Thousand Oaks, California, United States, October 20, 2026
Amgen and AstraZeneca have announced positive results from the Phase 3 CROSSING clinical trial evaluating TEZSPIRE® (tezepelumab-ekko) in adolescents and adults with symptomatic, uncontrolled eosinophilic esophagitis (EoE). The study demonstrated statistically significant improvements in histologic remission, difficulty swallowing, and endoscopic disease activity, with benefits observed through 52 weeks of treatment. EoE is a chronic inflammatory condition affecting the esophagus, the tube that carries food from the mouth to the stomach. The disease can cause painful swallowing, food becoming stuck in the esophagus, and narrowing of the esophageal passage. In the CROSSING trial, TEZSPIRE was administered as a subcutaneous injection every four weeks at doses of 210 mg or 420 mg. At Week 24, histologic remission was achieved by 64.8% of patients receiving the 210 mg dose and 68.9% receiving the 420 mg dose, compared with 3.5% of patients receiving placebo. Improvements in swallowing symptoms were also reported, and key benefits were sustained through Week 52. The results support further development of TEZSPIRE as a potential treatment for EoE, an indication for which the medicine is not currently approved. The findings were announced on October 20, 2026, and are scheduled for presentation at United European Gastroenterology Week 2026 in Barcelona, Spain.
TEZSPIRE Demonstrates Histologic Remission in EoE
The Phase 3 CROSSING study evaluated whether TEZSPIRE could reduce esophageal inflammation and improve symptoms in patients whose EoE remained symptomatic and uncontrolled. Histologic remission, one of the trial’s co-primary endpoints, was defined as a peak eosinophil count of six or fewer cells per high-power field in esophageal tissue samples examined under a microscope. Eosinophils are immune cells that can accumulate in the esophagus and contribute to inflammation and tissue damage in EoE. At Week 24, 64.8% of patients receiving TEZSPIRE 210 mg and 68.9% receiving 420 mg achieved histologic remission, compared with 3.5% in the placebo group. Both comparisons were statistically significant. The results remained encouraging at Week 52, when histologic remission was observed in 67.8% of patients receiving 210 mg and 63.3% receiving 420 mg, compared with 5.4% receiving placebo. These findings indicate that the treatment’s effect on esophageal inflammation was sustained during the study period. However, histologic remission represents one measure of disease control and must be interpreted alongside symptoms, endoscopic findings, and patient safety.
Swallowing Symptoms and Endoscopic Outcomes Improve
The CROSSING trial also assessed swallowing difficulties using the Dysphagia Symptom Questionnaire (DSQ), a patient-reported measure of symptom frequency and severity. At Week 24, average DSQ scores decreased by 18.8 points with the 210 mg dose and 22.0 points with the 420 mg dose, compared with a 14.7-point decrease with placebo. The difference versus placebo reached statistical significance for both doses, although the result for 210 mg was more modest. At Week 52, the average reductions from baseline were 22.1 points for the 210 mg group and 24.0 points for the 420 mg group, compared with 13.2 points for placebo. Investigators also evaluated visible disease features through endoscopy, including swelling, rings, white patches, furrows, and strictures. At Week 52, total endoscopic remission, defined as the absence of the assessed endoscopic features, was achieved by 34.4% of patients receiving 210 mg and 29.5% receiving 420 mg, compared with 4.1% receiving placebo. These results provide additional evidence of improvements across different measures of EoE. The trial allowed patients to continue stable background therapies, including proton pump inhibitors and swallowed topical corticosteroids, providing insight into the potential effects of TEZSPIRE alongside existing treatment.
Advertisement
TSLP Inhibition Advances Amgen and AstraZeneca Research
TEZSPIRE is a monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), an epithelial cytokine involved in initiating multiple inflammatory pathways. By blocking TSLP, the medicine is designed to act upstream in the inflammatory cascade rather than targeting only a single downstream inflammatory signal. TEZSPIRE is already approved for certain patients with severe asthma and inadequately controlled chronic rhinosinusitis with nasal polyps in specified markets. Its potential application in EoE represents an expansion of research into epithelial-driven inflammatory diseases. The Phase 3 CROSSING trial randomized 368 patients aged 12–80 years to receive TEZSPIRE 210 mg, TEZSPIRE 420 mg, or placebo. The most frequently reported adverse events in the TEZSPIRE groups included upper respiratory infection, headache, and diarrhea, and the reported safety profile was consistent with the medicine’s approved indications. TEZSPIRE is not currently approved for eosinophilic esophagitis, and the trial results do not by themselves establish regulatory approval for this use. Amgen and AstraZeneca will continue evaluating the evidence and its implications for potential future treatment options. The findings mark a significant clinical-development milestone for a condition in which many patients continue to experience symptoms despite standard treatment.
Source: Amgen, AstraZeneca press release
