Tezepelumab for Asthma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Research Site, Sao Bernardo do Campo, Brazil
Asthma
Tezepelumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled 40-week Phase 3 Efficacy and Safety Study of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Asthma

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Baseline, Week 12 and Week 28

Baseline to Week 28
Annualised asthma exacerbation rate (AAER) over 28 weeks
Categorised percent reduction from baseline in the daily maintenance OCS dose at Week 28 whilst maintaining asthma control.
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Score at Week 28
Change from baseline in Asthma Control Questionnaire 6 (ACQ-6) score at Week 28
Change from baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) total score at Week 28
Change from baseline in fractional exhaled nitric oxide (FeNO) at Week 28
Change from baseline in peripheral blood eosinophils at Week 28
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) at Week 28
Change from baseline in total serum immunoglobulin E (IgE) at Week 28
Change from baseline in weekly mean home peak expiratory flow (PEF) (morning and evening) at Week 28
Proportion of subjects with 100% reduction from baseline in daily OCS dose at Week 28
Proportion of subjects with ≥50% reduction from baseline in daily OCS dose at Week 28
Time to first asthma exacerbation
Baseline to Week 40
Immunogenicity: Incidence of anti-drug antibodies (ADA) at Week 0, 12, 28, and 40
Week 28
PK: Serum trough concentrations at Week 0, 12 and 28
Week 28
Proportion of subjects with daily OCS dose ≤5 mg at Week 28

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Asthma

Side Effects for

Tezepelumab
16%Nasopharyngitis
12%Upper respiratory tract infection
8%Asthma
8%Bronchitis bacterial
5%Bronchitis
5%Oral candidiasis
5%Myalgia
4%Headache
4%Fall
3%Hypertension
1%Incisional hernia
1%Arthralgia
1%Invasive breast carcinoma
1%Sinusitis
1%Supraventricular tachycardia
1%Pneumonia
1%Cardiac failure
1%Septic shock
1%Cardiac arrest
1%Inguinal hernia
1%Intervertebral discitis
1%Cataract
1%Acute kidney injury
1%Nephrolithiasis
0%Nasal polyps
0%H1n1 influenza
0%Arthritis
0%Influenza like illness
0%Spinal compression fracture
0%Muscle spasms
0%Cholecystitis acute
0%Road traffic accident
0%Migraine
0%Bronchial secretion retention
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT03406078) in the Tezepelumab ARM group. Side effects include: Nasopharyngitis with 16%, Upper respiratory tract infection with 12%, Asthma with 8%, Bronchitis bacterial with 8%, Bronchitis with 5%.

Trial Design

2 Treatment Groups

Tezepelumab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

207 Total Participants · 2 Treatment Groups

Primary Treatment: Tezepelumab · Has Placebo Group · Phase 3

Tezepelumab
Biological
Experimental Group · 1 Intervention: Tezepelumab · Intervention Types: Biological
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tezepelumab
2018
Completed Phase 3
~1730

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 12 and week 28
Closest Location: Research Site · Quebec, Canada
1900First Recorded Clinical Trial
227 TrialsResearching Asthma
2950 CompletedClinical Trials

Who is running the clinical trial?

AmgenIndustry Sponsor
1,279 Previous Clinical Trials
1,300,483 Total Patients Enrolled
21 Trials studying Asthma
5,521 Patients Enrolled for Asthma
AstraZenecaLead Sponsor
3,933 Previous Clinical Trials
91,864,951 Total Patients Enrolled
305 Trials studying Asthma
696,242 Patients Enrolled for Asthma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Participants must have received physician prescribed LABA and high dose ICS for at least 3 months prior to Visit 1.
The use of additional maintenance asthma controller medications is allowed.
You have a history of at least 1 asthma exacerbation event within 24 months prior to Visit 1.
You have documented physician-diagnosed asthma for at least 12 months prior to Visit 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.