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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 0,2,4,6,8,16,24,36, 60 and 12 weeks after last ip dose

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

Asthma

Sinusitis

Headache

Bronchitis

Upper respiratory tract infection

Influenza

Back pain

Cough

Dyspnoea

Hypertension

Rhinitis

Urosepsis

Nephrolithiasis

Intervertebral disc protrusion

Umbilical hernia

Adverse drug reaction

Hypersensitivity

Vertigo

Nausea

Dermatitis atopic

Urinary tract infection bacterial

100%

80%

60%

40%

20%

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

~10320

Placebo

1995

Completed Phase 3

~2670