Trial Outcomes & Findings for Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy (NCT NCT01723072)

Last Updated: 2020-09-09

Results Overview

The CU-Q2oL is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It consists of 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Participants 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). An overall score is calculated and normalized to a scale of 1 to 100.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

91 participants

Primary outcome timeframe

Baseline, 4, 12, 20, 28 and 36 weeks

Results posted on

2020-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	Omalizumab Omalizumab once a month via subcutaneous injection.	Placebo Placebo of omalizumab once a month via subcutaneous injection
Overall Study STARTED	44	47
Overall Study COMPLETED	33	26
Overall Study NOT COMPLETED	11	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Omalizumab Omalizumab once a month via subcutaneous injection.	Placebo Placebo of omalizumab once a month via subcutaneous injection
Overall Study Withdrawal by Subject	7	13
Overall Study Discon for rescue medication after wk 24	0	5
Overall Study Other	4	3

Baseline Characteristics

Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omalizumab n=44 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=47 Participants Placebo of omalizumab once a month via subcutaneous injection	Total n=91 Participants Total of all reporting groups
Age, Continuous	44.9 years STANDARD_DEVIATION 13.7 • n=5 Participants	41.1 years STANDARD_DEVIATION 10.6 • n=7 Participants	42.9 years STANDARD_DEVIATION 12.3 • n=5 Participants
Age, Customized <65 years	41 Participants n=5 Participants	47 Participants n=7 Participants	88 Participants n=5 Participants
Age, Customized >=65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	33 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	42 Participants n=5 Participants	46 Participants n=7 Participants	88 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
BMI	27.3 kg/m^2 STANDARD_DEVIATION 6.3 • n=5 Participants	29.0 kg/m^2 STANDARD_DEVIATION 5.9 • n=7 Participants	28.2 kg/m^2 STANDARD_DEVIATION 6.1 • n=5 Participants
BMI group <18.5	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
BMI group 18.5-25	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
BMI group >25	24 Participants n=5 Participants	35 Participants n=7 Participants	59 Participants n=5 Participants
Smoking status Never smoked	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Smoking status Current smoker	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Smoking status Ex-smoker	7 Participants n=5 Participants	16 Participants n=7 Participants	23 Participants n=5 Participants
Disease history and baseline characteristics of angioedema (FAS) Daily	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Disease history and baseline characteristics of angioedema (FAS) Weekly	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Disease history and baseline characteristics of angioedema (FAS) >6 episodes per year	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Disease history and baseline characteristics of angioedema (FAS) <6 episodes a year	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
[Disease history and baseline characteristics of angioedema (FAS)] <24 hours	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
[Disease history and baseline characteristics of angioedema (FAS)] >24 hours	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Disease history and baseline characteristics of angioedema (FAS) Eyes/lids/periorbital	36 participants n=5 Participants	41 participants n=7 Participants	77 participants n=5 Participants
Disease history and baseline characteristics of angioedema (FAS) Lips/perioral	37 participants n=5 Participants	41 participants n=7 Participants	78 participants n=5 Participants
Disease history and baseline characteristics of angioedema (FAS) Mouth/laryngeal	22 participants n=5 Participants	28 participants n=7 Participants	50 participants n=5 Participants
Disease history and baseline characteristics of angioedema (FAS) Trunk	10 participants n=5 Participants	20 participants n=7 Participants	30 participants n=5 Participants
Disease history and baseline characteristics of angioedema (FAS) Arms/legs	24 participants n=5 Participants	28 participants n=7 Participants	52 participants n=5 Participants
Disease history and baseline characteristics of angioedema (FAS) Hands	27 participants n=5 Participants	34 participants n=7 Participants	61 participants n=5 Participants
Disease history and baseline charactaristics	8.4 years STANDARD_DEVIATION 9.3 • n=5 Participants	7.4 years STANDARD_DEVIATION 8.8 • n=7 Participants	7.9 years STANDARD_DEVIATION 9.0 • n=5 Participants
Disease history and baseline charactaristics <2 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Disease history and baseline charactaristics 2-10 years	18 Participants n=5 Participants	27 Participants n=7 Participants	45 Participants n=5 Participants
Disease history and baseline charactaristics >10 years	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Disease history and baseline charactaristics No	33 Participants n=5 Participants	32 Participants n=7 Participants	65 Participants n=5 Participants
Disease history and baseline charactaristics Yes	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Disease history and baseline charactaristics <=2 years	42 Participants n=5 Participants	40 Participants n=7 Participants	82 Participants n=5 Participants
Disease history and baseline charactaristics 3-5 years	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Disease history and baseline charactaristics >5 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4, 12, 20, 28 and 36 weeks

Population: full analysis set

Outcome measures

Outcome measures
Measure	Omalizumab n=44 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=47 Participants Placebo of omalizumab once a month via subcutaneous injection
Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS) V3 (week 4)	-25.5 score Standard Deviation 21.3	-6.4 score Standard Deviation 15.9
Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS) Follow-up (week 36)	-23.9 score Standard Deviation 23.0	-14.7 score Standard Deviation 19.2
Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS) V5 (week 12)	-32.1 score Standard Deviation 21.8	-12.1 score Standard Deviation 20.3
Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS) V7 (week 20)	-31.4 score Standard Deviation 23.7	-16.2 score Standard Deviation 18.8
Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS) V9 (week 28)	-35.1 score Standard Deviation 24.2	-13.9 score Standard Deviation 17.7

SECONDARY outcome

Timeframe: Baseline, week 28; and the follow-up period (weeks 29-36)

Population: full analysis set

Outcome measures

Outcome measures
Measure	Omalizumab n=44 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=47 Participants Placebo of omalizumab once a month via subcutaneous injection
Number of Angioedema Burdened Days by Study Phase (Observed Cases With Imputation) Screening (Week -2 to -1)	5.2 days Standard Deviation 3.9	6.8 days Standard Deviation 4.3
Number of Angioedema Burdened Days by Study Phase (Observed Cases With Imputation) Treatment (Week 1 to 28)	14.6 days Standard Deviation 19.5	49.5 days Standard Deviation 50.8
Number of Angioedema Burdened Days by Study Phase (Observed Cases With Imputation) Follow-up (Week 29 to 36)	5.8 days Standard Deviation 9.1	12.8 days Standard Deviation 16.2

SECONDARY outcome

Timeframe: Baseline to week 28

Population: full analysis set

Outcome measures

Outcome measures
Measure	Omalizumab n=44 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=47 Participants Placebo of omalizumab once a month via subcutaneous injection
Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes 1st to 2nd episode	20 days Standard Deviation 41.63	7.8 days Standard Deviation 14.29
Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes 2nd to 3rd episode	11.0 days Standard Deviation 19.52	7.2 days Standard Deviation 10.16
Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes 3rd to 4th episode	26.4 days Standard Deviation 50.73	8.3 days Standard Deviation 13.24
Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes 4th to 5th episode	14.9 days Standard Deviation 23.87	8.6 days Standard Deviation 20.44
Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes 5th to 6th episode	14.2 days Standard Deviation 20.54	13.6 days Standard Deviation 30.09
Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes 6th to 7th episode	11.2 days Standard Deviation 22.11	7.5 days Standard Deviation 11.32
Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes 7th to 8th episode	18.1 days Standard Deviation 29.41	9.1 days Standard Deviation 17.58
Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes 8th to 9th episode	10.7 days Standard Deviation 15.05	8.0 days Standard Deviation 12.26
Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes 9th to 10th episode	11.4 days Standard Deviation 20.16	8.7 days Standard Deviation 12.26
Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes 10th to 11th episode	11.5 days Standard Deviation 13.02	8.5 days Standard Deviation 10.41
Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes 11th to 12th episode	8.9 days Standard Deviation 9.42	9.4 days Standard Deviation 13.89
Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes 12th to 13th episode	6.0 days Standard Deviation 4.47	4.3 days Standard Deviation 4.43
Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes 13th to 14th episode	3.6 days Standard Deviation 3.02	7.3 days Standard Deviation 4.56
Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes 14th to 15th episode	6.9 days Standard Deviation 9.96	10.1 days Standard Deviation 11.86

SECONDARY outcome

Timeframe: Baseline to week 28; and follow-up period (to week 36)

Population: full analysis set

A cumulative activity score, evaluated in the screening period and throughout the study. The records each evening on a daily basis symptoms of itch and hives into a patient diary. min. score = 0 ; max. score= 100

