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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01264939




Registration number
NCT01264939
Ethics application status
Date submitted
20/12/2010
Date registered
22/12/2010
Date last updated
26/11/2013

Titles & IDs
Public title
A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
Scientific title
A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
Secondary ID [1] 0 0
GA00889
Secondary ID [2] 0 0
Q4883g
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Idiopathic Urticaria 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Omalizumab
Treatment: Drugs - Placebo
Treatment: Drugs - H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist
Treatment: Drugs - Diphenhydramine

Placebo Comparator: Placebo - Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.

Experimental: Omalizumab 300 mg - Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.


Treatment: Drugs: Omalizumab
Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.

Treatment: Drugs: Placebo
Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.

Treatment: Drugs: H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist
Participants were required to maintain stable doses of their pre-randomization combination therapy with an H1 antihistamine and either an H2 blocker or leukotriene receptor antagonist, or all 3 drugs in combination, throughout the 24-week treatment period and 16-week follow-up period of the 40-week study.

Treatment: Drugs: Diphenhydramine
Participants were provided with diphenhydramine 25 mg for itch relief on an as-needed basis, up to a maximum of 3 doses within 24 hours for the duration of the 40-week study.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events - The percentage of participants with serious adverse events and other adverse events is summarized by MedDRA preferred terms and organ classes in the Reported Adverse Events section below.
Timepoint [1] 0 0
Baseline to the end of study (up to 40 weeks)
Secondary outcome [1] 0 0
Change From Baseline to Week 12 in the Weekly Itch Severity Score - The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [2] 0 0
Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7) - The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement.
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [3] 0 0
Change From Baseline to Week 12 in the Weekly Number of Hives Score - The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.
Timepoint [3] 0 0
Baseline to Week 12
Secondary outcome [4] 0 0
Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12 - The time to the MID response is the number of weeks from the start of treatment (Baseline) until the time point at which the first MID response occurs. The MID response is defined as a reduction = 5 points from Baseline in the weekly itch severity score. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching.
Timepoint [4] 0 0
Baseline to Week 12
Secondary outcome [5] 0 0
Percentage of Participants With a UAS7 Score = 6 at Week 12 - The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of Weekly Itch Severity Score MID Responders at Week 12 - The percentage of participants with an itch severity score at 12 Weeks at least 5 points lower than at Baseline. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching.
Timepoint [6] 0 0
Baseline to Week 12
Secondary outcome [7] 0 0
Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score - The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.
Timepoint [7] 0 0
Baseline to Week 12
Secondary outcome [8] 0 0
Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12 - The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.
Timepoint [8] 0 0
Baseline to Week 12
Secondary outcome [9] 0 0
Percentage of Angioedema-free Days From Week 4 to Week 12 - The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days for which a patient responded "No" to the angioedema question in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.
Timepoint [9] 0 0
Week 4 to Week 12
Secondary outcome [10] 0 0
Percentage of Complete Responders (UAS7 = 0) at Week 12 - A complete responder was defined as a participant with a UAS7 score = 0 at Week 12. The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.
Timepoint [10] 0 0
Week 12

Eligibility
Key inclusion criteria
- Diagnosis of chronic idiopathic urticaria (CIU) refractory to H1 antihistamines, H2
blockers, and/or leukotriene receptor antagonists (LTRA) at the time of randomization.

- The presence of itch and hives for > 6 consecutive weeks at any time prior to
enrollment despite current use of H1 antihistamine (up to 4 times the approved
dosage), H2 blocker, and/or LTRA treatment during this time.

- Urticaria activity score over 7 days (UAS7) score (range 0-42) = 16 and itch
component of UAS7 (range 0-21) = 8 during 7 days prior to randomization (Week 0).

- In-clinic UAS = 4 on at least one of the screening visit days (Day -14, Day -7,
or Day 1).

- For women of childbearing potential, agreement to use an acceptable form of
contraception and to continue its use for the duration of the study.
Minimum age
12 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Treatment with an investigational agent within 30 days prior to screening.

- Weight less than 20 kg (44 lbs).

- Clearly defined underlying etiology for chronic urticarias other than CIU.

- Evidence of parasitic infection.

- Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or
other skin disease associated with itch.

- Previous treatment with omalizumab within a year prior to screening.

- Routine doses of the following medications within 30 days prior to screening: Systemic
or cutaneous (topical) corticosteroids (prescription or over the counter),
hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.

- Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to
screening.

- Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to screening.

- Patients with current malignancy, history of malignancy, or currently under work-up
for suspected malignancy except non-melanoma skin cancer that has been treated or
excised and is considered resolved.

- Hypersensitivity to omalizumab or any component of the formulation.

- History of anaphylactic shock.

- Presence of clinically significant cardiovascular, neurological, psychiatric,
metabolic, or other pathological conditions that could interfere with the
interpretation of the study results and or compromise the safety of the patients.

- Evidence of current drug or alcohol abuse.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,QLD,VIC
Recruitment hospital [1] 0 0
- Canberra
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Carlton
Recruitment hospital [4] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
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State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
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Michigan
Country [11] 0 0
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Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Montana
Country [13] 0 0
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New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
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Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
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South Carolina
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Tennessee
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Texas
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Utah
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Vermont
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United States of America
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Virginia
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Germany
State/province [25] 0 0
Berlin
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Germany
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Erlangen
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Koeln
Country [30] 0 0
Germany
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Lübeck
Country [31] 0 0
Germany
State/province [31] 0 0
Mainz
Country [32] 0 0
Germany
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Marburg
Country [33] 0 0
Germany
State/province [33] 0 0
Tübingen
Country [34] 0 0
New Zealand
State/province [34] 0 0
Auckland
Country [35] 0 0
New Zealand
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Beckenham
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New Zealand
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Tauranga
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New Zealand
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Wellington
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Warszawa
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Singapore
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Singapore
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Switzerland
State/province [42] 0 0
Aarau
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Switzerland
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Bern
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Switzerland
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St. Gallen
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United Kingdom
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Cambridge
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Norwich
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United Kingdom
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Oxford
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United Kingdom
State/province [50] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled,
parallel-group study to evaluate the safety and efficacy of omalizumab administered
subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged
12-75 who have been diagnosed with chronic idiopathic urticaria (CIU) who remain symptomatic
despite standard-dosed H1 antihistamine treatment (including doses up to 4 times above the
approved dose level), H2 blockers, and/or leukotriene receptor antagonists (LTRA).
Trial website
https://clinicaltrials.gov/show/NCT01264939
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edward R. Conner, M.D.
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications