← Back to Search

Monoclonal Antibodies

EGPA Cohort: Benralizumab for Churg-Strauss Syndrome (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
* Male or female patients must be aged 6 to \< 18 years of age at the time of signing the assent form and their caregiver signing the informed consent form.
* Body weight greater than (\>=) 15 kilograms (kg).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 12, 24, 36, 48, and 52
Awards & highlights

Summary

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

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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 12, 24, 36, 48, and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 12, 24, 36, 48, and 52 for reporting.

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 more

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255
15%
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

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
~10540

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,350 Previous Clinical Trials
288,652,919 Total Patients Enrolled
3 Trials studying Churg-Strauss Syndrome
906 Patients Enrolled for Churg-Strauss Syndrome
~9 spots leftby Dec 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top