Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00481676
• Collaborator: (none)
• Enrollment: 49
• Locations: 11
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 4.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.

Condition or Disease	Intervention/Treatment	Phase
Chronic Urticaria	Drug: Omalizumab 75-375 mg; Drug: Placebo to omalizumab; Drug: Loratadine; Drug: Clemastine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, 24 Weeks, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Omalizumab in Adult Patients With Chronic Urticaria Who Exhibit IgE Against Thyroperoxidase
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Omalizumab 75-375 mg Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.	Drug: Omalizumab 75-375 mg; Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg of omalizumab upon reconstitution with 1.4 ml sterile water for injection.; Other Names: Xolair ; Drug: Loratadine; All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.; Other Names: Lorano®
Placebo Comparator: Placebo to omalizumab Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.	Drug: Placebo to omalizumab; Placebo to omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg placebo to omalizumab upon reconstitution with 1.4 ml sterile water for injection.; Drug: Loratadine; All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.; Other Names: Lorano® ; Drug: Clemastine; All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.; Other Names: Tavegil®

Outcome Measures

Primary Outcome Measures

1. Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24) [Baseline to end of the study (Week 24)]

   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 daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. Because of 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 UASs, ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change score (Week 24 score minus Baseline score) indicates improvement.

Secondary Outcome Measures

1. Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study [At the end of the study (Week 24)]

   Patients kept a daily diary of the number of wheals and erythema and the severity of pruritus and angioedemas during the study.

2. Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24) [Baseline to the end of the study (Week 24)]

   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 daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. A higher score indicates worse disease. AUC was calculated from daily UASs where no urticaria medication was taken using the trapezoidal rule. The standardized AUC UAS was calculated as the sum of trapezoids divided by the length of time.

3. Use of Concomitant and Rescue Medications [At Weeks 4, 8, 12, 16, 20, and 24]

   Data was collected from the patients' diaries about the number of clemastine and loratadine pills taken during the last 7 days of each month of the study.

4. Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24) [Baseline to the end of the study (Week 24)]

   The DLQI is a dermatology-specific quality of life (QoL) questionnaire designed for use in patients over 16 years of age. Patients are asked to respond to each of 10 questions on a 4-point Likert scale in regard to how much their skin problem has affected their life over the last week (0=not at all, 1=a little, 2=a lot, 3=very much). The overall (total) DLQI score (range=0 to 30) is calculated by summing the scores of all 10 questions. The higher the score, the more QoL is impaired. A negative change score (Week 24 score minus Baseline score) indicates improvement.

5. Change in the Skindex Score From Baseline to the End of the Study (Week 24) [Baseline to the end of the study (Week 24)]

   Skindex is a 30-item questionnaire with 3 scores (functioning, emotions,symptoms) and a composite score (average scale score) that assesses the effects of skin disease on patients' quality of life (QoL). Item responses are standardized on a scale from 0 to 100. The mean of all 61 items was calculated. A higher score indicates a lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.

6. Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) [Baseline to the end of the study (Week 24)]

   The CU-Q2oL (German version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It has 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Patients are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1=not at all to 5=very much). Each domain and the overall (total) scores are normalized to a scale of 1 to 100. A higher score indicates lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.

7. Patient's Global Assessment of Their Chronic Urticaria Symptoms [At Baseline and at the end of the study (Week 24)]

   Patients made a global assessment of their chronic urticaria symptoms on a 4-point Likert scale (none, mild moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.

8. Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms [At Baseline and at the end of the study (Week 24)]

   The investigator made a global assessment of the patient's chronic urticaria symptoms on a 4-point Likert scale (none, mild, moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Males or females from 18-70 years of age

• Body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 IU/mL and ≤ 700 IU/mL

• Specific serum IgE anti-TPO level ≥ 8.0 IU/mL, documented within 3 months prior to randomization or time of pre-screening

• Diagnosis of moderate to severe chronic urticaria

• Subject's current episode of chronic urticaria according to the European Academy of Allergology and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum (EAACI/GA2LEN/EDF) guideline at the time of screening

• Current episode of chronic urticaria has not responded to the approved marketed dose of antihistamine for 2 weeks or longer

• Urticaria activity score (UAS) ≥ 0 at any of the 7 days of the first section of the screening period

• UAS7 ≥ 10 at the time of randomization

Exclusion criteria:

• Females of child-bearing potential or breast feeding

• Present or past medical conditions that could have interfered with the study results

• Randomized into any other omalizumab study or who had received omalizumab

• Received investigational drugs within 30 days of enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Berlin		Germany
2	Novartis Investigative Site	Bonn		Germany
3	Novartis Investigative Site	Dresden		Germany
4	Novartis Investigative Site	Giessen		Germany
5	Novartis Investigative Site	Hamburg		Germany
6	Novartis Investigative Site	Hannover		Germany
7	Novartis Investigative Site	Koeln		Germany
8	Novartis Investigative Site	Leipzig		Germany
9	Novartis Investigative Site	Luebeck		Germany
10	Novartis Investigative Site	Mainz		Germany
11	Novartis Investigative Site	Munich		Germany

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00481676
• Other Study ID Numbers: CIGE025ADE05
• First Posted: Jun 4, 2007
• Last Update Posted: Oct 21, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Novartis: Chronic urticaria, omalizumab, thyroperoxidase, IgE
• Additional relevant MeSH terms: Urticaria; Chronic Urticaria; Omalizumab; Loratadine; Clemastine; Antibodies, Monoclonal

Study Results

Participant Flow

Arm/Group Title	Omalizumab 75-375 mg	Placebo to Omalizumab
Arm/Group Description	Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.	Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
Period Title: Overall Study
STARTED	27	22
COMPLETED	25	17
NOT COMPLETED	2	5

Baseline Characteristics

Arm/Group Title	Omalizumab 75-375 mg	Placebo to Omalizumab	Total
Arm/Group Description	Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.	Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.	Total of all reporting groups
Overall Participants	27	22	49
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.1 (9.0)	42.3 (15.0)	40.5 (12.0)
Sex: Female, Male (Count of Participants)
Female	19 70.4%	19 86.4%	38 77.6%
Male	8 29.6%	3 13.6%	11 22.4%

Outcome Measures

1. Primary Outcome

Title	Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24)
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 daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. Because of 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 UASs, ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change score (Week 24 score minus Baseline score) indicates improvement.
Time Frame	Baseline to end of the study (Week 24)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.

Arm/Group Title	Omalizumab 75-375 mg	Placebo to Omalizumab
Arm/Group Description	Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.	Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
Measure Participants	27	22
Mean (Standard Deviation) [Units on a scale]	-17.8 (10.52)	-5.8 (11.52)

2. Secondary Outcome

Title	Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Description	Patients kept a daily diary of the number of wheals and erythema and the severity of pruritus and angioedemas during the study.
Time Frame	At the end of the study (Week 24)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.

Arm/Group Title	Omalizumab 75-375 mg	Placebo to Omalizumab
Arm/Group Description	Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.	Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
Measure Participants	27	22
Wheals - None	19 70.4%	1 4.5%
Wheals - < 10	3 11.1%	11 50%
Wheals - 10-50	1 3.7%	3 13.6%
Wheals - > 50	1 3.7%	1 4.5%
Erythemas - None	18 66.7%	4 18.2%
Erythemas - < 10	4 14.8%	7 31.8%
Erythemas - 10-50	1 3.7%	4 18.2%
Erythemas - > 50	1 3.7%	1 4.5%
Pruritus - None	16 59.3%	2 9.1%
Pruritus - Mild	4 14.8%	8 36.4%
Pruritus - Moderate	3 11.1%	3 13.6%
Pruritus - Severe	1 3.7%	3 13.6%
Angioedema - None	21 77.8%	8 36.4%
Angioedema - Mild	1 3.7%	6 27.3%
Angioedema - Moderate	0 0%	1 4.5%
Angioedema - Severe	2 7.4%	1 4.5%

3. Secondary Outcome

Title	Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24)
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 daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. A higher score indicates worse disease. AUC was calculated from daily UASs where no urticaria medication was taken using the trapezoidal rule. The standardized AUC UAS was calculated as the sum of trapezoids divided by the length of time.
Time Frame	Baseline to the end of the study (Week 24)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.

Arm/Group Title	Omalizumab 75-375 mg	Placebo to Omalizumab
Arm/Group Description	Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.	Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
Measure Participants	27	21
Mean (Standard Deviation) [Units on a scale]	1.0 (1.28)	2.5 (1.23)

4. Secondary Outcome

Title	Use of Concomitant and Rescue Medications
Description	Data was collected from the patients' diaries about the number of clemastine and loratadine pills taken during the last 7 days of each month of the study.
Time Frame	At Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.

