Trial Outcomes & Findings for Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria (NCT NCT04976192)

Results Overview

The severity of the itch was recorded by the participants twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly itch score (ISS7) was defined as the sum of the available daily itch severity scores in that week, divided by the number of days for which a daily itch severity score was available, multiplied by 7. The daily ISS was calculated as the average of the morning and evening scores. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severe itching. Least square (LS) mean and 95% confidence interval (CI) were calculated using analysis of covariance (ANCOVA) model. Multiple imputation performed both for the participants having missing ISS7 at week 12 and for participants using any disallowed concomitant medication.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

608 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2025-10-07

Participant Flow

The study included a 24-week treatment period consisting of a 12-week double-blind main treatment period and a 12-week double-blind transition period, which was followed by a 16-week follow-up period.

Participant milestones

Participant milestones
Measure	Main Treatment Period: TEV-45779 High Dose Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: TEV-45779 Low Dose Participants received TEV-45779 SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: TEV-45779/TEV-45779 High Dose Participants who received TEV-45779 SC injection at a high dose level in the main treatment period, continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: TEV-45779/TEV-45779 Low Dose Participants who received TEV-45779 SC injection at a low dose level in the main treatment period, continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/XOLAIR High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/XOLAIR Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Main Treatment Period (12 Weeks) STARTED	201	102	203	102	0	0	0	0	0	0
Main Treatment Period (12 Weeks) Received at Least 1 Dose of Study Drug	201	102	203	102	0	0	0	0	0	0
Main Treatment Period (12 Weeks) COMPLETED	188	98	194	101	0	0	0	0	0	0
Main Treatment Period (12 Weeks) NOT COMPLETED	13	4	9	1	0	0	0	0	0	0
Transition Treatment Period (12 Weeks) STARTED	0	0	0	0	188	98	97	51	97	50
Transition Treatment Period (12 Weeks) Received at Least 1 Dose of Study Drug	0	0	0	0	188	98	97	51	97	50
Transition Treatment Period (12 Weeks) COMPLETED	0	0	0	0	178	90	93	49	95	47
Transition Treatment Period (12 Weeks) NOT COMPLETED	0	0	0	0	10	8	4	2	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Main Treatment Period: TEV-45779 High Dose Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: TEV-45779 Low Dose Participants received TEV-45779 SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: TEV-45779/TEV-45779 High Dose Participants who received TEV-45779 SC injection at a high dose level in the main treatment period, continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: TEV-45779/TEV-45779 Low Dose Participants who received TEV-45779 SC injection at a low dose level in the main treatment period, continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/XOLAIR High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/XOLAIR Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Main Treatment Period (12 Weeks) Adverse Event	0	1	0	0	0	0	0	0	0	0
Main Treatment Period (12 Weeks) Withdrawal by Subject	12	3	8	1	0	0	0	0	0	0
Main Treatment Period (12 Weeks) Other Than Specified	1	0	1	0	0	0	0	0	0	0
Transition Treatment Period (12 Weeks) Withdrawal by Subject	0	0	0	0	9	7	4	2	2	3
Transition Treatment Period (12 Weeks) Other Than Specified	0	0	0	0	1	0	0	0	0	0
Transition Treatment Period (12 Weeks) Lost to Follow-up	0	0	0	0	0	1	0	0	0	0

