Trial Outcomes & Findings for Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (NCT NCT04987307)

NCT ID: NCT04987307

Last Updated: 2026-01-13

Results Overview

Clinical remission was defined as a modified Mayo score of 0 to 2, including a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and a centrally read endoscopy subscore of 0 or 1 (modified so that 1 did not include friability). The modified Mayo score was the total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 221 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2026-01-13

Participant Flow

The trial was conducted at 200 centers in 26 countries (Argentina, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Latvia, Mexico, Netherlands, Poland, Romania, Slovakia, South Korea, Spain, Switzerland, Taiwan, Turkey, and the United States) between January 2022 to October 2024.

Participants were randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period in 1:1:1:1 ratio. Participants who completed the 12-week induction period had the option to enter an exploratory long-term treatment (LTT) period for up to 40 weeks (total of up to 52 weeks of treatment). The study was terminated due to meeting a predefined futility criterion and not related to any safety concerns.

Participant milestones

Measure	Placebo Q2W Participants received placebo matching efavaleukin alfa every 2 weeks (Q2W) through a subcutaneous (SC) injection for up to 52 weeks. Participants randomized to placebo who achieved clinical response continued in placebo, while those who did not achieve clinical response at week 12 were reassigned in a blinded manner to efavaleukin alfa 1100 micrograms (mcg) Q2W during the LTT period.	Efavaleukin Alfa 400 µg Q2W Participants received efavaleukin alfa 400 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1100 µg Q2W Participants received efavaleukin alfa 1100 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1800 µg Q2W Participants received efavaleukin alfa 1800 mcg Q2W through a SC injection for up to 52 weeks.
Overall Study STARTED	57	57	54	53
Overall Study Responder at Week 12 in Placebo Q2W	15	0	0	0
Overall Study Non-responder at Week 12 in Placebo Q2W	42	0	0	0
Overall Study COMPLETED	10	14	14	6
Overall Study NOT COMPLETED	47	43	40	47

Reasons for withdrawal

Measure	Placebo Q2W Participants received placebo matching efavaleukin alfa every 2 weeks (Q2W) through a subcutaneous (SC) injection for up to 52 weeks. Participants randomized to placebo who achieved clinical response continued in placebo, while those who did not achieve clinical response at week 12 were reassigned in a blinded manner to efavaleukin alfa 1100 micrograms (mcg) Q2W during the LTT period.	Efavaleukin Alfa 400 µg Q2W Participants received efavaleukin alfa 400 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1100 µg Q2W Participants received efavaleukin alfa 1100 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1800 µg Q2W Participants received efavaleukin alfa 1800 mcg Q2W through a SC injection for up to 52 weeks.
Overall Study Protocol-specified criteria	2	0	0	3
Overall Study Withdrawal by Subject	34	30	29	35
Overall Study Decision by sponsor	10	13	11	9
Overall Study Lost to Follow-up	1	0	0	0

Baseline Characteristics

Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis

Baseline characteristics by cohort

Measure	Placebo Q2W n=57 Participants Participants received placebo matching efavaleukin alfa Q2W through a SC injection for up to 52 weeks. Participants randomized to placebo who achieved clinical response continued in placebo, while those who did not achieve clinical response at week 12 were reassigned in a blinded manner to efavaleukin alfa 1100 mcg Q2W during the LTT period.	Efavaleukin Alfa 400 µg Q2W n=57 Participants Participants received efavaleukin alfa 400 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1100 µg Q2W n=54 Participants Participants received efavaleukin alfa 1100 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1800 µg Q2W n=53 Participants Participants received efavaleukin alfa 1800 mcg Q2W through a SC injection for up to 52 weeks.	Total n=221 Participants Total of all reporting groups
Age, Continuous	44.3 years STANDARD_DEVIATION 14.8 • n=210 Participants	43.8 years STANDARD_DEVIATION 14.4 • n=19 Participants	44.7 years STANDARD_DEVIATION 16.8 • n=123 Participants	44.6 years STANDARD_DEVIATION 15.2 • n=123 Participants	44.3 years STANDARD_DEVIATION 15.2 • n=615 Participants
Sex: Female, Male Female	29 Participants n=210 Participants	17 Participants n=19 Participants	17 Participants n=123 Participants	23 Participants n=123 Participants	86 Participants n=615 Participants
Sex: Female, Male Male	28 Participants n=210 Participants	40 Participants n=19 Participants	37 Participants n=123 Participants	30 Participants n=123 Participants	135 Participants n=615 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=210 Participants	6 Participants n=19 Participants	8 Participants n=123 Participants	5 Participants n=123 Participants	30 Participants n=615 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=210 Participants	47 Participants n=19 Participants	45 Participants n=123 Participants	42 Participants n=123 Participants	176 Participants n=615 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=210 Participants	4 Participants n=19 Participants	1 Participants n=123 Participants	6 Participants n=123 Participants	15 Participants n=615 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants	2 Participants n=123 Participants	2 Participants n=615 Participants
Race/Ethnicity, Customized Asian	8 Participants n=210 Participants	9 Participants n=19 Participants	7 Participants n=123 Participants	5 Participants n=123 Participants	29 Participants n=615 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=210 Participants	1 Participants n=19 Participants	1 Participants n=123 Participants	0 Participants n=123 Participants	2 Participants n=615 Participants
Race/Ethnicity, Customized White	45 Participants n=210 Participants	40 Participants n=19 Participants	45 Participants n=123 Participants	39 Participants n=123 Participants	169 Participants n=615 Participants
Race/Ethnicity, Customized Other	0 Participants n=210 Participants	3 Participants n=19 Participants	1 Participants n=123 Participants	2 Participants n=123 Participants	6 Participants n=615 Participants
Race/Ethnicity, Customized Missing	4 Participants n=210 Participants	4 Participants n=19 Participants	0 Participants n=123 Participants	5 Participants n=123 Participants	13 Participants n=615 Participants

PRIMARY outcome

Timeframe: Week 12

Population: FAS included all participants randomized. Only participants with available data were included in this outcome measure.

Clinical remission was defined as a modified Mayo score of 0 to 2, including a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and a centrally read endoscopy subscore of 0 or 1 (modified so that 1 did not include friability). The modified Mayo score was the total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease.

Outcome measures

Measure	Placebo Q2W n=53 Participants Participants received placebo matching efavaleukin alfa Q2W through a SC injection for up to 52 weeks. Participants randomized to placebo who achieved clinical response continued in placebo, while those who did not achieve clinical response at week 12 were reassigned in a blinded manner to efavaleukin alfa 1100 mcg Q2W during the LTT period.	Efavaleukin Alfa 400 µg Q2W n=51 Participants Participants received efavaleukin alfa 400 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1100 µg Q2W n=52 Participants Participants received efavaleukin alfa 1100 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1800 µg Q2W n=48 Participants Participants received efavaleukin alfa 1800 mcg Q2W through a SC injection for up to 52 weeks.
Percentage of Participants With Clinical Remission at Week 12	7.5 percentage of participants	9.8 percentage of participants	9.6 percentage of participants	10.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS included all participants randomized. Only participants with available data were included in this outcome measure.

Clinical response was defined as a decrease from baseline in the modified Mayo score of ≥ 2 points and at least a 30% reduction from baseline, and a decrease in the rectal bleeding subscore of ≥ 1 or an absolute rectal bleeding subscore of 0 or 1. The modified Mayo score was the total Mayo score without the physician's global assessment subscore and ranged from 0 to 9 points, with higher scores indicating more severe disease. Only participants who had the opportunity to complete the visit by the date of the decision for the study termination were included in this outcome measure. Efficacy data collected after this date were censored and excluded from analyses.

Outcome measures

Measure	Placebo Q2W n=53 Participants Participants received placebo matching efavaleukin alfa Q2W through a SC injection for up to 52 weeks. Participants randomized to placebo who achieved clinical response continued in placebo, while those who did not achieve clinical response at week 12 were reassigned in a blinded manner to efavaleukin alfa 1100 mcg Q2W during the LTT period.	Efavaleukin Alfa 400 µg Q2W n=51 Participants Participants received efavaleukin alfa 400 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1100 µg Q2W n=52 Participants Participants received efavaleukin alfa 1100 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1800 µg Q2W n=48 Participants Participants received efavaleukin alfa 1800 mcg Q2W through a SC injection for up to 52 weeks.
Percentage of Participants With Clinical Response at Week 12	20.8 percentage of participants	19.6 percentage of participants	25.0 percentage of participants	25.0 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS included all participants randomized. Only participants with available data were included in this outcome measure.

Endoscopic remission was defined as a Mayo centrally read endoscopy subscore of 0 or 1 (modified so that a score of 1 did not include friability). The modified Mayo score was the total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease.

