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Monoclonal Antibodies

Allergic Participants for Allergic Rhinitis (TEZARS Trial)

Phase 2

Recruiting

Led By Anne K Ellis, MD

Research Sponsored by Dr. Anne Ellis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

People between the ages of 18 and 65

Body weight greater than 45 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, and 12 months

Awards & highlights

TEZARS Trial Summary

This trial is studying a drug called tezepelumab to see how well it works in people with both allergic asthma and hay fever. It wants to find out if tezepelum

Who is the study for?

The TEZARS trial is for people with both severe asthma and allergic rhinitis (hayfever). Participants must be able to visit the clinic multiple times. Non-allergic individuals will also participate but won't receive the drug; instead, they'll help compare results.Check my eligibility

What is being tested?

This study tests Tezepelumab's effectiveness in reducing nasal symptoms and certain chemicals in the nose after allergen exposure. Allergic participants get monthly injections for a year, while non-allergic ones only undergo allergen challenges.See study design

What are the potential side effects?

While specific side effects are not listed here, Tezepelumab may cause reactions at injection sites, potential allergic responses to medication components, or other immune-related issues as seen with similar treatments.

TEZARS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Select...

My weight is over 45 kg.

TEZARS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Total Nasal Symptom Score (TNSS)

Secondary outcome measures

Asthma Control Questionnaire 5 (ACQ5).

Concentration of alarmins (TSLP, IL-33, IL-25) and type 2 cytokines (IL-4, Il-5, IL-13, etc.) from nasal fluids.

Concentration of chymase from nasal fluids.

+12 more

Other outcome measures

Adverse reactions induced by Nasal Allergen Challenge

Asthma symptoms induced by Nasal Allergen Challenge (spirometry).

Asthma symptoms induced by Nasal Allergen Challenge (symptom scores).

Side effects data

From 2020 Phase 3 trial • 150 Patients • NCT03406078

16%

Nasopharyngitis

12%

Upper respiratory tract infection

Asthma

Bronchitis bacterial

Myalgia

Bronchitis

Oral candidiasis

Headache

Fall

Hypertension

Cardiac failure

Cataract

Supraventricular tachycardia

Inguinal hernia

Intervertebral discitis

Pneumonia

Septic shock

Incisional hernia

Arthralgia

Invasive breast carcinoma

Acute kidney injury

Nephrolithiasis

Sinusitis

Cardiac arrest

100%

80%

60%

40%

20%

Study treatment Arm

Tezepelumab

Placebo

TEZARS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Allergic ParticipantsExperimental Treatment1 Intervention

Group II: Non-allergic ParticipantsActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tezepelumab

2018

Completed Phase 3

~2120

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dr. Anne EllisLead Sponsor

1 Previous Clinical Trials

100 Total Patients Enrolled

Anne K Ellis, MDPrincipal InvestigatorQueen's University

4 Previous Clinical Trials

350 Total Patients Enrolled

Frequently Asked Questions

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

Are potential participants still able to apply for enrollment in this ongoing research study?

"Apologies for the confusion. According to clinicaltrials.gov, this particular trial is no longer actively seeking participants. It was initially posted on January 31st, 2024 and had its last update on December 18th, 2023. However, it's worth noting that there are currently 344 other ongoing clinical trials actively recruiting patients at this time."

Answered by AI

What are the criteria for eligibility to participate in this research study?

"Eligible individuals for this clinical trial must have a diagnosis of allergic rhinitis and be between the ages of 18 and 65. The study aims to enroll approximately 19 participants."

Answered by AI

Are individuals who are older than 40 years of age eligible to participate in this medical study?

"To participate in this clinical trial, individuals between the ages of 18 and 65 are eligible. It is worth noting that there are a total of 132 trials available for patients under 18 years old and 223 trials specifically targeting individuals over the age of 65."

Answered by AI

What is the level of safety for individuals with allergies participating in this intervention?

"Based on the information provided, our team at Power assesses the safety of allergic participants to be a 2. This is because the trial is in Phase 2, indicating that there is some evidence supporting its safety but no data yet regarding efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tezepelumab in Allergic Rhinitis and Asthma Study (TEZARS)

Dr. Anne Ellis 2024. "Tezepelumab in Allergic Rhinitis and Asthma Study (TEZARS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06189742.