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

Brief summary (registry, in English)

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.

What you commit to

• Study type: Observational
• Participants enrolled: 156
• From 17 Dec 2024 to the primary completion date, 30 Jun 2028
• 8 sites in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

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