Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monoclonal Antibody
1 other identifier
interventional
12
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2017
CompletedFirst Posted
Study publicly available on registry
June 9, 2017
CompletedStudy Start
First participant enrolled
September 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2018
CompletedJuly 10, 2019
July 1, 2019
1.2 years
May 25, 2017
July 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
change in urticarial activity score averaged over 7 days- no units
subject completed form
through study completion, up to 7 months
Secondary Outcomes (7)
change in blood anti-FCER1 level (kU/l)
through study completion, up to 7 months
change in blood anti-TPO level (IU/L)
through study completion, up to 7 months
change in Blood ECP level (ug/L)
through study completion, up to 7 months
change in blood eotaxin level (pg/ml)
through study completion, up to 7 months
change in RNA testing
through study completion, up to 7 months
- +2 more secondary outcomes
Other Outcomes (4)
adverse events
through study completion, up to 7 months
change in blood pressure
through study completion, up to 7 months
change in pulse rate
through study completion, up to 7 months
- +1 more other outcomes
Study Arms (2)
placebo
PLACEBO COMPARATORplacebo for benralizumab sc given during run-in phase
benralizumab
EXPERIMENTALbenralizumab sc once a month for 3 months for subjects who meet inclusion/exclusion criteria after run-in phase
Interventions
Eligibility Criteria
You may qualify if:
- hives for over 6 weeks of unknown cause hives most days of the despite use of antihistamines
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- single-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PI/ co-owner
Study Record Dates
First Submitted
May 25, 2017
First Posted
June 9, 2017
Study Start
September 12, 2017
Primary Completion
November 6, 2018
Study Completion
November 6, 2018
Last Updated
July 10, 2019
Record last verified: 2019-07