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Monoclonal Antibodies

Benralizumab for Asthma (CHINOOK Trial)

Phase 4
Recruiting
Led By Mario Castro, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fewer than 12 exacerbations within the 6 months prior to Visit 3
Fewer than 12 exacerbations within the 6 months prior to Visit 3.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 52 (visit 11)
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will help assess the effect of benralizumab on structural and lung function changes in severe asthmatics over a 48-week period.

Who is the study for?
Adults aged 18-70 with severe eosinophilic asthma, not well-controlled despite using inhaled steroids and long-acting beta agonists. They must have specific levels of blood eosinophils and less than 12 asthma attacks in the past six months. Excluded are those who've had certain treatments like benralizumab or bronchial thermoplasty recently, current smokers, cancer patients, pregnant women, or those on immunosuppressants.
What is being tested?
The trial is testing if benralizumab can improve lung structure and function over a 48-week period compared to a placebo in patients with severe eosinophilic asthma. Participants will be monitored for changes after treatment and during a four-week follow-up.
What are the potential side effects?
While not specified here, common side effects of benralizumab may include headache, sore throat, fever; rare but serious effects could involve allergic reactions or worsening breathing problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had fewer than 12 asthma attacks in the last 6 months.
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I've had fewer than 12 flare-ups of my condition in the last 6 months.
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I am between 18 and 70 years old.
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I have asthma treated with strong medication for over a year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 52 (visit 11)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 52 (visit 11) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The change in airway wall area percentage as the overall median for airway generations 3 and 4 combined as measured by quantitative computed tomography (QCT) imaging
The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
Secondary study objectives
Absolute change from baseline to End of Treatment in mucus score assessed using computed tomography (CT) scans
Absolute change in R5-R20 (peripheral airway resistance defined as the difference in resistance between 5 Hz [R5, total respiratory system resistance] and 20 Hz [R20, central resistance]) as measured by airwave oscillometry (AO)
Lung
+32 more
Other study objectives
The number of Adverse events (AEs)/serious adverse events (SAEs).

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255
15%
Nasopharyngitis
8%
Asthma
7%
Sinusitis
7%
Headache
7%
Bronchitis
6%
Upper respiratory tract infection
4%
Influenza
3%
Back pain
3%
Cough
3%
Dyspnoea
3%
Hypertension
3%
Rhinitis
1%
Urosepsis
1%
Nephrolithiasis
1%
Intervertebral disc protrusion
1%
Umbilical hernia
1%
Adverse drug reaction
1%
Hypersensitivity
1%
Vertigo
1%
Nausea
1%
Dermatitis atopic
1%
Urinary tract infection bacterial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.4 Weeks
Benra 30 mg q.8 Weeks
Placebo

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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: BenralizumabExperimental Treatment1 Intervention
Administrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks
Group II: PlaceboPlacebo Group1 Intervention
Administrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
2016
Completed Phase 4
~10320

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,121,576 Total Patients Enrolled
347 Trials studying Asthma
661,388 Patients Enrolled for Asthma
Mario Castro, MDPrincipal InvestigatorUniversity of Kansas School of Medicine 3901 Rainbow Blvd. Kansas City, KS 66160, USA
6 Previous Clinical Trials
2,236 Total Patients Enrolled
6 Trials studying Asthma
2,236 Patients Enrolled for Asthma

Media Library

Benralizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03953300 — Phase 4
Asthma Research Study Groups: Placebo, Benralizumab
Asthma Clinical Trial 2023: Benralizumab Highlights & Side Effects. Trial Name: NCT03953300 — Phase 4
Benralizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03953300 — Phase 4
~21 spots leftby Sep 2026
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