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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
Ongoing symptoms for at least 12 weeks prior to enrolment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 56
Awards & highlights

ORCHID Trial Summary

This trial is testing whether the drug benralizumab can help treat patients with severe nasal polyposis. The trial is double-blind, meaning that neither the patients nor the researchers will know who is receiving the drug and who is receiving the placebo. The trial is international, meaning it will be conducted in multiple countries.

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.Check my eligibility
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.See study design
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.

ORCHID Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with asthma by a doctor.
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I have had symptoms for at least 3 months before joining.
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I have been using nasal sprays for allergies consistently for the last 4 weeks.
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I have severe nasal polyps in both nostrils.
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I have severe nasal polyps in both nostrils.
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I often have a blocked nose that bothers me.
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I have had surgery or been treated with steroids for nasal polyps.
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I often have a blocked nose that bothers me.
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I am between 18 and 75 years old.

ORCHID Trial 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

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

ORCHID Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BenralizumabExperimental Treatment1 Intervention
Benralizumab administered subcutaneously
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered subcutaneously

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,237 Previous Clinical Trials
288,449,379 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

Frequently Asked Questions

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

Does this research project exclude elderly patients?

"Eligibility requirements for this particular clinical trial state that potential patients must be between 18-75 years old. There are alternative medical trials available for those outside of this age range: 6 for children and 62 for adults over 65."

Answered by AI

What sets this research apart from other similar investigations?

"Benralizumab 30 mg is being trialed in 20 different ongoing studies across 352 cities and 42 countries. The first study was completed in 2014 and involved 20 patients. 43 studies have been completed in total."

Answered by AI

Does Benralizumab 30 mg have any negative side effects?

"Given that this is a Phase 3 trial with both efficacy and safety data, Benralizumab 30 mg was rated a 3 for safety by our team at Power."

Answered by AI

Are there any other ongoing research projects using Benralizumab at a dose of 30 mg?

"Benralizumab 30 mg was first trialed in 2014 at National Institutes of Health Clinical Center. As of now, 43 studies have been completed with 20 more underway. Of these 20, a considerable amount are taking place in Boston, Massachusetts."

Answered by AI

What treatments or techniques are being tested in this clinical trial?

"The primary outcome metric for this study, which will be assessed over a Baseline and week 56 time frame is Nasal Polyp Burden. However, Secondary outcomes include Sense of Smell ( Change from baseline in difficulty with sense of smell [DSS] score), Sinus Opacification by CT Scan (Change from baseline in Lund Mackay score), and Disease specific health-related quality of life (HRQoL) (Change from baseline in SinoNasal Outcome Test [SNOT-22] score)."

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?

I HAVE TRIED OTHER MEDICATIONS BUT THEY HAVEN'T WORKED. Because I have a runny nose 24/7 it’s bad. I use sinus washes and nasal spray but nothing helps.I’ve even used Benadryl thinking it was allergies but I just got drowsy. I don’t know if I qualify but I would sure like to rectify this condition.
PatientReceived no prior treatments
~21 spots leftby Aug 2024