A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria
XTEND-CIU (Xolair Treatment Efficacy of Longer Duration in Chronic Idiopathic Urticaria): A Phase IV, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Omalizumab Through 48 Weeks in Patients With Chronic Idiopathic Urticaria
1 other identifier
interventional
206
1 country
40
Brief Summary
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48 weeks for treatment of H1 antihistamine refractory chronic idiopathic urticaria (CIU). After completing an initial 24-week open-label treatment period with omalizumab 300 milligrams (mg) every 4 weeks (Q4W), participants responding to omalizumab will be randomized at a 3:2 ratio (omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a further 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2015
40 active sites
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
March 13, 2015
CompletedFirst Posted
Study publicly available on registry
March 19, 2015
CompletedStudy Start
First participant enrolled
May 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2017
CompletedResults Posted
Study results publicly available
March 26, 2018
CompletedMarch 29, 2018
March 1, 2018
1.8 years
March 13, 2015
February 21, 2018
March 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by Urticaria Activity Score Over 7 Days (UAS7) (Clinical Worsening: UAS7 Greater Than or Equal to [>/=] 12, Maintained for At Least 2 Consecutive Weeks)
Urticaria activity score (UAS) is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals (hives) per 24 hours and the intensity of the pruritus (itch). The total UAS score (sum of the wheal and pruritus scores) ranges from 0 to 6. Due to variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Clinical worsening in CIU was defined as UAS7 \>/=12 for at least 2 consecutive weeks post-randomization between Weeks 24 and 48.
From randomization (Week 24) to Week 48
Secondary Outcomes (4)
Time to Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 >/=12, Maintained for At Least 2 Consecutive Weeks)
From randomization (Week 24) to Week 48
Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 Greater Than [>] 6, Maintained for At Least 2 Consecutive Weeks)
From randomization (Week 24) to Week 48
Change From Randomization (Week 24) to Week 48 in UAS7 Among Participants Who Received Total 48 Weeks Treatment With Omalizumab
Week 24 (randomization) and Week 48
Retreatment Efficacy: Change From Time of Retreatment to 12 Weeks After Retreatment in UAS7 Among Participants Randomized to Placebo and Who Were Retreated With Open-Label Omalizumab After Randomization
At start of retreatment (any time between Weeks 24 and Week 48) and 12 weeks after retreatment (up to Week 60)
Study Arms (2)
Omalizumab
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Omalizumab 300 mg administered SC Q4W.
Eligibility Criteria
You may qualify if:
- Diagnosis of CIU refractory to H1 antihistamines at baseline
- 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
You may not qualify if:
- Treatment with an investigational agent within 30 days of the initial screening visit
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (40)
Allergy and Asthma Relief Experts
Granada Hills, California, 91344, United States
Allergy & Asthma Care Center of Southern California
Long Beach, California, 90808, United States
Dermatology Research Associate
Los Angeles, California, 90045, United States
Southern California Research Center
Mission Viejo, California, 92691, United States
Choc Psf, Amc
Orange, California, 92868, United States
Allergy & Asthma Consultants
Redwood City, California, 94063, United States
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, 94598, United States
IMMUNOe Research Centers
Centennial, Colorado, 80112, United States
Colorado Allergy & Asthma Centers, Pc
Denver, Colorado, 80230, United States
Florida Center for Allergy and Asthma Research
Aventura, Florida, 33180, United States
Florida Ctr-Allergy & Asthma
Miami, Florida, 33173, United States
Sarasota Clinical Research
Sarasota, Florida, 34239, United States
University of South Florida
Tampa, Florida, 33613, United States
Clinical Research Center of Southern Illinois LLC
Shiloh, Illinois, 62269, United States
Deaconess Clinic
Evansville, Indiana, 47713, United States
Dawes Fretzin Clinical Res LLC
Indianapolis, Indiana, 46256, United States
Abraham Research PLLC
Fort Mitchell, Kentucky, 41017, United States
Dermatology Specialists Research, LLC
Louisville, Kentucky, 40241, United States
Allergy & Asthma Specialists, PSC
Owensboro, Kentucky, 42301, United States
Asthma, Allergy & Sinus Center
Baltimore, Maryland, 21236, United States
Institute for Asthma & Allergy
Chevy Chase, Maryland, 20815, United States
Respiratory Medicine Research; Institue of Michigan P.L.C.
Ypsilanti, Michigan, 48197, United States
James Q. Del Rosso, DO, LLC
Las Vegas, Nevada, 89117, United States
Ocean Allergy & Resp Res Ctr
Brick, New Jersey, 08724, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Aair Research Center
Rochester, New York, 14618, United States
University of Rochester Medical Center; University Dermatology Associates
Rochester, New York, 14642, United States
Montefiore Medical Group;Department of Medicine
The Bronx, New York, 10461, United States
Allergy Partners of Western NC
Asheville, North Carolina, 28801, United States
Allergy & Respiratory Center
Canton, Ohio, 44718, United States
Bernstein Clinical Research Center Llc
Cincinnati, Ohio, 45231, United States
Toledo Inst of Clin Research
Toledo, Ohio, 43617, United States
Vital Prospects Clin Res Pc
Tulsa, Oklahoma, 74136, United States
Asthma, Nasal Disease, and Allergy Research Center of New England
East Providence, Rhode Island, 02914, United States
National Allergy and Asthma Research
Charleston, South Carolina, 29407, United States
Live Oak Allergy & Asthma Clinic
Live Oak, Texas, 78233, United States
Allergy & Asthma Research Center
San Antonio, Texas, 78229, United States
Timber Lane Allergy-Asth Res
South Burlington, Vermont, 05403, United States
O & O Alpan, LLC
Fairfax, Virginia, 22030, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
Related Publications (1)
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.
PMID: 31034999DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2015
First Posted
March 19, 2015
Study Start
May 18, 2015
Primary Completion
March 9, 2017
Study Completion
March 9, 2017
Last Updated
March 29, 2018
Results First Posted
March 26, 2018
Record last verified: 2018-03