A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria
NCT ID: NCT02392624
Last Updated: 2018-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
206 participants
INTERVENTIONAL
2015-05-18
2017-03-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Omalizumab
Participants will receive open-label omalizumab treatment at 300 mg SC Q4W for 24 weeks. After 24 weeks open-label treatment, eligible participants will be randomized to receive omalizumab treatment at 300 mg SC Q4W for next 24 weeks (up to Week 48). Participants randomized to omalizumab may, at the discretion of the investigator, be transitioned from blinded study drug to open-label omalizumab at 300 mg SC Q4W if they experience clinically significant worsening in their CIU (as judged by the investigator). Participants who are transitioned to open-label omalizumab will continue to receive open-label omalizumab as study drug until Week 48.
Omalizumab
Omalizumab 300 mg administered SC Q4W.
Placebo
Participants will receive open-label omalizumab treatment at 300 mg SC Q4W for 24 weeks. After 24 weeks open-label treatment, eligible participants will be randomized to receive placebo SC Q4W for next 24 weeks (up to Week 48). Participants randomized to placebo may, at the discretion of the investigator, be transitioned from blinded study drug to open-label omalizumab at 300 mg SC Q4W if they experience clinically significant worsening in their CIU (as judged by the investigator). Participants who are transitioned to open-label omalizumab will continue to receive open-label omalizumab as study drug until Week 48.
Omalizumab
Omalizumab 300 mg administered SC Q4W.
Placebo
Placebo matched to omalizumab administered SC Q4W.
Interventions
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Omalizumab
Omalizumab 300 mg administered SC Q4W.
Placebo
Placebo matched to omalizumab administered SC Q4W.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of itch and hives for at least 8 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine treatment (up to four times the approved dose) during this time period
* UAS7 score (range 0-42) ≥ 16 and itch component of UAS7 (range 0-21) ≥ 8 during 7 days prior to baseline
* Participants must have been on a non-sedating H1 antihistamine treatment (up to four times the approved dose) for CIU for at least 3 consecutive days immediately prior to screening visit with continued current use on the day of the initial screening visit
* CIU diagnosis for ≥ 6 months
* Willing and able to complete a daily symptom eDiary for the duration of the study
Exclusion Criteria
* Body weight less than 20 kilograms
* Clearly defined underlying etiology for chronic urticarias other than CIU
* Evidence of a parasitic infection
* Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch
* Previous treatment with omalizumab within 1 year prior to the initial screening visit
* Participants may not have taken during treatment period or have been taking within 30 days before the initial screening visit any of the following medications or treatments:
regular (daily/every other day during 5 or more consecutive days) systemic corticosteroids, hydroxychloroquine, methotrexate, mycophenolate, cyclosporine, cyclophosphamide, intravenous immunoglobulin G or plasmapheresis
* Regular (daily/every other day) oral doxepin use within 14 days prior to the initial screening visit
* Pregnant or lactating women, or women intending to become pregnant during the study
12 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Allergy and Asthma Relief Experts
Granada Hills, California, United States
Allergy & Asthma Care Center of Southern California
Long Beach, California, United States
Dermatology Research Associate
Los Angeles, California, United States
Southern California Research Center
Mission Viejo, California, United States
Choc Psf, Amc
Orange, California, United States
Allergy & Asthma Consultants
Redwood City, California, United States
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, United States
IMMUNOe Research Centers
Centennial, Colorado, United States
Colorado Allergy & Asthma Centers, Pc
Denver, Colorado, United States
Florida Center for Allergy and Asthma Research
Aventura, Florida, United States
Florida Ctr-Allergy & Asthma
Miami, Florida, United States
Sarasota Clinical Research
Sarasota, Florida, United States
University of South Florida
Tampa, Florida, United States
Clinical Research Center of Southern Illinois LLC
Shiloh, Illinois, United States
Deaconess Clinic
Evansville, Indiana, United States
Dawes Fretzin Clinical Res LLC
Indianapolis, Indiana, United States
Abraham Research PLLC
Fort Mitchell, Kentucky, United States
Dermatology Specialists Research, LLC
Louisville, Kentucky, United States
Allergy & Asthma Specialists, PSC
Owensboro, Kentucky, United States
Asthma, Allergy & Sinus Center
Baltimore, Maryland, United States
Institute for Asthma & Allergy
Chevy Chase, Maryland, United States
Respiratory Medicine Research; Institue of Michigan P.L.C.
Ypsilanti, Michigan, United States
James Q. Del Rosso, DO, LLC
Las Vegas, Nevada, United States
Ocean Allergy & Resp Res Ctr
Brick, New Jersey, United States
Winthrop University Hospital
Mineola, New York, United States
Aair Research Center
Rochester, New York, United States
University of Rochester Medical Center; University Dermatology Associates
Rochester, New York, United States
Montefiore Medical Group;Department of Medicine
The Bronx, New York, United States
Allergy Partners of Western NC
Asheville, North Carolina, United States
Allergy & Respiratory Center
Canton, Ohio, United States
Bernstein Clinical Research Center Llc
Cincinnati, Ohio, United States
Toledo Inst of Clin Research
Toledo, Ohio, United States
Vital Prospects Clin Res Pc
Tulsa, Oklahoma, United States
Asthma, Nasal Disease, and Allergy Research Center of New England
East Providence, Rhode Island, United States
National Allergy and Asthma Research
Charleston, South Carolina, United States
Live Oak Allergy & Asthma Clinic
Live Oak, Texas, United States
Allergy & Asthma Research Center
San Antonio, Texas, United States
Timber Lane Allergy-Asth Res
South Burlington, Vermont, United States
O & O Alpan, LLC
Fairfax, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
Countries
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References
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Casale TB, Murphy TR, Holden M, Rajput Y, Yoo B, Bernstein JA. Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: Results from a randomized study (XTEND-CIU). J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2487-2490.e1. doi: 10.1016/j.jaip.2019.04.020. Epub 2019 Apr 26. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ML29510
Identifier Type: -
Identifier Source: org_study_id
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