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Monoclonal Antibodies

Tezepelumab for Allergic Asthma

Phase 2

Waitlist Available

Led By Gail Gauvreau, PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

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

Must have

Male and female 18 through 65 years of age

Mannitol DRR ≤ 42.3mg/FEV1 %f all (equivalent to PD15 ≤ 635mg)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week -1 to week 24

Awards & highlights

Study Summary

This trial will explore how Tezepelumab, an injectable medication, can help improve asthma by stopping inflammation, and how it affects mast cells and airway constriction.

Who is the study for?

This trial is for adults aged 18-65 with mild allergic asthma, who have a certain level of airway responsiveness and are not heavy smokers or drug/alcohol abusers. Participants must test positive to an allergen, not be pregnant or breastfeeding, and cannot have other significant diseases like cancer or autoimmune disorders.Check my eligibility

What is being tested?

The study tests Tezepelumab's effects on mast cells in the lungs and how it might prevent airway constriction in people with mild allergic asthma. It compares Tezepelumab injections against a placebo to see if it can benefit patients by reducing inflammation caused by these immune cells.See study design

What are the potential side effects?

Potential side effects of Tezepelumab may include reactions at the injection site, headache, fatigue, and possible hypersensitivity reactions. Since this medication impacts the immune system, there could also be an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

Select...

My lung response to Mannitol is within the required range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week -1 to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week -1 to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week -1 to week 24 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Methacholine PD20

Secondary outcome measures

Dose response ratio to mannitol

Mast cell tryptase levels.

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TezepelumabExperimental Treatment1 Intervention

tezepelumab 210 mg sc q4wks 20 weeks treatment

Group II: PlaceboPlacebo Group1 Intervention

placebo sc q4wks 20 weeks treatment

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?

McMaster UniversityLead Sponsor

880 Previous Clinical Trials

2,597,794 Total Patients Enrolled

University of SaskatchewanOTHER

251 Previous Clinical Trials

154,376 Total Patients Enrolled

Gail Gauvreau, PhDPrincipal InvestigatorMcMaster University

14 Previous Clinical Trials

536 Total Patients Enrolled

Media Library

Tezepelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05740748 — Phase 2

Tezepelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05740748 — Phase 2

Allergic Asthma Clinical Trial 2023: Tezepelumab Highlights & Side Effects. Trial Name: NCT05740748 — Phase 2

Allergic Asthma Research Study Groups: Tezepelumab, Placebo

Frequently Asked Questions

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

What have been the reported adverse effects of Tezepelumab?

"Tezepelumab's safety is rated a 2 due to the lack of positive efficacy trials, yet some data has been collected indicating its potential for harmlessness."

Answered by AI

Are those over the age of twenty admissible for this investigation?

"According to the specifications of this study, only individuals between 18 and 65 years old can participate. For patients who are younger or older respectively, there are 122 and 204 different clinical trials available."

Answered by AI

Are there any current opportunities for individuals to enroll in this clinical trial?

"Clinicaltrials.gov data reveals that this clinical trial is not currently looking for participants, despite having been posted on April 1st 2023 and updated as recently as February 22nd 2023. Nonetheless, there are presently 329 other trials actively enrolling patients."

Answered by AI

What criteria must participants meet to join this medical experiment?

"This clinical trial is accepting 34 people with asthma and allergies, aged between 18 to 65 years old. To be eligible for the study, applicants must abide by the following conditions: willingly provide their informed consent before taking part in any tests related to this experiment; categorically male or female from ages 18 -65; have a positive skin prick test reaction towards a common airborne allergen; measure up to 200mcg on Metacholine PD20; record 42.3mg/FEV1 %f Mannitol DRR (or equivalent amount of 635 mg as per PD15); possess baseline FEV1 level that meets at least"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tezepelumab and Methacholine Airway Hyperresponsiveness in Participants With Mild Allergic Asthma

2023. "Tezepelumab and Methacholine Airway Hyperresponsiveness in Participants With Mild Allergic Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05740748.