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Table 2 Primary and secondary objectives and endpoints

From: CASCADE: a phase 2, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the effect of tezepelumab on airway inflammation in patients with uncontrolled asthma

Objective Endpoint(s)a
Primary objective
 To explore the airway anti-inflammatory effect of tezepelumab Change from baseline to week 28 in airway submucosal inflammatory cells (eosinophils, neutrophils, T cells and mast cells) from bronchoscopic biopsies
Secondary objectives
 To explore the effect of tezepelumab on RBM thickening Change from baseline to week 28 in RBM thickness
 To explore the effect of tezepelumab on airway epithelial integrity Change from baseline to week 28 in airway epithelial integrity
 To explore the airway anti-inflammatory effect of tezepelumab across the spectrum of T2 status Change from baseline to week 28 in airway submucosal inflammatory cells (eosinophils, neutrophils, T cells and mast cells) of bronchoscopic biopsies in patients across the T2 spectrum
  1. aOwing to the COVID-19 pandemic, endpoints for some participants may not be assessed at week 28; these participants will receive extended dosing and endpoints will be assessed at timepoints up to week 52
  2. RBM Reticular basement membrane, T2 type 2