Trial Outcomes & Findings for Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria (NCT NCT00481676)
NCT ID: NCT00481676
Last Updated: 2011-10-21
Results Overview
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.
COMPLETED
PHASE2
49 participants
Baseline to end of the study (Week 24)
2011-10-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
22
|
|
Overall Study
COMPLETED
|
25
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
4
|
|
Overall Study
Administrative problem
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria
Baseline characteristics by cohort
| Measure |
Omalizumab 75-375 mg
n=27 Participants
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
n=22 Participants
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
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
39.1 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
40.5 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of the study (Week 24)Population: 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.
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.
Outcome measures
| Measure |
Omalizumab 75-375 mg
n=27 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24)
|
-17.8 Units on a scale
Standard Deviation 10.52
|
-5.8 Units on a scale
Standard Deviation 11.52
|
SECONDARY outcome
Timeframe: At the end of the study (Week 24)Population: 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.
Patients kept a daily diary of the number of wheals and erythema and the severity of pruritus and angioedemas during the study.
Outcome measures
| Measure |
Omalizumab 75-375 mg
n=27 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Wheals - None
|
19 Participants
|
1 Participants
|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Wheals - < 10
|
3 Participants
|
11 Participants
|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Wheals - 10-50
|
1 Participants
|
3 Participants
|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Wheals - > 50
|
1 Participants
|
1 Participants
|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Erythemas - None
|
18 Participants
|
4 Participants
|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Erythemas - < 10
|
4 Participants
|
7 Participants
|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Erythemas - 10-50
|
1 Participants
|
4 Participants
|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Erythemas - > 50
|
1 Participants
|
1 Participants
|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Pruritus - None
|
16 Participants
|
2 Participants
|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Pruritus - Mild
|
4 Participants
|
8 Participants
|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Pruritus - Moderate
|
3 Participants
|
3 Participants
|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Pruritus - Severe
|
1 Participants
|
3 Participants
|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Angioedema - None
|
21 Participants
|
8 Participants
|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Angioedema - Mild
|
1 Participants
|
6 Participants
|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Angioedema - Moderate
|
0 Participants
|
1 Participants
|
|
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Angioedema - Severe
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (Week 24)Population: 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.
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.
Outcome measures
| Measure |
Omalizumab 75-375 mg
n=27 Participants
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
n=21 Participants
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.
|
|---|---|---|
|
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)
|
1.0 Units on a scale
Standard Deviation 1.28
|
2.5 Units on a scale
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: At Weeks 4, 8, 12, 16, 20, and 24Population: 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.
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.
Outcome measures
| Measure |
Omalizumab 75-375 mg
n=27 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Use of Concomitant and Rescue Medications
Week 4 - clemastine (N=27,21)
|
0.7 Pills
Standard Deviation 3.10
|
3.7 Pills
Standard Deviation 5.30
|
|
Use of Concomitant and Rescue Medications
Week 4 - loratadine (N=27,22)
|
1.3 Pills
Standard Deviation 2.51
|
4.2 Pills
Standard Deviation 2.61
|
|
Use of Concomitant and Rescue Medications
Week 8 - clemastine (N=26,20)
|
1.3 Pills
Standard Deviation 4.05
|
2.4 Pills
Standard Deviation 3.69
|
|
Use of Concomitant and Rescue Medications
Week 8 - loratadine (N=26,21)
|
1.2 Pills
Standard Deviation 2.45
|
4.2 Pills
Standard Deviation 2.62
|
|
Use of Concomitant and Rescue Medications
Week 12 - clemastine (N=25,17)
|
1.1 Pills
Standard Deviation 3.81
|
1.8 Pills
Standard Deviation 3.80
|
|
Use of Concomitant and Rescue Medications
Week 12 - loratadine (N=25,19)
|
1.2 Pills
Standard Deviation 2.33
|
3.3 Pills
Standard Deviation 2.64
|
|
Use of Concomitant and Rescue Medications
Week 16 - clemastine (N=24,16)
|
0.2 Pills
Standard Deviation 0.72
|
1.4 Pills
Standard Deviation 2.13
|
|
Use of Concomitant and Rescue Medications
Week 16 - loratadine (N=24,17)
|
0.6 Pills
Standard Deviation 1.56
|
3.6 Pills
Standard Deviation 3.00
|
|
Use of Concomitant and Rescue Medications
Week 20 - clemastine (N=24,16)
|
0.9 Pills
Standard Deviation 3.88
|
2.2 Pills
Standard Deviation 2.88
|
|
Use of Concomitant and Rescue Medications
Week 20 - loratadine (N=24,17)
|
0.5 Pills
Standard Deviation 1.47
|
4.6 Pills
Standard Deviation 3.48
|
|
Use of Concomitant and Rescue Medications
Week 24 - clemastine (N=23,14)
|
0.7 Pills
Standard Deviation 2.72
|
1.4 Pills
Standard Deviation 2.13
|
|
Use of Concomitant and Rescue Medications
Week 24 - clemastine (N=23,16)
|
0.3 Pills
Standard Deviation 1.11
|
3.3 Pills
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (Week 24)Population: 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.
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.
Outcome measures
| Measure |
Omalizumab 75-375 mg
n=27 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24)
Baseline (N=27, 22)
|
10.1 Units on a scale
Standard Deviation 6.04
|
9.8 Units on a scale
Standard Deviation 5.29
|
|
Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24)
Week 24 (N=27,21)
|
3.7 Units on a scale
Standard Deviation 7.12
|
8.1 Units on a scale
Standard Deviation 6.11
|
|
Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24)
Week 24 minus Baseline (N=27,21)
|
-6.3 Units on a scale
Standard Deviation 8.36
|
-1.5 Units on a scale
Standard Deviation 5.83
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (Week 24)Population: 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.
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.
Outcome measures
| Measure |
Omalizumab 75-375 mg
n=27 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Change in the Skindex Score From Baseline to the End of the Study (Week 24)
Baseline (N=27,22)
|
1.8 Units on a scale
Standard Deviation 0.69
|
1.6 Units on a scale
Standard Deviation 0.53
|
|
Change in the Skindex Score From Baseline to the End of the Study (Week 24)
Week 24 (N=27,21)
|
0.9 Units on a scale
Standard Deviation 1.00
|
1.5 Units on a scale
Standard Deviation 0.79
|
|
Change in the Skindex Score From Baseline to the End of the Study (Week 24)
Week 24 minus Baseline (N=27,21)
|
-0.9 Units on a scale
Standard Deviation 0.89
|
-0.1 Units on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (Week 24)Population: 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.
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.
Outcome measures
| Measure |
Omalizumab 75-375 mg
n=27 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Baseline : Limits Looks (N=27,21)
|
31.5 Units on a scale
Standard Deviation 23.86
|
34.5 Units on a scale
Standard Deviation 24.97
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Baseline : Swelling/eating (N=27,22)
|
21.8 Units on a scale
Standard Deviation 20.17
|
26.7 Units on a scale
Standard Deviation 19.97
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Baseline : Sleep (N=27,22)
|
45.8 Units on a scale
Standard Deviation 24.02
|
46.6 Units on a scale
Standard Deviation 23.91
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Baseline : Mental status (N=27,22)
|
42.6 Units on a scale
Standard Deviation 21.72
|
42.4 Units on a scale
Standard Deviation 18.71
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Baseline : Functioning (N=27,22)
|
36.0 Units on a scale
Standard Deviation 22.47
|
30.7 Units on a scale
Standard Deviation 15.88
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Baseline : Itching/embarrassment (N=27,22)
|
58.1 Units on a scale
Standard Deviation 18.97
|
56.8 Units on a scale
Standard Deviation 14.80
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Baseline : Total score (N=27,22)
|
39.5 Units on a scale
Standard Deviation 16.34
|
38.9 Units on a scale
Standard Deviation 8.87
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Week 24 : Limits looks (N=27,21)
|
17.1 Units on a scale
Standard Deviation 20.26
|
23.2 Units on a scale
Standard Deviation 20.27
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Week 24 : Swelling/eating (N=27,21)
|
10.4 Units on a scale
Standard Deviation 23.58
|
27.4 Units on a scale
Standard Deviation 23.92
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Week 24 : Sleep (N=27,21)
|
27.3 Units on a scale
Standard Deviation 29.73
|
47.3 Units on a scale
Standard Deviation 27.36
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Week 24 : Mental status (N=27,21)
|
25.9 Units on a scale
Standard Deviation 27.77
|
40.1 Units on a scale
Standard Deviation 25.22
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Week 24 : Functioning (N=27,21)
|
11.9 Units on a scale
Standard Deviation 22.43
|
27.0 Units on a scale
Standard Deviation 20.73
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Week 24 : Itching/embarrassment (N=27,21)
|
22.9 Units on a scale
Standard Deviation 29.42
|
57.4 Units on a scale
Standard Deviation 22.41
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Week 24 : Total score (N=27,21)
|
18.5 Units on a scale
Standard Deviation 22.66
|
37.3 Units on a scale
Standard Deviation 16.22
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Week 24 - Baseline: Limits looks (N=27,20)
|
-14.4 Units on a scale
Standard Deviation 24.69
|
-9.4 Units on a scale
Standard Deviation 18.08
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Week 24 - Baseline: Swelling/eating (N=27,21)
|
-11.3 Units on a scale
Standard Deviation 22.40
|
-0.6 Units on a scale
Standard Deviation 18.74
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Week 24 - Baseline: Sleep (N=27,21)
|
-18.5 Units on a scale
Standard Deviation 27.05
|
-0.6 Units on a scale
Standard Deviation 23.13
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Week 24 - Baseline: Mental status (N=27,21)
|
-16.7 Units on a scale
Standard Deviation 27.35
|
-2.4 Units on a scale
Standard Deviation 19.57
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Week 24 - Baseline: Functioning (N=27,21)
|
-24.1 Units on a scale
Standard Deviation 23.94
|
-3.8 Units on a scale
Standard Deviation 21.08
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Week 24 - Baseline: itching/embarrassmen (N=27,21)
|
-35.2 Units on a scale
Standard Deviation 32.71
|
-0.9 Units on a scale
Standard Deviation 20.76
|
|
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Week 24 - Baseline: Total score (N=27,21)
|
-21.0 Units on a scale
Standard Deviation 21.97
|
-2.3 Units on a scale
Standard Deviation 14.14
|
SECONDARY outcome
Timeframe: At Baseline and at the end of the study (Week 24)Population: 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.
