EVOLVE Study: The Real-life Clinical Practice With Tezepelumab in Greece

NCT06724575 | Active Not Recruiting

• 1 other identifier: D5180R00032
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 8

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.

Conditions

Asthma

Keywords

severe asthma, tezepelumab, real world data, patient reported outcomes, Greece

Outcome Measures

Primary Outcomes (1)

• Change in the ACQ-6 score at baseline and up to 104 weeks post-index

  Asthma Control Questionnaire-6 (ACQ-6) score at different timepoints Change in ACQ-6 score from baseline Proportion of patients with ACQ-6 response (i.e., achieving the Minimum Clinically Important Difference (MCID) of ≥0.5 reduction in score from baseline) Proportion of patients with major improvement in asthma control (defined as decrease in ACQ-6 score ≥1 point \[i.e., 2xMCID\] from baseline) Proportion of patients with well-controlled asthma (ACQ-6 score ≤ 0.75) Proportion of patients with ACQ-6 score in categories 0.75 to \<1.5 and ≥1.5 Time to ACQ-6 score response

  Before treatment initiation and at Weeks 4, 12, 24, 52, 72, 104 after treatment initiation

Secondary Outcomes (15)

• Change in asthma-specific HRQoL using the SGRQ at baseline and up to 52 weeks post-index

  Before treatment initiation and at Weeks 24 and 52 after treatment initiation

• Change in FEV1 (forced expiratory volume in 1 second) at baseline and up to 104 weeks post-index

  Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation

• Change in FVC (Forced Vital Capacity) at baseline and up to 104 weeks post-index

  Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation

• Change in pre-BD FEF25-75 (Forced Expiratory Flow) at baseline and up to 104 weeks post-index

  Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation

• Change in lung function at baseline and up to 104 weeks post-index

  Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (8)

Research Site

Alexandroupoli, Greece

Location

Research Site

Athens, Greece

Location

Research Site

Corfu, Greece

Location

Research Site

Crete, Greece

Location

Research Site

Ioannina, Greece

Location

Research Site

Larissa, Greece

Location

Research Site

Pátrai, Greece

Location

Research Site

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: December 9, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Locations

GR (8)