Back to resultsA Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria
Primary Purpose
Urticaria
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omalizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Urticaria
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
Sites / Locations
- Allergy and Asthma Relief Experts
- Allergy & Asthma Care Center of Southern California
- Dermatology Research Associate
- Southern California Research Center
- Choc Psf, Amc
- Allergy & Asthma Consultants
- Allergy and Asthma Clinical Research, Inc.
- IMMUNOe Research Centers
- Colorado Allergy & Asthma Centers, Pc
- Florida Center for Allergy and Asthma Research
- Florida Ctr-Allergy & Asthma
- Sarasota Clinical Research
- University of South Florida
- Clinical Research Center of Southern Illinois LLC
- Deaconess Clinic
- Dawes Fretzin Clinical Res LLC
- Abraham Research PLLC
- Dermatology Specialists Research, LLC
- Allergy & Asthma Specialists, PSC
- Asthma, Allergy & Sinus Center
- Institute for Asthma & Allergy
- Respiratory Medicine Research; Institue of Michigan P.L.C.
- James Q. Del Rosso, DO, LLC
- Ocean Allergy & Resp Res Ctr
- Montefiore Medical Group;Department of Medicine
- Winthrop University Hospital
- Aair Research Center
- University of Rochester Medical Center; University Dermatology Associates
- Allergy Partners of Western NC
- Allergy & Respiratory Center
- Bernstein Clinical Research Center Llc
- Toledo Inst of Clin Research
- Vital Prospects Clin Res Pc
- Asthma, Nasal Disease, and Allergy Research Center of New England
- National Allergy and Asthma Research
- Live Oak Allergy & Asthma Clinic
- Allergy & Asthma Research Center
- Timber Lane Allergy-Asth Res
- O & O Alpan, LLC
- Premier Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Omalizumab
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 >/=12, Maintained for At Least 2 Consecutive Weeks)
The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 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. Time to clinical worsening in CIU was defined as the number of weeks from the first double-blind treatment to the first two-week interval with UAS7 >/=12 for both weeks. If clinical worsening did not occur, time to clinical worsening was censored at the end of the last week for which the UAS7 score was not missing and less than (<) 12, prior to last randomized dose + 4 weeks, or the first open-label transition dose, whichever was earlier. Median time to clinical worsening was estimated using Kaplan-Meier analysis and corresponding 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.
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)
The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 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 >6 for at least 2 consecutive weeks post-randomization between weeks 24 and 48.
Change From Randomization (Week 24) to Week 48 in UAS7 Among Participants Who Received Total 48 Weeks Treatment With Omalizumab
The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 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. A negative change in score (Week 48 score minus Week 24 score) indicates improvement.
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
The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 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. A negative change in score indicates improvement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02392624
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 18, 2015 (Actual)
Primary Completion Date
March 9, 2017 (Actual)
Study Completion Date
March 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omalizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Omalizumab
Other Intervention Name(s)
Xolair; RO5489789
Intervention Description
Omalizumab 300 mg administered SC Q4W.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to omalizumab administered SC Q4W.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
From randomization (Week 24) to Week 48
Secondary Outcome Measure Information:
Title
Time to Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 >/=12, Maintained for At Least 2 Consecutive Weeks)
Description
The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 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. Time to clinical worsening in CIU was defined as the number of weeks from the first double-blind treatment to the first two-week interval with UAS7 >/=12 for both weeks. If clinical worsening did not occur, time to clinical worsening was censored at the end of the last week for which the UAS7 score was not missing and less than (<) 12, prior to last randomized dose + 4 weeks, or the first open-label transition dose, whichever was earlier. Median time to clinical worsening was estimated using Kaplan-Meier analysis and corresponding 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.
Time Frame
From randomization (Week 24) to Week 48
Title
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)
Description
The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 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 >6 for at least 2 consecutive weeks post-randomization between weeks 24 and 48.
Time Frame
From randomization (Week 24) to Week 48
Title
Change From Randomization (Week 24) to Week 48 in UAS7 Among Participants Who Received Total 48 Weeks Treatment With Omalizumab
Description
The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 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. A negative change in score (Week 48 score minus Week 24 score) indicates improvement.
Time Frame
Week 24 (randomization) and Week 48
Title
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
Description
The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 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. A negative change in score indicates improvement.
Time Frame
At start of retreatment (any time between Weeks 24 and Week 48) and 12 weeks after retreatment (up to Week 60)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Allergy and Asthma Relief Experts
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
Allergy & Asthma Care Center of Southern California
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
Dermatology Research Associate
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Southern California Research Center
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Choc Psf, Amc
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Allergy & Asthma Consultants
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Allergy and Asthma Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
IMMUNOe Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Colorado Allergy & Asthma Centers, Pc
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Florida Center for Allergy and Asthma Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Florida Ctr-Allergy & Asthma
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Sarasota Clinical Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Clinical Research Center of Southern Illinois LLC
City
Shiloh
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Facility Name
Deaconess Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Dawes Fretzin Clinical Res LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Abraham Research PLLC
City
Fort Mitchell
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Dermatology Specialists Research, LLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Allergy & Asthma Specialists, PSC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Asthma, Allergy & Sinus Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Institute for Asthma & Allergy
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Respiratory Medicine Research; Institue of Michigan P.L.C.
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
James Q. Del Rosso, DO, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
Facility Name
Ocean Allergy & Resp Res Ctr
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Montefiore Medical Group;Department of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Aair Research Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
University of Rochester Medical Center; University Dermatology Associates
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Allergy Partners of Western NC
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Allergy & Respiratory Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Bernstein Clinical Research Center Llc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Toledo Inst of Clin Research
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
Vital Prospects Clin Res Pc
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Asthma, Nasal Disease, and Allergy Research Center of New England
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
National Allergy and Asthma Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Live Oak Allergy & Asthma Clinic
City
Live Oak
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Allergy & Asthma Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Timber Lane Allergy-Asth Res
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
O & O Alpan, LLC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31034999
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.
Results Reference
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A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria
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