Baseline Characteristics

Here, 'number analyzed' = participants evaluable at Baseline for this baseline characteristic.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Main Treatment Period: TEV-45779 High Dose n=201 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: TEV-45779 Low Dose n=102 Participants Participants received TEV-45779 SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=203 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=102 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Total n=608 Participants Total of all reporting groups
Age, Continuous	41.1 years STANDARD_DEVIATION 14.30 • n=201 Participants	42.7 years STANDARD_DEVIATION 13.64 • n=102 Participants	42.0 years STANDARD_DEVIATION 13.75 • n=203 Participants	41.5 years STANDARD_DEVIATION 14.29 • n=102 Participants	41.7 years STANDARD_DEVIATION 13.99 • n=608 Participants
Sex: Female, Male Female	132 Participants n=201 Participants	69 Participants n=102 Participants	138 Participants n=203 Participants	67 Participants n=102 Participants	406 Participants n=608 Participants
Sex: Female, Male Male	69 Participants n=201 Participants	33 Participants n=102 Participants	65 Participants n=203 Participants	35 Participants n=102 Participants	202 Participants n=608 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	45 Participants n=201 Participants	13 Participants n=102 Participants	26 Participants n=203 Participants	11 Participants n=102 Participants	95 Participants n=608 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	153 Participants n=201 Participants	88 Participants n=102 Participants	174 Participants n=203 Participants	89 Participants n=102 Participants	504 Participants n=608 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=201 Participants	1 Participants n=102 Participants	3 Participants n=203 Participants	2 Participants n=102 Participants	9 Participants n=608 Participants
Race/Ethnicity, Customized Race · American Indian/Alaskan/Native American	12 Participants n=201 Participants	4 Participants n=102 Participants	4 Participants n=203 Participants	0 Participants n=102 Participants	20 Participants n=608 Participants
Race/Ethnicity, Customized Race · Asian	65 Participants n=201 Participants	35 Participants n=102 Participants	75 Participants n=203 Participants	38 Participants n=102 Participants	213 Participants n=608 Participants
Race/Ethnicity, Customized Race · Black/African American	0 Participants n=201 Participants	3 Participants n=102 Participants	2 Participants n=203 Participants	0 Participants n=102 Participants	5 Participants n=608 Participants
Race/Ethnicity, Customized Race · White	123 Participants n=201 Participants	59 Participants n=102 Participants	118 Participants n=203 Participants	61 Participants n=102 Participants	361 Participants n=608 Participants
Race/Ethnicity, Customized Race · Other/Mixed	1 Participants n=201 Participants	0 Participants n=102 Participants	3 Participants n=203 Participants	2 Participants n=102 Participants	6 Participants n=608 Participants
Race/Ethnicity, Customized Race · Not Reported/Unknown	0 Participants n=201 Participants	1 Participants n=102 Participants	1 Participants n=203 Participants	1 Participants n=102 Participants	3 Participants n=608 Participants
Weekly Itch Severity Score (ISS7)	16.26 units on a scale STANDARD_DEVIATION 3.721 • n=196 Participants • Here, 'number analyzed' = participants evaluable at Baseline for this baseline characteristic.	16.14 units on a scale STANDARD_DEVIATION 3.361 • n=100 Participants • Here, 'number analyzed' = participants evaluable at Baseline for this baseline characteristic.	16.28 units on a scale STANDARD_DEVIATION 3.524 • n=203 Participants • Here, 'number analyzed' = participants evaluable at Baseline for this baseline characteristic.	16.00 units on a scale STANDARD_DEVIATION 3.723 • n=102 Participants • Here, 'number analyzed' = participants evaluable at Baseline for this baseline characteristic.	16.20 units on a scale STANDARD_DEVIATION 3.590 • n=601 Participants • Here, 'number analyzed' = participants evaluable at Baseline for this baseline characteristic.

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The ITT analysis set included all randomized participants.

The severity of the itch was recorded by the participants twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly itch score (ISS7) was defined as the sum of the available daily itch severity scores in that week, divided by the number of days for which a daily itch severity score was available, multiplied by 7. The daily ISS was calculated as the average of the morning and evening scores. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severe itching. Least square (LS) mean and 95% confidence interval (CI) were calculated using analysis of covariance (ANCOVA) model. Multiple imputation performed both for the participants having missing ISS7 at week 12 and for participants using any disallowed concomitant medication.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=201 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=203 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Change From Baseline in the ISS7 at Week 12, TEV-45779 High Dose Compared to XOLAIR High Dose (For European Medicines Agency [EMA] Submission)	-10.92 units on a scale 95% Confidence Interval -11.85 • Interval -11.85 to -9.99	-10.61 units on a scale 95% Confidence Interval -11.51 • Interval -11.51 to -9.71	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The ITT analysis set included all randomized participants.

The severity of the itch was recorded by the participants twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly itch score (ISS7) was defined as the sum of the available daily itch severity scores in that week, divided by the number of days for which a daily itch severity score was available, multiplied by 7. The daily ISS was calculated as the average of the morning and evening scores. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severe itching. LS mean and 90% CI were calculated using ANCOVA model. Multiple imputation performed for the participants having missing ISS7 at week 12.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=201 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=203 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Change From Baseline in the ISS7 at Week 12, TEV-45779 High Dose Compared to XOLAIR High Dose (For Food and Drug Administration [FDA] Submission)	-10.77 units on a scale Interval -11.61 to -9.93	-10.38 units on a scale Interval -11.24 to -9.52	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4 and 12

Population: The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable at specified timepoint.

