All > Bullous Pemphigoid
Monoclonal Antibodies

Benralizumab for Bullous Pemphigoid

Research Site, Indianapolis, IN
Benralizumab +1 morePhase 3RecruitingLed by Janet A. Fairley, MDResearch Sponsored by AstraZeneca

Study Summary

This trial will test whether the medication benralizumab can help improve symptoms for people with Bullous Pemphigoid, a skin condition.

Eligible Conditions
  • Bullous Pemphigoid

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You may need to take steroids for a medical condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ weeks 0,2,4,6,8,16,24,36, 60 and 12 weeks after last ip dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0,2,4,6,8,16,24,36, 60 and 12 weeks after last ip dose 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 participants who are in complete remission while off OCS for ≥ 2 months at Week 36 (FAS)
Secondary outcome measures
Change from baseline in BPDAI activity score at Week 16.
Change from baseline in BPDAI activity score at Week 36.
Change from baseline in BPDAI-Pruritus score at Week 16.
+14 more

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255
15%
Nasopharyngitis
8%
Asthma
7%
Headache
7%
Bronchitis
7%
Sinusitis
6%
Upper respiratory tract infection
4%
Influenza
3%
Back pain
3%
Cough
3%
Dyspnoea
3%
Hypertension
3%
Rhinitis
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
1%
Urosepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.4 Weeks
Placebo
Benra 30 mg q.8 Weeks

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Placebo plus Oral Corticosteroids per SoC tapering. Open-Label (OLE): after completion of the double-blind treatment period, all participants will have the option of entering an OLE period, starting at week 36 benralizumab SC until study closure.
Group II: BenralizumabExperimental Treatment1 Intervention
Benralizumab subcutaneously (SC) loading dose followed by repeat dosing of SC benralizumab plus Oral Corticosteroids per SoC tapering. Open-Label (OLE): after completion of the double-blind treatment period, all participants will have the option of entering an OLE period, starting at week 36 benralizumab SC until study closure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
FDA approved
Placebo
1995
Completed Phase 3
~2670

Find a site

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,118 Previous Clinical Trials
336,413,724 Total Patients Enrolled
Janet A. Fairley, MDPrincipal Investigator
University of Iowa

Media Library

Benralizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04612790 — Phase 3
Benralizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04612790 — Phase 3
Bullous Pemphigoid Clinical Trial 2023: Benralizumab Highlights & Side Effects. Trial Name: NCT04612790 — Phase 3
Bullous Pemphigoid Research Study Groups: Benralizumab, Placebo

Frequently Asked Questions

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

Does this research opportunity have an age limit?

"This clinical trial is recruiting patients that are aged 18-130. If you are under 18 or over 65, there are other clinical trials that might be a better fit."

Answered by AI

Are patients being accepted into this research program at this time?

"The latest information on clinicaltrials.gov suggests that this study is still actively looking for volunteers. This trial was originally posted on March 31st, 2021 and was updated September 27th, 2022. They need 120 individuals total, and have already recruited patients from 6 different hospitals."

Answered by AI

In how many places is this experiment being conducted?

"Right now, there are 6 sites where patients can be enrolled in this trial. Some of the locations include Atlanta, Centennial and Margate. It is recommended that you choose the centre closest to your home to reduce travel-related stress."

Answered by AI

Are there any other similar trials taking place right now?

"Benralizumab has undergone 20 trials since 2014, with the most recent one completed in Phase 2 & 3. In total, there have been 18254 completed trials for this medication."

Answered by AI

Does Benralizumab have any adverse effects on patients?

"Benralizumab has been given a score of 3 for safety. This is due to it being a Phase 3 trial, which means that there is efficacy data as well as multiple rounds of data that support its safety."

Answered by AI

What are some similar studies to Benralizumab that have already been completed?

"The medication benralizumab was first studied in 2014 at the National Institutes of Health Clinical Center. Out of the 18,254 completed clinical trials, 20 are recruiting patients as of now. The majority of these trial sites are located in Atlanta, Georgia."

Answered by AI

How many people are allowed to participate in this test phase of the research?

"According to clinicaltrials.gov, this study is still recruiting patients. The trial was originally posted on 3/31/2021 and was updated as recently as 9/27/2022. The study is looking for 120 participants at 6 different locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid.
2021. "A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04612790.
~23 spots leftby May 2024
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