Trial Outcomes & Findings for Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria (NCT NCT04833855)

NCT ID: NCT04833855

Last Updated: 2025-04-09

Results Overview

The UAS is a CSU-specific patient-reported outcome measure with 2 components: Hives Severity Score (HSS) for number of wheals and an Itch Severity Score (ISS) for itch intensity, and are each scored from 0 (no wheals, no itch) to 3 (\>50 wheals, severe itch) for the previous 24 hours. The HSS and ISS are combined to give a daily UAS ranging from 0 to 6. The sum of the daily UAS over a 7-day period provides the UAS7, from 0 (no symptoms) to 42 (severe urticaria). The least squares mean (LSM) estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline UAS7, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in urticaria activity.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 183 participants
• Primary outcome timeframe: Baseline and Week 16
• Results posted on: 2025-04-09

Participant Flow

Participants were enrolled at 56 study centers in Japan, Republic of Korea, France, Germany, Greece, Italy, Poland, Spain, Canada, and the United States, and participated from 15 April 2021 to 13 April 2023.

Participants with chronic spontaneous urticaria (CSU) and symptomatic despite treatment with second generation H1-antihistamines (sgAH) were randomized based on if they were previously treated with anti-immunoglobulin E (IgE) therapies or were anti-IgE naïve.

Participant milestones

Measure	Placebo Participants with and without previous anti-IgE therapy experience were randomized to receive placebo subcutaneously (SC) every 2 weeks (Q2W) for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC every 4 weeks (Q4W) for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Overall Study STARTED	48	31	52	52
Overall Study COMPLETED	43	29	45	48
Overall Study NOT COMPLETED	5	2	7	4

Reasons for withdrawal

Measure	Placebo Participants with and without previous anti-IgE therapy experience were randomized to receive placebo subcutaneously (SC) every 2 weeks (Q2W) for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC every 4 weeks (Q4W) for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Overall Study Decision by sponsor	0	1	0	0
Overall Study Withdrawal by Subject	4	1	3	1
Overall Study Lost to Follow-up	1	0	2	2
Overall Study Protocol specified criteria	0	0	2	1

Baseline Characteristics

Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria

Baseline characteristics by cohort

Measure	Placebo n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=31 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Total n=183 Participants Total of all reporting groups
Age, Continuous	42.8 years STANDARD_DEVIATION 15.2 • n=5 Participants	39.8 years STANDARD_DEVIATION 13.1 • n=7 Participants	45.0 years STANDARD_DEVIATION 14.7 • n=5 Participants	42.9 years STANDARD_DEVIATION 14.5 • n=4 Participants	42.9 years STANDARD_DEVIATION 14.5 • n=21 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	23 Participants n=7 Participants	35 Participants n=5 Participants	39 Participants n=4 Participants	134 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants	13 Participants n=4 Participants	49 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	14 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	29 Participants n=7 Participants	49 Participants n=5 Participants	46 Participants n=4 Participants	169 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Asian	18 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants	14 Participants n=4 Participants	60 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White	29 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants	34 Participants n=4 Participants	114 Participants n=21 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Week 16

Population: The full analysis set (FAS) included all randomized participants who received at least 1 dose of investigational product.

The UAS is a CSU-specific patient-reported outcome measure with 2 components: Hives Severity Score (HSS) for number of wheals and an Itch Severity Score (ISS) for itch intensity, and are each scored from 0 (no wheals, no itch) to 3 (>50 wheals, severe itch) for the previous 24 hours. The HSS and ISS are combined to give a daily UAS ranging from 0 to 6. The sum of the daily UAS over a 7-day period provides the UAS7, from 0 (no symptoms) to 42 (severe urticaria). The least squares mean (LSM) estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline UAS7, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in urticaria activity.

Outcome measures

Measure	Placebo n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=31 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Week 16	-13.6 score on a scale Standard Error 1.6	-18.4 score on a scale Standard Error 2.0	-13.5 score on a scale Standard Error 1.6	-14.7 score on a scale Standard Error 1.5

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product.

The ISS is a component of the UAS, a CSU-specific patient-reported outcome measure and assessed itch intensity, with daily scores ranging from 0 (no itch) to 3 (severe itch) for the previous 24 hours. The sum of daily ISS over a 7-day period provides the ISS7, from 0 (no symptoms) to 21 (severe itch). The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline ISS7, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in urticaria activity.

