What side effects are associated with this type of intervention?

Common treatments for nasal polyps include corticosteroids, surgery, and biologics like Benralizumab. Corticosteroids can cause side effects such as nasal irritation, nosebleeds, and, with long-term use, systemic effects like adrenal suppression. Surgical treatments may lead to bleeding, infection, and recurrence of polyps. Biologics like Benralizumab, which deplete eosinophils, are generally well-tolerated but can cause injection site reactions, headache, and, rarely, hypersensitivity reactions. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of nasal polyps, particularly those targeting eosinophilic inflammation. Dupilumab, an IL-4 receptor alpha antagonist, was approved for nasal polyps in 2019. Omalizumab, an anti-IgE antibody, received approval for nasal polyps in 2020. These treatments, like Benralizumab, aim to reduce inflammation and polyp size by targeting specific pathways involved in eosinophilic activity.

What other types of research exist?

Promising alternatives to Benralizumab for treating nasal polyps include Dupilumab, an IL-4 receptor alpha antagonist that inhibits IL-4 and IL-13 signaling, and Omalizumab, an anti-IgE monoclonal antibody. Both have shown efficacy in reducing nasal polyp size and improving symptoms in clinical trials. Additionally, emerging therapies targeting other inflammatory pathways, such as IL-5 inhibitors (e.g., Mepolizumab) and TSLP inhibitors, are being investigated and may offer new options for patients in 2024.

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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

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

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I have been diagnosed with asthma by a doctor.

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I have severe nasal polyps in both nostrils.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken any experimental or approved biologic drugs in the last 6 months.

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I have received spinal cord stimulation within the last 4 weeks or have it scheduled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 56

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

0 / 7Eligibility criteria met

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.