Key Findings from the CROSSING Trial
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AstraZeneca and Amgen announced positive results from the Phase III CROSSING trial evaluating Tezspire (tezepelumab) in adolescents and adults with symptomatic and uncontrolled eosinophilic esophagitis (EoE).
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The trial demonstrated statistically significant and clinically meaningful improvements in the co-primary endpoints of histologic remission and the frequency and severity of dysphagia at Week 24, compared with placebo.
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Improvements were observed with both Tezspire doses despite continued treatment with stable background medications.
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Benefits were sustained through Week 52 across key secondary endpoints.
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The results were presented in a late-breaking oral presentation at United European Gastroenterology Week 2026 in Barcelona, Spain.
Histologic Remission and Dysphagia Improvements
Tezspire was administered subcutaneously every four weeks. The trial showed improvements in esophageal inflammation and swallowing symptoms.
Histologic remission at Week 24:
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210 mg dose: 64.8% of patients achieved histologic remission.
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420 mg dose: 68.9% of patients achieved histologic remission.
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Placebo: 3.5% of patients achieved histologic remission.
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Both Tezspire doses demonstrated statistically significant improvements compared with placebo (p less than 0.001).
Improvement in dysphagia symptoms at Week 24:
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210 mg dose: 18.8-point reduction from baseline in the Dysphagia Symptom Questionnaire (DSQ) score (p=0.049).
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420 mg dose: 22.0-point reduction from baseline (p less than 0.001).
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Placebo: 14.7-point reduction from baseline.
The DSQ is a patient-reported measure of the frequency and severity of swallowing difficulties, with higher scores indicating more severe symptoms.
Benefits Sustained Through Week 52
Key secondary endpoints showed that improvements in histologic remission and dysphagia symptoms continued through Week 52.
- Histologic remission:
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67.8% of patients receiving 210 mg achieved remission.
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63.3% of patients receiving 420 mg achieved remission.
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5.4% of patients receiving placebo achieved remission.
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Both Tezspire doses showed statistically significant improvements compared with placebo (p less than 0.001).
- Dysphagia symptom improvement:
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The 210 mg group achieved an average 22.1-point reduction in DSQ score.
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The 420 mg group achieved an average 24.0-point reduction.
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The placebo group achieved a 13.2-point reduction.
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The improvements with Tezspire were statistically significant compared with placebo (p less than 0.001).
Improvements in Endoscopic Disease Features
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Tezspire demonstrated statistically significant improvements in endoscopic features and disease severity at Weeks 24 and 52, measured using the EoE Endoscopic Reference Score (EREFS).
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At Week 52, total endoscopic remission, defined as the absence of visible EoE features, was achieved by:
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34.4% of patients receiving 210 mg.
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29.5% of patients receiving 420 mg.
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4.1% of patients receiving placebo.
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Both Tezspire groups showed statistically significant improvements compared with placebo (p less than 0.001).
EREFS assesses visible features of EoE, including swelling, rings, white patches, furrows and esophageal narrowing.
Expert Perspectives on the CROSSING Trial
Evan Dellon, MD, Professor of Medicine and Adjunct Professor of Epidemiology at the University of North Carolina School of Medicine and the US principal investigator, highlighted the growing burden of EoE and its impact on eating and swallowing.
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The disease can cause frequent swallowing difficulties and food impaction.
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The trial results suggest that once-every-four-weeks tezepelumab may offer a potential treatment option addressing symptoms, esophageal inflammation and endoscopic outcomes.
Arjan Bredenoord, MD, Professor of Gastroenterology at Amsterdam University Medical Center and international coordinating investigator, emphasized the consistency of improvements across the three key measures: histologic remission, dysphagia symptoms and endoscopic remission.
He also noted that these benefits were observed in patients who continued their stable background therapies.
Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, said the findings support the potential of Tezspire's mechanism of action, which targets thymic stromal lymphopoietin (TSLP), and the company's efforts to bring the treatment to patients with EoE.
Safety Profile and Background Treatment
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Tezspire demonstrated a safety profile consistent with its approved indications.
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The most frequently reported adverse events in the CROSSING trial were:
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Nasopharyngitis (upper respiratory infection).
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Headache.
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Diarrhoea.
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Patients were permitted to continue stable background EoE medications, including proton pump inhibitors and swallowed topical corticosteroids, throughout the treatment period.
About the CROSSING Trial
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CROSSING was a randomised, double-blind, placebo-controlled, multicentre Phase III trial.
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It evaluated Tezspire in patients aged 12–80 years with symptomatic and histologically active EoE.
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A total of 368 patients were randomised in a 1:1:1 ratio to receive:
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Tezspire 210 mg.
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Tezspire 420 mg.
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Placebo.
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Treatment was administered subcutaneously every four weeks.
The co-primary endpoints at Week 24 were the proportion of patients achieving histologic remission and the mean change from baseline in DSQ score. Key secondary endpoints included histologic remission and dysphagia symptoms at Week 52, endoscopic disease severity, and total endoscopic remission.
About Tezspire (Tezepelumab)
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Tezspire is a first-in-class human monoclonal antibody developed by AstraZeneca in collaboration with Amgen.
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It inhibits TSLP, an epithelial cytokine involved in initiating and sustaining multiple inflammatory pathways.
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Tezspire is approved for severe asthma in the US, European Union, China, Japan and more than 70 countries worldwide.
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It is also approved for chronic rhinosinusitis with nasal polyps (CRSwNP) in the US, EU, China and Japan.
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The therapy is being investigated for additional indications, including EoE and chronic obstructive pulmonary disease (COPD).
Tezspire received US FDA Orphan Drug Designation for EoE in October 2021. The CROSSING results support further evaluation of its potential in this indication; the reported findings do not, by themselves, establish regulatory approval for EoE.
About Eosinophilic Esophagitis (EoE)
Eosinophilic esophagitis is a chronic, progressive inflammatory disorder affecting the esophagus. It involves inflammation and dysfunction of the esophageal lining and can interfere with swallowing and eating.
Common symptoms include:
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Difficulty or pain when swallowing.
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Food becoming stuck in the esophagus.
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Nausea and vomiting.
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Anxiety or concern about choking during meals.
Treatment options include dietary modifications, proton pump inhibitors and swallowed topical corticosteroids. However, some patients do not achieve adequate disease control with existing therapies, highlighting the need for additional treatment options.
About AstraZeneca and Amgen
AstraZeneca is a global biopharmaceutical company focused on prescription medicines across oncology, rare diseases, and biopharmaceuticals, including cardiovascular, renal and metabolic diseases, respiratory conditions and immunology.
Amgen is a biotechnology company that collaborates with AstraZeneca on Tezspire. Under their collaboration, AstraZeneca leads development, Amgen leads manufacturing, and the companies share costs and profits under their agreement.
