Benralizumab for Eosinophilic Diseases

(CLIPS Trial)

Recruiting at 5 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Malignancy, Anaphylaxis history, System abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 4

Duration: 52 weeks

14 Participants Needed

Trial Summary

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

The trial requires that if you are on corticosteroids or immunosuppressive therapy, your dosage must be stable for at least 4 weeks before starting the trial. This means you should not change your current medication dose during that time.

Is Benralizumab safe for humans?

Research shows that Benralizumab, also known as Fasenra, has been tested for safety in both healthy individuals and patients with severe eosinophilic asthma. Studies, including phase 1 and phase 3 trials, have demonstrated its safety and tolerability in these groups. ^{1 2 3 4 5}

How is the drug Benralizumab unique for treating eosinophilic diseases?

Benralizumab is unique because it targets the interleukin-5 receptor on eosinophils, a type of white blood cell, and rapidly depletes them, which can help reduce symptoms in conditions like severe eosinophilic asthma. This mechanism is different from other treatments that may not specifically target eosinophils or work as quickly. ^{1 4 5 6 7}

What is the purpose of this trial?

The main purpose of study is to assess the safety, tolerability, and pharmacokinetic (PK) of benralizumab.

Eligibility Criteria

This trial is for children with eosinophilic diseases such as Churg-Strauss Syndrome or Granulomatosis with Polyangiitis. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and cannot have factors that would exclude them from safely participating.

Inclusion Criteria

My body weight is at least 15 kg.

I am between 6 and 17 years old, and my caregiver has agreed to the study.

My steroid treatment for EGPA has been stable for at least 4 weeks.

Exclusion Criteria

My EGPA has relapsed within the last 3 months.

I have had a severe EGPA flare-up within the last 3 months.

I currently have cancer or have had cancer in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 to 4 weeks

Treatment

Participants receive benralizumab subcutaneous injections every 4 weeks

52 weeks

Visits every 4 weeks

Open-label extension

Participants may continue treatment for at least an additional year

At least 52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Weeks after last investigational product administration

Treatment Details

Interventions

• Benralizumab

Trial Overview The study is testing Benralizumab to see how safe it is for children, how well they tolerate it, and how their bodies process the drug (pharmacokinetics).

Participant Groups

Group I: EGPA Cohort: Benralizumab Experimental Treatment 1 Intervention

Participants with greater than or equal to (\>=) 35 kg weight will receive benralizumab dose-1 and participants with less than (\<) 35 kg weight will receive benralizumab dose-2 as SC injection Q4W during the 52-week treatment period. All participants, who complete the 52-week treatment period, will be offered the opportunity to continue into an extension period.

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

References

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

Benralizumab: First Global Approval. [2022]

2. England pubmed.ncbi.nlm.nih.gov

ChAracterization of ItaliaN severe uncontrolled Asthmatic patieNts Key features when receiving Benralizumab in a real-life setting: the observational rEtrospective ANANKE study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting &#946;2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. [2022]

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

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

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

Safety, Tolerability, and Pharmacokinetics of Benralizumab: A Phase 1, Randomized, Single-Blind Study of Healthy Chinese Participants. [2023]

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

Real-World Effectiveness of Benralizumab in Severe Eosinophilic Asthma. [2023]

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

Benralizumab Effectiveness in Severe Asthma Is Independent of Previous Biologic Use. [2022]