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Monoclonal Antibodies
Tezepelumab for Eosinophilic Esophagitis (CROSSING Trial)
Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 4, 12, 24, and 52
Awards & highlights
Pivotal Trial
Summary
This trial tests an injection treatment for people with a condition that causes swelling in the esophagus. The treatment aims to reduce this swelling by calming the immune system.
Who is the study for?
Adults and adolescents aged 12-80 with a confirmed diagnosis of EoE, weighing at least 40 kg, experiencing swallowing difficulties at least twice weekly. Participants must have been on a stable diet and any acid reflux or allergy medications for 8 weeks before the trial starts.
What is being tested?
The study is testing Tezepelumab, given by injection using a pre-filled syringe, against a placebo to see if it's effective and safe in treating eosinophilic esophagitis (EoE). It's randomized and double-blind so neither doctors nor patients know who gets the real treatment.
What are the potential side effects?
Possible side effects of Tezepelumab are not detailed here but could include reactions at the injection site, allergic responses, or other immune-related issues as commonly seen with monoclonal antibody therapies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 0, 4, 12, 24, and 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 4, 12, 24, and 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Deglutition Disorders
Change from baseline in EoE EREFS (Endoscopic reference score )
Eosinophil
+1 moreOther study objectives
Anti-drug antibody
Change from baseline in EoE-HSS (Histologic scoring system) grade score
Change from baseline in EoE-HSS (Histologic scoring system) stage score
+3 moreSide effects data
From 2020 Phase 3 trial • 150 Patients • NCT0340607816%
Nasopharyngitis
12%
Upper respiratory tract infection
8%
Bronchitis bacterial
8%
Asthma
5%
Bronchitis
5%
Oral candidiasis
5%
Myalgia
4%
Headache
4%
Fall
3%
Hypertension
1%
Sinusitis
1%
Cardiac arrest
1%
Cardiac failure
1%
Supraventricular tachycardia
1%
Septic shock
1%
Incisional hernia
1%
Acute kidney injury
1%
Inguinal hernia
1%
Intervertebral discitis
1%
Pneumonia
1%
Arthralgia
1%
Invasive breast carcinoma
1%
Nephrolithiasis
1%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tezepelumab
Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Tezepelumab Low DoseExperimental Treatment1 Intervention
Tezepelumab subcutaneous injections, in accessorised pre-filled syringes
Group II: Tezepelumab High DoseExperimental Treatment1 Intervention
Tezepelumab subcutaneous injections, in accessorised pre-filled syringes
Group III: PlaceboPlacebo Group1 Intervention
Placebo subcutaneous injections, in accessorised pre-filled syringes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tezepelumab
2018
Completed Phase 3
~2120
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Eosinophilic Esophagitis (EoE) include dietary management, proton pump inhibitors (PPIs), topical corticosteroids, and biologic therapies. Dietary management involves eliminating specific allergens that trigger EoE.
PPIs reduce acid production, which can help decrease inflammation. Topical corticosteroids, such as fluticasone or budesonide, reduce local inflammation in the esophagus.
Biologic therapies, like Tezepelumab, target specific immune pathways; Tezepelumab inhibits thymic stromal lymphopoietin (TSLP), a cytokine involved in the inflammatory response. This inhibition is crucial for EoE patients as it can reduce eosinophil activation and inflammation, leading to symptom relief and improved esophageal function.
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,388 Previous Clinical Trials
289,109,382 Total Patients Enrolled
5 Trials studying Eosinophilic Esophagitis
325 Patients Enrolled for Eosinophilic Esophagitis
AmgenIndustry Sponsor
1,431 Previous Clinical Trials
1,384,805 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with EGPA vasculitis.I do not have significant gastrointestinal issues like Crohn's, ulcerative colitis, or IBS.I am between 12 and 80 years old.I have a narrow esophagus that makes it hard for standard medical scopes to pass.I have been diagnosed with EoE through a biopsy.I have had trouble swallowing food at least twice a week in the last month.I have had trouble swallowing food at least twice a week in the last month.I had my esophagus stretched within the last 8 weeks.I weigh at least 40 kg.I have followed standard treatments like PPI, STC, or diet changes.My medication for stomach acid has been the same for the last 8 weeks and I agree not to change it during the study.I stopped my EoE medication 8 weeks ago, or any biologic treatment 4 months or 5 half-lives ago.I have been on a stable dose of my asthma or allergy medication for at least 4 weeks.I have been diagnosed with hypereosinophilic syndrome.I have been diagnosed with EoE through a biopsy.I have been on stable stomach medication for at least 8 weeks and agree not to change it during the study.I am between 12 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Tezepelumab Low Dose
- Group 2: Tezepelumab High Dose
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Eosinophilic Esophagitis Patient Testimony for trial: Trial Name: NCT05583227 — Phase 3
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