Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1) (NCT NCT01292473)
NCT ID: NCT01292473
Last Updated: 2013-10-11
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
323 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2013-10-11
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo subcutaneously (sc) every 4 weeks.
|
Omalizumab 75 mg
Omalizumab 75 mg sc every 4 weeks.
|
Omalizumab 150 mg
Omalizumab 150 mg sc every 4 weeks.
|
Omalizumab 300 mg
Omalizumab 300 mg sc every 4 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
79
|
82
|
83
|
79
|
|
Overall Study
COMPLETED
|
74
|
75
|
74
|
67
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
9
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Placebo subcutaneously (sc) every 4 weeks.
|
Omalizumab 75 mg
Omalizumab 75 mg sc every 4 weeks.
|
Omalizumab 150 mg
Omalizumab 150 mg sc every 4 weeks.
|
Omalizumab 300 mg
Omalizumab 300 mg sc every 4 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
3
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Disease Progression
|
0
|
1
|
3
|
6
|
Baseline Characteristics
A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
Baseline characteristics by cohort
| Measure |
Placebo
n=79 Participants
Placebo administered subcutaneously (sc) every 4 weeks.
|
Omalizumab 75 mg
n=82 Participants
Omalizumab 75 mg sc every 4 weeks.
|
Omalizumab 150 mg
n=82 Participants
Omalizumab 150 mg sc every 4 weeks.
|
Omalizumab 300 mg
n=79 Participants
Omalizumab 300 mg sc every 4 weeks.
|
Total
n=322 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
43.1 Years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
39.7 Years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
43.0 Years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
44.3 Years
STANDARD_DEVIATION 13.7 • n=4 Participants
|
42.5 Years
STANDARD_DEVIATION 13.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
244 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Modified intent-to-treat population: All randomized patients who received at least one 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=79 Participants
Placebo administered subcutaneously (sc) every 4 weeks
|
Omalizumab 75 mg
n=82 Participants
Omalizumab 75 mg sc every 4 weeks
|
Omalizumab 150 mg
n=82 Participants
Omalizumab 150 mg sc every 4 weeks.
|
Omalizumab 300 mg
n=79 Participants
Omalizumab 300 mg sc every 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in the Weekly Itch Severity Score at Week 12
|
-5.14 Units on a scale
Standard Deviation 5.58
|
-5.87 Units on a scale
Standard Deviation 6.45
|
-8.14 Units on a scale
Standard Deviation 6.44
|
-9.77 Units on a scale
Standard Deviation 5.95
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.
The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.
Outcome measures
| Measure |
Placebo
n=79 Participants
Placebo administered subcutaneously (sc) every 4 weeks
|
Omalizumab 75 mg
n=82 Participants
Omalizumab 75 mg sc every 4 weeks
|
Omalizumab 150 mg
n=82 Participants
Omalizumab 150 mg sc every 4 weeks.
|
Omalizumab 300 mg
n=79 Participants
Omalizumab 300 mg sc every 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in the Weekly Urticaria Activity Score (UAS7) at Week 12
|
-10.36 Units on a scale
Standard Deviation 11.61
|
-13.08 Units on a scale
Standard Deviation 12.67
|
-17.89 Units on a scale
Standard Deviation 13.23
|
-21.74 Units on a scale
Standard Deviation 12.78
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Modified intent-to-treat population: All randomized patients who received at least one 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=79 Participants
Placebo administered subcutaneously (sc) every 4 weeks
|
Omalizumab 75 mg
n=82 Participants
Omalizumab 75 mg sc every 4 weeks
|
Omalizumab 150 mg
n=82 Participants
Omalizumab 150 mg sc every 4 weeks.
|
Omalizumab 300 mg
n=79 Participants
Omalizumab 300 mg sc every 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in the Weekly Number of Hives Score at Week 12
|
-5.22 Units on a scale
Standard Deviation 6.56
|
-7.21 Units on a scale
Standard Deviation 6.96
|
-9.75 Units on a scale
Standard Deviation 7.28
|
-11.97 Units on a scale
Standard Deviation 7.58
|
SECONDARY outcome
Timeframe: by Week 12Population: Modified intent-to-treat population: All randomized patients who received at least one 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. The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. The time to weekly itch severity score MID response was defined as the time (in weeks) from Day 1 to the study week when weekly itch severity score MID response was first achieved.
Outcome measures
| Measure |
Placebo
n=79 Participants
Placebo administered subcutaneously (sc) every 4 weeks
|
Omalizumab 75 mg
n=82 Participants
Omalizumab 75 mg sc every 4 weeks
|
Omalizumab 150 mg
n=82 Participants
Omalizumab 150 mg sc every 4 weeks.
|
Omalizumab 300 mg
n=79 Participants
Omalizumab 300 mg sc every 4 weeks.
|
|---|---|---|---|---|
|
Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12
|
4.0 Weeks
Interval 3.0 to 5.0
|
2.0 Weeks
Interval 2.0 to 3.0
|
2.0 Weeks
Interval 1.0 to 2.0
|
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 one dose of study drug.
The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.
Outcome measures
| Measure |
Placebo
n=79 Participants
Placebo administered subcutaneously (sc) every 4 weeks
|
Omalizumab 75 mg
n=82 Participants
Omalizumab 75 mg sc every 4 weeks
|
Omalizumab 150 mg
n=82 Participants
Omalizumab 150 mg sc every 4 weeks.
|
Omalizumab 300 mg
n=79 Participants
Omalizumab 300 mg sc every 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With a UAS7 Less Than or Equal to 6 at Week 12
|
19.0 Percentage of participants
|
26.8 Percentage of participants
|
42.7 Percentage of participants
|
65.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Modified intent-to-treat population: All randomized patients who received at least one 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. The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. This outcome measure shows the percentage of participants classified as MID Responders at Week 12, meaning their weekly itch severity scores at Week 12 were at least 5 points lower than at Baseline.
Outcome measures
| Measure |
Placebo
n=79 Participants
Placebo administered subcutaneously (sc) every 4 weeks
|
Omalizumab 75 mg
n=82 Participants
Omalizumab 75 mg sc every 4 weeks
|
Omalizumab 150 mg
n=82 Participants
Omalizumab 150 mg sc every 4 weeks.
|
Omalizumab 300 mg
n=79 Participants
Omalizumab 300 mg sc every 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Weekly Itch Severity Score MID Responders at Week 12
|
48.1 Percentage of participants
|
56.1 Percentage of participants
|
69.5 Percentage of participants
|
78.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.
The size of the largest hive is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (\> 2.5 cm). The daily score is the average of the morning and evening scores. The weekly size of the largest hive score is the sum of the daily scores over 7 days, and ranges from 0 to 21. The Baseline weekly size of the largest hive score is the sum of daily scores 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=79 Participants
Placebo administered subcutaneously (sc) every 4 weeks
|
Omalizumab 75 mg
n=82 Participants
Omalizumab 75 mg sc every 4 weeks
|
Omalizumab 150 mg
n=82 Participants
Omalizumab 150 mg sc every 4 weeks.
|
Omalizumab 300 mg
n=79 Participants
Omalizumab 300 mg sc every 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12
|
-4.04 Units on a scale
Standard Deviation 5.55 • Interval -18.5 to 7.5
|
-6.52 Units on a scale
Standard Deviation 6.33 • Interval -5.61 to -1.9
|
-7.84 Units on a scale
Standard Deviation 6.75 • Interval -12.61 to -9.39
|
-11.00 Units on a scale
Standard Deviation 7.18
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Modified intent-to-treat population: All randomized patients who received at least one dose of study drug and who had a DLQI score at Week 12.
The dermatology life quality index (DLQI) is a 10-item dermatology-specific health-related quality of life measure. Participants rate 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=69 Participants
Placebo administered subcutaneously (sc) every 4 weeks
|
Omalizumab 75 mg
n=68 Participants
Omalizumab 75 mg sc every 4 weeks
|
Omalizumab 150 mg
n=70 Participants
Omalizumab 150 mg sc every 4 weeks.
|
Omalizumab 300 mg
n=73 Participants
Omalizumab 300 mg sc every 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) at Week 12
|
-6.09 Units on a scale
Standard Deviation 7.47
|
-7.50 Units on a scale
Standard Deviation 7.16
|
-8.29 Units on a scale
Standard Deviation 6.31
|
-10.15 Units on a scale
Standard Deviation 6.83
|
SECONDARY outcome
Timeframe: Week 4 to Week 12Population: Modified intent-to-treat population: All randomized patients who received at least one dose of study drug. Patients who withdrew before the Week 4 visit or who had missing responses for more than 40% of the daily diary entries between the Week 4 visit and the Week 12 visit were not included in the analysis.
The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days a patient reported as angioedema-free 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=70 Participants
Placebo administered subcutaneously (sc) every 4 weeks
|
Omalizumab 75 mg
n=71 Participants
Omalizumab 75 mg sc every 4 weeks
|
Omalizumab 150 mg
n=74 Participants
Omalizumab 150 mg sc every 4 weeks.
|
Omalizumab 300 mg
n=74 Participants
Omalizumab 300 mg sc every 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Angioedema-free Days From Week 4 to Week 12
|
89.2 Percentage of days
Standard Deviation 19.0
|
93.5 Percentage of days
Standard Deviation 14.9
|
91.6 Percentage of days
Standard Deviation 17.4
|
95.5 Percentage of days
Standard Deviation 14.5
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Omalizumab 75 mg
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Omalizumab 150 mg
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Omalizumab 300 mg
Serious events: 5 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=79 participants at risk
Placebo administered subcutaneously (sc) every 4 weeks.
|
Omalizumab 75 mg
n=76 participants at risk
Omalizumab 75 mg sc every 4 weeks.
|
Omalizumab 150 mg
n=88 participants at risk
Omalizumab 150 mg sc every 4 weeks.
|
Omalizumab 300 mg
n=79 participants at risk
Omalizumab 300 mg sc every 4 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Haemorrhoids
|
1.3%
1/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
1.3%
1/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.3%
1/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
1.3%
1/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
1.1%
1/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
1.3%
1/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Skin and subcutaneous tissue disorders
Malignant melanoma in situ
|
0.00%
0/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
1.3%
1/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
1.3%
1/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Skin and subcutaneous tissue disorders
Idiopathic urticaria
|
0.00%
0/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
1.1%
1/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
1.3%
1/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
1.1%
1/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
Other adverse events
| Measure |
Placebo
n=79 participants at risk
Placebo administered subcutaneously (sc) every 4 weeks.
|
Omalizumab 75 mg
n=76 participants at risk
Omalizumab 75 mg sc every 4 weeks.
|
Omalizumab 150 mg
n=88 participants at risk
Omalizumab 150 mg sc every 4 weeks.
|
Omalizumab 300 mg
n=79 participants at risk
Omalizumab 300 mg sc every 4 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
4/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
2.6%
2/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
4.5%
4/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
3.8%
3/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Infections and infestations
Nasopharyngitis
|
19.0%
15/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
17.1%
13/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
17.0%
15/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
15.2%
12/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.9%
7/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
2.3%
2/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
7.6%
6/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Infections and infestations
Influenza
|
5.1%
4/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
6.6%
5/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
3.4%
3/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
2.5%
2/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Infections and infestations
Sinusitis
|
2.5%
2/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
3.9%
3/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
2.3%
2/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
7.6%
6/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Infections and infestations
Bronchitis
|
2.5%
2/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
5.3%
4/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
3.8%
3/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
5.3%
4/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
3.4%
3/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
0.00%
0/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
4/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
1.3%
1/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
2.3%
2/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
5.1%
4/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Nervous system disorders
Headache
|
8.9%
7/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
5.3%
4/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
20.5%
18/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
11.4%
9/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
3/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
5.3%
4/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
2.3%
2/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
2.5%
2/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
|
Skin and subcutaneous tissue disorders
Idiopathic urticaria
|
3.8%
3/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
10.5%
8/76 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
6.8%
6/88 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
5.1%
4/79 • Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
|
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