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Monoclonal Antibodies

Benralizumab vs Mepolizumab for Vasculitis (MANDARA Trial)

Phase 3
Waitlist Available
Led By Michael Wechsler, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of relapsing or refractory EGPA within specified timeframes
Stable dose of immunosuppressive therapy if applicable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48 through week 52
Awards & highlights

MANDARA Trial Summary

This trial is testing a new drug, benralizumab, to see if it is more effective and has fewer side effects than the current standard of care drug, mepolizumab, for people with a certain type of blood cancer who have not responded well to other treatments.

Who is the study for?
Adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) who are on stable corticosteroid and possibly immunosuppressive therapy, not pregnant, without recent malignancies or severe diseases that could interfere with the study. They must have a history of asthma and eosinophilia.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of Benralizumab compared to Mepolizumab in treating EGPA. Both drugs are given by injection over a year, with an option for extended open-label treatment using Benralizumab.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, headaches, fatigue, and possible increased risk of infections due to immune system effects. Specific side effect profiles will be monitored throughout the study.

MANDARA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My EGPA has returned or didn't respond to treatment recently.
Select...
My dose of immunosuppressive medication has been stable.
Select...
I have been on a stable dose of prednisolone or prednisone for at least 4 weeks.
Select...
I have been diagnosed with EGPA, including asthma and high eosinophils.
Select...
I am 18 years old or older.

MANDARA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48 through week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 through week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients who are in remission at both weeks 36 and 48
Secondary outcome measures
Annualized relapse rate
Based on the average daily prednisolone/prednisone dose during Weeks 48 through 52
Change from baseline in ACQ-6
+14 more
Other outcome measures
Anti-drug antibodies (ADA) titers as measure of immunogenicity
Change from baseline in clinical chemistry parameters of Alanine Aminotransferase (ALT), alkaline phosphatase, Aspartate Aminotransferase (AST), creatinine kinase, indirect and total bilirubin, creatinine and glucose
Change from baseline in hematology parameters of hemoglobin, leukocytes, lymphocytes, monocytes, basophils, eosinophils, neutrophils, and platelets
+12 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
Placebo
Benra 30 mg q.8 Weeks

MANDARA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Benralizumab armExperimental Treatment2 Interventions
1x benralizumab SC injection + 3x placebo to mepolizumab SC injections
Group II: Mepolizumab armActive Control2 Interventions
3x mepolizumab SC injections + 1x placebo to benralizumab 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
4,243 Previous Clinical Trials
288,525,754 Total Patients Enrolled
Michael Wechsler, MDPrincipal InvestigatorNational Jewish Health, 1400 Jackson St Denver, CO 80206
4 Previous Clinical Trials
69 Total Patients Enrolled

Media Library

Benralizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04157348 — Phase 3
Eosinophilic Granulomatosis with Polyangiitis Research Study Groups: Benralizumab arm, Mepolizumab arm
Eosinophilic Granulomatosis with Polyangiitis Clinical Trial 2023: Benralizumab Highlights & Side Effects. Trial Name: NCT04157348 — Phase 3
Benralizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04157348 — Phase 3

Frequently Asked Questions

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

Does this test have an age limit?

"This trial is meant for patients that are 18-130 years old. For patients outside of this age bracket, there are other clinical trials; 13 for those under 18 and 72 for seniors above 65."

Answered by AI

How many individuals are participating in this research project?

"Presently, this trial is not looking for any more participants. The clinical trial was first posted on 11/5/2019 and edited for the last time on 9/1/2022. However, there are 40 other trials actively recruiting patients with eosinophilic granulomatous vasculitis and 35 trials involving Benralizumab that are still enrolling patients."

Answered by AI

What is the current standing of Benralizumab in the United States?

"Benralizumab is safe according to our Power team's estimation. This estimate comes from the fact that this medication is in Phase 3 of clinical trials."

Answered by AI

For what ailments is Benralizumab commonly prescribed?

"Benralizumab is a medication used to treat hypereosinophilic syndrome, but it can also be given to patients with other conditions like polyangiitis or corticosteroid therapy."

Answered by AI

Are new participants being taken in for this experiment?

"Unfortunately, this particular clinical trial is not seeking new candidates at the moment. The listing on clinicaltrials.gov shows that the study was initially posted on November 5th, 2019 and was last updated September 1st, 2020. With that being said, there are 75 other trials currently looking for participants which can be found on our website."

Answered by AI

Is this a new clinical trial?

"First studied in 2014, Benralizumab rapidly received Phase 2 & 3 drug approval after initial clinical testing. Today, there are 35 different ongoing trials for this medication being conducted in 455 cities and 42 countries."

Answered by AI

Do you have any information about other research studies that have used Benralizumab?

"35 clinical trials are underway to research Benralizumab. Of these, 17 have reached Phase 3 and are ongoing. Most of the trial sites for this medication are based in Hamilton, Ontario; however, there are 1865 total locations running studies related to this treatment across the world."

Answered by AI

Are there several locations where this study is being conducted within the United States?

"To make the trial more accessible to a wider range of patients, 29 sites have been selected. These are in Calgary, Boston, Columbus and 26 other locations. If you enroll in the study, it is best to choose the site nearest you so that you will not need to travel as much."

Answered by AI

If I enroll in the study, am I able to see its benefits for myself?

"This trial is looking for 140 patients that have eosinophilic granulomatous vasculitis and are between 18 and 130 years old. Applicants must meet the following criteria: a history of relapsing EGPA (defined as at least one confirmed relapse within the last two years), refractory EGPA (failure to achieve remission after treatment with standard induction therapy for at least three months), or recurrence of symptoms when tapering off oral corticosteroids. Additionally, applicants must be on a stable dose of oral prednisolone or prednisone of at least 7.5 mg/"

Answered by AI
~26 spots leftby Mar 2025