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

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ClinicalTrials.gov Identifier: NCT00481676
Recruitment Status : Completed
First Posted : June 4, 2007
Results First Posted : October 21, 2011
Last Update Posted : October 21, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Urticaria
Interventions Drug: Omalizumab 75-375 mg
Drug: Placebo to omalizumab
Drug: Loratadine
Drug: Clemastine
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Omalizumab 75-375 mg Placebo to Omalizumab
Hide 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
Reason Not Completed
Adverse Event             0             1
Unsatisfactory therapeutic effect             1             4
Administrative problem             1             0
Arm/Group Title Omalizumab 75-375 mg Placebo to Omalizumab Total
Hide 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 Number of Baseline Participants 27 22 49
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 22 participants 49 participants
39.1  (9.0) 42.3  (15.0) 40.5  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 22 participants 49 participants
Female
19
  70.4%
19
  86.4%
38
  77.6%
Male
8
  29.6%
3
  13.6%
11
  22.4%
1.Primary Outcome
Title Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 27 22
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 27 22
Measure Type: Number
Unit of Measure: Participants
Wheals - None 19 1
Wheals - < 10 3 11
Wheals - 10-50 1 3
Wheals - > 50 1 1
Erythemas - None 18 4
Erythemas - < 10 4 7
Erythemas - 10-50 1 4
Erythemas - > 50 1 1
Pruritus - None 16 2
Pruritus - Mild 4 8
Pruritus - Moderate 3 3
Pruritus - Severe 1 3
Angioedema - None 21 8
Angioedema - Mild 1 6
Angioedema - Moderate 0 1
Angioedema - Severe 2 1
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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 27 21
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.0  (1.28) 2.5  (1.23)
4.Secondary Outcome
Title Use of Concomitant and Rescue Medications
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 27 22
Mean (Standard Deviation)
Unit of Measure: Pills
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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 27 22
Mean (Standard Deviation)
Unit of Measure: Units on a scale
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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 27 22
Mean (Standard Deviation)
Unit of Measure: Units on a scale
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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 27 22
Mean (Standard Deviation)
Unit of Measure: Units on a scale
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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 27 22
Measure Type: Number
Unit of Measure: Participants
Baseline: Missing 0 0
Baseline: No complaints 3 0
Baseline: Moderate complaints 13 13
Baseline: Severe complaints 11 8
Baseline: Maximum complaints 0 1
Week 24: Missing 1 1
Week 24: No complaints 16 3
Week 24: Moderate complaints 6 7
Week 24: Severe complaints 3 9
Week 24: Maximum complaints 1 2
9.Secondary Outcome
Title Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 27 22
Measure Type: Number
Unit of Measure: Participants
Baseline: Missing 1 0
Baseline: None 1 0
Baseline: Mild 7 9
Baseline: Moderate 13 6
Baseline: Severe 5 7
Week 24: Missing 0 1
Week 24: None 18 1
Week 24: Mild 6 9
Week 24: Moderate 1 4
Week 24: Severe 2 7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omalizumab 75-375 mg Placebo to Omalizumab
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Omalizumab 75-375 mg Placebo to Omalizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   2/22 (9.09%) 
Infections and infestations     
Eye Infection  1  0/27 (0.00%)  1/22 (4.55%) 
Nervous system disorders     
Syncope  1  0/27 (0.00%)  1/22 (4.55%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  0/27 (0.00%)  1/22 (4.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Omalizumab 75-375 mg Placebo to Omalizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   19/27 (70.37%)   12/22 (54.55%) 
Gastrointestinal disorders     
Abdominal Pain  1  0/27 (0.00%)  2/22 (9.09%) 
Diarrhoea  1  4/27 (14.81%)  2/22 (9.09%) 
General disorders     
Injection Site Pain  1  0/27 (0.00%)  1/22 (4.55%) 
Infections and infestations     
Gastroenteritis  1  2/27 (7.41%)  0/22 (0.00%) 
Gastrointestinal Infection  1  3/27 (11.11%)  2/22 (9.09%) 
Nasopharyngitis  1  9/27 (33.33%)  11/22 (50.00%) 
Sinusitis  1  3/27 (11.11%)  0/22 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/27 (11.11%)  1/22 (4.55%) 
Back Pain  1  1/27 (3.70%)  2/22 (9.09%) 
Nervous system disorders     
Headache  1  10/27 (37.04%)  6/22 (27.27%) 
Psychiatric disorders     
Insomnia  1  2/27 (7.41%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/27 (7.41%)  0/22 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  0/27 (0.00%)  3/22 (13.64%) 
Eczema  1  2/27 (7.41%)  2/22 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00481676    
Other Study ID Numbers: CIGE025ADE05
First Submitted: June 1, 2007
First Posted: June 4, 2007
Results First Submitted: December 17, 2010
Results First Posted: October 21, 2011
Last Update Posted: October 21, 2011