Trial Outcomes & Findings for A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment (NCT NCT01287117)
NCT ID: NCT01287117
Last Updated: 2013-11-27
Results Overview
The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
319 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2013-11-27
Participant Flow
Randomized population: All randomized participants regardless of whether they received any study drug.
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 75 mg
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 150 mg
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 300 mg
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
80
|
78
|
80
|
81
|
|
Overall Study
Received Treatment
|
80
|
77
|
80
|
81
|
|
Overall Study
COMPLETED
|
65
|
64
|
64
|
69
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
16
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 75 mg
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 150 mg
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 300 mg
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
1
|
|
Overall Study
Patient/Legal Guardian's Decision
|
2
|
6
|
8
|
5
|
|
Overall Study
Disease Progression
|
10
|
5
|
6
|
5
|
Baseline Characteristics
A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment
Baseline characteristics by cohort
| Measure |
Placebo
n=80 Participants
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 75 mg
n=77 Participants
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 150 mg
n=80 Participants
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 300 mg
n=81 Participants
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Total
n=318 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
40.4 years
STANDARD_DEVIATION 15.6 • n=93 Participants
|
40.7 years
STANDARD_DEVIATION 15.2 • n=4 Participants
|
41.1 years
STANDARD_DEVIATION 14.0 • n=27 Participants
|
42.4 years
STANDARD_DEVIATION 13.2 • n=483 Participants
|
41.2 years
STANDARD_DEVIATION 14.5 • n=36 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
60 Participants
n=483 Participants
|
231 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
87 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.
The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 75 mg
n=77 Participants
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 150 mg
n=80 Participants
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 300 mg
n=81 Participants
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in the Weekly Itch Severity Score
|
-3.63 Units on a scale
Standard Deviation 5.22
|
-6.46 Units on a scale
Standard Deviation 6.14
|
-6.66 Units on a scale
Standard Deviation 6.28
|
-9.40 Units on a scale
Standard Deviation 5.73
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.
The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 75 mg
n=77 Participants
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 150 mg
n=80 Participants
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 300 mg
n=81 Participants
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)
|
-8.01 Units on a scale
Standard Deviation 11.47
|
-13.82 Units on a scale
Standard Deviation 13.26
|
-14.44 Units on a scale
Standard Deviation 12.95
|
-20.75 Units on a scale
Standard Deviation 12.17
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.
The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (\> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 75 mg
n=77 Participants
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 150 mg
n=80 Participants
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 300 mg
n=81 Participants
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in the Weekly Number of Hives Score
|
-4.37 Units on a scale
Standard Deviation 6.60
|
-7.36 Units on a scale
Standard Deviation 7.52
|
-7.78 Units on a scale
Standard Deviation 7.08
|
-11.35 Units on a scale
Standard Deviation 7.25
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.
The time to the MID response is the number of weeks from the start of treatment (Baseline) until the time point at which the first MID response occurs. The MID response is defined as a reduction ≥ 5 points from Baseline in the weekly itch severity score.
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 75 mg
n=57 Participants
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 150 mg
n=66 Participants
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 300 mg
n=76 Participants
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
|---|---|---|---|---|
|
Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12
|
4.0 Weeks
Interval 2.0 to 6.0
|
3.0 Weeks
Interval 2.0 to 5.0
|
2.0 Weeks
Interval 2.0 to 3.0
|
1.0 Weeks
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Week 12Population: Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.
The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 75 mg
n=77 Participants
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 150 mg
n=80 Participants
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 300 mg
n=81 Participants
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
|---|---|---|---|---|
|
Percentage of Participants With a UAS7 Score ≤ 6 at Week 12
|
11.3 Percentage of participants
|
26.0 Percentage of participants
|
40.0 Percentage of participants
|
51.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.
The percentage of participants with an itch severity score at 12 Weeks at least 5 points lower than at Baseline.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 75 mg
n=77 Participants
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 150 mg
n=80 Participants
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 300 mg
n=81 Participants
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
|---|---|---|---|---|
|
Percentage of Weekly Itch Severity Score MID Responders at Week 12
|
36.3 Percentage of participants
|
55.8 Percentage of participants
|
56.3 Percentage of participants
|
75.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.
The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (\> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 75 mg
n=77 Participants
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 150 mg
n=80 Participants
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 300 mg
n=81 Participants
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score
|
-3.93 Units on a scale
Standard Deviation 5.44
|
-6.20 Units on a scale
Standard Deviation 6.29
|
-6.96 Units on a scale
Standard Deviation 6.68
|
-9.79 Units on a scale
Standard Deviation 6.66
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.
The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 75 mg
n=66 Participants
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 150 mg
n=63 Participants
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 300 mg
n=72 Participants
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12
|
-6.13 Units on a scale
Standard Deviation 6.25
|
-6.33 Units on a scale
Standard Deviation 6.08
|
-8.00 Units on a scale
Standard Deviation 7.24
|
-10.29 Units on a scale
Standard Deviation 7.23
|
SECONDARY outcome
Timeframe: Week 4 to Week 12Population: Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.
The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days for which a patient responded "No" to the angioedema question in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.
Outcome measures
| Measure |
Placebo
n=66 Participants
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 75 mg
n=69 Participants
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 150 mg
n=70 Participants
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 300 mg
n=74 Participants
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
|---|---|---|---|---|
|
Percentage of Angioedema-free Days From Week 4 to Week 12
|
88.2 Percentage
Standard Deviation 19.4
|
86.5 Percentage
Standard Deviation 28.4
|
89.6 Percentage
Standard Deviation 20.6
|
96.1 Percentage
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: Week 12Population: Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.
A complete responder was defined as a participant with a UAS7 score = 0 at Week 12.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 75 mg
n=77 Participants
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 150 mg
n=80 Participants
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 300 mg
n=81 Participants
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
|---|---|---|---|---|
|
Percentage of Complete Responders (UAS7 = 0) at Week 12
|
8.8 Percentage of participants
|
11.7 Percentage of participants
|
15.0 Percentage of participants
|
35.8 Percentage of participants
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 38 other events
Deaths: 0 deaths
Omalizumab 75 mg
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Omalizumab 150 mg
Serious events: 5 serious events
Other events: 46 other events
Deaths: 0 deaths
Omalizumab 300 mg
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=80 participants at risk
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 75 mg
n=70 participants at risk
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 150 mg
n=87 participants at risk
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 300 mg
n=81 participants at risk
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
1.1%
1/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
1.2%
1/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
1.1%
1/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.2%
1/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.2%
1/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Shock hypoglycaemic
|
0.00%
0/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
1.2%
1/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
1.1%
1/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
1.2%
1/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
1.1%
1/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Idiopathic urticaria
|
1.2%
1/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
1.1%
1/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
1.1%
1/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
1.1%
1/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=80 participants at risk
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 75 mg
n=70 participants at risk
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 150 mg
n=87 participants at risk
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
Omalizumab 300 mg
n=81 participants at risk
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
21.2%
17/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
7.1%
5/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
16.1%
14/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
12.3%
10/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
6.2%
5/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
8.6%
6/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
8.0%
7/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
6.2%
5/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
3/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
8.6%
6/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
4.6%
4/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
4.9%
4/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
7.5%
6/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
7.1%
5/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
2.3%
2/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
2.5%
2/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
3/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
4.3%
3/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
8.0%
7/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
2.5%
2/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
4.3%
3/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
5.7%
5/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
4.9%
4/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
5.0%
4/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
7.1%
5/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
13.8%
12/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
8.6%
7/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.0%
4/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
4.6%
4/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
2.5%
2/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
4/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
2.9%
2/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
5.7%
5/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
3/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
5.7%
4/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
3.4%
3/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Idiopathic urticaria
|
5.0%
4/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
14.3%
10/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
8.0%
7/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
13.6%
11/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
8/80 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
11.4%
8/70 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
8.0%
7/87 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
6.2%
5/81 • Adverse events were reported starting with the first dose of study drug through the end of the study (up to 40 weeks).
Safety population: All randomized participants who received at least 1 dose of study drug.
|
Additional Information
Medical Communications
Genentech, Inc.
Phone: 800 821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER