Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monoclonal Antibody

Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monocloncal Antibody

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03183024

Enrollment

Registered

2017-06-09

Start date

2017-09-12

Completion date

2018-11-06

Last updated

2019-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Idiopathic Urticaria

Brief summary

Study to determine the efficacy of benralizumab when compared to placebo in patients with chronic hives that do not respond to antihistamine treatment

Detailed description

Subjects with chronic hives that do not respond to antihistamine treatment and have hives of unknown cause will be eligible. Subjects who meet the inclusion/exclusion criteria after the run-in phase will receive 3 doses of study medication. The study also involved blood draws and a punch biopsy of a hive

Interventions

BIOLOGICALbenralizumab

open-label treatment

BIOLOGICALplacebo

sterile water to mimic benralizumab

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

single-blind

Eligibility

Sex/Gender

ALL

Age

19 Years to 70 Years

Healthy volunteers

Inclusion criteria

* hives for over 6 weeks of unknown cause hives most days of the despite use of antihistamines

Exclusion criteria

* hives due to known reasons history of cancer pregnant or nursing History of HIV or Hepatitis recent parasitic infection currently or have received treatment with a monoclonal antibody

Design outcomes

Primary

Measure	Time frame	Description
change in urticarial activity score averaged over 7 days- no units	through study completion, up to 7 months	subject completed form

Secondary

Measure	Time frame	Description
change in Blood ECP level (ug/L)	through study completion, up to 7 months	specific blood test
change in blood eotaxin level (pg/ml)	through study completion, up to 7 months	specific blood test
change in RNA testing	through study completion, up to 7 months	gene expression profile using RNA-sequencing in skin biopsy samples (lesional vs non-lesional skin) (log 2 fold-change)
change in skin biopsy inflammatory cell counts	through study completion, up to 7 months	inflammatory cell count in skin biopsy (number of cells/sq mm)
change in cytokine quantification in skin biopsy (units/mL)	through study completion, up to 7 months	skin biopsy
change in blood anti-FCER1 level (kU/l)	through study completion, up to 7 months	specific lab test
change in blood anti-TPO level (IU/L)	through study completion, up to 7 months	specific blood test

Other

Measure	Time frame	Description
change in pulse rate	through study completion, up to 7 months	pulse rate- bpm
change in blood urea nitrogen	through study completion, up to 7 months	blood urea nitrogen lab test - mg/dl
adverse events	through study completion, up to 7 months	adverse events
change in blood pressure	through study completion, up to 7 months	blood pressure- mm Hg

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026