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

NCT ID: NCT03183024

Last Updated: 2019-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-12

Study Completion Date

2018-11-06

Brief Summary

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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

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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

Conditions

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Chronic Idiopathic Urticaria

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
single-blind

Study Groups

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placebo

placebo for benralizumab sc given during run-in phase

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

sterile water to mimic benralizumab

benralizumab

benralizumab sc once a month for 3 months for subjects who meet inclusion/exclusion criteria after run-in phase

Group Type EXPERIMENTAL

benralizumab

Intervention Type BIOLOGICAL

open-label treatment

Interventions

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benralizumab

open-label treatment

Intervention Type BIOLOGICAL

placebo

sterile water to mimic benralizumab

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jonathan A. Bernstein, MD

OTHER

Sponsor Role lead

Responsible Party

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Jonathan A. Bernstein, MD

PI/ co-owner

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Bernstein Clinical Research Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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SAIRB-17-0036

Identifier Type: -

Identifier Source: org_study_id

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