Benralizumab for Nasal Polyps

(ORCHID Trial)

No longer recruiting at 131 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: Intranasal corticosteroids

Must not be taking: Systemic corticosteroids, Biologics

Disqualifiers: Recent nasal surgery, Allergic fungal sinusitis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 56 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called benralizumab for individuals with severe nasal polyps, which are growths in the nose causing stuffiness and discomfort. Researchers aim to determine if benralizumab, administered as an injection, is safe and more effective than a placebo (a shot with no medicine) in reducing symptoms. Individuals with ongoing nasal issues for at least 12 weeks and a history of asthma might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications to join the trial?

The trial requires that you continue using intranasal corticosteroids (INCS) for at least 4 weeks before joining and throughout the screening period. However, you cannot have received systemic corticosteroids (SCS) within 4 weeks before screening or during the study.

Is there any evidence suggesting that benralizumab is likely to be safe for humans?

Research shows that benralizumab has been tested for safety in people with nasal polyps. In earlier studies, it reduced nasal blockage more than a placebo, indicating potential effectiveness. But what about safety?

Benralizumab has also been tested in people with other conditions, like severe asthma, and was generally well-tolerated. Some experienced side effects, usually mild, such as headaches and sore throats.

The FDA has approved benralizumab for treating severe asthma in both children and adults, suggesting it is considered safe for regular use in those cases.

While all treatments can have side effects, current research suggests benralizumab is relatively safe. Always consult a healthcare provider about potential risks before joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for nasal polyps?

Unlike the standard treatments for nasal polyps, such as corticosteroids or surgery, Benralizumab offers a unique approach by targeting the IL-5 receptor on eosinophils, a type of white blood cell involved in inflammation. This mechanism helps reduce inflammation and shrink polyps more effectively. Researchers are excited about Benralizumab because it not only targets the root cause of nasal polyps but also provides the convenience of subcutaneous administration, potentially improving patient compliance and outcomes.

What evidence suggests that benralizumab might be an effective treatment for nasal polyps?

Research has shown that benralizumab, which participants in this trial may receive, can help treat nasal polyps. One study showed that benralizumab significantly reduced the size of nasal polyps by week 40, outperforming a placebo. Another study found a noticeable decrease in nasal polyp size, indicating strong improvement. Patients using benralizumab reported fewer symptoms, such as nasal blockage. Overall, these studies suggest that benralizumab can reduce nasal polyps and improve related symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Luo Zhang, Prof. Dr.

Principal Investigator

Beijing Tongren Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your SNOT-22 score is 20 or higher when you join the study.

I have been diagnosed with asthma by a doctor.

I have had symptoms for at least 3 months before joining.

Exclusion Criteria

I do not have conditions like severe nasal blockage or specific sinus issues that would prevent accurate assessment of the treatment's effectiveness.

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

Currently pregnant or breastfeeding

Timeline for a Trial Participant

Screening/Run-in

Participants are screened for eligibility to participate in the trial

6 weeks

Treatment

Participants receive benralizumab 30 mg SC or placebo every 4 weeks for the first 3 doses and every 8 weeks thereafter

56 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term with benralizumab 30 mg

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Benralizumab

Trial Overview

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.

How Is the Trial Designed?

Group I: Benralizumab Experimental Treatment 1 Intervention

Benralizumab administered subcutaneously

Group II: Placebo Placebo Group 1 Intervention

Placebo administered subcutaneously

Benralizumab is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Fasenra for:

• Severe eosinophilic asthma

Approved in United States as Fasenra for:

• Severe asthma with an eosinophilic phenotype

Approved in Canada as Fasenra for:

• Severe eosinophilic asthma

Approved in Japan as Fasenra for:

• Severe eosinophilic asthma

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Published Research Related to This Trial

Benralizumab (Fasenra™) is a monoclonal antibody that targets the interleukin-5 receptor alpha chain, specifically designed to treat severe eosinophilic asthma and chronic obstructive pulmonary disease (COPD).

The drug has been approved by the US FDA as an add-on maintenance therapy for patients with severe asthma characterized by eosinophilia, highlighting its efficacy in depleting eosinophils, which are linked to asthma and COPD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benralizumab: First Global Approval. Markham, A.[2022]

In a study of 441 patients with severe asthma, 19% were found to be eligible for benralizumab treatment, indicating a significant subset of patients who may benefit from this therapy.

Patients eligible for benralizumab had poorer lung function and asthma control, experiencing more frequent exacerbations and hospitalizations, highlighting the need for effective treatment options in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort. Aubier, M., Thabut, G., Fabry-Vendrand, C.[2022]

Citations

1.

frontiersin.org

frontiersin.org/journals/allergy/articles/10.3389/falgy.2025.1501196/full

a post hoc analysis from the ANANKE study

After a median treatment period of 9.8 months, benralizumab treatment improved all clinical outcomes in both groups, with a more pronounced effect in reducing ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11003468/

Benralizumab in Severe Eosinophilic Asthma and Chronic ...

The RANS study data show that patients with SEA and comorbid NP experienced improvements in both NP and asthma outcomes during the 12 months ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11433401/

Sinonasal Outcomes Obtained after 2 Years of Treatment ...

In a small proof-of-concept study, benralizumab was shown to reduce baseline nasal polyp score (NPS) and improve symptoms, including the sense ...

4.

jacionline.org

jacionline.org/article/S0091-6749(21)01459-7/abstract

Efficacy and safety of benralizumab in chronic ...

Benralizumab significantly improved NPS and nasal blockage score compared to placebo at week 40 (P ≤ .005). Improvements in Sinonasal Outcome ...

5.

journals.lww.com

journals.lww.com/atmr/fulltext/2024/04000/efficacy_of_benralizumab_in_paediatric_and_adult.7.aspx

Efficacy of Benralizumab in Paediatric and Adult... ...

The combined SMD across all studies is −0.91, indicating a statistically significant reduction in nasal polyp scores due to Benralizumab treatment. The ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34599979/

Efficacy and safety of benralizumab in chronic ...

Benralizumab significantly improved NPS and nasal blockage score compared to placebo at week 40 (P ≤ .005). Improvements in Sinonasal Outcome ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04157335

NCT04157335 | Efficacy and Safety Study of Benralizumab ...

This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat ...

8.

jacionline.org

jacionline.org/article/S0091-6749(21)01459-7/fulltext

Efficacy and safety of benralizumab in chronic ...

Benralizumab significantly improved NPS and nasal blockage score compared to placebo at week 40 (P ≤ .005). Improvements in Sinonasal Outcome ...

9.

astrazenecaclinicaltrials.com

astrazenecaclinicaltrials.com/study/D3252C00001

Efficacy and Safety Study of Benralizumab for Patients with ...

The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still ...

10.

astrazeneca-us.com

astrazeneca-us.com/media/press-releases/2024/fasenra-approved-for-treatment-of-children-aged-6-to-11-with-severe-asthma.html

FASENRA approved for treatment of children aged 6 to 11 ...

Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID). ... data or safety data.