Outcome measures

Measure	Placebo n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=31 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Change From Baseline in ISS Over 7 Days (ISS7) at Week 16	-7.7 score on a scale Standard Error 0.8	-9.6 score on a scale Standard Error 1.0	-7.3 score on a scale Standard Error 0.8	-8.0 score on a scale Standard Error 0.8

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product.

The HSS is a component of the UAS, a CSU-specific patient-reported outcome measure and assessed the number of wheals, with daily scores ranging from 0 (no wheals) to 3 (>50 wheals) for the previous 24 hours. The sum of daily HSS over a 7-day period provides the HSS7, from 0 (no symptoms) to 21 (severe wheals). The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline HSS7, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in urticaria activity.

Outcome measures

Measure	Placebo n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=31 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Change From Baseline in HSS Over 7 Days (HSS7) at Week 16	-5.8 score on a scale Standard Error 0.8	-8.8 score on a scale Standard Error 1.1	-6.3 score on a scale Standard Error 0.8	-6.7 score on a scale Standard Error 0.8

SECONDARY outcome

Timeframe: Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with observed data are included.

The sum of the daily UAS over a 7-day period provides the UAS7, from 0 (no symptoms) to 42 (severe urticaria). Minimal residual disease in UAS7 was defined as a score ≤ 6 and indicates well-controlled urticaria and a good response to treatment.

Outcome measures

Measure	Placebo n=39 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=25 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=39 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Number of Participants With a UAS7 of ≤ 6 (Minimal Residual Disease) at Week 16	8 Participants	14 Participants	10 Participants	13 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with observed data are included.

The sum of the daily UAS over a 7-day period provides the UAS7, from 0 (no symptoms) to 42 (severe urticaria). Minimal important difference in UAS7 was defined as a change from baseline of ≤ -10.

Outcome measures

Measure	Placebo n=39 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=25 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=39 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Number of Participants With a Change From Baseline in UAS7 of ≤ -10 (Minimal Important Difference)	28 Participants	20 Participants	27 Participants	32 Participants

SECONDARY outcome

Timeframe: Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with observed data are included.

The sum of the daily UAS over a 7-day period provides the UAS7, from 0 (no symptoms) to 42 (severe urticaria). A complete response was defined as UAS7 = 0 at Week 16.

Outcome measures

Measure	Placebo n=39 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=25 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=39 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Number of Participants With a UAS7 = 0 at Week 16 (Complete Response)	4 Participants	11 Participants	7 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with observed data are included.

The sum of daily ISS over a 7-day period provides the ISS7, from 0 (no symptoms) to 21 (severe itch). An ISS7 = 0 indicates a complete resolution of itch.

Outcome measures

Measure	Placebo n=39 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=25 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=39 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Number of Participants With ISS7 = 0 at Week 16 (Complete Resolution)	4 Participants	12 Participants	7 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with observed data are included.

The sum of daily ISS over a 7-day period provides the ISS7, from 0 (no symptoms) to 21 (severe itch). Minimal important difference in ISS7 was defined as a change from baseline of ≤ -5.

Outcome measures

Measure	Placebo n=39 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=25 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=39 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Number of Participants With a Change From Baseline in ISS7 of ≤ -5 (Minimal Important Difference)	29 Participants	20 Participants	28 Participants	34 Participants

SECONDARY outcome

Timeframe: Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with observed data are included.

The sum of daily HSS over a 7-day period provides the HSS7, from 0 (no symptoms) to 21 (severe wheals). An HSS7 = 0 indicates a complete resolution of hives.

Outcome measures

Measure	Placebo n=39 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=25 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=39 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Number of Participants With HSS7 = 0 at Week 16 (Complete Resolution)	6 Participants	11 Participants	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with observed data are included.

The sum of daily HSS over a 7-day period provides the HSS7, from 0 (no symptoms) to 21 (severe wheals). Minimal important difference in HSS7 was defined as a change from baseline of ≤ -5.5.

