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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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)
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
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
Timepoint [4] 0 0
Baseline to Week 12
Secondary outcome [5] 0 0
Percentage of Participants With a UAS7 Score = 6 at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of Weekly Itch Severity Score MID Responders at Week 12
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
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
Timepoint [8] 0 0
Baseline to Week 12
Secondary outcome [9] 0 0
Percentage of Angioedema-free Days From Week 4 to Week 12
Timepoint [9] 0 0
Week 4 to Week 12
Secondary outcome [10] 0 0
Percentage of Complete Responders (UAS7 = 0) at Week 12
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
Sex
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
1/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
336
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
United States of America
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
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Montana
Country [13] 0 0
United States of America
State/province [13] 0 0
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
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Vermont
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Erlangen
Country [27] 0 0
Germany
State/province [27] 0 0
Freiburg
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
Koeln
Country [30] 0 0
Germany
State/province [30] 0 0
Lübeck
Country [31] 0 0
Germany
State/province [31] 0 0
Mainz
Country [32] 0 0
Germany
State/province [32] 0 0
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
State/province [35] 0 0
Beckenham
Country [36] 0 0
New Zealand
State/province [36] 0 0
Tauranga
Country [37] 0 0
New Zealand
State/province [37] 0 0
Wellington
Country [38] 0 0
Poland
State/province [38] 0 0
Krakow
Country [39] 0 0
Poland
State/province [39] 0 0
Lodz
Country [40] 0 0
Poland
State/province [40] 0 0
Warszawa
Country [41] 0 0
Singapore
State/province [41] 0 0
Singapore
Country [42] 0 0
Switzerland
State/province [42] 0 0
Aarau
Country [43] 0 0
Switzerland
State/province [43] 0 0
Bern
Country [44] 0 0
Switzerland
State/province [44] 0 0
St. Gallen
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Cambridge
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Leicester
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Norwich
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Oxford
Country [50] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01264939