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Monoclonal Antibodies

Benralizumab for Bullous Pemphigoid (FJORD Trial)

Phase 3
Waitlist Available
Led By Janet A. Fairley, MD
Research Sponsored by AstraZeneca
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 weeks 0,4,6,8,16,24,36, 60 and 12 weeks after last ip dose
Awards & highlights
Pivotal Trial

Summary

This trial is testing benralizumab to see if it helps elderly patients with Bullous Pemphigoid, a rare skin disease. The medication aims to reduce inflammation by targeting specific immune cells. Benralizumab works by reducing the number of certain immune cells called eosinophils.

Eligible Conditions
  • Bullous Pemphigoid

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants who are in complete remission while off OCS for ≥ 2 months at Week 36 (FAS)
Secondary study objectives
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%
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
2016
Completed Phase 4
~10540
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,378 Previous Clinical Trials
288,738,851 Total Patients Enrolled
Janet A. Fairley, MDPrincipal InvestigatorUniversity 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
~15 spots leftby Oct 2025
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