Benralizumab for Hypereosinophilic Syndrome
(NATRON Trial)
Trial Summary
Do I need to stop my current medications for this trial?
No, you do not need to stop your current medications. The trial allows you to continue your stable HES background therapy while participating.
Do I need to stop my current medications to join the trial?
No, you do not need to stop your current medications. The trial allows participants to continue their stable HES treatment while receiving either benralizumab or a placebo.
What data supports the idea that Benralizumab for Hypereosinophilic Syndrome is an effective treatment?
The available research does not provide specific data on Benralizumab's effectiveness for Hypereosinophilic Syndrome. Instead, it focuses on its use for severe eosinophilic asthma, where it has been shown to reduce asthma flare-ups and improve patient outcomes. For Hypereosinophilic Syndrome, another drug, Mepolizumab, is mentioned as effective in reducing disease flares. Therefore, while Benralizumab is effective for asthma, there is no direct evidence in the provided research supporting its effectiveness for Hypereosinophilic Syndrome.12345
What data supports the effectiveness of the drug Benralizumab for treating hypereosinophilic syndrome?
What safety data is available for Benralizumab in treating hypereosinophilic syndrome?
The safety data for Benralizumab, also known as Fasenra, has been primarily evaluated in the context of severe eosinophilic asthma. Studies, including phase 1 trials in healthy participants and phase 3 trials in patients with severe eosinophilic asthma, have demonstrated its safety and tolerability. However, specific safety data for its use in hypereosinophilic syndrome is not detailed in the provided research.12367
Is Benralizumab safe for humans?
Is the drug Benralizumab a promising treatment for Hypereosinophilic Syndrome?
What makes the drug Benralizumab unique for treating hypereosinophilic syndrome?
What is the purpose of this trial?
This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase III study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This study comprises 2 distinct periods (together defined as the 'main study'): A 24-week, DB treatment period, during which patients will be randomised to receive either benralizumab or placebo, in addition to their prior stable HES background therapy, and an open-label extension (OLE) period, during which all patients will receive benralizumab.The primary database lock (DBL) will occur when approximately 38 patients have had their first HES worsening/flare event during the DB treatment period and all randomised patients have had the opportunity to be followed up for the 24-week DB treatment period.A patient must complete the 24-week DB treatment period on investigational product (IP) to be eligible to enter the OLE treatment period. The final DBL will occur after the last patient completes the OLE.
Eligibility Criteria
This trial is for patients with Hypereosinophilic Syndrome (HES) who are 12 years or older, have a stable HES treatment regimen, and show signs of HES worsening. They must not have certain gene mutations or life-threatening events related to HES in the past 12 weeks. Women able to bear children must agree to use effective birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Double-blind Treatment
Participants receive either benralizumab or placebo for 24 weeks
Open-label Extension
Participants receive open-label benralizumab for at least 1 year for adults and at least 2 years for adolescents
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Benralizumab
- Placebo
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