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A study to investigate changes in symptoms and esophageal histology with tezepelumab compared with placebo in patients aged 12 to 80 years old with eosinophilic esophagitis
EU CTIS ID: 2023-504277-20-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- Japan
- Canada
- Israel
- Brazil
- China
- United Kingdom
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; Japan; Canada; Israel; Brazil; China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.