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.
Outcome measures
| Measure |
Omalizumab 75-375 mg
n=27 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Patient's Global Assessment of Their Chronic Urticaria Symptoms
Baseline: Missing
|
0 Participants
|
0 Participants
|
|
Patient's Global Assessment of Their Chronic Urticaria Symptoms
Baseline: No complaints
|
3 Participants
|
0 Participants
|
|
Patient's Global Assessment of Their Chronic Urticaria Symptoms
Baseline: Moderate complaints
|
13 Participants
|
13 Participants
|
|
Patient's Global Assessment of Their Chronic Urticaria Symptoms
Baseline: Severe complaints
|
11 Participants
|
8 Participants
|
|
Patient's Global Assessment of Their Chronic Urticaria Symptoms
Baseline: Maximum complaints
|
0 Participants
|
1 Participants
|
|
Patient's Global Assessment of Their Chronic Urticaria Symptoms
Week 24: Missing
|
1 Participants
|
1 Participants
|
|
Patient's Global Assessment of Their Chronic Urticaria Symptoms
Week 24: No complaints
|
16 Participants
|
3 Participants
|
|
Patient's Global Assessment of Their Chronic Urticaria Symptoms
Week 24: Moderate complaints
|
6 Participants
|
7 Participants
|
|
Patient's Global Assessment of Their Chronic Urticaria Symptoms
Week 24: Severe complaints
|
3 Participants
|
9 Participants
|
|
Patient's Global Assessment of Their Chronic Urticaria Symptoms
Week 24: Maximum complaints
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Baseline and at the end of the study (Week 24)Population: 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.
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.
Outcome measures
| Measure |
Omalizumab 75-375 mg
n=27 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
Baseline: Missing
|
1 Participants
|
0 Participants
|
|
Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
Baseline: None
|
1 Participants
|
0 Participants
|
|
Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
Baseline: Mild
|
7 Participants
|
9 Participants
|
|
Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
Baseline: Moderate
|
13 Participants
|
6 Participants
|
|
Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
Baseline: Severe
|
5 Participants
|
7 Participants
|
|
Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
Week 24: Missing
|
0 Participants
|
1 Participants
|
|
Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
Week 24: None
|
18 Participants
|
1 Participants
|
|
Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
Week 24: Mild
|
6 Participants
|
9 Participants
|
|
Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
Week 24: Moderate
|
1 Participants
|
4 Participants
|
|
Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
Week 24: Severe
|
2 Participants
|
7 Participants
|
Adverse Events
Omalizumab 75-375 mg
Placebo to Omalizumab
Serious adverse events
| Measure |
Omalizumab 75-375 mg
n=27 participants at risk
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
n=22 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Eye Infection
|
0.00%
0/27
|
4.5%
1/22
|
|
Nervous system disorders
Syncope
|
0.00%
0/27
|
4.5%
1/22
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/27
|
4.5%
1/22
|
Other adverse events
| Measure |
Omalizumab 75-375 mg
n=27 participants at risk
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
n=22 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/27
|
9.1%
2/22
|
|
Gastrointestinal disorders
Diarrhoea
|
14.8%
4/27
|
9.1%
2/22
|
|
General disorders
Injection Site Pain
|
0.00%
0/27
|
4.5%
1/22
|
|
Infections and infestations
Gastroenteritis
|
7.4%
2/27
|
0.00%
0/22
|
|
Infections and infestations
Gastrointestinal Infection
|
11.1%
3/27
|
9.1%
2/22
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
9/27
|
50.0%
11/22
|
|
Infections and infestations
Sinusitis
|
11.1%
3/27
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
3/27
|
4.5%
1/22
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.7%
1/27
|
9.1%
2/22
|
|
Nervous system disorders
Headache
|
37.0%
10/27
|
27.3%
6/22
|
|
Psychiatric disorders
Insomnia
|
7.4%
2/27
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
2/27
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/27
|
13.6%
3/22
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.4%
2/27
|
9.1%
2/22
|
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER