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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

CROSSING Trial Summary

This trial tests a drug to treat EoE, a disease affecting the esophagus, in adults & adolescents. It's randomized, double-blind, placebo-controlled & multicenter.

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.Check my eligibility
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.See study design
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.

CROSSING Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 4, 12, 24, and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 4, 12, 24, and 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Deglutition Disorders
Change from baseline in EoE EREFS (Endoscopic reference score )
Eosinophil
+1 more
Other outcome measures
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 more

Side effects data

From 2020 Phase 3 trial • 150 Patients • NCT03406078
16%
Nasopharyngitis
12%
Upper respiratory tract infection
8%
Asthma
8%
Bronchitis bacterial
5%
Myalgia
5%
Bronchitis
5%
Oral candidiasis
4%
Headache
4%
Fall
3%
Hypertension
1%
Cardiac failure
1%
Cataract
1%
Supraventricular tachycardia
1%
Inguinal hernia
1%
Intervertebral discitis
1%
Pneumonia
1%
Septic shock
1%
Incisional hernia
1%
Arthralgia
1%
Invasive breast carcinoma
1%
Acute kidney injury
1%
Nephrolithiasis
1%
Sinusitis
1%
Cardiac arrest
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tezepelumab
Placebo

CROSSING 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

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,612,499 Total Patients Enrolled
5 Trials studying Eosinophilic Esophagitis
325 Patients Enrolled for Eosinophilic Esophagitis
AmgenIndustry Sponsor
1,371 Previous Clinical Trials
1,377,777 Total Patients Enrolled

Media Library

Tezepelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05583227 — Phase 3
Eosinophilic Esophagitis Research Study Groups: Tezepelumab Low Dose, Tezepelumab High Dose, Placebo
Eosinophilic Esophagitis Clinical Trial 2023: Tezepelumab Highlights & Side Effects. Trial Name: NCT05583227 — Phase 3
Tezepelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05583227 — Phase 3
Eosinophilic Esophagitis Patient Testimony for trial: Trial Name: NCT05583227 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial only open to elderly patients?

"This particular trial is only for patients that fall between the ages of 12 and 80. However, if you are ineligible for this study, there are 26 other clinical trials you could potentially participate in. If you are over the age of 65, there are 34 other trials."

Answered by AI

In how many different geographies is this research project being conducted?

"Presently, this clinical trial is recruiting patients from 11 sites. The locations are based in Philadelphia, Los Angeles and Montreal as well as 11 other locations. If you are considering participating, it may be helpful to select the location closest you to minimize travel requirements."

Answered by AI

Are medical professionals still enrolling individuals for this experiment?

"According to the latest information on clinicaltrials.gov, this study is not looking for any new participants at this time. The trial was first posted on October 31st, 2022 and was edited most recently on October 13th, 2022. There are, however, 49 other trials with open recruitment at the moment."

Answered by AI

What is the maximum amount of Tezepelumab that a patient can take without experiencing negative side effects?

"There is some evidence for efficacy and multiple rounds of data supporting safety, so tezepelumab high dose received a score of 3."

Answered by AI

Are there any medical restrictions for participants in this trial?

"This study is looking for 360 participants who currently have eosinophilic esophagitis and are between the ages of 12 and 80. Patients must also meet the following criteria in order to be eligible: • Weight ≥ 40 kg at Visit 1• Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming a diagnosis of EoE.• 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)"

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Ontario
New York
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1
2

Why did patients apply to this trial?

My food limitations are soy, gluten, dairy, and pork. I've lost 60lbs.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
2022. "Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05583227.
All > Eosinophilic Esophagitis
~211 spots leftby May 2026
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