Outcome measures

Outcome measures
Measure	Omalizumab n=44 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=47 Participants Placebo of omalizumab once a month via subcutaneous injection
Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation) Diary week 28	-20.6 AAS (Angioedema Activity Score) Standard Deviation 21.5	-10.8 AAS (Angioedema Activity Score) Standard Deviation 21.3
Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation) Diary week 4	-17.7 AAS (Angioedema Activity Score) Standard Deviation 20.0	-5.0 AAS (Angioedema Activity Score) Standard Deviation 18.2
Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation) Diary week 12	-19.0 AAS (Angioedema Activity Score) Standard Deviation 22.4	-9.0 AAS (Angioedema Activity Score) Standard Deviation 22.8
Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation) Diary week 20	-21.3 AAS (Angioedema Activity Score) Standard Deviation 21.6	-16.9 AAS (Angioedema Activity Score) Standard Deviation 21.0
Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation) Diary week 36	-9.6 AAS (Angioedema Activity Score) Standard Deviation 18.4	-15.3 AAS (Angioedema Activity Score) Standard Deviation 20.8

SECONDARY outcome

Timeframe: week -2 to -1

Population: full analysis set

data points per group

Outcome measures

Outcome measures
Measure	Omalizumab n=44 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=47 Participants Placebo of omalizumab once a month via subcutaneous injection
Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1) Acute swelling episode, Diameter <10cm	146 Number of episodes	165 Number of episodes
Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1) Acute swelling episode, Diameter 10-20cm	54 Number of episodes	99 Number of episodes
Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1) Acute swelling episode, Diameter >20cm	19 Number of episodes	46 Number of episodes
Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1) unknown	12 Number of episodes	15 Number of episodes

SECONDARY outcome

Timeframe: weeks 25 to 28

Population: actual patient numbers

data points per group

Outcome measures

Outcome measures
Measure	Omalizumab n=34 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=25 Participants Placebo of omalizumab once a month via subcutaneous injection
Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28) Acute swelling episode, Diameter 10-20cm	0 Number of episodes	94 Number of episodes
Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28) Acute swelling episode, Diameter 20cm	0 Number of episodes	24 Number of episodes
Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28) unknown	0 Number of episodes	12 Number of episodes
Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28) Acute swelling episode, Diameter <10cm	31 Number of episodes	76 Number of episodes

SECONDARY outcome

Timeframe: weeks 33 to 36

Population: full analysis set

data points per group

Outcome measures

Outcome measures
Measure	Omalizumab n=33 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=23 Participants Placebo of omalizumab once a month via subcutaneous injection
Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36) Acute swelling episode, Diameter <10cm	92 Number of episodes	90 Number of episodes
Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36) Acute swelling episode, Diameter 10-20cm	28 Number of episodes	58 Number of episodes
Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36) Acute swelling episode, Diameter >20cm	8 Number of episodes	19 Number of episodes
Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36) unknown	17 Number of episodes	18 Number of episodes

SECONDARY outcome

Timeframe: weeks -2 to -1

Population: full analysis set

data points per group

Outcome measures

Outcome measures
Measure	Omalizumab n=44 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=47 Participants Placebo of omalizumab once a month via subcutaneous injection
Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1) Shortness of breath: No	203 number of episodes	264 number of episodes
Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1) Shortness of breath: Slightly	13 number of episodes	25 number of episodes
Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1) Shortness of breath: Moderately	7 number of episodes	25 number of episodes
Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1) Shortness of breath: Severely	1 number of episodes	7 number of episodes
Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1) Unknown	7 number of episodes	4 number of episodes

SECONDARY outcome

Timeframe: weeks 25 to 28

Population: full analysis set

data points per group

Outcome measures

Outcome measures
Measure	Omalizumab n=31 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=25 Participants Placebo of omalizumab once a month via subcutaneous injection
Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28) Unknown	0 Number of episodes	1 Number of episodes
Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28) Shortness of breath: No	28 Number of episodes	195 Number of episodes
Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28) Shortness of breath: Slightly	3 Number of episodes	5 Number of episodes
Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28) Shortness of breath: Moderately	0 Number of episodes	5 Number of episodes
Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28) Shortness of breath: Severely	0 Number of episodes	0 Number of episodes

SECONDARY outcome

Timeframe: weeks 33 to 36

Population: full analysis set

data points per group

Outcome measures

Outcome measures
Measure	Omalizumab n=145 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=185 Participants Placebo of omalizumab once a month via subcutaneous injection
Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36) Shortness of breath: No	127 Number of episodes	172 Number of episodes
Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36) Shortness of breath: Slightly	14 Number of episodes	5 Number of episodes
Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36) Unknown	3 Number of episodes	4 Number of episodes
Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36) Shortness of breath: Moderately	1 Number of episodes	3 Number of episodes
Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36) Shortness of breath: Severely	0 Number of episodes	1 Number of episodes

