← Back to Search

Monoclonal Antibodies

Benralizumab for Nasal Polyps (ORCHID Trial)

Phase 3
Waitlist Available
Led By Luo Zhang, Prof. Dr.
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented physician-diagnosed asthma
Bilateral sinonasal polyposis with a nasal polyp score (NPS) of 5 at enrolment and randomization (unilateral score of at least 2 for each nostril)
Must not have
Receipt of any marketed or investigational biologic product within 6 months of enrolment
Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 56
Awards & highlights
Pivotal Trial

Summary

This trial tests benralizumab injections in patients with severe nasal polyps who haven't responded to other treatments. The medication reduces specific cells that cause inflammation, aiming to improve symptoms. Benralizumab has been studied for its effects on severe asthma and nasal polyps.

Who is the study for?
Adults aged 18-75 with severe nasal polyps, stable on intranasal corticosteroids, and a history of systemic steroids or sinus surgery. Must have ongoing symptoms for at least 12 weeks, moderate to severe nasal blockage, and certain blood eosinophil levels. Excludes those who've had recent biologic treatments or sinus surgery, are pregnant/breastfeeding, or have conditions affecting trial evaluation.
What is being tested?
The study is testing the effectiveness and safety of Benralizumab (30 mg) compared to a placebo in patients with severe nasal polyposis. It's randomized and double-blind meaning neither participants nor researchers know who gets the real treatment versus placebo.
What are the potential side effects?
Potential side effects of Benralizumab may include common cold symptoms, headache, sore throat, fever; rare but serious effects like allergic reactions can occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with asthma by a doctor.
Select...
I have severe nasal polyps in both nostrils.
Select...
I have had surgery or been treated with steroids for nasal polyps.
Select...
I often have a blocked nose that bothers me.
Select...
I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't taken any experimental or approved biologic drugs in the last 6 months.
Select...
I have received spinal cord stimulation within the last 4 weeks or have it scheduled.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Nasal Polyp Burden
Administration, Intranasal
Secondary study objectives
Disease specific health-related quality of life (HRQoL)
Nasal Polyp Surgery
Sense of Smell
+3 more
Other study objectives
Assessment the safety and tolerability of benralizumab

Awards & Highlights

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
Benralizumab administered subcutaneously
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered subcutaneously

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
Common treatments for nasal polyps, such as Benralizumab, work by targeting and depleting eosinophils, which are key contributors to inflammation and polyp formation. Corticosteroids reduce inflammation by inhibiting multiple inflammatory pathways, while biologics like Dupilumab block IL-4 and IL-13 signaling to reduce inflammation. These mechanisms are important for patients to understand as they directly address the underlying causes of nasal polyps, leading to better symptom control and improved quality of life.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,375 Previous Clinical Trials
288,738,447 Total Patients Enrolled
5 Trials studying Nasal Polyps
1,145 Patients Enrolled for Nasal Polyps
Luo Zhang, Prof. Dr.Principal InvestigatorBeijing Tongren Hospital

Media Library

Benralizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04157335 — Phase 3
Nasal Polyps Research Study Groups: Benralizumab, Placebo
Nasal Polyps Clinical Trial 2023: Benralizumab Highlights & Side Effects. Trial Name: NCT04157335 — Phase 3
Benralizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04157335 — Phase 3
~51 spots leftby Oct 2025