Trial Outcomes & Findings for Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID) (NCT NCT04180488)

NCT ID: NCT04180488

Last Updated: 2025-08-20

Results Overview

ISS was recorded in e-diary. The ISS represents severity of itch on a scale ranging from 0 (none) to 3 (intense). The ISS7 score was the sum of daily ISS scores recorded by a participant at the same time each day over 7 days with an overall scale of 0 (no impact) to 21 (severe impact). Higher scores indicated greater intensity of itch. Least squares (LS) mean is presented. Baseline was defined as the sum of daily scores obtained for 7 days prior to randomization.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 397 participants
• Primary outcome timeframe: Baseline (Day 1) and Week 24
• Results posted on: 2025-08-20

Participant Flow

This study comprised of 3 randomized studies of similar design: 2 studies were conducted in participants who were omalizumab naïve (Study A [55 centers in 9 countries] and Study C [50 centers in 9 countries]) and 1 study was conducted in participants who were omalizumab intolerant or incomplete responders (Study B [61 centers in 11 countries]).

A total of 138 participants in Study A, 108 participants in Study B and 151 participants in Study C were randomized in a 1:1 ratio to receive either weight-tiered dupilumab or matching placebo in respective studies. As pre-specified in the protocol and statistical analysis plan (SAP), the results are presented by study and treatment group/intervention.

Participant milestones

Measure	Study A: Placebo Participants who were omalizumab naïve received placebo matched to dupilumab as subcutaneous (SC) injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 milligrams (mg) SC injection every 2 weeks (q2w) for adults and those adolescents who weighed \>=60 kilograms (kg) at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection every 4 weeks (q4w) for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Overall Study STARTED	68	70	54	54	77	74
Overall Study COMPLETED	55	63	47	49	67	66
Overall Study NOT COMPLETED	13	7	7	5	10	8

Reasons for withdrawal

Measure	Study A: Placebo Participants who were omalizumab naïve received placebo matched to dupilumab as subcutaneous (SC) injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 milligrams (mg) SC injection every 2 weeks (q2w) for adults and those adolescents who weighed \>=60 kilograms (kg) at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection every 4 weeks (q4w) for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Overall Study Not related to Coronavirus Disease-2019 (COVID-19)	2	1	1	3	2	2
Overall Study Withdrawal by Subject	8	4	5	2	8	6
Overall Study Adverse Event	3	2	0	0	0	0
Overall Study Poor compliance to protocol	0	0	1	0	0	0

Baseline Characteristics

Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)

Baseline characteristics by cohort

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Total n=397 Participants Total of all reporting groups
Age, Continuous	41.9 years STANDARD_DEVIATION 14.8 • n=5 Participants	40.7 years STANDARD_DEVIATION 16.2 • n=7 Participants	46.8 years STANDARD_DEVIATION 16.3 • n=5 Participants	48.6 years STANDARD_DEVIATION 15.6 • n=4 Participants	44.0 years STANDARD_DEVIATION 16.7 • n=21 Participants	45.6 years STANDARD_DEVIATION 17.1 • n=8 Participants	44.4 years STANDARD_DEVIATION 16.3 • n=8 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	41 Participants n=7 Participants	41 Participants n=5 Participants	37 Participants n=4 Participants	59 Participants n=21 Participants	47 Participants n=8 Participants	275 Participants n=8 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	29 Participants n=7 Participants	13 Participants n=5 Participants	17 Participants n=4 Participants	18 Participants n=21 Participants	27 Participants n=8 Participants	122 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants	19 Participants n=7 Participants	11 Participants n=5 Participants	6 Participants n=4 Participants	29 Participants n=21 Participants	33 Participants n=8 Participants	114 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	10 Participants n=8 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	47 Participants n=7 Participants	41 Participants n=5 Participants	43 Participants n=4 Participants	38 Participants n=21 Participants	32 Participants n=8 Participants	249 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	5 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants	7 Participants n=8 Participants	16 Participants n=8 Participants
Weekly Itch-Severity (ISS7) Score	15.7 score on a scale STANDARD_DEVIATION 4.1 • n=5 Participants	16.1 score on a scale STANDARD_DEVIATION 4.0 • n=7 Participants	16.2 score on a scale STANDARD_DEVIATION 3.8 • n=5 Participants	15.9 score on a scale STANDARD_DEVIATION 4.0 • n=4 Participants	15.0 score on a scale STANDARD_DEVIATION 3.9 • n=21 Participants	15.3 score on a scale STANDARD_DEVIATION 3.6 • n=8 Participants	15.7 score on a scale STANDARD_DEVIATION 3.9 • n=8 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: The intent-to-treat (ITT) population included all randomized participants analyzed according to the intervention group allocated by randomization.

ISS was recorded in e-diary. The ISS represents severity of itch on a scale ranging from 0 (none) to 3 (intense). The ISS7 score was the sum of daily ISS scores recorded by a participant at the same time each day over 7 days with an overall scale of 0 (no impact) to 21 (severe impact). Higher scores indicated greater intensity of itch. Least squares (LS) mean is presented. Baseline was defined as the sum of daily scores obtained for 7 days prior to randomization.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Change From Baseline in Weekly Itch Severity Score at Week 24	-6.01 score on a scale Standard Error 0.94	-10.24 score on a scale Standard Error 0.91	-4.81 score on a scale Standard Error 1.08	-7.68 score on a scale Standard Error 1.10	-6.10 score on a scale Standard Error 1.40	-8.64 score on a scale Standard Error 1.41

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

UAS is a validated composite patient-reported outcome (PRO) measure for assessing chronic spontaneous urticaria (CSU) activity. The once daily UAS is the sum of the daily hives severity score (HSS) and daily ISS recorded in e-diary. Daily HSS assesses number of wheals and range from 0 (none) to 3 (more than 50 hives) whereas daily ISS assesses itch intensity and range from 0 (none) to 3 (intense). The daily UAS scores range from 0 to 6 point/day. Once daily UAS scores are summed over 7-day period to create the UAS7 with an overall scale of 0 (no urticaria) to 42 (severe urticaria). Higher scores indicate greater severity of urticaria symptoms. LS mean is presented. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Change From Baseline in Weekly Urticaria Activity Score at Week 24	-12.00 score on a scale Standard Error 1.81	-20.53 score on a scale Standard Error 1.76	-8.54 score on a scale Standard Error 2.14	-14.37 score on a scale Standard Error 2.16	-11.21 score on a scale Standard Error 2.65	-15.86 score on a scale Standard Error 2.66

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

Daily HSS was recorded in e-diary. The HSS7 score is the sum of daily HSS ranging from 0 (none) to 3 (more than 50 hives) recorded by a participant at the same time of each day over 7 days with an overall scale of 0 (no hives) to 21 (severe hives). Higher scores indicate greater intensity of hives. LS mean is presented. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Change From Baseline in Weekly Hives Severity Score at Week 24	-5.90 score on a scale Standard Error 0.93	-10.28 score on a scale Standard Error 0.91	-3.63 score on a scale Standard Error 1.11	-6.64 score on a scale Standard Error 1.11	-5.11 score on a scale Standard Error 1.31	-7.27 score on a scale Standard Error 1.32

SECONDARY outcome

Timeframe: Week 24

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

The ISS represents severity of itch on a scale ranging from 0 (none) to 3 (intense). The ISS7 score was the sum of daily ISS scores recorded by a participant at the same time each day over 7 days with an overall scale of 0 (no impact) to 21 (severe impact). Higher scores indicated greater intensity of itch. An ISS7 MID response was defined as >=5 points decrease from baseline after study intervention.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Percentage of Responders for Weekly Itch Severity Score Minimally Important Difference (MID) at Week 24	42.6 percentage of participants	72.9 percentage of participants	38.9 percentage of participants	59.3 percentage of participants	51.9 percentage of participants	70.3 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

UAS is a validated composite PRO measure for assessing CSU activity. The once daily UAS is the sum of the daily HSS and daily ISS recorded in e-diary. Daily HSS assesses number of wheals and range from 0 (none) to 3 (more than 50 hives) whereas daily ISS assesses itch intensity and range from 0 (none) to 3 (intense). The daily UAS scores range from 0 to 6 point/day. Once daily UAS scores are summed over 7-day period to create the UAS7 with an overall scale of 0 (no urticaria) to 42 (severe urticaria). Higher scores indicate greater severity of urticaria symptoms. In evaluating urticaria control using UAS7, an UAS7 score of <=6 indicated a well-controlled urticaria.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Percentage of Participants With Weekly Urticaria Activity Score <=6 at Week 24	23.5 percentage of participants	45.7 percentage of participants	18.5 percentage of participants	24.1 percentage of participants	23.4 percentage of participants	40.5 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

UAS is a validated composite PRO measure for assessing CSU activity. The once daily UAS is the sum of the daily HSS and daily ISS recorded in e-diary. Daily HSS assesses number of wheals and range from 0 (none) to 3 (more than 50 hives) whereas daily ISS assesses itch intensity and range from 0 (none) to 3 (intense). The daily UAS scores range from 0 to 6 point/day. Once daily UAS scores are summed over 7-day period to create the UAS7 with an overall scale of 0 (no urticaria) to 42 (severe urticaria). Higher scores indicate greater severity of urticaria symptoms. In evaluating urticaria control using UAS7, an UAS7 score of 0 indicated an absence of both itch and hives and a complete resolution of CSU symptoms.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Percentage of Participants With Weekly Urticaria Activity Score =0 at Week 24	13.2 percentage of participants	31.4 percentage of participants	9.3 percentage of participants	13.0 percentage of participants	18.2 percentage of participants	29.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

The UCT assessed urticaria control based on 4 items (severity of pruritus and wheals urticaria symptoms; frequency of treatment being not sufficient; quality-of-life [QoL] impairment; overall urticarial control). Each item was rated on a 5-point Likert-type scale from 0 (no control) to 4 (maximum control). The overall UCT score was the sum of all 4 individual item scores with a range of 0 (no disease control) to 16 (complete disease control). Higher scores indicated greater disease control. LS mean is presented. Baseline was defined as the last available value up to randomization date and prior to the first dose of study intervention.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Change From Baseline in Urticaria Control Test (UCT) at Week 24	4.88 score on a scale Standard Error 0.61	7.71 score on a scale Standard Error 0.59	3.38 score on a scale Standard Error 0.74	5.33 score on a scale Standard Error 0.77	4.16 score on a scale Standard Error 0.94	5.09 score on a scale Standard Error 0.95

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

ISS was recorded in e-diary. The ISS represents severity of itch on a scale ranging from 0 (none) to 3 (intense). The ISS7 score was the sum of daily ISS scores recorded by a participant at the same time each day over 7 days with an overall scale of 0 (no impact) to 21 (severe impact). Higher scores indicated greater intensity of itch. LS mean is presented. Baseline was defined as the sum of daily scores obtained for 7 days prior to randomization.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Change From Baseline in Weekly Itch Severity Score at Week 12	-6.01 score on a scale Standard Error 0.85	-8.37 score on a scale Standard Error 0.84	-4.52 score on a scale Standard Error 0.95	-7.37 score on a scale Standard Error 0.97	-5.31 score on a scale Standard Error 1.32	-7.15 score on a scale Standard Error 1.32

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

UAS is a validated composite PRO measure for assessing CSU activity. The once daily UAS is the sum of the daily HSS and daily ISS recorded in e-diary. Daily HSS assesses number of wheals and range from 0 (none) to 3 (more than 50 hives) whereas daily ISS assesses itch intensity and range from 0 (none) to 3 (intense). The daily UAS scores range from 0 to 6 point/day. Once daily UAS scores are summed over 7-day period to create the UAS7 with an overall scale of 0 (no urticaria) to 42 (severe urticaria). Higher scores indicate greater severity of urticaria symptoms. LS mean is presented. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Change From Baseline in Weekly Urticaria Activity Score at Week 12	-11.79 score on a scale Standard Error 1.64	-16.81 score on a scale Standard Error 1.62	-8.22 score on a scale Standard Error 1.91	-13.33 score on a scale Standard Error 1.94	-9.51 score on a scale Standard Error 2.54	-12.87 score on a scale Standard Error 2.54

SECONDARY outcome

Timeframe: Week 12

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

UAS is a validated composite PRO measure for assessing CSU activity. The once daily UAS is the sum of the daily HSS and daily ISS recorded in e-diary. Daily HSS assesses number of wheals and range from 0 (none) to 3 (more than 50 hives) whereas daily ISS assesses itch intensity and range from 0 (none) to 3 (intense). The daily UAS scores range from 0 to 6 point/day. Once daily UAS scores are summed over 7-day period to create the UAS7 with an overall scale of 0 (no urticaria) to 42 (severe urticaria). Higher scores indicate greater severity of urticaria symptoms. In evaluating urticaria control using UAS7, an UAS7 score of <=6 indicated a well-controlled urticaria and an UAS7 score of 0 indicated an absence of both itch and hives and a complete resolution of CSU symptoms.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Percentage of Participants With Weekly Urticaria Activity Score <=6 and =0 at Week 12 UAS7 <=6	17.6 percentage of participants	34.3 percentage of participants	9.3 percentage of participants	24.1 percentage of participants	16.9 percentage of participants	31.1 percentage of participants
Percentage of Participants With Weekly Urticaria Activity Score <=6 and =0 at Week 12 UAS7=0	8.8 percentage of participants	15.7 percentage of participants	1.9 percentage of participants	13.0 percentage of participants	11.7 percentage of participants	17.6 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

The ISS represents severity of itch on a scale ranging from 0 (none) to 3 (intense). The ISS7 score was the sum of daily ISS scores recorded by a participant at the same time each day over 7 days with an overall scale of 0 (no impact) to 21 (severe impact). Higher scores indicated greater intensity of itch. An ISS7 MID response was defined as >=5 points decrease from baseline after study intervention.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Percentage of Responders for Weekly Itch Severity Score Minimally Important Difference at Week 12	52.9 percentage of participants	70.0 percentage of participants	46.3 percentage of participants	64.8 percentage of participants	51.9 percentage of participants	58.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

Daily HSS was recorded in e-diary. The HSS7 score is the sum of daily HSS ranging from 0 (none) to 3 (more than 50 hives) recorded by a participant at the same time of each day over 7 days with an overall scale of 0 (no hives) to 21 (severe hives). Higher scores indicate greater intensity of hives. LS mean is presented. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Change From Baseline in Weekly Hives Severity Score at Week 12	-5.69 score on a scale Standard Error 0.83	-8.39 score on a scale Standard Error 0.83	-3.71 score on a scale Standard Error 1.01	-5.97 score on a scale Standard Error 1.02	-4.22 score on a scale Standard Error 1.28	-5.75 score on a scale Standard Error 1.28

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

The UCT assessed urticaria control based on 4 items (severity of pruritus and wheals urticaria symptoms; frequency of treatment being not sufficient; quality-of-life [QoL] impairment; overall urticarial control). Each item was rated on a 5-point Likert-type scale from 0 (no control) to 4 (maximum control). The overall UCT score was the sum of all 4 individual item scores with a range of 0 (no disease control) to 16 (complete disease control). Higher scores indicated greater disease control. LS mean is presented. Baseline was defined as the last available value up to randomization date and prior to the first dose of study intervention.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Change From Baseline in Urticaria Control Test at Week 12	4.62 score on a scale Standard Error 0.57	6.48 score on a scale Standard Error 0.57	3.11 score on a scale Standard Error 0.65	5.48 score on a scale Standard Error 0.67	3.26 score on a scale Standard Error 0.88	4.61 score on a scale Standard Error 0.89

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 4, 8, 16 and 20

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization. Only those participants with data collected at specified timepoints are reported.

ISS was recorded in e-diary. The ISS represents severity of itch on a scale ranging from 0 (none) to 3 (intense). The ISS7 score was the sum of daily ISS scores recorded by a participant at the same time each day over 7 days with an overall scale of 0 (no impact) to 21 (severe impact). Higher scores indicated greater intensity of itch. Mean is presented. Baseline was defined as the sum of daily scores obtained for 7 days prior to randomization.

Outcome measures

Measure	Study A: Placebo n=65 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=72 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Change From Baseline in Weekly Itch Severity Score at Weeks 4, 8, 16 and 20 Week 4	-3.30 score on a scale Standard Deviation 6.54	-4.96 score on a scale Standard Deviation 5.49	-4.12 score on a scale Standard Deviation 6.28	-5.51 score on a scale Standard Deviation 5.64	-3.78 score on a scale Standard Deviation 4.73	-5.26 score on a scale Standard Deviation 5.16
Change From Baseline in Weekly Itch Severity Score at Weeks 4, 8, 16 and 20 Week 8	-4.98 score on a scale Standard Deviation 7.49	-6.99 score on a scale Standard Deviation 6.78	-4.27 score on a scale Standard Deviation 5.92	-7.25 score on a scale Standard Deviation 6.29	-4.92 score on a scale Standard Deviation 5.67	-7.83 score on a scale Standard Deviation 6.02
Change From Baseline in Weekly Itch Severity Score at Weeks 4, 8, 16 and 20 Week 16	-5.61 score on a scale Standard Deviation 7.45	-9.43 score on a scale Standard Deviation 6.86	-4.52 score on a scale Standard Deviation 6.68	-8.05 score on a scale Standard Deviation 7.43	-6.22 score on a scale Standard Deviation 5.78	-8.24 score on a scale Standard Deviation 7.37
Change From Baseline in Weekly Itch Severity Score at Weeks 4, 8, 16 and 20 Week 20	-6.40 score on a scale Standard Deviation 7.82	-10.04 score on a scale Standard Deviation 7.22	-5.35 score on a scale Standard Deviation 7.17	-7.54 score on a scale Standard Deviation 7.94	-6.64 score on a scale Standard Deviation 6.43	-9.27 score on a scale Standard Deviation 6.58

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 24

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

The ISS represents severity of itch on a scale ranging from 0 (none) to 3 (intense). The ISS7 score was the sum of daily ISS scores recorded by a participant at the same time each day over 7 days with an overall scale of 0 (no impact) to 21 (severe impact). Higher scores indicated greater intensity of itch. The MID for ISS7 was a change of 5.0 points. Time to first ISS7 MID response (ISS7 >=5) was defined as time to reduction from baseline of 5 points or more. Kaplan-Meier estimate is presented. Baseline was defined as the sum of daily scores obtained for 7 days prior to randomization.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Time to First Weekly Itch Severity Score Minimally Important Difference Response During the 24-Week Treatment Period	4.0 weeks Interval 2.0 to 8.0	3.0 weeks Interval 2.0 to 5.0	4.0 weeks Interval 2.0 to 7.0	3.0 weeks Interval 2.0 to 4.0	5.0 weeks Interval 3.0 to 7.0	3.5 weeks Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 12 and 24

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization. Only those participants with angioedema at baseline and with data collected at specified timepoints are reported.

The AAS is a diary in which participants document on a daily basis the presence or absence of angioedema during the past 24 hours. If angioedema is present, participants answer 5 additional questions about the time of the day the swelling episode occurred and the severity and impact on daily functioning and appearance this swelling episode has had. Each AAS item is scored between 0 (minimum) and 3 (maximum). The daily AASs range from 0 (no episode) to 15 (severe) points. The AAS7 score is the sum of daily AAS scores reported by a participant at the same time of each day over 7 days, with a range of 0 (no angioedema episodes) to 105 (highest angioedema severity). Higher scores indicate greater angioedema activity. Mean is presented. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization.

Outcome measures

Measure	Study A: Placebo n=31 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=27 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=32 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=20 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=21 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=12 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Change From Baseline in Angioedema Activity Score Over 7 Days (AAS7) at Weeks 12 and 24 Week 12	-23.46 score on a scale Standard Deviation 21.76	-19.14 score on a scale Standard Deviation 18.89	-16.74 score on a scale Standard Deviation 21.74	-19.41 score on a scale Standard Deviation 34.44	-32.14 score on a scale Standard Deviation 32.15	-34.33 score on a scale Standard Deviation 36.19
Change From Baseline in Angioedema Activity Score Over 7 Days (AAS7) at Weeks 12 and 24 Week 24	-23.56 score on a scale Standard Deviation 23.04	-18.76 score on a scale Standard Deviation 22.85	-15.83 score on a scale Standard Deviation 25.73	-13.95 score on a scale Standard Deviation 37.22	-31.00 score on a scale Standard Deviation 36.38	-36.28 score on a scale Standard Deviation 27.61

SECONDARY outcome

Timeframe: Weeks 12 and 24

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

The UCT assessed urticaria control based on 4 items (severity of pruritus and wheals urticaria symptoms; frequency of treatment being not sufficient; QoL impairment; overall urticarial control). Each item was rated on a 5-point Likert-type scale from 0 (no control) to 4 (maximum control). The overall UCT score was the sum of all 4 individual item scores with a range of 0 (no disease control) to 16 (complete disease control). Higher scores indicated greater disease control. An UCT score of >=12 (out of maximum 16) indicated a well-controlled urticaria disease status.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Percentage of Well-controlled Participants (Urticaria Control Test >=12) at Weeks 12 and 24 Week 24	30.9 percentage of participants	48.6 percentage of participants	20.4 percentage of participants	44.4 percentage of participants	39.0 percentage of participants	50.0 percentage of participants
Percentage of Well-controlled Participants (Urticaria Control Test >=12) at Weeks 12 and 24 Week 12	27.9 percentage of participants	44.3 percentage of participants	18.5 percentage of participants	51.9 percentage of participants	22.1 percentage of participants	37.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 12 and 24

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization. Only those participants \>=16 years with data collected at specified timepoints are reported.

The DLQI is an assessment assessing the impact of skin disease on participants' HRQoL over the previous week and contains 10 questions related to symptoms, leisure activities, work/school or holiday time, personal relationships including intimate, the side effects of treatment, and emotional reactions to having a skin disease. The questions (except question 7) were scored on a 4-point Likert scale: 0 (not at all), 1 (a little), 2 (a lot), 3 (very much). Question 7 about work/studying asked whether work/study had been prevented and then (if "No") to what degree the skin condition has been a problem at work/study; the item was again rated on a 3-point Likert scale: 0 (not at all) to 3 (a lot). Total DLQI was calculated by summing the score of each question and ranged from 0 (no impact) to 30 (severe impact). Higher scores indicated poor HRQoL. Mean is presented. Baseline was defined as the last available value up to randomization date and prior to the first dose of study intervention.

Outcome measures

Measure	Study A: Placebo n=65 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=65 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=51 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=47 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=67 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Change From Baseline in Health-related Quality-of-life (HRQoL) as Measured by Dermatology Life Quality Index (DLQI) in Participants >=16 Years Old at Weeks 12 and 24 Week 12	-7.55 score on a scale Standard Deviation 7.47	-8.55 score on a scale Standard Deviation 6.27	-4.53 score on a scale Standard Deviation 6.28	-6.77 score on a scale Standard Deviation 6.92	-5.01 score on a scale Standard Deviation 6.25	-6.61 score on a scale Standard Deviation 7.04
Change From Baseline in Health-related Quality-of-life (HRQoL) as Measured by Dermatology Life Quality Index (DLQI) in Participants >=16 Years Old at Weeks 12 and 24 Week 24	-7.56 score on a scale Standard Deviation 8.13	-9.50 score on a scale Standard Deviation 5.92	-4.96 score on a scale Standard Deviation 6.87	-6.91 score on a scale Standard Deviation 7.51	-6.81 score on a scale Standard Deviation 6.54	-8.09 score on a scale Standard Deviation 7.66

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 12 and 24

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization. Only those participants \>=6 and \<16 years with data collected at specified timepoints are reported.

The CDLQI is a validated questionnaire designed to measure the impact of skin disease on children's HRQoL. Participants provide responses to 10 questions (symptoms feelings associated with disease, the impact of the disease on leisure, school or holidays, personal relationships, sleep, and side effects of treatment for the skin disease). The instrument has a recall period of 7 days. 9 of the 10 questions are scored on a 4-point Likert scale ranging from 0 (not at all/question unanswered) to 3 (very much). Question 7 has an additional possible response (prevented school) which is assigned a score of 3 (0 [not at all] to 3 [definitely]). The total CDLQI score is the sum of the score of each question ranging 0 (no impact) to 30 (severe impact). The higher the score, the greater the impact is on the child's HRQoL. Mean is presented. Baseline was defined as the last available value up to randomization date and prior to the first dose of study intervention.

Outcome measures

Measure	Study A: Placebo n=1 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=2 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=1 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=5 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=2 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Change From Baseline in Health-related Quality-of-life as Measured by Children's Dermatology Life Quality Index (CDLQI) in Participants >=6 to <16 Years Old at Weeks 12 and 24 Week 12	-5.00 score on a scale Standard Deviation NA NA indicates that standard deviation could not be calculated for 1 participant.	-8.00 score on a scale Standard Deviation 5.66	—	-7 score on a scale Standard Deviation NA NA indicates that standard deviation could not be calculated for 1 participant.	-4.60 score on a scale Standard Deviation 10.04	-9.00 score on a scale Standard Deviation 2.83
Change From Baseline in Health-related Quality-of-life as Measured by Children's Dermatology Life Quality Index (CDLQI) in Participants >=6 to <16 Years Old at Weeks 12 and 24 Week 24	—	-12.50 score on a scale Standard Deviation 12.02	—	-7 score on a scale Standard Deviation NA NA indicates that standard deviation could not be calculated for 1 participant.	-5.60 score on a scale Standard Deviation 7.83	-4.50 score on a scale Standard Deviation 7.78

SECONDARY outcome

Timeframe: Weeks 12 and 24

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization. Only those participants with data collected at Weeks 12 and 24 are reported.

The PGIC is a 1-item questionnaire that asks the participant to provide the overall self-assessment of change in their CSU on a 7-point scale compared to just before participant started taking the study intervention. Response choices are: 0 (very much better), 1 (moderately better), 2 (a little better), 3 (no change), 4 (a little worse), 5 (moderately worse), 6 (very much worse). Higher score indicate worsening.

Outcome measures

Measure	Study A: Placebo n=66 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=69 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=52 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=73 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=73 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Patient Global Impression of Change (PGIC) of Chronic Spontaneous Urticaria at Weeks 12 and 24 Week 12	1.68 score on a scale Standard Deviation 1.43	1.10 score on a scale Standard Deviation 1.24	2.06 score on a scale Standard Deviation 1.29	1.62 score on a scale Standard Deviation 1.46	1.59 score on a scale Standard Deviation 1.23	1.27 score on a scale Standard Deviation 1.44
Patient Global Impression of Change (PGIC) of Chronic Spontaneous Urticaria at Weeks 12 and 24 Week 24	1.70 score on a scale Standard Deviation 1.50	1.04 score on a scale Standard Deviation 1.51	1.90 score on a scale Standard Deviation 1.64	1.44 score on a scale Standard Deviation 1.55	1.18 score on a scale Standard Deviation 1.36	1.01 score on a scale Standard Deviation 1.48

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 12 and 24

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization. Only those participants with data collected at specified timepoints are reported.

The PGIS is a 1-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week. Response choices are: 1 (none), 2 (mild), 3 (moderate), 4 (severe). Higher score indicate more severity. Baseline was defined as the last available value up to randomization date and prior to the first dose of study intervention.

Outcome measures

Measure	Study A: Placebo n=66 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=69 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=52 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=73 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=73 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Change From Baseline in Patient Global Impression of Severity (PGIS) of Chronic Spontaneous Urticaria at Weeks 12 and 24 Week 12	-0.89 score on a scale Standard Deviation 0.98	-1.23 score on a scale Standard Deviation 0.93	-0.46 score on a scale Standard Deviation 0.93	-1.15 score on a scale Standard Deviation 1.04	-0.82 score on a scale Standard Deviation 0.98	-0.95 score on a scale Standard Deviation 0.97
Change From Baseline in Patient Global Impression of Severity (PGIS) of Chronic Spontaneous Urticaria at Weeks 12 and 24 Week 24	-0.97 score on a scale Standard Deviation 1.18	-1.44 score on a scale Standard Deviation 0.92	-0.54 score on a scale Standard Deviation 1.16	-0.96 score on a scale Standard Deviation 1.05	-1.03 score on a scale Standard Deviation 1.09	-1.33 score on a scale Standard Deviation 1.05

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 24

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

Participants receiving OCS as rescue medications for CSU were recorded by the Investigator in e-case report form (eCRF) during the 24-week treatment period. Kaplan-Meier estimate for time to first OCS use is presented.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Time to First Oral Corticosteroid (OCS) Use for Chronic Spontaneous Urticaria During the 24-week Treatment Period	0.110 weeks Interval 0.048 to 0.2	0.087 weeks Interval 0.035 to 0.168	0.158 weeks Interval 0.074 to 0.271	0.116 weeks Interval 0.047 to 0.22	0.067 weeks Interval 0.025 to 0.138	0.014 weeks Interval 0.001 to 0.068

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 24

Population: The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.

Percentage of participants receiving OCS as rescue medications for CSU were recorded by the Investigator in eCRF during the 24-week treatment period.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Percentage of Participants Receiving Oral Corticosteroid for Chronic Spontaneous Urticaria During the 24-week Treatment Period	10.3 percentage of participants	8.6 percentage of participants	14.8 percentage of participants	11.1 percentage of participants	6.5 percentage of participants	1.4 percentage of participants

SECONDARY outcome

Timeframe: From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C

Population: The safety population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.

Outcome measures

Measure	Study A: Placebo n=68 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TEAEs	40 Participants	38 Participants	29 Participants	33 Participants	41 Participants	40 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TESAEs	5 Participants	2 Participants	2 Participants	3 Participants	1 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to Week 24

Population: The ADA population included all participants in the safety population who had at least 1 non-missing ADA result after first dose of the study intervention.

Blood samples were collected at specified timepoints and ADA samples were assayed using validated methods. Treatment-emergent ADA response was defined as a positive response in the ADA assay post first dose when baseline results were negative or missing. Number of participants with treatment-emergent ADA response is presented.

Outcome measures

Measure	Study A: Placebo n=66 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=69 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=53 Participants Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=52 Participants Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=75 Participants Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=72 Participants Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Against Dupilumab	1 Participants	9 Participants	2 Participants	10 Participants	0 Participants	1 Participants

Adverse Events

Study A: Placebo

Serious events: 5 serious events

Other events: 19 other events

Deaths: 1 deaths

Study A: Dupilumab

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Study B: Placebo

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Study B: Dupilumab

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Study C: Placebo

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Study C: Dupilumab

Serious events: 5 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Study A: Placebo n=68 participants at risk Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 participants at risk Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 participants at risk Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 participants at risk Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 participants at risk Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 participants at risk Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Infections and infestations Covid-19 Pneumonia	1.5% 1/68 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Infections and infestations Pneumonia Bacterial	0.00% 0/68 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.4% 1/74 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Adenocarcinoma	0.00% 0/68 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.4% 1/74 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Psychiatric disorders Completed Suicide	1.5% 1/68 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Psychiatric disorders Depression	0.00% 0/68 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.4% 1/70 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Cardiac disorders Angina Unstable	0.00% 0/68 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.4% 1/74 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/68 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.3% 1/77 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 1/68 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Gastrointestinal disorders Abdominal Pain Upper	1.5% 1/68 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Gastrointestinal disorders Haemorrhoids	0.00% 0/68 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.4% 1/70 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/68 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.9% 1/54 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Gastrointestinal disorders Nausea	1.5% 1/68 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Hepatobiliary disorders Hepatic Steatosis	0.00% 0/68 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.4% 1/74 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Skin and subcutaneous tissue disorders Angioedema	1.5% 1/68 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Skin and subcutaneous tissue disorders Chronic Spontaneous Urticaria	0.00% 0/68 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.9% 1/54 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Skin and subcutaneous tissue disorders Dermatitis Atopic	1.5% 1/68 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Skin and subcutaneous tissue disorders Idiopathic Angioedema	0.00% 0/68 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.9% 1/54 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/68 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.9% 1/54 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/68 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.9% 1/54 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Injury, poisoning and procedural complications Concussion	0.00% 0/68 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.4% 1/74 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.

Other adverse events

Measure	Study A: Placebo n=68 participants at risk Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study A: Dupilumab n=70 participants at risk Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.	Study B: Placebo n=54 participants at risk Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study B: Dupilumab n=54 participants at risk Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.	Study C: Placebo n=77 participants at risk Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.	Study C: Dupilumab n=74 participants at risk Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Infections and infestations Covid-19	2.9% 2/68 • Number of events 2 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.4% 1/70 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	7.4% 4/54 • Number of events 4 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	9.3% 5/54 • Number of events 5 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	5.2% 4/77 • Number of events 4 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	8.1% 6/74 • Number of events 6 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Infections and infestations Nasopharyngitis	4.4% 3/68 • Number of events 3 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.4% 1/70 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	7.4% 4/54 • Number of events 5 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.9% 1/54 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	7.8% 6/77 • Number of events 6 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	5.4% 4/74 • Number of events 4 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Vascular disorders Hypertension	0.00% 0/68 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/70 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.9% 1/54 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	5.6% 3/54 • Number of events 3 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/74 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Skin and subcutaneous tissue disorders Angioedema	5.9% 4/68 • Number of events 4 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.4% 1/70 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	3.7% 2/54 • Number of events 2 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.3% 1/77 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	4.1% 3/74 • Number of events 3 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Skin and subcutaneous tissue disorders Chronic Spontaneous Urticaria	8.8% 6/68 • Number of events 6 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	4.3% 3/70 • Number of events 4 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	5.6% 3/54 • Number of events 4 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	11.1% 6/54 • Number of events 8 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	3.9% 3/77 • Number of events 4 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	2.7% 2/74 • Number of events 2 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
General disorders Injection Site Erythema	5.9% 4/68 • Number of events 9 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	4.3% 3/70 • Number of events 13 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	5.6% 3/54 • Number of events 4 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/54 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	0.00% 0/77 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	5.4% 4/74 • Number of events 10 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
General disorders Injection Site Reaction	2.9% 2/68 • Number of events 10 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	5.7% 4/70 • Number of events 9 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.9% 1/54 • Number of events 2 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.9% 1/54 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.3% 1/77 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	4.1% 3/74 • Number of events 8 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.
Injury, poisoning and procedural complications Accidental Overdose	0.00% 0/68 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	1.4% 1/70 • Number of events 1 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	3.7% 2/54 • Number of events 2 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	5.6% 3/54 • Number of events 3 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	2.6% 2/77 • Number of events 2 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.	6.8% 5/74 • Number of events 5 • From first dose of study intervention (Day 1) up to end of follow-up, approximately 36 weeks each for Study A, B and C Analysis was performed on the safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group/intervention.

Additional Information

Trial Transparency Team

Sanofi aventis recherche & développement

Phone: 800-633-1610

Email: Contact-US@sanofi.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
• Publication restrictions are in place

Restriction type: OTHER