SECONDARY outcome

Timeframe: baseline to week 28; and then follow-up to week 36

Population: full analysis set

The AE-Q2oL is a questionnaire for patients suffering from angioedema. It consists of 29 questions relevant to angioedema and its specific impact on quality of life. Patients are asked to respond how much they are troubled be each problem on a 5-point Likert scale (1= does not apply to 5= very much). An overall score is calculated and a higher score indicates lower quality of life. A negative change score (week 28 score minus baseline score) indicates improvement. Each AE-QoL question has 5 answer options (scored 1-5), with lower and higher scores indicting less and more adverse impact, respectively. The total score is calculated, which is then transformed into a linear scale that ranges from 0 to 100, with a score of 100 indicating the worst possible impairment of HRQoL

Outcome measures

Outcome measures
Measure	Omalizumab n=44 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=47 Participants Placebo of omalizumab once a month via subcutaneous injection
Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) week 12 (n= 35, 29)	-37.4 AE-QoL Score Standard Deviation 23.8	-20.4 AE-QoL Score Standard Deviation 27.4
Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) week 28 (n=34, 25)	-41.4 AE-QoL Score Standard Deviation 25.7	-24.2 AE-QoL Score Standard Deviation 24.3
Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) week 4 (n=38,36)	-26.5 AE-QoL Score Standard Deviation 20.4	-10.3 AE-QoL Score Standard Deviation 21.0
Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) week 20 (n=34,27)	-37.1 AE-QoL Score Standard Deviation 26.5	-28.8 AE-QoL Score Standard Deviation 22
Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) follow-up, week 36 (n=33,23)	-27.2 AE-QoL Score Standard Deviation 26.4	-24.6 AE-QoL Score Standard Deviation 23.3

SECONDARY outcome

Timeframe: baseline to 28 weeks

Population: safety set

Outcome measures

Outcome measures
Measure	Omalizumab n=44 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=47 Participants Placebo of omalizumab once a month via subcutaneous injection
Rescue Medication During the Treatment Period Prednisolone	3 participants	3 participants
Rescue Medication During the Treatment Period Any rescue medication	25 participants	35 participants
Rescue Medication During the Treatment Period Any nsH1 - antihistamine rescue medication	19 participants	27 participants
Rescue Medication During the Treatment Period Any clemastine rescue medication	12 participants	26 participants
Rescue Medication During the Treatment Period Any corticosteroid rescue medication	5 participants	13 participants
Rescue Medication During the Treatment Period Betamethasone	2 participants	12 participants
Rescue Medication During the Treatment Period Prednisolone succinate	2 participants	0 participants

SECONDARY outcome

Timeframe: baseline to 28 weeks

Population: safety set

data points per group

Outcome measures

Outcome measures
Measure	Omalizumab n=44 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=47 Participants Placebo of omalizumab once a month via subcutaneous injection
Days of Rescue Medication During the Treatment Period Any rescue medication	507 days	787 days
Days of Rescue Medication During the Treatment Period Any nsH1 - antihistamine rescue medication	403 days	524 days
Days of Rescue Medication During the Treatment Period Any clemastine rescue medication	92 days	236 days
Days of Rescue Medication During the Treatment Period Any corticosteroid rescue medication	25 days	113 days

SECONDARY outcome

Timeframe: weeks 33 to 36

Population: safety set

data points per group

Outcome measures

Outcome measures
Measure	Omalizumab n=44 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=47 Participants Placebo of omalizumab once a month via subcutaneous injection
Days of Rescue Medication During the Follow-up Period Any clemastine rescue medication	15 days	19 days
Days of Rescue Medication During the Follow-up Period Any corticosteroid rescue medication	0 days	17 days
Days of Rescue Medication During the Follow-up Period Any rescue medication	165 days	118 days
Days of Rescue Medication During the Follow-up Period Any nsH1 - antihistamine rescue medication	158 days	85 days

SECONDARY outcome

Timeframe: baseline to week 28; and then follow-up to week 36

Population: full analysis set

The UAS7 is the sum of urticaria activity scores over a seven day period. The possible range of the weekly UAS7 score is 0-42. 0 means complete response and a better outcome and 42 means no response and a worse outcome. Complete UAS7 response is defined as UAS7=0. The UAS7 is the sum of the Hive Severity Score over seven days (HSS7) and the Itch Severity Score over seven days (ISS7) . The Hive Severity Score has a scale of 0 (none) to 3 (intense/severe). Complete hives response is defined as HSS7=0. The Itch Severity Score has a scale of 0 (None) to 3 (Severe (difficult to tolerate)). Complete itch response is defined as ISS7=0

