Trial Outcomes & Findings for A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria (NCT NCT02392624)

Last Updated: 2018-03-29

Results Overview

Urticaria activity score (UAS) is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals (hives) per 24 hours and the intensity of the pruritus (itch). The total UAS score (sum of the wheal and pruritus scores) ranges from 0 to 6. Due to variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Clinical worsening in CIU was defined as UAS7 \>/=12 for at least 2 consecutive weeks post-randomization between Weeks 24 and 48.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

206 participants

Primary outcome timeframe

From randomization (Week 24) to Week 48

Results posted on

2018-03-29

Participant Flow

A total of 206 participants were enrolled in the study, but only 205 participants received at least one dose of any study treatment. Results include only the treated 205 participants.

Participant milestones

Participant milestones
Measure	Omalizumab (Non-Randomized Participants) Participants received open-label omalizumab treatment at a dose of 300 milligrams (mg) via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks. After Week 24, participants did not receive any treatment and only returned for a final follow-up visit (12 weeks after Week 24 visit).	Omalizumab (Randomized Participants) Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their chronic idiopathic urticaria (CIU) (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.	Placebo (Randomized Participants) Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
Overall Study STARTED	71	81	53
Overall Study COMPLETED	0	66	40
Overall Study NOT COMPLETED	71	15	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Omalizumab (Non-Randomized Participants) Participants received open-label omalizumab treatment at a dose of 300 milligrams (mg) via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks. After Week 24, participants did not receive any treatment and only returned for a final follow-up visit (12 weeks after Week 24 visit).	Omalizumab (Randomized Participants) Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their chronic idiopathic urticaria (CIU) (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.	Placebo (Randomized Participants) Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
Overall Study Withdrawal by Subject	15	12	9
Overall Study Adverse Event	4	1	2
Overall Study Pregnancy	1	0	0
Overall Study Protocol Violation	0	0	1
Overall Study Sponsor/Investigator Decision	2	1	0
Overall Study Other	49	1	1

Baseline Characteristics

A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omalizumab (Non-Randomized Participants) n=71 Participants Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After Week 24, participants did not receive any treatment and only returned for a final follow-up visit (12 weeks after Week 24 visit).	Omalizumab (Randomized Participants) n=81 Participants Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.	Placebo (Randomized Participants) n=53 Participants Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.	Total n=205 Participants Total of all reporting groups
Age, Continuous	43.5 years STANDARD_DEVIATION 14.76 • n=5 Participants	43.1 years STANDARD_DEVIATION 14.68 • n=7 Participants	48.5 years STANDARD_DEVIATION 13.22 • n=5 Participants	44.6 years STANDARD_DEVIATION 14.46 • n=4 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	60 Participants n=7 Participants	40 Participants n=5 Participants	153 Participants n=4 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	21 Participants n=7 Participants	13 Participants n=5 Participants	52 Participants n=4 Participants
Race/Ethnicity, Customized Race: American Indian or Alaska Native	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Race/Ethnicity, Customized Race: Asian	0 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants	5 participants n=4 Participants
Race/Ethnicity, Customized Race: Black or African American	10 participants n=5 Participants	6 participants n=7 Participants	7 participants n=5 Participants	23 participants n=4 Participants
Race/Ethnicity, Customized Race: White	58 participants n=5 Participants	68 participants n=7 Participants	42 participants n=5 Participants	168 participants n=4 Participants
Race/Ethnicity, Customized Race: Mixed/Unknown	3 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	7 participants n=4 Participants
Race/Ethnicity, Customized Ethnicity: Hispanic or Latino	20 participants n=5 Participants	18 participants n=7 Participants	5 participants n=5 Participants	43 participants n=4 Participants
Race/Ethnicity, Customized Ethnicity: Not Hispanic or Latino	50 participants n=5 Participants	63 participants n=7 Participants	48 participants n=5 Participants	161 participants n=4 Participants
Race/Ethnicity, Customized Ethnicity: Unknown	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants

PRIMARY outcome

Timeframe: From randomization (Week 24) to Week 48

Population: Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of blinded study drug, and achieved one post-baseline efficacy assessment.

Outcome measures

Outcome measures
Measure	Omalizumab (Randomized Participants) n=81 Participants Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.	Placebo (Randomized Participants) n=53 Participants Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by Urticaria Activity Score Over 7 Days (UAS7) (Clinical Worsening: UAS7 Greater Than or Equal to [>/=] 12, Maintained for At Least 2 Consecutive Weeks)	21.0 percentage of participants Interval 12.7 to 31.5	60.4 percentage of participants Interval 46.0 to 73.5

SECONDARY outcome

Timeframe: From randomization (Week 24) to Week 48

Population: Analysis was performed on mITT population.

The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Time to clinical worsening in CIU was defined as the number of weeks from the first double-blind treatment to the first two-week interval with UAS7 \>/=12 for both weeks. If clinical worsening did not occur, time to clinical worsening was censored at the end of the last week for which the UAS7 score was not missing and less than (\<) 12, prior to last randomized dose + 4 weeks, or the first open-label transition dose, whichever was earlier. Median time to clinical worsening was estimated using Kaplan-Meier analysis and corresponding 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.

Outcome measures

Outcome measures
Measure	Omalizumab (Randomized Participants) n=81 Participants Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.	Placebo (Randomized Participants) n=53 Participants Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
Time to Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 >/=12, Maintained for At Least 2 Consecutive Weeks)	NA weeks Median and corresponding 95% CI could not be estimated due to higher number of censored participants.	12.0 weeks Interval 9.0 to Upper limit of 95% CI could not be estimated due to higher number of censored participants.

SECONDARY outcome

Timeframe: From randomization (Week 24) to Week 48

Population: Analysis was performed on mITT population.

Outcome measures

Outcome measures
Measure	Omalizumab (Randomized Participants) n=81 Participants Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.	Placebo (Randomized Participants) n=53 Participants Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 Greater Than [>] 6, Maintained for At Least 2 Consecutive Weeks)	32.1 percentage of participants Interval 22.2 to 43.4	64.2 percentage of participants Interval 49.8 to 76.9

SECONDARY outcome

Timeframe: Week 24 (randomization) and Week 48

Population: Analysis was performed on participants in mITT population who received total 48 weeks of treatment with omalizumab. If UAS7 data was missing, last observation carry forward (LOCF) method was used post-Week 24 for the closest non-missing UAS7 data up to Week 48.

Outcome measures

Outcome measures
Measure	Omalizumab (Randomized Participants) n=72 Participants Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.	Placebo (Randomized Participants) Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
Change From Randomization (Week 24) to Week 48 in UAS7 Among Participants Who Received Total 48 Weeks Treatment With Omalizumab Week 24 (Randomization)	0.69 units on a scale Standard Deviation 1.448	—
Change From Randomization (Week 24) to Week 48 in UAS7 Among Participants Who Received Total 48 Weeks Treatment With Omalizumab Change at Week 48	1.77 units on a scale Standard Deviation 6.470	—

SECONDARY outcome

Timeframe: At start of retreatment (any time between Weeks 24 and Week 48) and 12 weeks after retreatment (up to Week 60)

Population: Analysis was performed on participants in mITT population who were randomized to placebo arm and who were retreated with open-label omalizumab after randomization. Here, 'Number Analyzed' signifies number of participants with available data for this outcome at specified time-point.

Outcome measures

Outcome measures
Measure	Omalizumab (Randomized Participants) n=19 Participants Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.	Placebo (Randomized Participants) Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
Retreatment Efficacy: Change From Time of Retreatment to 12 Weeks After Retreatment in UAS7 Among Participants Randomized to Placebo and Who Were Retreated With Open-Label Omalizumab After Randomization UAS7 at the Time of Retreatment	30.51 units on a scale Standard Deviation 8.831	—
Retreatment Efficacy: Change From Time of Retreatment to 12 Weeks After Retreatment in UAS7 Among Participants Randomized to Placebo and Who Were Retreated With Open-Label Omalizumab After Randomization Change at 12 Weeks After Retreatment	-29.48 units on a scale Standard Deviation 9.632	—

Adverse Events

Omalizumab (Non-Randomized Participants)

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Omalizumab (Randomized Participants)

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo (Randomized Participants)

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Omalizumab (Non-Randomized Participants) n=71 participants at risk Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After Week 24, participants did not receive any treatment and only returned for a final follow-up visit (12 weeks after Week 24 visit).	Omalizumab (Randomized Participants) n=81 participants at risk Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.	Placebo (Randomized Participants) n=53 participants at risk Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
Blood and lymphatic system disorders Anaemia	0.00% 0/71 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	0.00% 0/81 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	1.9% 1/53 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.
Cardiac disorders Acute myocardial infarction	0.00% 0/71 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	1.2% 1/81 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	0.00% 0/53 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.
Gastrointestinal disorders Abdominal pain	0.00% 0/71 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	0.00% 0/81 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	1.9% 1/53 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/71 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	0.00% 0/81 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	1.9% 1/53 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.
Infections and infestations Pneumonia	0.00% 0/71 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	1.2% 1/81 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	0.00% 0/53 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/71 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	0.00% 0/81 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	1.9% 1/53 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.

Other adverse events

Other adverse events
Measure	Omalizumab (Non-Randomized Participants) n=71 participants at risk Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After Week 24, participants did not receive any treatment and only returned for a final follow-up visit (12 weeks after Week 24 visit).	Omalizumab (Randomized Participants) n=81 participants at risk Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.	Placebo (Randomized Participants) n=53 participants at risk Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
General disorders Fatigue	0.00% 0/71 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	1.2% 1/81 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	5.7% 3/53 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.
Infections and infestations Viral upper respiratory tract infection	4.2% 3/71 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	12.3% 10/81 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	11.3% 6/53 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.
Infections and infestations Upper respiratory tract infection	2.8% 2/71 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	7.4% 6/81 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	5.7% 3/53 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.
Infections and infestations Bronchitis	1.4% 1/71 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	2.5% 2/81 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	5.7% 3/53 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.
Nervous system disorders Headache	7.0% 5/71 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	7.4% 6/81 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	5.7% 3/53 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.
Skin and subcutaneous tissue disorders Urticaria	14.1% 10/71 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	7.4% 6/81 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	5.7% 3/53 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.
Skin and subcutaneous tissue disorders Angioedema	4.2% 3/71 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	4.9% 4/81 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	5.7% 3/53 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.
Skin and subcutaneous tissue disorders Chronic spontaneous urticaria	0.00% 0/71 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	0.00% 0/81 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	5.7% 3/53 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.
Reproductive system and breast disorders Prostatomegaly	5.6% 1/18 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	0.00% 0/21 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.	0.00% 0/13 • From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64) Analysis was performed on safety evaluable population.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

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