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

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ClinicalTrials.gov Identifier: NCT03183024
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan A. Bernstein, MD, Bernstein Clinical Research Center

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

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Urticaria Biological: benralizumab Biological: placebo Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: single-blind
Primary Purpose: Treatment
Official Title: Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monocloncal Antibody
Actual Study Start Date : September 12, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo
placebo for benralizumab sc given during run-in phase
Biological: placebo
sterile water to mimic benralizumab

Experimental: benralizumab
benralizumab sc once a month for 3 months for subjects who meet inclusion/exclusion criteria after run-in phase
Biological: benralizumab
open-label treatment




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183024


Contacts
Contact: Karen Murphy, BS, CCRC 5133541746 kmurphy@bernsteincrc.com

Locations
United States, Ohio
Bernstein Clinical Research Center Recruiting
Cincinnati, Ohio, United States, 45231
Contact: Karen Murphy, BS, CCRC    513-354-1746    kmurphy@bernsteincrc.com   
Principal Investigator: Jonathan Bernstein, MD         
Sponsors and Collaborators
Jonathan A. Bernstein, MD

Responsible Party: Jonathan A. Bernstein, MD, PI/ co-owner, Bernstein Clinical Research Center
ClinicalTrials.gov Identifier: NCT03183024     History of Changes
Other Study ID Numbers: SAIRB-17-0036
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies
Histamine Antagonists
Histamine H1 Antagonists
Immunologic Factors
Physiological Effects of Drugs
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action