Outcome measures

Outcome measures
Measure	Omalizumab n=44 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=47 Participants Placebo of omalizumab once a month via subcutaneous injection
Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) week 4	-12.6 scores on a scale Standard Deviation 13.3	-3.0 scores on a scale Standard Deviation 9.4
Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) week 12	-16.4 scores on a scale Standard Deviation 14.3	-4.4 scores on a scale Standard Deviation 13.3
Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) week 20	-15.0 scores on a scale Standard Deviation 15.0	-7.2 scores on a scale Standard Deviation 14.7
Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) week 28	-16.8 scores on a scale Standard Deviation 14.8	-6.5 scores on a scale Standard Deviation 13.4
Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) follow-up, week 36	-8.3 scores on a scale Standard Deviation 15.3	-6.2 scores on a scale Standard Deviation 13.3

SECONDARY outcome

Timeframe: baseline to week 28; and follow-up to week 36

Population: full analysis set

change in Dermatology Quality of Life Index scores The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.

Outcome measures

Outcome measures
Measure	Omalizumab n=44 Participants Omalizumab once a month via subcutaneous injection.	Placebo n=46 Participants Placebo of omalizumab once a month via subcutaneous injection
Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) week 4	-8.3 DLQI Score Standard Deviation 7.3	-2.4 DLQI Score Standard Deviation 6.9
Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) week 12	-10.1 DLQI Score Standard Deviation 7.5	-3.9 DLQI Score Standard Deviation 7.6
Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) week 20	-9.5 DLQI Score Standard Deviation 8.4	-5.1 DLQI Score Standard Deviation 8.3
Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) week 28	-10.5 DLQI Score Standard Deviation 8.3	-5.6 DLQI Score Standard Deviation 8.0
Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) follow-up, week 36	-6.8 DLQI Score Standard Deviation 8.6	-5.4 DLQI Score Standard Deviation 8.3

Adverse Events

Omalizumab

Serious events: 4 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Omalizumab n=44 participants at risk Omalizumab once a month via subcutaneous injection.	Placebo n=47 participants at risk Placebo of omalizumab once a month via subcutaneous injection
Injury, poisoning and procedural complications Alcohol poisoning	2.3% 1/44	0.00% 0/47
Injury, poisoning and procedural complications Femur fracture	2.3% 1/44	0.00% 0/47
Injury, poisoning and procedural complications Intentional overdose	2.3% 1/44	0.00% 0/47
Injury, poisoning and procedural complications Joint dislocation	2.3% 1/44	0.00% 0/47
Injury, poisoning and procedural complications Ligament injury	0.00% 0/44	2.1% 1/47
Injury, poisoning and procedural complications Pelvic fracture	2.3% 1/44	0.00% 0/47
Nervous system disorders Sciatica	2.3% 1/44	0.00% 0/47
Psychiatric disorders Suicide attempt	2.3% 1/44	0.00% 0/47
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.3% 1/44	0.00% 0/47
Skin and subcutaneous tissue disorders Angioedema	2.3% 1/44	0.00% 0/47
Vascular disorders Hypertension	0.00% 0/44	2.1% 1/47

Other adverse events

Other adverse events
Measure	Omalizumab n=44 participants at risk Omalizumab once a month via subcutaneous injection.	Placebo n=47 participants at risk Placebo of omalizumab once a month via subcutaneous injection
Gastrointestinal disorders Abdominal pain upper	0.00% 0/44	8.5% 4/47
Gastrointestinal disorders Diarrhoea	6.8% 3/44	10.6% 5/47
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/44	4.3% 2/47
General disorders Fatigue	4.5% 2/44	4.3% 2/47
General disorders Pyrexia	0.00% 0/44	4.3% 2/47
Infections and infestations Nasopharyngitis	20.5% 9/44	27.7% 13/47
Infections and infestations Sinusitis	4.5% 2/44	0.00% 0/47
Investigations Hepatic enzyme increased	0.00% 0/44	4.3% 2/47
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/44	8.5% 4/47
Musculoskeletal and connective tissue disorders Back pain	6.8% 3/44	6.4% 3/47
Nervous system disorders Dizziness	4.5% 2/44	2.1% 1/47
Nervous system disorders Headache	9.1% 4/44	8.5% 4/47
Skin and subcutaneous tissue disorders Angioedema	2.3% 1/44	4.3% 2/47
Skin and subcutaneous tissue disorders Urticaria	2.3% 1/44	12.8% 6/47
Vascular disorders Hypertension	2.3% 1/44	6.4% 3/47

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 1-888-669-6682

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. Publications from a single-site are postponed until publication of the pooled clinical trial data (i.e., data from all sites) or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER