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Monoclonal Antibodies
Benralizumab for Hypereosinophilic Syndrome (NATRON Trial)
Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Signs or symptoms of HES worsening/flare and/or laboratory abnormalities indicative of HES worsening/flare (other than isolated eosinophilia) at Visit 1.
Documented diagnosis of HES (history of persistent eosinophilia >1500 cells/μL without secondary cause on 2 examinations [interval ≥1 month; Valent et al 2012] and evidence of end organ manifestations attributable to the eosinophilia).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 24
Awards & highlights
NATRON Trial Summary
This trial is testing a new drug, benralizumab, to see if it is effective and safe for patients with hypereosinophilic syndrome.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones for similar treatments include injection site reactions, headache, fatigue, fever, and potential allergic reactions. The exact side effects will be monitored throughout the trial.
NATRON Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am experiencing worsening symptoms or lab results indicating my HES is getting worse.
Select...
I have been diagnosed with HES, showing high eosinophil counts twice, a month apart, affecting my organs.
Select...
My asthma improved with steroids within two days.
Select...
My tests for the FIP1L1-PDGFRA gene fusion are negative.
NATRON Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to first HES worsening/flare
Secondary outcome measures
Adverse Events (AEs) as an evaluation of safety and tolerability of benralizumab
Anti-drug antibodies (ADA) titers and neutralizing antibodies (nAb) as measure of immunogenicity
Change from baseline in fatigue severity
+10 moreSide effects data
From 2016 Phase 3 trial • 220 Patients • NCT0207525516%
Nasopharyngitis
11%
Bronchitis
8%
Headache
8%
Rhinitis
7%
Upper respiratory tract infection
5%
Sinusitis
4%
Hypertension
4%
Vertigo
3%
Back pain
3%
Pneumonia
1%
Asthma
1%
Cough
1%
Dyspnoea
1%
Cardiac failure acute
1%
Atrial fibrillation
1%
Presyncope
1%
Influenza
1%
Oesophagitis
1%
Gallbladder polyp
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.8 Weeks
Benra 30 mg q.4 Weeks
Placebo
NATRON Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
2016
Completed Phase 3
~10580
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,612,576 Total Patients Enrolled
2 Trials studying Hypereosinophilic Syndrome
270 Patients Enrolled for Hypereosinophilic Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 am experiencing worsening symptoms or lab results indicating my HES is getting worse.I have been diagnosed with eosinophilic granulomatosis with polyangiitis.My cancer has a specific genetic change that responds to certain medication.You have had serious blood clotting issues, stroke, or heart damage caused by a specific condition called HES. If these events were life-threatening and still pose a risk to your health, you may not be eligible for the study. However, if these issues have been resolved or are stable and participating in the study won't endanger you, you may still be able to participate.You have an existing medical condition that is not well controlled with standard treatment and may put you at risk or affect your ability to complete the study.I have been diagnosed with HES, showing high eosinophil counts twice, a month apart, affecting my organs.My HES treatment dose has been the same for at least 4 weeks.My condition is considered life-threatening by my doctor.I have an active liver disease.I have a history of significant heart issues noted in tests within the last year.My asthma improved with steroids within two days.I have stable chronic hepatitis B or C, or another stable liver condition without severe symptoms.I had cancer before, but it was treated and I've been in remission for over 5 years.My tests for the FIP1L1-PDGFRA gene fusion are negative.I have a current cancer or a history of cancer.I am 12 years old or older.I needed urgent medical help for a severe HES event in the last 12 weeks.I have been diagnosed with systemic mastocytosis.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo arm
- Group 2: Benralizumab arm
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide the total number of research sites for this project?
"Currently, this study is enrolling patients at 10 sites. These locations are in Cleveland, Columbus and Atlanta as well as other places. If you want to reduce the amount of travel required, please choose the site that is closest to your home."
Answered by AI
What is the governmental approval status of Benralizumab?
"Benralizumab has undergone Phase 3 clinical trials, meaning that there is some efficacy data and multiple rounds of safety data. This makes it a safe medication with few risks."
Answered by AI
Is this the first clinical test of its type?
"Since 2014, Benralizumab has been the focus of various clinical studies. The first trial was conducted in 2014 by AstraZeneca and only involved 20 patients. However, this initial study led to Phase 2 & 3 drug approval for Benralizumab. Now, there are a total of 20 active trials being performed in 352 cities and 42 countries worldwide."
Answered by AI
What is the precedent for Benralizumab's clinical usage?
"As of now, there are 20 ongoing clinical trials researching Benralizumab. 10 of these trials are in Phase 3. Most of the clinical trials for Benralizumab are located in Bethesda, Maryland; however, there are 1481 locations conducting studies on this medication."
Answered by AI
Does this medical study allow patients that are over 25 years old to enroll?
"This particular trial is only open to people between the ages of 12 and 130. There are a total of 388 studies for children under 18 and 1051 studies for senior citizens above 65."
Answered by AI
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