Benralizumab for Nasal Polyps

(ORCHID Trial)

Recruiting at 107 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

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

296 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Benralizumab for treating nasal polyps?

Research shows that Benralizumab significantly improved symptoms and reduced the size of nasal polyps in patients with severe asthma and nasal polyps. Patients experienced better nasal health and fewer asthma attacks after treatment. ^{1 2 3 4 5}

Is Benralizumab safe for humans?

Benralizumab, also known as Fasenra, has been approved for use in treating severe eosinophilic asthma and has shown safety in humans. It is a monoclonal antibody (a type of protein made in the lab) that targets specific cells involved in inflammation, and its use has been associated with improvements in symptoms without significant safety concerns reported in the studies. ^{1 2 3 5 6}

How does the drug Benralizumab differ from other treatments for nasal polyps?

Benralizumab is unique because it targets and blocks the IL-5 receptor, which helps reduce eosinophils (a type of white blood cell involved in inflammation) in the body, leading to significant improvements in nasal symptoms and polyp size for patients with nasal polyps and severe asthma. ^{1 2 3 4 5}

Research Team

Luo Zhang, Prof. Dr.

Principal Investigator

Beijing Tongren Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Real-life effects of benralizumab on allergic chronic rhinosinusitis and nasal polyposis associated with severe asthma. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Benralizumab in Patients With Severe Eosinophilic Asthma and Chronic Rhinosinusitis With Nasal Polyps: A Case Series. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Benralizumab: First Global Approval. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Real-Life Effectiveness of Benralizumab, Mepolizumab and Omalizumab in Severe Allergic Asthma Associated with Nasal Polyps. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort. [2022]

6. Denmark pubmed.ncbi.nlm.nih.gov

Benralizumab improves symptoms of patients with severe, eosinophilic asthma with a diagnosis of nasal polyposis. [2022]