Outcome measures

Measure	Placebo Q2W n=53 Participants Participants received placebo matching efavaleukin alfa Q2W through a SC injection for up to 52 weeks. Participants randomized to placebo who achieved clinical response continued in placebo, while those who did not achieve clinical response at week 12 were reassigned in a blinded manner to efavaleukin alfa 1100 mcg Q2W during the LTT period.	Efavaleukin Alfa 400 µg Q2W n=51 Participants Participants received efavaleukin alfa 400 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1100 µg Q2W n=52 Participants Participants received efavaleukin alfa 1100 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1800 µg Q2W n=48 Participants Participants received efavaleukin alfa 1800 mcg Q2W through a SC injection for up to 52 weeks.
Percentage of Participants With Endoscopic Remission at Week 12	11.3 percentage of participants	15.7 percentage of participants	11.5 percentage of participants	12.5 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS included all participants randomized. Only participants with available data were included in this outcome measure.

Symptomatic remission was defined as Mayo stool frequency subscore of 0 or 1 and rectal bleeding subscore of 0. The modified Mayo score was the total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease.

Outcome measures

Measure	Placebo Q2W n=53 Participants Participants received placebo matching efavaleukin alfa Q2W through a SC injection for up to 52 weeks. Participants randomized to placebo who achieved clinical response continued in placebo, while those who did not achieve clinical response at week 12 were reassigned in a blinded manner to efavaleukin alfa 1100 mcg Q2W during the LTT period.	Efavaleukin Alfa 400 µg Q2W n=51 Participants Participants received efavaleukin alfa 400 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1100 µg Q2W n=52 Participants Participants received efavaleukin alfa 1100 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1800 µg Q2W n=48 Participants Participants received efavaleukin alfa 1800 mcg Q2W through a SC injection for up to 52 weeks.
Percentage of Participants With Symptomatic Remission at Week 12	15.1 percentage of participants	17.6 percentage of participants	23.1 percentage of participants	22.9 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS included all participants randomized. Only participants with available data were included in this outcome measure.

Combined endoscopic and histologic remission was defined as combined endoscopic remission (Mayo centrally read endoscopy subscore of 0 or 1) and histologic remission of the colon tissue (Geboes Score < 2.0; no neutrophils in epithelium crypts or lamina propria and no increase in eosinophils, no crypt destruction and no erosions, ulcerations or granulation tissue). Geobes score was defined as: grade 0, structural (architectural change); grade 1, chronic inflammatory infiltrate; grade 2A, lamina propria eosinophils; grade 2B, lamina propria neutrophils; grade 3, neutrophils in epithelium; grade 4, crypt destruction; and grade 5, erosion or ulceration. Each grade included subscores that indicated degree of abnormality, with subscores of 0 indicating normal appearance and higher subscores indicating increasingly abnormal appearance. The modified Mayo score was total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease.

Outcome measures

Measure	Placebo Q2W n=53 Participants Participants received placebo matching efavaleukin alfa Q2W through a SC injection for up to 52 weeks. Participants randomized to placebo who achieved clinical response continued in placebo, while those who did not achieve clinical response at week 12 were reassigned in a blinded manner to efavaleukin alfa 1100 mcg Q2W during the LTT period.	Efavaleukin Alfa 400 µg Q2W n=51 Participants Participants received efavaleukin alfa 400 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1100 µg Q2W n=52 Participants Participants received efavaleukin alfa 1100 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1800 µg Q2W n=48 Participants Participants received efavaleukin alfa 1800 mcg Q2W through a SC injection for up to 52 weeks.
Percentage of Participants With Combined Endoscopic Remission and Histologic Remission of the Colon Tissue at Week 12	0.0 percentage of participants	7.8 percentage of participants	1.9 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: FAS included all participants randomized. Only participants with available data were included in this outcome measure.

The Geboes score was an instrument used to standardize histologic assessment in ulcerative colitis (UC). It comprised seven categories (or grades), each describing a histologic feature. These categories were as follows: grade 0, structural (architectural change); grade 1, chronic inflammatory infiltrate; grade 2A, lamina propria eosinophils; grade 2B, lamina propria neutrophils; grade 3, neutrophils in epithelium; grade 4, crypt destruction; and grade 5, erosion or ulceration. Each grade included subscores that indicated the degree of abnormality observed for that histologic feature. Subscores ranged from 0 to 5.4, where a score of 0 indicated no or minimal inflammation, and a maximum score of 5.4 reflected severe histological activity.

Outcome measures

Measure	Placebo Q2W n=51 Participants Participants received placebo matching efavaleukin alfa Q2W through a SC injection for up to 52 weeks. Participants randomized to placebo who achieved clinical response continued in placebo, while those who did not achieve clinical response at week 12 were reassigned in a blinded manner to efavaleukin alfa 1100 mcg Q2W during the LTT period.	Efavaleukin Alfa 400 µg Q2W n=51 Participants Participants received efavaleukin alfa 400 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1100 µg Q2W n=49 Participants Participants received efavaleukin alfa 1100 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1800 µg Q2W n=46 Participants Participants received efavaleukin alfa 1800 mcg Q2W through a SC injection for up to 52 weeks.
Change From Baseline in Histological Score at Week 12 as Measured by the Geboes Score	-0.53 score on scale Standard Deviation 1.31	-0.30 score on scale Standard Deviation 1.39	-0.34 score on scale Standard Deviation 1.49	-0.45 score on scale Standard Deviation 1.04

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Safety analysis set included all participants randomized and received at least 1 dose of IP.

TEAEs were events categorized as adverse events (AEs) that started on or after the first dose of investigational product (IP), and up to 12 weeks in induction period.

Outcome measures

Measure	Placebo Q2W n=57 Participants Participants received placebo matching efavaleukin alfa Q2W through a SC injection for up to 52 weeks. Participants randomized to placebo who achieved clinical response continued in placebo, while those who did not achieve clinical response at week 12 were reassigned in a blinded manner to efavaleukin alfa 1100 mcg Q2W during the LTT period.	Efavaleukin Alfa 400 µg Q2W n=57 Participants Participants received efavaleukin alfa 400 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1100 µg Q2W n=53 Participants Participants received efavaleukin alfa 1100 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1800 µg Q2W n=53 Participants Participants received efavaleukin alfa 1800 mcg Q2W through a SC injection for up to 52 weeks.
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	33 Participants	42 Participants	42 Participants	46 Participants

Adverse Events

Placebo Q2W in Induction

Serious events: 5 serious events

Other events: 39 other events

Deaths: 0 deaths

Placebo Q2W in LTT

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Efavaleukin Alfa 1100 µg Q2W LTT

Serious events: 5 serious events

Other events: 29 other events

Deaths: 0 deaths

Efavaleukin Alfa 400 µg Q2W

Serious events: 3 serious events

Other events: 47 other events

Deaths: 0 deaths

Efavaleukin Alfa 1100 µg Q2W

Serious events: 7 serious events

Other events: 44 other events

Deaths: 0 deaths

Efavaleukin Alfa 1800 µg Q2W

Serious events: 9 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo Q2W in Induction n=57 participants at risk Participants were randomized to receive placebo matching efavaleukin alfa once Q2W through a SC injection in the induction period (from Weeks 1 to 12).	Placebo Q2W in LTT n=14 participants at risk Participants randomized to placebo Q2W during the induction period (from Weeks 1 to 12) who achieved a clinical response at Week 12 and continued to receive placebo Q2W throughout the LTT period (from Weeks 13 to 52).	Efavaleukin Alfa 1100 µg Q2W LTT n=42 participants at risk Participants randomized to placebo Q2W during the induction period (from Weeks 1 to 12) who did not achieve a clinical response at Week 12 and received efavaleukin alfa 1100 mcg administered Q2W through a SC injection throughout the LTT period (from Weeks 13 to 52).	Efavaleukin Alfa 400 µg Q2W n=57 participants at risk Participants received efavaleukin alfa 400 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1100 µg Q2W n=53 participants at risk Participants received efavaleukin alfa 1100 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1800 µg Q2W n=53 participants at risk Participants received efavaleukin alfa 1800 mcg Q2W through a SC injection for up to 52 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	3.8% 2/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Gastrointestinal disorders Colitis	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Gastrointestinal disorders Colitis ulcerative	7.0% 4/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	9.5% 4/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.5% 4/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	9.4% 5/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Hepatobiliary disorders Cholelithiasis	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Infections and infestations Abdominal abscess	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	2.4% 1/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Infections and infestations Cellulitis	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	2.4% 1/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Infections and infestations Cytomegalovirus colitis	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Infections and infestations Cytomegalovirus infection	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Infections and infestations Herpes zoster disseminated	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Skin and subcutaneous tissue disorders Rash	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	2.4% 1/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Vascular disorders Deep vein thrombosis	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.

