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Monoclonal Antibodies

Open-Label for Asthma (BITE Trial)

Phase 2
Waitlist Available
Led By Michael Wechsler, MD
Research Sponsored by National Jewish Health
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 up to 12 months
Awards & highlights

BITE Trial Summary

This trial is testing a new drug, benralizumab, to see if it can help people with EGPA. The drug works by blocking a protein in the body called interleukin-5.

Eligible Conditions
  • Asthma

BITE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All adverse events will be reported by count of events (safety and tolerability )
Secondary outcome measures
Change in corticosteroid dosage
Change in the rate of EGPA exacerbations during the study period.

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255
16%
Nasopharyngitis
11%
Bronchitis
8%
Headache
8%
Rhinitis
7%
Upper respiratory tract infection
5%
Sinusitis
4%
Hypertension
4%
Vertigo
3%
Back pain
3%
Pneumonia
1%
Asthma
1%
Cough
1%
Dyspnoea
1%
Cardiac failure acute
1%
Atrial fibrillation
1%
Presyncope
1%
Influenza
1%
Oesophagitis
1%
Gallbladder polyp
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.8 Weeks
Benra 30 mg q.4 Weeks
Placebo

BITE Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-LabelExperimental Treatment1 Intervention
All subjects will receive the study medication- benralizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
FDA approved

Find a Location

Who is running the clinical trial?

National Jewish HealthLead Sponsor
140 Previous Clinical Trials
316,226 Total Patients Enrolled
23 Trials studying Asthma
17,774 Patients Enrolled for Asthma
AstraZenecaIndustry Sponsor
4,274 Previous Clinical Trials
288,613,411 Total Patients Enrolled
328 Trials studying Asthma
639,130 Patients Enrolled for Asthma
Michael Wechsler, MDPrincipal InvestigatorNational Jewish Health
4 Previous Clinical Trials
199 Total Patients Enrolled
2 Trials studying Asthma
49 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study
Michael Wechsler, MD 2017. "Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03010436.
All > Granulomatosis With Polyangiitis
~1 spots leftby May 2025
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