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Tezepelumab for Asthma (SUNRISE 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
Participants must have received a physician-prescribed medium- or high-dose ICS for at least 12 months prior to Visit 1
Participants must have received physician prescribed LABA and high dose ICS for at least 3 months prior to Visit 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12 and week 28
Awards & highlights

SUNRISE 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.Check my eligibility
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.See study design
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.

SUNRISE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a medium or high dose of prescribed inhaler steroids for over a year.
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I have been on prescribed LABA and high dose ICS for at least 3 months.
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I am between 18 and 80 years old.
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I have been taking oral steroids for asthma for at least 6 months and have been on a stable dose for the last month.
Select...
I have been on a stable dose of oral corticosteroids for at least 2 weeks.

SUNRISE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12 and week 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 and week 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Categorised percent reduction from baseline in the daily maintenance OCS dose at Week 28 whilst maintaining asthma control.
Secondary outcome measures
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 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

SUNRISE 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
1,370 Previous Clinical Trials
1,377,481 Total Patients Enrolled
22 Trials studying Asthma
5,902 Patients Enrolled for Asthma
AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,579 Total Patients Enrolled
328 Trials studying Asthma
639,427 Patients Enrolled for Asthma

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05398263 — Phase 3
Asthma Research Study Groups: Placebo, Tezepelumab
Asthma Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05398263 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05398263 — Phase 3

Frequently Asked Questions

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

Does this research restrict participation to adults over 30?

"This study is looking for individuals that fall between 18-80 years old."

Answered by AI

Are there any vacancies in this clinical trial for new patients?

"The clinical trial mentioned is still open and looking for participants, with the original posting on 8/9/2022. The most recent update to the listing was on 11/14/2022."

Answered by AI

Is Tezepelumab known to have negative effects on patients?

"There is existing clinical data that supports the safety of Tezepelumab, thus it received a score of 3."

Answered by AI

Which patients does this clinical trial target?

"This study is seeking 207 participants with asthma between the ages of 18 and 80. Candidates should meet the following criteria: Participant must be 18 to 80 years of age., Participants must have received a physician-prescribed medium- or high-dose ICS for at least 12 months prior to Visit 1., Participants must have received OCS for the treatment of asthma for at least 6 months prior to Visit 1 and on a stable dose of between ≥7.5 to ≤ 30 mg (prednisone or prednisolone) daily or daily equivalent for at least 1 month prior to Visit 1., Morning pre- bronchod"

Answered by AI

Is this research being conducted in a number of different locations across Canada?

"To make participation more logistically feasible, this clinical trial offers 17 different sites. They are situated in Kingwood, Hazelwood, Bronx and 14 other locations."

Answered by AI

How many volunteers are helping with this research project?

"Yes, the listed information on clinicaltrials.gov affirms that the trial is actively recruiting patients. The trial was first posted on August 9th, 2022 and has since been updated on November 14th, 2022. They are looking for a total of 207 participants from 17 different locations."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

After having COVID for the fourth time, and pneumonia for the second time (in Nov./Dec. 2023), I my fatigue and asthma symptoms have intensified. I have tried a few different inhalers, as well as been on oral steroids, but have not improved.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Tezepelumab Efficacy and Safety in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma
2022. "Tezepelumab Efficacy and Safety in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05398263.
All > Pediatric Asthma > Asthma
~73 spots leftby Apr 2025
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