117 Participants Needed

Benralizumab for Hypereosinophilic Syndrome

(NATRON Trial)

Recruiting at 66 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
Must be taking: Corticosteroids
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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?

Benralizumab has been shown to effectively reduce severe asthma attacks in patients with high levels of eosinophils (a type of white blood cell) in their blood, suggesting it may also help manage hypereosinophilic syndrome, which involves similar eosinophil-related issues.12345

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?

Research shows that Benralizumab has been studied for safety in both healthy individuals and those with severe eosinophilic asthma, and it has been found to be generally safe and well-tolerated.12367

Is the drug Benralizumab a promising treatment for Hypereosinophilic Syndrome?

Yes, Benralizumab is a promising drug for treating Hypereosinophilic Syndrome. It has shown significant improvement in symptoms and reduced the need for other medications in patients with severe cases.12678

What makes the drug Benralizumab unique for treating hypereosinophilic syndrome?

Benralizumab is unique because it specifically targets and reduces eosinophils, a type of white blood cell involved in hypereosinophilic syndrome, by blocking the interleukin-5 receptor. This mechanism is different from other treatments that may not specifically target eosinophils.910111213

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

I am experiencing worsening symptoms or lab results indicating my HES is getting worse.
I have been diagnosed with HES, showing high eosinophil counts twice, a month apart, affecting my organs.
AEC ≥1000 cells/μL at Visit 1 (assessed by local laboratory).
See 6 more

Exclusion Criteria

I had skin or cervical cancer but have been in remission for over a year.
I do not have any ongoing infections needing systemic treatment.
I have been diagnosed with eosinophilic granulomatosis with polyangiitis.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 days

Double-blind Treatment

Participants receive either benralizumab or placebo for 24 weeks

24 weeks
Visits every 4 weeks for SC injection

Open-label Extension

Participants receive open-label benralizumab for at least 1 year for adults and at least 2 years for adolescents

At least 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Benralizumab
  • Placebo
Trial Overview The study tests Benralizumab's effectiveness and safety against a placebo over 24 weeks in addition to standard HES therapy. Participants will be randomly assigned to either receive Benralizumab or a placebo without knowing which one they're getting until after the primary analysis phase.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Benralizumab armExperimental Treatment1 Intervention
1x Benralizumab SC injection
Group II: Placebo armPlacebo Group1 Intervention
1x Benralizumab matching placebo SC injection

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

Find a Clinic Near You

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

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.
Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort.Aubier, M., Thabut, G., Fabry-Vendrand, C.[2022]
In a Phase 1 study involving 36 healthy Chinese adults, a single subcutaneous injection of benralizumab was found to be well tolerated, with only mild adverse events reported, indicating a favorable safety profile.
Benralizumab effectively depleted eosinophils within 2 days of administration, and this effect was maintained for up to 85 days, demonstrating its potential efficacy in targeting eosinophilic conditions.
Safety, Tolerability, and Pharmacokinetics of Benralizumab: A Phase 1, Randomized, Single-Blind Study of Healthy Chinese Participants.Cheung, TT., Mai, TH., Chia, YL., et al.[2023]
In a real-world study of 205 patients with severe eosinophilic asthma treated with benralizumab for an average of 9.8 months, there was a dramatic reduction in exacerbations, with 81% of patients becoming exacerbation-free and a 93.3% decrease in the annualized exacerbation rate.
Benralizumab treatment also led to significant reductions in oral corticosteroid use, with 43.2% of patients able to stop OCS therapy and an overall dose reduction of 56%, indicating its effectiveness in managing severe asthma symptoms.
ChAracterization of ItaliaN severe uncontrolled Asthmatic patieNts Key features when receiving Benralizumab in a real-life setting: the observational rEtrospective ANANKE study.Menzella, F., Bargagli, E., Aliani, M., et al.[2022]

References

Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort. [2022]
Safety, Tolerability, and Pharmacokinetics of Benralizumab: A Phase 1, Randomized, Single-Blind Study of Healthy Chinese Participants. [2023]
ChAracterization of ItaliaN severe uncontrolled Asthmatic patieNts Key features when receiving Benralizumab in a real-life setting: the observational rEtrospective ANANKE study. [2022]
Mepolizumab Reduces Hypereosinophilic Syndrome Flares Irrespective of Blood Eosinophil Count and Interleukin-5. [2022]
Clinical Features and Efficacy of Benralizumab in Patients with Blood Eosinophil Count Between 300 and 450 Cells/mm3: A Post Hoc Analysis from the ANANKE Study. [2022]
Benralizumab: First Global Approval. [2022]
Benralizumab for PDGFRA-Negative Hypereosinophilic Syndrome. [2020]
Severe hypereosinophilic syndrome successfully treated with a monoclonal antibody against interleukin 5 receptor α - benralizumab. [2021]
Expedited Desensitization to Canakinumab. [2022]
Anakinra effectiveness in refractory polyserositis: An Italian multicenter study. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty-Two-Week Randomized, Double-Blind, Placebo-Controlled Study. [2022]
Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase III trials. [2022]
Evaluation of a novel autoinjector for subcutaneous self-administration of belimumab in systemic lupus erythematosus . [2019]
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