The severity of the itch was recorded by the participants twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly itch score (ISS7) was defined as the sum of the available daily itch severity scores in that week, divided by the number of days for which a daily itch severity score was available, multiplied by 7. The daily ISS was calculated as the average of the morning and evening scores. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severe itching. The observed mean and standard deviation values are reported here with no imputation performed.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=192 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=98 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=198 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=97 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Change From Baseline in the ISS7 at Weeks 4 and 12 Change at Week 4	-7.64 units on a scale Standard Deviation 6.383	-7.35 units on a scale Standard Deviation 6.236	-7.87 units on a scale Standard Deviation 6.033	-7.27 units on a scale Standard Deviation 6.084	—	—
Change From Baseline in the ISS7 at Weeks 4 and 12 Change at Week 12	-10.92 units on a scale Standard Deviation 6.512	-9.96 units on a scale Standard Deviation 6.340	-10.65 units on a scale Standard Deviation 6.490	-10.35 units on a scale Standard Deviation 6.082	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

The UAS was a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0 - 3 (0 = none to 3 = intense/severe) for (1) the number of wheals (hives); and (2) the intensity of the itch separately, measured twice daily (morning and evening). The daily UAS was the average of the morning and evening scores, which ranged from 0 (none) to 6 (severe). The UAS7 was the sum of the daily UAS scores over 7 days, which ranged from 0 (minimum) to 42 (highest urticaria severity). Higher scores indicated greater severity of urticaria symptoms.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=184 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=96 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=196 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=97 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12	-22.10 units on a scale Standard Deviation 13.204 • Interval 13.204 to	-20.67 units on a scale Standard Deviation 12.223 • Interval 12.223 to	-21.73 units on a scale Standard Deviation 12.651 • Interval 12.651 to	-21.67 units on a scale Standard Deviation 12.158 • Interval 12.158 to	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

The UAS was a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0 - 3 (0 = none to 3 = intense/severe) for (1) the number of wheals (hives); and (2) the intensity of the itch separately, measured twice daily (morning and evening). The daily UAS was the average of the morning and evening scores, which ranged from 0 (none) to 6 (severe). The UAS7 is the number of participants achieving the endpoint of less than or equal to 6. UAS7 was calculated as the sum of the daily UAS scores over 7 days, which ranged from 0 (minimum) to 42 (highest urticaria severity). Higher scores indicated greater severity of urticaria symptoms.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=184 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=96 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=196 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=97 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Percentage of Participants With a UAS7 Score ≤6 at Week 12	49.5 percentage of participants	45.8 percentage of participants	46.4 percentage of participants	48.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

The UAS was a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0 - 3 (0 = none to 3 = intense/severe) for (1) the number of wheals (hives); and (2) the intensity of the itch separately, measured twice daily (morning and evening). The daily UAS was the average of the morning and evening scores, which ranged from 0 (none) to 6 (severe). The UAS7 was the sum of the daily UAS scores over 7 days, which ranged from 0 (minimum) to 42 (highest urticaria severity). Higher scores indicated greater severity of urticaria symptoms. Complete responders were participants with a UAS7 score = 0.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=184 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=96 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=196 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=97 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Percentage of Complete Responders (UAS7 Score = 0) at Week 12	33.2 percentage of participants	28.1 percentage of participants	29.6 percentage of participants	30.9 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Physician's (in-clinic) assessment of UAS score was performed using the in-clinic UAS. The physician, or the person designated, provided the sum of the score of the participant's urticaria lesions (number of wheals \[hives\]) and pruritus (itch) reflective of the participant's condition over the 12 hours prior to the visit using the rating scale of 0 - 6 (0 = none to 6 = intense/severe). Higher scores indicated greater severity of urticaria symptoms.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=185 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=96 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=193 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=101 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Change From Baseline in the Physician's (In-clinic) Assessment of UAS at Week 12	-3.38 units on a scale Standard Deviation 2.002 • Interval 2.002 to	-3.34 units on a scale Standard Deviation 1.907 • Interval 1.907 to	-3.55 units on a scale Standard Deviation 1.893 • Interval 1.893 to	-3.15 units on a scale Standard Deviation 2.085 • Interval 2.085 to	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

The wheals (hives) severity score, defined by number of wheals (hives), was recorded by the participant twice daily in their eDiary, on a scale of 0 (none) to 3 (\> 12 hives/12 hours). A weekly number of wheals score was derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score was therefore 0 (no wheals) - 21 (highest hives activity).

