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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12 and week 28
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Summary
This trial is testing the effectiveness of a new drug, tezepelumab, in reducing the amount of oral corticosteroids needed for people with asthma who are dependent on them.
Who is the study for?
Adults aged 18-80 with asthma dependent on oral corticosteroids (OCS) for at least 6 months, currently taking a stable OCS dose, and have had an asthma exacerbation in the past two years. Participants must not be current heavy smokers or recent users of certain medications and should not have significant other health issues that could interfere with the trial.
What is being tested?
The study is testing Tezepelumab's effectiveness in reducing the need for oral steroids compared to a placebo over 28 weeks. This phase 3 trial randomly assigns participants to either receive Tezepelumab or a placebo while keeping both doctors and patients unaware of who receives which treatment.
What are the potential side effects?
While specific side effects are not listed here, potential side effects may include reactions at the injection site, headaches, fatigue, and possible immune system changes since Tezepelumab affects inflammation pathways involved in asthma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 12 and week 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12 and week 28
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Categorised percent reduction from baseline in the daily maintenance OCS dose at Week 28 whilst maintaining asthma control.
Secondary study objectives
Annualised asthma exacerbation rate (AAER) over 28 weeks
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
+12 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
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TezepelumabExperimental Treatment1 Intervention
Tezepelumab subcutaneous injection, in an accessorised pre-filled syringe.
Group II: PlaceboPlacebo Group1 Intervention
Placebo subcutaneous injection, in an accessorised pre-filled syringe.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tezepelumab
FDA approved
Find a Location
Who is running the clinical trial?
AmgenIndustry Sponsor
1,433 Previous Clinical Trials
1,394,935 Total Patients Enrolled
24 Trials studying Asthma
6,454 Patients Enrolled for Asthma
AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,121,496 Total Patients Enrolled
347 Trials studying Asthma
661,262 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a current smoker or have a history of heavy smoking, or I use vaping products.I've needed more asthma medication or steroids in the last 30 days.I have been treated for tuberculosis within the last year.I had skin or cervical cancer treated over a year ago, or any cancer treated over 5 years ago.I do not have an active COVID-19 infection.I received a COVID-19 vaccine within the last 28 days.I haven't taken any experimental drugs or biologics recently.I have a lung condition that is not asthma.I have been on a medium or high dose of prescribed inhaler steroids for over a year.I have been using additional asthma control medications for at least 3 months.I have been on prescribed LABA and high dose ICS for at least 3 months.I have had an asthma attack in the last 2 years.I have asthma confirmed by tests in the last 5 years.I have a worm infection diagnosed in the last 6 months that hasn't improved with standard treatment.My asthma is controlled with a very low or high steroid dose, or after reducing my medication dose 3 times.I have been using a short-acting asthma inhaler regularly for the last month.I have been diagnosed with asthma for over a year.I am between 18 and 80 years old.I have been taking oral steroids for asthma for at least 6 months and have been on a stable dose for the last month.I have been on a stable dose of oral corticosteroids for at least 2 weeks.I finished treatment for a serious infection less than 2 weeks ago.You have shown good response to bronchodilator test in the past 5 years or have documented airway hyperresponsiveness in the past 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Tezepelumab
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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