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Completed

NCT Number: NCT03183024

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

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

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Key information

Conditions

Chronic Idiopathic Urticaria Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bernstein Clinical Research Center

Cincinnati, Ohio, 45231, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benralizumab

Biological

open-label treatment

Placebo

Biological

sterile water to mimic benralizumab

Primary outcomes

  1. change in urticarial activity score averaged over 7 days- no units

    Time frame: through study completion, up to 7 months

    subject completed form

Secondary outcomes

  1. change in blood anti-FCER1 level (kU/l)

    Time frame: through study completion, up to 7 months

    specific lab test

  2. change in blood anti-TPO level (IU/L)

    Time frame: through study completion, up to 7 months

    specific blood test

  3. change in Blood ECP level (ug/L)

    Time frame: through study completion, up to 7 months

    specific blood test

  4. change in blood eotaxin level (pg/ml)

    Time frame: through study completion, up to 7 months

    specific blood test

  5. change in RNA testing

    Time frame: 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)

  6. change in skin biopsy inflammatory cell counts

    Time frame: through study completion, up to 7 months

    inflammatory cell count in skin biopsy (number of cells/sq mm)

  7. change in cytokine quantification in skin biopsy (units/mL)

    Time frame: through study completion, up to 7 months

    skin biopsy

Other outcomes

  1. adverse events

    Time frame: through study completion, up to 7 months

    adverse events

  2. change in blood pressure

    Time frame: through study completion, up to 7 months

    blood pressure- mm Hg

  3. change in pulse rate

    Time frame: through study completion, up to 7 months

    pulse rate- bpm

  4. change in blood urea nitrogen

    Time frame: through study completion, up to 7 months

    blood urea nitrogen lab test - mg/dl

Sponsors and collaborators

Lead sponsor

Jonathan A. Bernstein, MD

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 9, 2017
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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