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=184 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=96 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=196 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=97 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Change From Baseline in the Weekly Number of Wheals Score at Week 12	-11.18 units on a scale Standard Deviation 7.127 • Interval 7.127 to	-10.70 units on a scale Standard Deviation 6.551 • Interval 6.551 to	-11.09 units on a scale Standard Deviation 6.740 • Interval 6.74 to	-11.33 units on a scale Standard Deviation 6.672 • Interval 6.672 to	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

The weekly size of the largest wheals score was calculated from the eDiary data. A wheal score of 0 was assigned when \<10 small wheals (diameter \<3 centimeters \[cm\]) were present, presence of 10-50 small wheals or less than 10 large wheals (diameter \>3 cm) was denoted by score of 1. A score of 2 was assigned when more than 50 small wheals or 10 to 50 large wheals were present. A score of 3 denoted wheals covering almost the entire body surface area. A weekly score was defined as the sum of the available daily size of the largest wheals scores in that week, divided by the number of days for which a daily score was available, multiplied by 7. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severity.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=184 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=96 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=196 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=97 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Change From Baseline in the Weekly Size of the Largest Wheals Score at Week 12	-10.28 units on a scale Standard Deviation 6.937 • Interval 6.937 to	-9.52 units on a scale Standard Deviation 6.670 • Interval 6.67 to	-10.45 units on a scale Standard Deviation 6.745 • Interval 6.745 to	-10.68 units on a scale Standard Deviation 6.838 • Interval 6.838 to	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants achieving MID up to Week 12.

Time to MID response was defined as time to a reduction from baseline in ISS7 of ≥5 points in ISS7 score by Week 12.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=177 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=87 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=185 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=87 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Time to Minimally Important Difference (MID) Response in ISS7 Score	2.0 weeks Interval 2.0 to 3.0	2.0 weeks Interval 1.0 to 2.0	2.0 weeks Confidence interval for median time to MID could not be calculated (NA) because MID was reached too early in the observation period, resulting in an insufficient number of observations to calculate upper and lower limits.	2.0 weeks Interval 2.0 to 3.0	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

A responder was defined as a participant with a reduction from baseline in ISS7 of ≥5 points in ISS7 score.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=184 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=96 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=196 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=97 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Percentage of ISS7 MID Responders at Week 12	81.0 percentage of participants	78.1 percentage of participants	80.6 percentage of participants	79.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 4 to Week 12

Population: The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Percentage of angioedema-free days from Week 4 to Week 12 were calculated based on the diary data as the number of days in the diary between the dates of Week 4 and Week 12 visits with no angioedema episodes, divided by the total number of days with diary entries in this time span \* 100%.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=195 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=99 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=202 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=102 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Percentage of Angioedema-Free Days From Week 4 to Week 12	100.00 percentage of days Full Range 0.0 • Interval 0.0 to 100.0	100.00 percentage of days Full Range 0.0 • Interval 0.0 to 100.0	100.00 percentage of days Full Range 0.0 • Interval 0.0 to 100.0	100.00 percentage of days Full Range 0.0 • Interval 0.0 to 100.0	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

The DLQI consisted of 10 questions concerning participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. The DLQI total score was calculated by adding the score of each question (scored as follows: Very much = 3; Yes \[in question 7.a\] = 3; A lot = 2; A little = 1; Not at all = 0; Not relevant = 0; No \[in question 7.a\] = 0; Question unanswered = 0), resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. A score higher than 10 indicated that the participant's life was being severely affected by their skin disease.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=188 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=98 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=193 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=100 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12	-9.72 units on a scale Standard Deviation 7.125 • Interval 7.125 to	-8.40 units on a scale Standard Deviation 7.28 • Interval 7.28 to	-9.54 units on a scale Standard Deviation 7.091 • Interval 7.091 to	-8.09 units on a scale Standard Deviation 6.432 • Interval 6.432 to	—	—

SECONDARY outcome

Timeframe: Week 12, Weeks 24 and 40

Population: The transition intent-to-treat (TITT) analysis set included all participants re-randomized in the transition period. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable at specified timepoint.

The severity of the itch was recorded by the participants twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly itch score (ISS7) was defined as the sum of the available daily itch severity scores in that week, divided by the number of days for which a daily itch severity score was available, multiplied by 7. The daily ISS was calculated as the average of the morning and evening scores. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severe itching.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=170 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=91 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=91 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=46 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose n=93 Participants Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose n=47 Participants Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Change From Week 12 in ISS7 at Weeks 24 and 40 Change at Week 24	-1.64 units on a scale Standard Deviation 3.598	-1.37 units on a scale Standard Deviation 4.576	-1.82 units on a scale Standard Deviation 4.016	-1.21 units on a scale Standard Deviation 3.186	-1.78 units on a scale Standard Deviation 4.226	-2.09 units on a scale Standard Deviation 4.585
Change From Week 12 in ISS7 at Weeks 24 and 40 Change at Week 40	1.84 units on a scale Standard Deviation 7.182	0.44 units on a scale Standard Deviation 6.982	1.43 units on a scale Standard Deviation 6.870	1.58 units on a scale Standard Deviation 5.274	2.03 units on a scale Standard Deviation 7.969	1.27 units on a scale Standard Deviation 6.718

SECONDARY outcome

Timeframe: Week 12, Week 24

Population: The TITT analysis set included all participants re-randomized in the transition period. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

The UAS was a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0 - 3 (0 = none to 3 = intense/severe) for (1) the number of wheals (hives); and (2) the intensity of the itch separately, measured twice daily (morning and evening). The daily UAS was the average of the morning and evening scores, which can range from 0 (none) to 6 (severe). The UAS7 was the sum of the daily UAS scores over 7 days, which can range from 0 (minimum) to 42 (highest urticaria severity). Higher scores indicated greater severity of urticaria symptoms.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=170 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=91 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=91 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=46 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose n=93 Participants Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose n=47 Participants Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Change From Week 12 in the UAS7 at Week 24	-3.37 units on a scale Standard Deviation 6.641 • Interval 6.641 to	-2.66 units on a scale Standard Deviation 9.524 • Interval 9.524 to	-3.65 units on a scale Standard Deviation 7.953 • Interval 7.953 to	-2.54 units on a scale Standard Deviation 7.546 • Interval 7.546 to	-3.45 units on a scale Standard Deviation 8.387 • Interval 8.387 to	-3.12 units on a scale Standard Deviation 9.419 • Interval 9.419 to

SECONDARY outcome

Timeframe: Week 12, Week 24

Population: The TITT analysis set included all participants re-randomized in the transition period. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Physician's (in-clinic) assessment of UAS score was performed using the in-clinic UAS. The physician, or the person designated, provided the sum of the score of the participant's urticaria lesions (number of wheals \[hives\]) and pruritus (itch) reflective of the participant's condition over the 12 hours prior to the visit using the rating scale of 0 - 6 (0 = none to 6 = intense/severe). Higher scores indicated greater severity of urticaria symptoms.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=175 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=91 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=93 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=49 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose n=92 Participants Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose n=48 Participants Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Change From Week 12 in the Physician's (In-clinic) Assessment of UAS7 at Week 24	-0.55 units on a scale Standard Deviation 1.556 • Interval 1.556 to	-0.40 units on a scale Standard Deviation 2.032 • Interval 2.032 to	-0.27 units on a scale Standard Deviation 1.360 • Interval 1.36 to	-0.53 units on a scale Standard Deviation 1.838 • Interval 1.838 to	-0.38 units on a scale Standard Deviation 1.413 • Interval 1.413 to	-0.67 units on a scale Standard Deviation 1.548 • Interval 1.548 to

SECONDARY outcome

Timeframe: Week 12, Weeks 24 and 40

Population: The TITT analysis set included all participants re-randomized in the transition period. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable at specified timepoint.

The wheals (hives) severity score, defined by number of wheals (hives), was recorded by the participant twice daily in their eDiary, on a scale of 0 (none) to 3 (\> 12 hives/12 hours). A weekly number of wheals score was derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score was therefore 0 (no wheals) - 21 (highest hives activity).

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=170 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=91 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=91 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=46 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose n=93 Participants Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose n=47 Participants Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Change From Week 12 in the Weekly Number of Wheals Score at Weeks 24 and 40 Change at Week 24	-1.73 units on a scale Standard Deviation 3.649	-1.29 units on a scale Standard Deviation 5.262	-1.84 units on a scale Standard Deviation 4.139	-1.33 units on a scale Standard Deviation 4.793	-1.67 units on a scale Standard Deviation 4.510	-1.03 units on a scale Standard Deviation 5.281
Change From Week 12 in the Weekly Number of Wheals Score at Weeks 24 and 40 Change at Week 40	1.87 units on a scale Standard Deviation 7.412	0.60 units on a scale Standard Deviation 8.236	1.53 units on a scale Standard Deviation 6.953	2.05 units on a scale Standard Deviation 6.110	2.77 units on a scale Standard Deviation 8.620	2.13 units on a scale Standard Deviation 7.809

SECONDARY outcome

Timeframe: Week 12, Weeks 24 and 40

Population: The TITT analysis set included all participants re-randomized in the transition period. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable at specified timepoint.

The weekly size of the largest wheals score was calculated from eDiary data. A wheal score of 0 was assigned when \<10 small wheals (diameter \<3 cm) were present, presence of 10-50 small wheals or less than 10 large wheals (diameter \>3 cm) was denoted by score 1. A score of 2 was assigned when more than 50 small wheals or 10 to 50 large wheals were present. A score of 3 denoted wheals covering almost the entire body surface area. A weekly score was defined as sum of available daily size of the largest wheals scores in that week, divided by the number of days for which a daily score was available, multiplied by 7. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severity.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=170 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=91 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=91 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=46 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose n=93 Participants Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose n=47 Participants Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Change From Week 12 in the Weekly Size of the Largest Wheals Score at Weeks 24 and 40 Change at Week 24	-1.87 units on a scale Standard Deviation 3.898	-1.28 units on a scale Standard Deviation 4.697	-1.78 units on a scale Standard Deviation 4.334	-1.18 units on a scale Standard Deviation 4.464	-1.94 units on a scale Standard Deviation 4.776	-0.88 units on a scale Standard Deviation 4.456
Change From Week 12 in the Weekly Size of the Largest Wheals Score at Weeks 24 and 40 Change at Week 40	1.46 units on a scale Standard Deviation 7.434	0.72 units on a scale Standard Deviation 7.899	1.34 units on a scale Standard Deviation 7.332	2.35 units on a scale Standard Deviation 5.968	2.71 units on a scale Standard Deviation 8.706	1.87 units on a scale Standard Deviation 7.798

SECONDARY outcome

Timeframe: Week 12 to Week 24

Population: The TITT analysis set included all participants re-randomized in the transition period. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Percentage of angioedema-free days from Week 12 to Week 24 was calculated based on the diary data as the number of days in the diary between the dates of Week 12 and Week 24 visits with no angioedema episodes, divided by the total number of days with diary entries in this time span \* 100%.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=184 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=97 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=97 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=51 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose n=97 Participants Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose n=50 Participants Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Percentage of Angioedema-Free Days From Week 12 to Week 24	100.00 percentage of days Full Range 0.0 • Interval 0.0 to 100.0	100.00 percentage of days Full Range 0.0 • Interval 0.0 to 100.0	100.00 percentage of days Full Range 0.0 • Interval 0.0 to 100.0	100.00 percentage of days Full Range 0.0 • Interval 0.0 to 100.0	100.00 percentage of days Full Range 0.0 • Interval 0.0 to 100.0	100.00 percentage of days Full Range 0.0 • Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Week 12, Weeks 24 and 40

Population: The TITT analysis set included all participants re-randomized in the transition period. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable at specified timepoint.

The DLQI consisted of 10 questions concerning participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. The DLQI total score was calculated by adding the score of each question (scored as follows: Very much = 3; Yes \[in question 7.a\] = 3; A lot = 2; A little = 1; Not at all = 0; Not relevant = 0; No \[in question 7.a\] = 0; Question unanswered = 0), resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. A score higher than 10 indicated that the participant's life was being severely affected by their skin disease.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=179 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=93 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=93 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=49 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose n=94 Participants Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose n=48 Participants Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Change From Week 12 in the Overall DLQI Score at Weeks 24 and 40 Change at Week 24	-1.44 units on a scale Standard Deviation 3.621	-0.43 units on a scale Standard Deviation 5.619	-1.19 units on a scale Standard Deviation 4.387	-1.82 units on a scale Standard Deviation 5.552	-0.88 units on a scale Standard Deviation 4.788	-1.60 units on a scale Standard Deviation 4.271
Change From Week 12 in the Overall DLQI Score at Weeks 24 and 40 Change at Week 40	1.65 units on a scale Standard Deviation 7.581	1.05 units on a scale Standard Deviation 7.545	0.51 units on a scale Standard Deviation 7.096	0.39 units on a scale Standard Deviation 5.098	2.45 units on a scale Standard Deviation 7.791	1.10 units on a scale Standard Deviation 7.570

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: The main treatment period safety analysis set included all randomized participants who received at least 1 dose of study drug during the main treatment period.

An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred or worsened on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=201 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=102 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=203 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=102 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) in the Main Treatment Period	64 Participants	37 Participants	71 Participants	33 Participants	—	—

SECONDARY outcome

Timeframe: Week 12 up to Week 24

Population: The transition period safety analysis set included all randomized participants who received the study drug at Week 12.

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred or worsened on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=188 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=98 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=97 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=51 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose n=97 Participants Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose n=50 Participants Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Number of Participants With at Least One TEAE Week 12 up to Week 24	78 Participants	34 Participants	43 Participants	18 Participants	38 Participants	16 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: The main treatment period safety analysis set included all randomized participants who received at least 1 dose of study drug during the main treatment period. 'Overall number of participants analyzed' = participants with ADA status at any time during the main treatment period.

Number of participants with positive ADA, positive ADA not treatment-related, and negative ADA are reported.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=199 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=101 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=201 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=102 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Number of Participants With Antidrug Antibodies (ADAs) in the Main Treatment Period Positive	18 Participants	6 Participants	37 Participants	13 Participants	—	—
Number of Participants With Antidrug Antibodies (ADAs) in the Main Treatment Period Positive, Not Treatment Related	8 Participants	5 Participants	5 Participants	4 Participants	—	—
Number of Participants With Antidrug Antibodies (ADAs) in the Main Treatment Period Negative	173 Participants	90 Participants	159 Participants	85 Participants	—	—

SECONDARY outcome

Timeframe: Week 12 up to Week 24

Population: The transition period safety analysis set included all randomized participants who received the study drug at Week 12. 'Overall number of participants analyzed' = participants with ADA status at any time during the transition period.

Number of participants with positive ADA, positive ADA not treatment-related, and negative ADA are reported.

Outcome measures

Outcome measures
Measure	Main Treatment Period: TEV-45779 High Dose n=182 Participants Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=95 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=96 Participants Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=50 Participants Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: XOLAIR/TEV-45779 High Dose n=96 Participants Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose n=48 Participants Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
Number of Participants With ADAs From Week 12 to Week 24 Positive	34 Participants	15 Participants	10 Participants	4 Participants	14 Participants	8 Participants
Number of Participants With ADAs From Week 12 to Week 24 Positive, Not Treatment Related	6 Participants	4 Participants	3 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With ADAs From Week 12 to Week 24 Negative	142 Participants	76 Participants	83 Participants	45 Participants	81 Participants	38 Participants

Adverse Events

Main Treatment Period: TEV-45779 High Dose

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Main Treatment Period: TEV-45779 Low Dose

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Main Treatment Period: XOLAIR High Dose

Serious events: 3 serious events

Other events: 30 other events

Deaths: 0 deaths

Main Treatment Period: XOLAIR Low Dose

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Transition Period: TEV-45779/TEV-45779 High Dose

Serious events: 4 serious events

Other events: 29 other events

Deaths: 0 deaths

Transition Period: TEV-45779/TEV-45779 Low Dose

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Transition Period: XOLAIR/XOLAIR High Dose

Serious events: 4 serious events

Other events: 16 other events

Deaths: 0 deaths

Transition Period: XOLAIR/XOLAIR Low Dose

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Transition Period: XOLAIR/TEV-45779 High Dose

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Transition Period: XOLAIR/TEV-45779 Low Dose

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Main Treatment Period: TEV-45779 High Dose n=201 participants at risk Participants received TEV-45779 SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: TEV-45779 Low Dose n=102 participants at risk Participants received TEV-45779 SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=203 participants at risk Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=102 participants at risk Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: TEV-45779/TEV-45779 High Dose n=188 participants at risk Participants who received TEV-45779 SC injection at a high dose level in the main treatment period continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: TEV-45779/TEV-45779 Low Dose n=98 participants at risk Participants who received TEV-45779 SC injection at a low dose level in the main treatment period continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/XOLAIR High Dose n=97 participants at risk Participants who received XOLAIR SC injection at a high dose level in the main treatment period continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/XOLAIR Low Dose n=51 participants at risk Participants who received XOLAIR SC injection at a low dose level in the main treatment period continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 High Dose n=97 participants at risk Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose n=50 participants at risk Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 at a low dose level at Weeks 12, 16, and 20 in the transition period.
Gastrointestinal disorders Colitis	0.00% 0/201 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/203 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/188 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/98 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	2.0% 1/50 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Gastrointestinal disorders Pancreatitis	0.00% 0/201 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.49% 1/203 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/188 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/98 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/50 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Gastrointestinal disorders Strangulated umbilical hernia	0.50% 1/201 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/203 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/188 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/98 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/50 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
General disorders Pyrexia	0.00% 0/201 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.49% 1/203 • Number of events 2 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/188 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/98 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/50 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Hepatobiliary disorders Cholelithiasis	0.00% 0/201 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.49% 1/203 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.53% 1/188 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/98 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/50 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Infections and infestations Epiglottitis	0.00% 0/201 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/203 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/188 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/98 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	1.0% 1/97 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/50 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Infections and infestations Erysipelas	0.00% 0/201 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/203 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.53% 1/188 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/98 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/50 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Infections and infestations Pyelonephritis chronic	0.00% 0/201 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/203 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/188 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/98 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	1.0% 1/97 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/50 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Infections and infestations Urinary tract infection	0.00% 0/201 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/203 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/188 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	1.0% 1/98 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/50 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/201 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/203 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/188 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/98 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	1.0% 1/97 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/50 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/201 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/203 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/188 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	1.0% 1/98 • Number of events 2 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/50 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Musculoskeletal and connective tissue disorders Chondromalacia	0.00% 0/201 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.49% 1/203 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/188 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/98 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/50 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/201 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/203 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.53% 1/188 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/98 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/50 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Reproductive system and breast disorders Adenomyosis	0.00% 0/201 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/203 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.53% 1/188 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/98 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/50 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/201 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/203 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/188 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/98 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	1.0% 1/97 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/50 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/201 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/203 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.53% 1/188 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	1.0% 1/98 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	1.0% 1/97 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/50 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.

