annualized rates of asthma-related HCRU

Timeframe: 12-month pre-exposure to depemokimab and 12-, 18-, and 24-months post depemokimab initiation

Interventions:
Not applicable
Enrollment:
700
Primary completion date:
2030-31-01
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 January 2030
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Confirmed asthma diagnosis with health care provider’s decision to initiate treatment with depemokimab
  • Participants must be able and willing to provide voluntary informed consent for study participation
  • 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 with an investigational drug and/or treatment for asthma with Type 2 inflammation (characterized by an eosinophilic phenotype). Participants who have previously been on depemokimab trial will not be excluded.
Inclusion and exclusion criteria
Inclusion criteria:

    Confirmed asthma diagnosis with health care provider’s decision to initiate treatment with depemokimab

    • 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 China where device will be provided to the participants) and internet access for electronic patient reported outcome (ePRO) and diary completion and be willing and able to comply with ePRO and diary 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 with an investigational drug and/or treatment for asthma with Type 2 inflammation (characterized by an eosinophilic phenotype). 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

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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