Clinical trial NCT02392624: A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urticaria
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-19
Enrollment: 206
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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)
timeFrame: From randomization (Week 24) to Week 48
Secondary outcomes:
measure: Time to Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 >/=12, Maintained for At Least 2 Consecutive Weeks)
timeFrame: From randomization (Week 24) to Week 48
measure: 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)
timeFrame: From randomization (Week 24) to Week 48
measure: Change From Randomization (Week 24) to Week 48 in UAS7 Among Participants Who Received Total 48 Weeks Treatment With Omalizumab
timeFrame: Week 24 (randomization) and Week 48
measure: 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
timeFrame: At start of retreatment (any time between Weeks 24 and Week 48) and 12 weeks after retreatment (up to Week 60)
Other outcomes:
Locations:
city: Granada Hills
country: United States
facility: Allergy and Asthma Relief Experts
state: California
city: Long Beach
country: United States
facility: Allergy & Asthma Care Center of Southern California
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associate
state: California
city: Mission Viejo
country: United States
facility: Southern California Research Center
state: California
city: Orange
country: United States
facility: Choc Psf, Amc
state: California
city: Redwood City
country: United States
facility: Allergy & Asthma Consultants
state: California
city: Walnut Creek
country: United States
facility: Allergy and Asthma Clinical Research, Inc.
state: California
city: Centennial
country: United States
facility: IMMUNOe Research Centers
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy & Asthma Centers, Pc
state: Colorado
city: Aventura
country: United States
facility: Florida Center for Allergy and Asthma Research
state: Florida
city: Miami
country: United States
facility: Florida Ctr-Allergy & Asthma
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Shiloh
country: United States
facility: Clinical Research Center of Southern Illinois LLC
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Res LLC
state: Indiana
city: Fort Mitchell
country: United States
facility: Abraham Research PLLC
state: Kentucky
city: Louisville
country: United States
facility: Dermatology Specialists Research, LLC
state: Kentucky
city: Owensboro
country: United States
facility: Allergy & Asthma Specialists, PSC
state: Kentucky
city: Baltimore
country: United States
facility: Asthma, Allergy & Sinus Center
state: Maryland
city: Chevy Chase
country: United States
facility: Institute for Asthma & Allergy
state: Maryland
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research; Institue of Michigan P.L.C.
state: Michigan
city: Las Vegas
country: United States
facility: James Q. Del Rosso, DO, LLC
state: Nevada
city: Brick
country: United States
facility: Ocean Allergy & Resp Res Ctr
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Group;Department of Medicine
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Rochester
country: United States
facility: Aair Research Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center; University Dermatology Associates
state: New York
city: Asheville
country: United States
facility: Allergy Partners of Western NC
state: North Carolina
city: Canton
country: United States
facility: Allergy & Respiratory Center
state: Ohio
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center Llc
state: Ohio
city: Toledo
country: United States
facility: Toledo Inst of Clin Research
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clin Res Pc
state: Oklahoma
city: East Providence
country: United States
facility: Asthma, Nasal Disease, and Allergy Research Center of New England
state: Rhode Island
city: Charleston
country: United States
facility: National Allergy and Asthma Research
state: South Carolina
city: Live Oak
country: United States
facility: Live Oak Allergy & Asthma Clinic
state: Texas
city: San Antonio
country: United States
facility: Allergy & Asthma Research Center
state: Texas
city: South Burlington
country: United States
facility: Timber Lane Allergy-Asth Res
state: Vermont
city: Fairfax
country: United States
facility: O & O Alpan, LLC
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.