Outcome measures

Measure	Placebo n=39 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=25 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=39 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Number of Participants With a Change From Baseline in HSS7 of ≤ -5.5 (Minimal Important Difference)	23 Participants	19 Participants	24 Participants	31 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product.

The SIS is part of the Urticaria Patient Daily Diary and was assessed by the participant using the electronic diary once daily in the morning. Participants scored sleep interference on a scale of 0 (no interference) to 3 (substantial, woke up often, severe interference with sleep). The SIS7 was a sum of the daily scores over 7 days ranging from 0 to 21. The LSM estimates were based on the repeated measure model with stratification factor (prior anti-IgE status), baseline SIS7, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in sleep interference.

Outcome measures

Measure	Placebo n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=31 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Change From Baseline in Weekly Sleep Interference Score (SIS7) at Week 16	-8.4 score on a scale Standard Error 0.7	-6.5 score on a scale Standard Error 0.9	-7.4 score on a scale Standard Error 0.7	-7.8 score on a scale Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product.

The SQS was assessed by the participant through 3 questions relating to falling asleep (Q1), wakefulness (Q2), and feeling rested in the morning (Q3). The sum of the 3 daily sleep quality items over 7 days, ranged from 0 (good quality sleep) to 63 (poor quality sleep). The LSM estimates were based on the repeated measure model with stratification factor (prior anti-IgE status), baseline SQS7 - sum of SQS, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in sleep quality.

Outcome measures

Measure	Placebo n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=31 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Change From Baseline in Weekly Sleep Quality Score (SQS7): Sum of Daily SQS at Week 16	-19.5 score on a scale Standard Error 1.8	-16.7 score on a scale Standard Error 2.3	-18.3 score on a scale Standard Error 1.7	-17.1 score on a scale Standard Error 1.6

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product.

The SQS was assessed by the participant through 3 questions relating to falling asleep (Q1), wakefulness (Q2), and feeling rested in the morning (Q3). The sum of average daily Q1 - Q3 score was generated by averaging 3 daily sleep quality items and then summing the daily average over 7 days with a score ranging from 0 (good quality sleep) to 21 (poor quality sleep) (sum of the average daily Q1 - Q3). The LSM estimates were based on the repeated measure model with stratification factor (prior anti-IgE status), baseline SQS7 - sum of average daily Q1 - Q3, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in sleep quality.

Outcome measures

Measure	Placebo n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=31 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Change From Baseline in SQS7: Sum of Average Daily Q1 - Q3 at Week 16	-6.5 score on a scale Standard Error 0.6	-5.6 score on a scale Standard Error 0.8	-6.1 score on a scale Standard Error 0.6	-5.7 score on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with observed data are included.

The UCT assesses disease control in participants with CSU through a retrospective validated scoring system, evaluating the physical symptoms of chronic urticaria (itch, hives and/or angioedema) and the effectiveness of treatment over 4 weeks. It consists of 4 questions with 5 answer options, scored from 0 to 4, and the UCT score is the sum of all 4 questions, with total score ranging from 0 (no control) to 16 (complete control). A score of ≥ 12 indicates well-controlled urticaria and a score of ≤ 11 points indicates poor disease control. A positive change from baseline indicates an improvement in disease control. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline UCT score, treatment, study week and the interaction between treatment and study week.

Outcome measures

Measure	Placebo n=46 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=29 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=49 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Change From Baseline in Urticaria Control Test (UCT) Score at Week 16	4.1 score on a scale Standard Error 0.6	6.3 score on a scale Standard Error 0.8	4.9 score on a scale Standard Error 0.6	5.9 score on a scale Standard Error 0.6

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product.

The AAS is a 5-item patient-reported outcome measure used to determine angioedema activity. Participants retrospectively documented the presence or absence of angioedema in the past 24 hours, and the AAS daily score ranged from 0 to 15 points, assessing 5 key factors when angioedema is present, including duration, physical discomfort, impact on daily activities, impact on appearance, and overall severity). The daily AAS scores are summed for 7 days to form the AAS7 with a range of 0 (not present) to 105 (most severe angioedema activity). Negative changes from baseline indicate an improvement in angioedema activity. The LSM estimates were based on the repeated measure model with stratification factor (prior anti-IgE status), baseline AAS7, treatment, study week and the interaction between treatment and study week.

Outcome measures

Measure	Placebo n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=31 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Change From Baseline in Weekly Angioedema Activity Score (AAS7) at Week 16	-19.0 score on a scale Standard Error 2.7	-18.7 score on a scale Standard Error 3.5	-20.8 score on a scale Standard Error 2.7	-15.6 score on a scale Standard Error 2.5

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with observed data are included.

The AAS is a 5-item patient-reported outcome measure used to determine angioedema activity. Participants retrospectively documented the presence or absence of angioedema in the past 24 hours, and the AAS daily score ranged from 0 to 15 points, assessing 5 key factors when angioedema is present, including duration, physical discomfort, impact on daily activities, impact on appearance, and overall severity). The daily AAS scores are summed for 7 days to form the AAS7 with a range of 0 (not present) to 105 (most severe angioedema activity). Angioedema occurrence free was defined as AAS7 = 0.

Outcome measures

Measure	Placebo n=40 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=26 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=44 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=37 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Number of Cumulative Weeks That Participants Achieved AAS7 = 0 at Week 16 (Angioedema Occurrence Free)	10.8 weeks Standard Deviation 5.2	11.3 weeks Standard Deviation 4.9	9.9 weeks Standard Deviation 5.8	11.5 weeks Standard Deviation 5.4

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with observed data are included.

The CU-Q2oL is a 23-item, self-reported urticaria-specific measure to evaluate 6 dimensions of quality of life (QoL): pruritus, impact on life activities, sleep problems, limitations, looks, and swelling. The total score is transformed to a linear scale of 0 to 100 with a higher CU-Q2oL score indicating a higher QoL impairment. A negative change from baseline indicates an improvement in QoL. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline CU-Q2oL score, treatment, study week and the interaction between treatment and study week.

Outcome measures

Measure	Placebo n=44 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=25 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=41 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=44 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Change From Baseline in the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) at Week 16	-19.6 score on a scale Standard Error 2.1	-19.8 score on a scale Standard Error 2.8	-19.3 score on a scale Standard Error 2.2	-18.7 score on a scale Standard Error 2.1

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with observed data are included.

The DLQI is a 10-item, participant-completed, health-related QoL assessment with content specific to those with dermatology conditions. The DLQI evaluates participant perceptions including dermatology-related symptoms and feelings, impacts on daily activities, leisure, work or school, personal relationships, and side effects of treatment. The recall period was 1 week. The DLQI total score ranges from 0 to 30 with a higher score indicating a greater QoL impairment. A negative change from baseline indicates an improvement in QoL. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline DLQI score, treatment, study week and the interaction between treatment and study week.

Outcome measures

Measure	Placebo n=44 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=25 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=41 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=44 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Change From Baseline in the Dermatology Life Quality Index (DLQI) at Week 16	-7.4 score on a scale Standard Error 0.9	-7.3 score on a scale Standard Error 1.2	-7.0 score on a scale Standard Error 0.9	-7.0 score on a scale Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with angioedema presence at baseline and at least 1 non-missing AE-QoL record were included.

The AE-QoL is a validated angioedema QoL questionnaire for participants with angioedema. It consists of 17 questions evaluating 4 domains including functioning, fatigue/mood, fear/shame, and food with a recall period of 4 weeks. The total score is transformed to a linear scale ranging from 0 to 100, with a higher score indicating a worse impairment in QoL. A negative change from baseline indicates an improvement in QoL. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline AE-QoL score, treatment, study week and the interaction between treatment and study week.

Outcome measures

Measure	Placebo n=20 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=7 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=15 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=16 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Change From Baseline in the Angioedema Quality of Life Questionnaire (AE-QoL) at Week 16	-29.2 score on a scale Standard Error 6.0	-24.1 score on a scale Standard Error 10.9	-24.6 score on a scale Standard Error 6.4	-13.1 score on a scale Standard Error 7.4

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with angioedema presence at baseline and at least 1 non-missing AECT record were included.

The AECT is a patient-reported outcome measure to evaluate disease control in the domains of signs and symptoms, QoL, anxiety/fear, and effectiveness of therapy. The total AECT score ranges from 0 to 16, with higher scores indicating well-controlled disease. A positive change from baseline indicates an improvement in angioedema control. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline AECT score, treatment, study week and the interaction between treatment and study week.

Outcome measures

Measure	Placebo n=20 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=7 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=15 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=16 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Change From Baseline in the Angioedema Control Test (AECT) Score at Week 16	4.2 score on a scale Standard Error 1.2	3.9 score on a scale Standard Error 2.2	4.6 score on a scale Standard Error 1.3	2.3 score on a scale Standard Error 1.5

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with observed data at Week 16 and angioedema presence at baseline and at least 1 non-missing AECT record were included.

The total AECT score ranges from 0 to 16, with higher scores indicating better controlled disease. Complete control was defined as AECT score = 16.

Outcome measures

Measure	Placebo n=15 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=5 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=14 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=14 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Number of Participants With an AECT Score = 16 at Week 16 (Complete Control)	3 Participants	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with observed data were included for each question.

The WPAI-CU is a questionnaire that assesses the impact of an intervention on work productivity, evaluating 4 areas including absenteeism, presenteeism, work productivity loss, and activity impairment over the past 7 days. Each of the areas is scored separately as a percentage, ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity. A negative change from baseline indicates an improvement. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline WPAI-CU score, treatment, study week and the interaction between treatment and study week.

Outcome measures

Measure	Placebo n=44 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=25 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=41 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=44 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Change From Baseline in the Work Productivity and Activity Impairment Questionnaire: Chronic Urticaria (WPAI-CU) Score at Week 16 Work productivity loss	-20.0 score on a scale Standard Error 5.4	-13.3 score on a scale Standard Error 6.7	-23.5 score on a scale Standard Error 5.5	-17.5 score on a scale Standard Error 5.9
Change From Baseline in the Work Productivity and Activity Impairment Questionnaire: Chronic Urticaria (WPAI-CU) Score at Week 16 Activity impairment	-28.5 score on a scale Standard Error 4.2	-30.3 score on a scale Standard Error 5.6	-27.2 score on a scale Standard Error 4.3	-24.1 score on a scale Standard Error 4.1
Change From Baseline in the Work Productivity and Activity Impairment Questionnaire: Chronic Urticaria (WPAI-CU) Score at Week 16 Presenteeism	-19.9 score on a scale Standard Error 5.2	-18.3 score on a scale Standard Error 6.6	-20.3 score on a scale Standard Error 5.3	-17.8 score on a scale Standard Error 5.7
Change From Baseline in the Work Productivity and Activity Impairment Questionnaire: Chronic Urticaria (WPAI-CU) Score at Week 16 Absenteeism	-4.7 score on a scale Standard Error 2.5	0.3 score on a scale Standard Error 3.0	-7.5 score on a scale Standard Error 2.5	-2.3 score on a scale Standard Error 2.7

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: The FAS included all randomized participants who received at least 1 dose of investigational product. Participants with observed data are included.

Participants recorded any need of sgAH rescue medication in their daily electronic diary.

Outcome measures

Measure	Placebo n=22 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=19 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=31 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=25 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Number of Cumulative Days of sgAH Rescue Medication Use From Baseline to Week 16	49.5 days Standard Deviation 39.0	31.6 days Standard Deviation 42.7	46.1 days Standard Deviation 39.3	32.7 days Standard Deviation 33.4

SECONDARY outcome

Timeframe: Week 1 pre-dose, Weeks 2, 4, 8, 12, 16, 24, and 32

Population: The pharmacokinetic analysis set included participants who received tezepelumab and had at least 1 sample with a measurable serum concentration. Participants with data available at each time point are included.

The lower limit of quantification was 10 ng/mL, and values below this limit were set to zero.

Outcome measures

Measure	Placebo n=51 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=52 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Serum Concentration of Tezepelumab Week 1	0.00 µg/mL Standard Deviation 0.00	0.00 µg/mL Standard Deviation 0.00	—	—
Serum Concentration of Tezepelumab Week 2	20.1 µg/mL Standard Deviation 6.93	41.3 µg/mL Standard Deviation 12.4	—	—
Serum Concentration of Tezepelumab Week 4	14.2 µg/mL Standard Deviation 5.78	71.3 µg/mL Standard Deviation 20.8	—	—
Serum Concentration of Tezepelumab Week 8	21.2 µg/mL Standard Deviation 8.54	101 µg/mL Standard Deviation 30.5	—	—
Serum Concentration of Tezepelumab Week 12	24.8 µg/mL Standard Deviation 9.67	123 µg/mL Standard Deviation 44.1	—	—
Serum Concentration of Tezepelumab Week 16	27.1 µg/mL Standard Deviation 10.7	136 µg/mL Standard Deviation 43.4	—	—
Serum Concentration of Tezepelumab Week 24	6.95 µg/mL Standard Deviation 5.65	37.3 µg/mL Standard Deviation 21.1	—	—
Serum Concentration of Tezepelumab Week 32	1.73 µg/mL Standard Deviation 1.73	11.0 µg/mL Standard Deviation 10.8	—	—

SECONDARY outcome

Timeframe: Day 1 Week 1 to Week 32, up to 32 weeks

Population: The safety analysis set consisted of all randomized participants who received at least 1 dose of investigational product.

An adverse event (AE) was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with study treatment. TEAEs were AEs that started on or after the first dose of investigational product up to the end of study (Week 32). A serious AE (SAE) was defined as any untoward medical occurrence that met at least 1 of the following serious criteria: immediately life-threatening, required hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other medically important serious event.

Outcome measures

Measure	Placebo n=48 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=31 Participants Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=52 Participants Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Number of Participants With Treatment-emergent Adverse Events (TEAEs) TEAEs	23 Participants	24 Participants	29 Participants	28 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) SAEs	0 Participants	1 Participants	1 Participants	0 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Omalizumab 300 mg SC Q4W

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Tezepelumab 210 mg SC Q4W

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Tezepelumab 420 mg SC Q2W

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=48 participants at risk Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=31 participants at risk Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=52 participants at risk Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=52 participants at risk Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.00% 0/48 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	0.00% 0/31 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	1.9% 1/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	0.00% 0/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.
Psychiatric disorders Intentional self-injury	0.00% 0/48 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	3.2% 1/31 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	0.00% 0/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	0.00% 0/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.

Other adverse events

Measure	Placebo n=48 participants at risk Participants with and without previous anti-IgE therapy experience were randomized to receive placebo SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Omalizumab 300 mg SC Q4W n=31 participants at risk Participants without previous anti-IgE experience were randomized to receive omalizumab 300 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 210 mg SC Q4W n=52 participants at risk Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 210 mg SC Q4W for 16 weeks. Participants received placebo SC at intervening study visits to ensure all participants received an injection Q2W. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).	Tezepelumab 420 mg SC Q2W n=52 participants at risk Participants with and without previous anti-IgE therapy experience were randomized to receive tezepelumab 420 mg SC Q2W for 16 weeks. Participants maintained a stable dose of sgAH as background medication from screening Visit 2 (Day -14) to the end of the Safety Follow-up Period (up to Week 32).
General disorders Injection site pain	2.1% 1/48 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	0.00% 0/31 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	7.7% 4/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	1.9% 1/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.
General disorders Pyrexia	2.1% 1/48 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	9.7% 3/31 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	5.8% 3/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	3.8% 2/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.
Infections and infestations COVID-19	6.2% 3/48 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	6.5% 2/31 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	15.4% 8/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	9.6% 5/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.
Infections and infestations Nasopharyngitis	4.2% 2/48 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	3.2% 1/31 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	1.9% 1/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	5.8% 3/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/48 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	0.00% 0/31 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	1.9% 1/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	5.8% 3/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.
Nervous system disorders Headache	4.2% 2/48 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	3.2% 1/31 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	9.6% 5/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	11.5% 6/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/48 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	0.00% 0/31 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	3.8% 2/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	5.8% 3/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.
Skin and subcutaneous tissue disorders Eczema	6.2% 3/48 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	3.2% 1/31 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	3.8% 2/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	0.00% 0/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.
Skin and subcutaneous tissue disorders Urticaria	8.3% 4/48 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	0.00% 0/31 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	7.7% 4/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.	5.8% 3/52 • All-cause mortality was collected from enrolment to the end of study visit, up to 38 weeks. SAEs and other AEs were collected from Day 1 up to Week 32, up to 32 weeks.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER