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Monoclonal Antibodies
Benralizumab for Eosinophilic Diseases (CLIPS Trial)
Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All Cohorts: Male or female patients aged 6 to < 18 years at the time of signing the assent form and their caregiver signing the informed consent form
All Cohorts: Body weight >= 15 kilograms (kg)
Must not have
EGPA Cohort: Life-threatening EGPA within 3 months prior to screening and through first administration of IP at baseline
All Cohorts: Previous receipt of benralizumab in an interventional clinical study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 12, 24, 36, 48, and 52
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial aims to evaluate how safe and well-tolerated benralizumab is, as well as how the body processes the drug.
Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
While specific side effects are not listed here, common ones associated with Benralizumab in other studies include headache, fever, fatigue, and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 6 and 17 years old, and my caregiver has agreed to the study.
Select...
My body weight is at least 15 kg.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a severe EGPA flare-up within the last 3 months.
Select...
I have previously received benralizumab in a clinical trial.
Select...
I currently have cancer or have had cancer in the past.
Select...
I have been diagnosed with either granulomatosis with polyangiitis or microscopic polyangiitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 0, 12, 24, 36, 48, and 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 12, 24, 36, 48, and 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Adverse Events (AEs)
Serum Concentrations of Benralizumab
Secondary study objectives
Change From Baseline in Peripheral Blood Eosinophil Count
EGPA Cohort: Percentage of Participants with Remission at Week 24
EGPA Cohort: Time to First EGPA Relapse
+1 moreSide effects data
From 2016 Phase 3 trial • 220 Patients • NCT0207525515%
Nasopharyngitis
8%
Asthma
7%
Sinusitis
7%
Headache
7%
Bronchitis
6%
Upper respiratory tract infection
4%
Influenza
3%
Back pain
3%
Cough
3%
Dyspnoea
3%
Hypertension
3%
Rhinitis
1%
Urosepsis
1%
Nephrolithiasis
1%
Intervertebral disc protrusion
1%
Umbilical hernia
1%
Adverse drug reaction
1%
Hypersensitivity
1%
Vertigo
1%
Nausea
1%
Dermatitis atopic
1%
Urinary tract infection bacterial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.4 Weeks
Benra 30 mg q.8 Weeks
Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: EGPA Cohort: BenralizumabExperimental Treatment1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
2016
Completed Phase 4
~10320
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,438 Total Patients Enrolled
3 Trials studying Churg-Strauss Syndrome
906 Patients Enrolled for Churg-Strauss Syndrome