Clinical trial NCT06724575: EVOLVE Study: The Real-life Clinical Practice With Tezepelumab in Greece
Official title: The EVOLVE Study: A Prospective, Observational Study to Evaluate Patient-centered Outcomes Over 2 Years of Treatment With Tezepelumab in Real-life Clinical Practice in Greece
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Keywords: severe asthma, tezepelumab, real world data, patient reported outcomes, Greece
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-12-09
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population from private practices and hospital clinics specializing in the management of Severe Asthma, in geographically diverse locations throughout Greece, with a balanced representation of public, academic and private sector in Greece.

Brief summary: Tezepelumab is a first-in-class human monoclonal antibody for uncontrolled severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), a key epithelial cytokine inducing both Type 2 and non- Type 2 inflammatory pathways. Considering the recent addition of tezepelumab to the severe asthma therapeutic arsenal, there is a need for real-world evidence that can inform treatment-decision making in clinical practice and support regulatory decisions.

EVOLVE is a prospective, observational study designed to generate real-world evidence on patient-reported outcomes of treatment with tezepelumab, assessing the effectiveness over a 2-year period in routine care settings in Greece.

The study plans to enroll 150 adult patients at an allocation ratio of: i) 70 percent Type 2-high/30 percent Type 2-low, and ii) 80 percent biologic naïve/20 percent switching from a prior biologic. Eligible patients must be newly prescribed tezepelumab according to the approved label.

Primary data will be collected at enrollment and 4, 12, 24, 52, 72 and 104 weeks after treatment initiation through visits as per the standard clinical practice in various healthcare settings (20-25 sites) across the country.

The primary objective is to describe the patient-reported asthma symptom control using the Asthma Control Questionnaire (ACQ-6) at baseline and up to 104 weeks post-index. Secondary and exploratory objectives include assessment of quality of life, lung function, exacerbation rate, corticosteroid use, health-care utilization. Novel composite endpoints will also be evaluated such as early clinically important improvement, disease stability, super-response and clinical remission at 2 years, which in the era of precision biologics, have the potential to shift treatment paradigms toward a treat-to-target approach.

Findings of EVOLVE are expected to not only complement evidence obtained from clinical trials, but also to provide valuable insights into the long-term durability of treatment benefits and sustainability of clinical response under pragmatic clinical conditions.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients aged 12 years or older at the time of signing the informed consent/assent form.
* Patients who have been prescribed but not yet initiated treatment with tezepelumab according to the label and local market reimbursement criteria.
* Diagnosis of asthma for at least 52 weeks prior to enrolment date and symptoms confirmed by the Investigator not to be due to alternative diagnoses.
* Receipt of at least one prescription of high-dose Inhaled Corticosteroids (ICS) (according to the Global Initiative for Asthma 2024) during the 52 weeks prior to enrolment date.
* Use of additional asthma maintenance controller medication(s) in addition to ICS either as free- or fixed-drug combination for at least 52 weeks prior to enrolment date.
* Documented history of at least 1 asthma exacerbation during the 52 weeks prior to enrolment date.
* Asthma Control Questionnaire (ACQ-6) score ≥1.5 (indicating inadequate asthma symptom control) at enrolment.
* Availability of at least one Blood Eosinophil Count (BEC) measurement (in medical records) in the 52-week period prior to enrolment date.
* Availability of participants' medical records for asthma exacerbations and unscheduled Health Care Resource Utilization (HCRU) for the 52 weeks prior to enrolment date.
* Patients are able to understand and complete the Patient-Reported Outcome (PROs).
* Provision of signed and dated written informed consent/assent (as applicable).

Exclusion Criteria:

* Any contraindication to tezepelumab as per the approved product label or in the opinion of the Investigator.
* Concurrent or recent (\<30 days before the index date) treatment with biologics for asthma, with the exception of stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment).
* Participation in an observational study that might, in the Investigator's opinion, influence the assessment for the current study, or participation in an interventional clinical trial in the last 3 months.
* Currently pregnant (or intention to become pregnant) or lactating women.

Primary outcomes:
measure: Change in the ACQ-6 score at baseline and up to 104 weeks post-index
timeFrame: Before treatment initiation and at Weeks 4, 12, 24, 52, 72, 104 after treatment initiation
Secondary outcomes:
measure: Change in asthma-specific HRQoL using the SGRQ at baseline and up to 52 weeks post-index
timeFrame: Before treatment initiation and at Weeks 24 and 52 after treatment initiation
measure: Change in FEV1 (forced expiratory volume in 1 second) at baseline and up to 104 weeks post-index
timeFrame: Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation
measure: Change in FVC (Forced Vital Capacity) at baseline and up to 104 weeks post-index
timeFrame: Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation
measure: Change in pre-BD FEF25-75 (Forced Expiratory Flow) at baseline and up to 104 weeks post-index
timeFrame: Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation
measure: Change in lung function at baseline and up to 104 weeks post-index
timeFrame: Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation
measure: Change in asthma exacerbations in the 52 and 104 weeks post-index
timeFrame: During 52 weeks before treatment initiation and 52 and 104 weeks after treatment initiation
measure: Proportion of patients with asthma exacerbations in the 52 and 104 weeks post-index
timeFrame: During 52 weeks before treatment initiation and 52 and 104 weeks after treatment initiation
measure: Time to first asthma exacerbation from index date
timeFrame: Until 104 weeks after treatment initiation
measure: Proportion of patients with asthma-related Systemic Corticosteroids (SCS) and Inhaled Corticosteroids (ICS) use during the 52 week-period pre- and post-index
timeFrame: During 52 weeks before treatment initiation and 52 weeks after treatment initiation
measure: Change in asthma-related Systemic Corticosteroids (SCS) and Inhaled Corticosteroids (ICS) use during the 52 week-period pre- and post-index
timeFrame: During 52 weeks before treatment initiation and 52 weeks after treatment initiation
measure: Time to earliest Systemic Corticosteroids (SCS) use from index date
timeFrame: During 52 weeks before treatment initiation and 52 weeks after treatment initiation
measure: Change in rate and duration of asthma-related HCRU for the 52 weeks pre- and post-index
timeFrame: During 52 weeks before treatment initiation and during 52 and 104 weeks after treatment initiation
measure: Changes in proportion of participants achieving (a) asthma disease stability or (b) partial stability up to 104 weeks post-index
timeFrame: At weeks 4, 12, 24, 52, 72 and 104 after treatment initiation
measure: Duration of therapy at 52 and 104 weeks post-index
timeFrame: At Week 52 and 104 after treatment initiation or at the moment of treatment discontinuation through study completion, an average of 2 years (104 weeks)
measure: Discontinuation rate at 52 and 104 weeks post-index
timeFrame: At Week 52 and 104 after treatment initiation or at the moment of treatment discontinuation through study completion, an average of 2 years (104 weeks)
Other outcomes:
Locations:
city: Alexandroupoli
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Corfu
country: Greece
facility: Research Site
city: Crete
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Larisa
country: Greece
facility: Research Site
city: Patra
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
Study officials:
References: