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Monoclonal Antibodies

Benralizumab for Severe Asthma (BURAN Trial)

Phase 4
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you been diagnosed with Asthma?
Have had at least two exacerbations within the last 12 months?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening to follow-up (up to 1.4 years)
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test benralizumab, a medication that reduces inflammation in the airways, on adults with severe eosinophilic asthma not well-controlled by standard treatments. The medication works by lowering the number of specific cells that cause breathing problems. Benralizumab helps improve lung function for patients with severe, uncontrolled asthma with eosinophilic inflammation.

Who is the study for?
This trial is for people with severe eosinophilic asthma who've had at least two flare-ups in the past year. They should be on a stable asthma treatment and able to stop their maintenance medication for 12-24 hours before certain visits. It's not open to those with significant other diseases, a current or past cancer diagnosis, or a history of specific lung procedures.
What is being tested?
The BURAN study is testing how benralizumab affects airway dynamics in patients with severe eosinophilic asthma. Researchers will use advanced imaging (Functional Respiratory Imaging) and CT scans to measure changes in lung structure and function.
What are the potential side effects?
Benralizumab may cause side effects such as headache, sore throat, fever, fatigue, allergic reactions including anaphylaxis, and injection site reactions like pain or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with asthma.
Select...
I have had two or more flare-ups of my condition in the past year.
Select...
My asthma treatment has not changed recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening to follow-up (up to 1.4 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to follow-up (up to 1.4 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in specific airway volume (siVaw)
Secondary study objectives
Change from baseline in Airway resistance (iRaw)
Change from baseline in Airway volume (iVaww)
Change from baseline in BVX with and without adjustment for pre-BD FEV1
+36 more

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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BenralizumabExperimental Treatment1 Intervention
Participants will receive 3 doses of benralizumab having a strength of 30 mg subcutaneously once every 4 weeks (Week 0, Week 4, and Week 8).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
2016
Completed Phase 4
~10540

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Asthma treatments often target the underlying inflammation and bronchoconstriction characteristic of the disease. Common treatments include inhaled corticosteroids (ICS) that reduce airway inflammation, and long-acting beta-agonists (LABA) that relax bronchial muscles to improve airflow. Biological therapies, such as Benralizumab, target specific pathways involved in asthma. Benralizumab is an anti-IL-5 receptor monoclonal antibody that depletes eosinophils, a type of white blood cell that contributes to airway inflammation and hyper-responsiveness in eosinophilic asthma. By reducing eosinophil levels, Benralizumab can decrease the frequency of asthma exacerbations and improve lung function. Understanding these mechanisms is crucial for asthma patients as it helps tailor treatments to their specific type of asthma, potentially leading to better disease management and improved quality of life.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,375 Previous Clinical Trials
288,738,605 Total Patients Enrolled
346 Trials studying Asthma
661,228 Patients Enrolled for Asthma

Media Library

Benralizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05552508 — Phase 4
Asthma Research Study Groups: Benralizumab
Asthma Clinical Trial 2023: Benralizumab Highlights & Side Effects. Trial Name: NCT05552508 — Phase 4
Benralizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05552508 — Phase 4
~46 spots leftby Oct 2025