Other adverse events

Other adverse events
Measure	Main Treatment Period: TEV-45779 High Dose n=201 participants at risk Participants received TEV-45779 SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: TEV-45779 Low Dose n=102 participants at risk Participants received TEV-45779 SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR High Dose n=203 participants at risk Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.	Main Treatment Period: XOLAIR Low Dose n=102 participants at risk Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.	Transition Period: TEV-45779/TEV-45779 High Dose n=188 participants at risk Participants who received TEV-45779 SC injection at a high dose level in the main treatment period continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: TEV-45779/TEV-45779 Low Dose n=98 participants at risk Participants who received TEV-45779 SC injection at a low dose level in the main treatment period continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/XOLAIR High Dose n=97 participants at risk Participants who received XOLAIR SC injection at a high dose level in the main treatment period continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/XOLAIR Low Dose n=51 participants at risk Participants who received XOLAIR SC injection at a low dose level in the main treatment period continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 High Dose n=97 participants at risk Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 at a high dose level at Weeks 12, 16, and 20 in the transition period.	Transition Period: XOLAIR/TEV-45779 Low Dose n=50 participants at risk Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 at a low dose level at Weeks 12, 16, and 20 in the transition period.
General disorders Injection site erythema	7.5% 15/201 • Number of events 24 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	9.8% 10/102 • Number of events 14 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	6.4% 13/203 • Number of events 21 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	6.9% 7/102 • Number of events 12 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	4.3% 8/188 • Number of events 17 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	5.1% 5/98 • Number of events 6 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	3.1% 3/97 • Number of events 4 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	3.9% 2/51 • Number of events 3 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	6.2% 6/97 • Number of events 9 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	6.0% 3/50 • Number of events 8 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
General disorders Injection site induration	6.0% 12/201 • Number of events 17 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	5.9% 6/102 • Number of events 6 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	5.9% 12/203 • Number of events 15 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	4.9% 5/102 • Number of events 7 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	3.7% 7/188 • Number of events 15 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	3.1% 3/98 • Number of events 4 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	3.1% 3/97 • Number of events 4 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	2.0% 1/51 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	3.1% 3/97 • Number of events 5 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	6.0% 3/50 • Number of events 9 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
General disorders Injection site pain	6.5% 13/201 • Number of events 30 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	8.8% 9/102 • Number of events 11 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	5.4% 11/203 • Number of events 21 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	4.9% 5/102 • Number of events 11 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	4.3% 8/188 • Number of events 14 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	3.1% 3/98 • Number of events 7 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	2.1% 2/97 • Number of events 2 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	3.9% 2/51 • Number of events 4 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	1.0% 1/97 • Number of events 2 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	4.0% 2/50 • Number of events 6 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
General disorders Injection site swelling	4.5% 9/201 • Number of events 10 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	3.9% 4/102 • Number of events 4 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	2.0% 4/203 • Number of events 4 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	2.9% 3/102 • Number of events 4 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	3.2% 6/188 • Number of events 9 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	1.0% 1/98 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	3.1% 3/97 • Number of events 3 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/51 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/97 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	6.0% 3/50 • Number of events 8 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Infections and infestations COVID-19	2.5% 5/201 • Number of events 5 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	4.9% 5/102 • Number of events 5 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	3.9% 8/203 • Number of events 8 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	4.8% 9/188 • Number of events 9 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	5.1% 5/98 • Number of events 5 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	7.2% 7/97 • Number of events 7 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	5.9% 3/51 • Number of events 3 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	1.0% 1/97 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	4.0% 2/50 • Number of events 2 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Infections and infestations Upper respiratory tract infection	2.5% 5/201 • Number of events 5 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	2.9% 3/102 • Number of events 4 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.99% 2/203 • Number of events 2 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	0.00% 0/102 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	4.8% 9/188 • Number of events 11 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	1.0% 1/98 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	5.2% 5/97 • Number of events 5 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	3.9% 2/51 • Number of events 2 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	1.0% 1/97 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.	2.0% 1/50 • Number of events 1 • Baseline up to Week 40 The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products, R&D Inc.

Phone: 888-483-8279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Publication restrictions are in place

Restriction type: OTHER