Arm/Group Title	Omalizumab 75-375 mg	Placebo to Omalizumab
Arm/Group Description	Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.	Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
Measure Participants	27	22
Week 4 - clemastine (N=27,21)	0.7 (3.10)	3.7 (5.30)
Week 4 - loratadine (N=27,22)	1.3 (2.51)	4.2 (2.61)
Week 8 - clemastine (N=26,20)	1.3 (4.05)	2.4 (3.69)
Week 8 - loratadine (N=26,21)	1.2 (2.45)	4.2 (2.62)
Week 12 - clemastine (N=25,17)	1.1 (3.81)	1.8 (3.80)
Week 12 - loratadine (N=25,19)	1.2 (2.33)	3.3 (2.64)
Week 16 - clemastine (N=24,16)	0.2 (0.72)	1.4 (2.13)
Week 16 - loratadine (N=24,17)	0.6 (1.56)	3.6 (3.00)
Week 20 - clemastine (N=24,16)	0.9 (3.88)	2.2 (2.88)
Week 20 - loratadine (N=24,17)	0.5 (1.47)	4.6 (3.48)
Week 24 - clemastine (N=23,14)	0.7 (2.72)	1.4 (2.13)
Week 24 - clemastine (N=23,16)	0.3 (1.11)	3.3 (2.50)

5. Secondary Outcome

Title	Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24)
Description	The DLQI is a dermatology-specific quality of life (QoL) questionnaire designed for use in patients over 16 years of age. Patients are asked to respond to each of 10 questions on a 4-point Likert scale in regard to how much their skin problem has affected their life over the last week (0=not at all, 1=a little, 2=a lot, 3=very much). The overall (total) DLQI score (range=0 to 30) is calculated by summing the scores of all 10 questions. The higher the score, the more QoL is impaired. A negative change score (Week 24 score minus Baseline score) indicates improvement.
Time Frame	Baseline to the end of the study (Week 24)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.

Arm/Group Title	Omalizumab 75-375 mg	Placebo to Omalizumab
Arm/Group Description	Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.	Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
Measure Participants	27	22
Baseline (N=27, 22)	10.1 (6.04)	9.8 (5.29)
Week 24 (N=27,21)	3.7 (7.12)	8.1 (6.11)
Week 24 minus Baseline (N=27,21)	-6.3 (8.36)	-1.5 (5.83)

6. Secondary Outcome

Title	Change in the Skindex Score From Baseline to the End of the Study (Week 24)
Description	Skindex is a 30-item questionnaire with 3 scores (functioning, emotions,symptoms) and a composite score (average scale score) that assesses the effects of skin disease on patients' quality of life (QoL). Item responses are standardized on a scale from 0 to 100. The mean of all 61 items was calculated. A higher score indicates a lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.
Time Frame	Baseline to the end of the study (Week 24)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.

Arm/Group Title	Omalizumab 75-375 mg	Placebo to Omalizumab
Arm/Group Description	Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.	Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
Measure Participants	27	22
Baseline (N=27,22)	1.8 (0.69)	1.6 (0.53)
Week 24 (N=27,21)	0.9 (1.00)	1.5 (0.79)
Week 24 minus Baseline (N=27,21)	-0.9 (0.89)	-0.1 (0.61)

7. Secondary Outcome

Title	Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Description	The CU-Q2oL (German version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It has 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Patients are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1=not at all to 5=very much). Each domain and the overall (total) scores are normalized to a scale of 1 to 100. A higher score indicates lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.
Time Frame	Baseline to the end of the study (Week 24)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.

Arm/Group Title	Omalizumab 75-375 mg	Placebo to Omalizumab
Arm/Group Description	Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.	Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
Measure Participants	27	22
Baseline : Limits Looks (N=27,21)	31.5 (23.86)	34.5 (24.97)
Baseline : Swelling/eating (N=27,22)	21.8 (20.17)	26.7 (19.97)
Baseline : Sleep (N=27,22)	45.8 (24.02)	46.6 (23.91)
Baseline : Mental status (N=27,22)	42.6 (21.72)	42.4 (18.71)
Baseline : Functioning (N=27,22)	36.0 (22.47)	30.7 (15.88)
Baseline : Itching/embarrassment (N=27,22)	58.1 (18.97)	56.8 (14.80)
Baseline : Total score (N=27,22)	39.5 (16.34)	38.9 (8.87)
Week 24 : Limits looks (N=27,21)	17.1 (20.26)	23.2 (20.27)
Week 24 : Swelling/eating (N=27,21)	10.4 (23.58)	27.4 (23.92)
Week 24 : Sleep (N=27,21)	27.3 (29.73)	47.3 (27.36)
Week 24 : Mental status (N=27,21)	25.9 (27.77)	40.1 (25.22)
Week 24 : Functioning (N=27,21)	11.9 (22.43)	27.0 (20.73)
Week 24 : Itching/embarrassment (N=27,21)	22.9 (29.42)	57.4 (22.41)
Week 24 : Total score (N=27,21)	18.5 (22.66)	37.3 (16.22)
Week 24 - Baseline: Limits looks (N=27,20)	-14.4 (24.69)	-9.4 (18.08)
Week 24 - Baseline: Swelling/eating (N=27,21)	-11.3 (22.40)	-0.6 (18.74)
Week 24 - Baseline: Sleep (N=27,21)	-18.5 (27.05)	-0.6 (23.13)
Week 24 - Baseline: Mental status (N=27,21)	-16.7 (27.35)	-2.4 (19.57)
Week 24 - Baseline: Functioning (N=27,21)	-24.1 (23.94)	-3.8 (21.08)
Week 24 - Baseline: itching/embarrassmen (N=27,21)	-35.2 (32.71)	-0.9 (20.76)
Week 24 - Baseline: Total score (N=27,21)	-21.0 (21.97)	-2.3 (14.14)

