Benralizumab for Nasal Polyps
(ORCHID Trial)
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.12345Why 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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening/Run-in
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive benralizumab 30 mg SC or placebo every 4 weeks for the first 3 doses and every 8 weeks thereafter
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term with benralizumab 30 mg
What Are the Treatments Tested in This Trial?
Interventions
- Benralizumab
Benralizumab is already approved in European Union, United States, Canada, Japan for the following indications:
- Severe eosinophilic asthma
- Severe asthma with an eosinophilic phenotype
- Severe eosinophilic asthma
- Severe eosinophilic asthma
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
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