Eosinophilic esophagitis (EoE) is a rare, chronic inflammatory disorder triggered by an immune response to foods and aeroantigens and characterized by a combination of esophageal dysfunction and eosinophilic infiltration of the esophagus MedDRA version: 20.1 Level: LLT Classification code 10064220 Term: Eosinophilic esophagitis System Organ Class: 100000004856
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be 12 to 80 years of age inclusive, at the time of signing the informed consent/assent. 2. Weight = 40 kg at Visit 1 3. Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming a diagnosis of EoE. 4. Participants who have symptomatic EoE as defined by a history of on average at least 2 episodes of dysphagia (any severity of food going down slowly or being stuck in the throat) per week in the 4 weeks prior to Visit 1. 5. Must remain on a stabilized diet for at least 8 weeks prior to Visit 1 and during the course of the study (stable diet is defined as no initiation of single or multiple elimination diets or reintroduction of previously eliminated food groups). 6. May be on any background medication for EoE, for example PPI and/or STC, during the course of the study, as long as background medications have been stable for at least 8 weeks prior to the screening/run-in period (Visit 1) and there is agreement not to change background medication or dosage unless medically indicated, during the screening/run-in and treatment period. 7. Participants currently leukotriene inhibitors and/or steroid treatments for asthma or allergies that are inhaled or administered intranasally, must report a stable dose for at least 4 weeks prior to the screening/run-in period (Visit 1). 8. If a medication for EoE (including PPI and/or STC) is discontinued prior to the screening/run-in, there should be a washout period of at least 8 weeks prior to Visit 1. Discontinuation of any marketed biologic (monoclonal or polyclonal antibody) should have a washout period of 4 months or 5 half-lives prior to Visit 1, whichever is longer. 9. Participants should have previously documented standard of care treatment, which could include PPI and/or STC and/or diet Are the trial subjects under 18? yes Number of subjects for this age range: 36 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 314 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, celiac disease, eosinophilic enteritis, colitis, diverticulitis, irritable bowel syndrome, or other clinically significant gastrointestinal conditions as per Investigator discretion. 2.Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening. 3. Use of a feeding tube, or having a pattern of not eating solid food = 3 days of the week. Solid food is defined as food that requires chewing before swallowing. 4. Hypereosinophilic syndrome. 5. EGPA vasculitis 6. Esophageal dilation performed within 8 weeks prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the effect of tezepelumab on the histologic response in adult and adolescent participants with symptomatic and histologically active EoE 2. To evaluate the effect of tezepelumab on symptom improvement in adult and adolescent participants with symptomatic and histologically active EoE;Secondary Objective: 1. To evaluate the effect of tezepelumab on the centrally-read EoE EREFS 2. To evaluate the effect of tezepelumab on the centrally-read EoE-HSS 3. To evaluate the long-term effect of tezepelumab on the histologic response 4. To evaluate the long-term effect of tezepelumab on symptom improvement 5. To evaluate the long-term effect of tezepelumab on the centrally-read EoE EREFS 6. To evaluate the effect of tezepelumab on achievement of clinico-histological remission 7. To evaluate the effect of tezepelumab on peak eosinophil count 8. To evaluate the effect of tezepelumab on EoE symptoms in adolescents 9. To evaluate the long-term effect of tezepelumab 10. To evaluate the PK and immunogenicity of tezepelumab;Primary end point(s): 1. Histologic response of peak esophageal eosinophil per HPF count of = 6 across all available esophageal levels at Week 24 2. Change from baseline in DSQ score at Week 24;Timepoint(s) of evaluation of this end point: 1. Week 24 2. Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in EoE EREFS at Week 24 and Week 52 2. Change from baseline in EoE-HSS grade score at Week 24 and Week 52 3. Change from baseline in EoE-HSS stage score at Week 24 and Week 52 4. Histologic response of peak esophageal eosinophil per HPF count of = 6 across all available esophageal levels at Week 52 5. Change from baseline in DSQ score at Week 52 6. Response of achieving clinico-histological remission at Week 24 and Week 52 7. Change from baseline in peak esophageal eosinophil count (EOS/HPF) at Week 24 and Week 52 8. Changes from baseline in PEESS Module at Week 24 and Week 52 (adolescents only) 9. Serum trough concentrations at Weeks 0, 4, 12, and 52 10. Anti-drug antibody at Weeks 0, 12, 24, and 52;Timepoint(s) of evaluation of this end point: Varies depending on the endpoint/objective | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Czech Republic, Denmark, Finland, Germany, Greece, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Slovakia, Spain, Sweden, United States
Contacts
Public ContactClinical Study Information Center
AstraZeneca
Outcome results
None listed