8. Secondary Outcome

Title	Patient's Global Assessment of Their Chronic Urticaria Symptoms
Description	Patients made a global assessment of their chronic urticaria symptoms on a 4-point Likert scale (none, mild moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.
Time Frame	At Baseline and at the end of the study (Week 24)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.

Arm/Group Title	Omalizumab 75-375 mg	Placebo to Omalizumab
Arm/Group Description	Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.	Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
Measure Participants	27	22
Baseline: Missing	0 0%	0 0%
Baseline: No complaints	3 11.1%	0 0%
Baseline: Moderate complaints	13 48.1%	13 59.1%
Baseline: Severe complaints	11 40.7%	8 36.4%
Baseline: Maximum complaints	0 0%	1 4.5%
Week 24: Missing	1 3.7%	1 4.5%
Week 24: No complaints	16 59.3%	3 13.6%
Week 24: Moderate complaints	6 22.2%	7 31.8%
Week 24: Severe complaints	3 11.1%	9 40.9%
Week 24: Maximum complaints	1 3.7%	2 9.1%

9. Secondary Outcome

Title	Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
Description	The investigator made a global assessment of the patient's chronic urticaria symptoms on a 4-point Likert scale (none, mild, moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.
Time Frame	At Baseline and at the end of the study (Week 24)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.

Arm/Group Title	Omalizumab 75-375 mg	Placebo to Omalizumab
Arm/Group Description	Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.	Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
Measure Participants	27	22
Baseline: Missing	1 3.7%	0 0%
Baseline: None	1 3.7%	0 0%
Baseline: Mild	7 25.9%	9 40.9%
Baseline: Moderate	13 48.1%	6 27.3%
Baseline: Severe	5 18.5%	7 31.8%
Week 24: Missing	0 0%	1 4.5%
Week 24: None	18 66.7%	1 4.5%
Week 24: Mild	6 22.2%	9 40.9%
Week 24: Moderate	1 3.7%	4 18.2%
Week 24: Severe	2 7.4%	7 31.8%

Adverse Events

Arm/Group Title	Omalizumab 75-375 mg		Placebo to Omalizumab
Arm/Group Description	Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.		Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
All Cause Mortality
	Omalizumab 75-375 mg		Placebo to Omalizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Omalizumab 75-375 mg		Placebo to Omalizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		2/22 (9.1%)
Infections and infestations
Eye Infection	0/27 (0%)		1/22 (4.5%)
Nervous system disorders
Syncope	0/27 (0%)		1/22 (4.5%)
Skin and subcutaneous tissue disorders
Angioedema	0/27 (0%)		1/22 (4.5%)
Other (Not Including Serious) Adverse Events
	Omalizumab 75-375 mg		Placebo to Omalizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/27 (70.4%)		12/22 (54.5%)
Gastrointestinal disorders
Abdominal Pain	0/27 (0%)		2/22 (9.1%)
Diarrhoea	4/27 (14.8%)		2/22 (9.1%)
General disorders
Injection Site Pain	0/27 (0%)		1/22 (4.5%)
Infections and infestations
Gastroenteritis	2/27 (7.4%)		0/22 (0%)
Gastrointestinal Infection	3/27 (11.1%)		2/22 (9.1%)
Nasopharyngitis	9/27 (33.3%)		11/22 (50%)
Sinusitis	3/27 (11.1%)		0/22 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/27 (11.1%)		1/22 (4.5%)
Back Pain	1/27 (3.7%)		2/22 (9.1%)
Nervous system disorders
Headache	10/27 (37%)		6/22 (27.3%)
Psychiatric disorders
Insomnia	2/27 (7.4%)		0/22 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	2/27 (7.4%)		0/22 (0%)
Skin and subcutaneous tissue disorders
Angioedema	0/27 (0%)		3/22 (13.6%)
Eczema	2/27 (7.4%)		2/22 (9.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. any publications from a single-site are postponed until the publication of the pooled date (ie, data from all sites) in the clinical trial.