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Monoclonal Antibodies

Benralizumab for Hypereosinophilic Syndrome (HESIL5R Trial)

Phase 2 & 3
Waitlist Available
Led By Amy D Klion, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

HESIL5R Trial Summary

This trial is testing if the drug benralizumab can safely decrease eosinophils in people with HES.

Who is the study for?
Adults aged 18-75 with Hypereosinophilic Syndrome (HES) who have been on stable HES therapy for at least a month but still show symptoms and high eosinophil levels. Participants must not be pregnant or breastfeeding, agree to use effective contraception, and cannot have life-threatening illnesses or certain infections like HIV or hepatitis.Check my eligibility
What is being tested?
The trial is testing if benralizumab can safely lower eosinophils in people with HES. It includes two phases: the first where participants are randomly given either benralizumab or placebo injections, followed by visits for monitoring; the second phase has all participants receiving benralizumab.See study design
What are the potential side effects?
Potential side effects of benralizumab may include allergic reactions similar to those from other antibody therapies. Specific side effects will be monitored throughout the study during regular check-ups after injections.

HESIL5R Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With 50% Reduction in Peripheral Blood Eosinophilia
Secondary outcome measures
Percent Reduction in Eosinophil Count

HESIL5R Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: DrugActive Control1 Intervention
Benralizumab (30mg) will be administered sc every 4 weeks for 3 doses (at weeks 0, 4 and 8). Eosinophil counts will be blinded during this time and background hypereosinophilic syndrome (HES) therapy will not be tapered.
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be administered sc every 4 weeks for 3 doses (at weeks 0, 4 and 8). Eosinophil counts will be blinded during this time and background HES therapy will not be tapered.

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,481,112 Total Patients Enrolled
2 Trials studying Leukocyte Disorders
176 Patients Enrolled for Leukocyte Disorders
AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,766 Total Patients Enrolled
Amy D Klion, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
8 Previous Clinical Trials
1,261 Total Patients Enrolled

Media Library

Benralizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02130882 — Phase 2 & 3
Leukocyte Disorders Research Study Groups: Drug, Placebo
Leukocyte Disorders Clinical Trial 2023: Benralizumab Highlights & Side Effects. Trial Name: NCT02130882 — Phase 2 & 3
Benralizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02130882 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment involve any geriatric individuals?

"This trial is available for people aged 18-75. There are 37 studies currently open for patients under the age of 18 and 72 for elderly patients over 65."

Answered by AI

Who would be a good candidate for this clinical trial?

"This trial is currently recruiting 20 patients that have had respiratory system agents. The upper age limit for participants is 75 years old and the lower age limit is 18 years old. To be eligible for this study, potential subjects must meet the following requirements: Male or female subject greater than or equal to18 and less than or equal to 75 years of age at screening., Females of non-child-bearing potential are defined as females with functioning ovaries with a documented history of tubal ligation or hysterectomy or females who are post-menopausal, as defined by 12 months of spontaneous amenorrhea with an appropriate clinical"

Answered by AI

Are people with the required medical conditions able to sign up for this trial right now?

"Yes, as of right now this study is not looking for any more patients. The study was originally posted on May 19th, 2014 but the information was most recently updated on January 20th, 2022. Even though this trial isn't currently recruiting, there are 99 other trials that are searching for participants."

Answered by AI

How many people fit the inclusion criteria for this research project?

"This study has already completed recruitment for patients. The listing was first made on May 19th, 2014 and updated as recently as January 20th, 2022. If you are looking for similar studies, there are 79 respiratory system agents trials and 20 Drug trials currently recruiting participants."

Answered by AI

What other similar trials exist for this purpose?

"Drug has been under clinical observation since 2014. The first trial was sponsored by AstraZeneca and took place that same year. After the initial study, which included 20 participants, Drug received approval for Phase 2 & 3 testing. Currently, there are 20 active studies involving Drug across 352 cities in 42 countries."

Answered by AI

Are there other scientific investigations that have used Drug?

"At the moment, there are 20 ongoing clinical trials for Drug. Of these studies, 10 have reached Phase 3. It's worth noting that while a majority of these experiments are taking place in Bethesda, Maryland; 1481 research sites across the globe are conducting similar investigations."

Answered by AI
Recent research and studies
~2 spots leftby Apr 2025