Thousand Oaks, California, United States, Aug. 27, 2026
Amgen and AstraZeneca have announced positive top-line results from the Phase 3 CROSSING trial evaluating TEZSPIRE® (tezepelumab-ekko) in patients with eosinophilic esophagitis (EoE). The investigational use of TEZSPIRE demonstrated statistically significant and clinically meaningful improvements across both co-primary endpoints and key secondary endpoints at Week 24, with treatment effects sustained through Week 52. The co-primary endpoints evaluated histologic remission and the frequency and severity of dysphagia, a major symptom of EoE characterized by difficulty swallowing. The safety profile reported in the trial was generally consistent with the established safety profile of TEZSPIRE in its approved indications. The findings add to the clinical development program for tezepelumab, a first-in-class human monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), and support its potential application in another epithelial-driven inflammatory disease. Full CROSSING trial results are expected to be presented to regulatory authorities and the scientific community at an upcoming medical meeting.
CROSSING Trial Shows Sustained Clinical Improvements
The CROSSING Phase 3 trial was designed as a randomized, double-blind, placebo-controlled, multicenter, parallel-group study evaluating subcutaneous TEZSPIRE administered every four weeks in patients aged 12 to 80 years with symptomatic and histologically active EoE. A total of 368 patients were randomized in a 1:1:1 ratio to receive either a low dose of TEZSPIRE, a high dose of TEZSPIRE or placebo. Patients were allowed to continue stable background EoE treatments, including proton pump inhibitors and swallowed topical corticosteroids, during the study. The two co-primary endpoints were assessed at Week 24. Histologic remission was defined by a peak esophageal eosinophil count of six or fewer eosinophils per high-power field, while changes in swallowing symptoms were measured using the patient-reported Dysphagia Symptom Questionnaire (DSQ). Key secondary endpoints included histologic remission and dysphagia at Week 52, changes in endoscopic disease characteristics, histologic severity and extent, as well as endoscopic response, inflammatory remission and total endoscopic remission.
TEZSPIRE Targets Central Inflammatory Pathway
TEZSPIRE works by targeting and blocking TSLP, an epithelial cytokine positioned near the beginning of multiple inflammatory pathways. TSLP is released by epithelial tissues in response to environmental triggers and can contribute to allergic, eosinophilic and other forms of epithelial-driven inflammation. In EoE, chronic inflammation can lead to esophageal remodeling, epithelial dysfunction, dysphagia and food impaction. The disease is chronic and progressive, and many patients continue to experience significant symptoms despite dietary interventions or first-line treatments such as proton pump inhibitors and swallowed topical corticosteroids. The CROSSING results are therefore notable because TEZSPIRE demonstrated improvements in both an underlying measure of esophageal inflammation and a patient-reported measure of swallowing difficulty. The company reported that efficacy in EoE represents the third epithelial-driven inflammatory condition in which TEZSPIRE has demonstrated clinical activity, expanding the potential scope of its TSLP-targeting mechanism beyond its currently approved uses.
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Phase 3 Results Expand TEZSPIRE Development Program
EoE affects more than 470,000 people in the United States, according to the supplied release, with prevalence reported to have increased substantially since 2009. The inflammatory disorder can interfere with eating and daily activities because food may move slowly through the esophagus or become lodged, while progressive inflammation can contribute to esophageal narrowing. The CROSSING findings provide additional clinical evidence for evaluating TEZSPIRE in EoE, although the indication remains investigational and the reported top-line findings do not constitute FDA approval for this use. TEZSPIRE is currently approved in the United States for the add-on maintenance treatment of patients aged 12 years and older with severe asthma and for patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The medicine is also approved for severe asthma in the European Union, China, Japan and more than 70 countries globally, while development continues in additional conditions including chronic obstructive pulmonary disease and eosinophilic esophagitis. Amgen and AstraZeneca share global development responsibilities, with AstraZeneca leading global development and Amgen manufacturing and supplying TEZSPIRE worldwide. The companies now plan to advance the CROSSING findings through regulatory and scientific channels as they evaluate the potential role of TSLP inhibition in EoE.
Source: Amgen, AstraZeneca press relese