Other adverse events

Measure	Placebo Q2W in Induction n=57 participants at risk Participants were randomized to receive placebo matching efavaleukin alfa once Q2W through a SC injection in the induction period (from Weeks 1 to 12).	Placebo Q2W in LTT n=14 participants at risk Participants randomized to placebo Q2W during the induction period (from Weeks 1 to 12) who achieved a clinical response at Week 12 and continued to receive placebo Q2W throughout the LTT period (from Weeks 13 to 52).	Efavaleukin Alfa 1100 µg Q2W LTT n=42 participants at risk Participants randomized to placebo Q2W during the induction period (from Weeks 1 to 12) who did not achieve a clinical response at Week 12 and received efavaleukin alfa 1100 mcg administered Q2W through a SC injection throughout the LTT period (from Weeks 13 to 52).	Efavaleukin Alfa 400 µg Q2W n=57 participants at risk Participants received efavaleukin alfa 400 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1100 µg Q2W n=53 participants at risk Participants received efavaleukin alfa 1100 mcg Q2W through a SC injection for up to 52 weeks.	Efavaleukin Alfa 1800 µg Q2W n=53 participants at risk Participants received efavaleukin alfa 1800 mcg Q2W through a SC injection for up to 52 weeks.
Blood and lymphatic system disorders Anaemia	10.5% 6/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	14.3% 6/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.0% 4/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	3.8% 2/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Blood and lymphatic system disorders Iron deficiency anaemia	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 1/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	2.4% 1/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.5% 4/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Gastrointestinal disorders Abdominal pain	5.3% 3/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 1/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	4.8% 2/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.0% 4/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	3.8% 2/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.5% 4/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Gastrointestinal disorders Colitis ulcerative	24.6% 14/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	28.6% 4/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	21.4% 9/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	21.1% 12/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	17.0% 9/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	9.4% 5/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Gastrointestinal disorders Nausea	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	4.8% 2/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Gastrointestinal disorders Vomiting	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	2.4% 1/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	9.4% 5/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
General disorders Asthenia	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	2.4% 1/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
General disorders Chest pain	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
General disorders Fatigue	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	4.8% 2/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.5% 4/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	15.1% 8/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
General disorders Influenza like illness	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	2.4% 1/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.5% 4/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
General disorders Injection site erythema	19.3% 11/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	23.8% 10/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	42.1% 24/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	41.5% 22/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	56.6% 30/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
General disorders Injection site oedema	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
General disorders Injection site pain	5.3% 3/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 3/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.5% 4/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
General disorders Injection site pruritus	5.3% 3/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	4.8% 2/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	21.1% 12/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	15.1% 8/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	20.8% 11/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
General disorders Injection site rash	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	2.4% 1/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.3% 3/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.5% 4/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.5% 4/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
General disorders Injection site reaction	5.3% 3/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 3/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.0% 4/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	11.3% 6/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
General disorders Injection site swelling	5.3% 3/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	4.8% 2/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	15.8% 9/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	11.3% 6/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	17.0% 9/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
General disorders Pyrexia	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	4.8% 2/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	15.8% 9/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	17.0% 9/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	9.4% 5/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Infections and infestations COVID-19	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 1/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	2.4% 1/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Infections and infestations Influenza	7.0% 4/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 1/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 3/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Infections and infestations Nasopharyngitis	5.3% 3/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 3/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.3% 3/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.5% 4/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	3.8% 2/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Infections and infestations Rhinitis	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 1/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Infections and infestations Upper respiratory tract infection	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	4.8% 2/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.3% 3/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	3.8% 2/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Infections and infestations Urinary tract infection	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	2.4% 1/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Musculoskeletal and connective tissue disorders Arthralgia	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	4.8% 2/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.0% 4/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	17.0% 9/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.5% 4/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Nervous system disorders Headache	5.3% 3/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 1/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	4.8% 2/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	8.8% 5/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	9.4% 5/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Skin and subcutaneous tissue disorders Erythema	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	2.4% 1/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	3.5% 2/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	13.2% 7/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	9.4% 5/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Skin and subcutaneous tissue disorders Pruritus	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	2.4% 1/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	13.2% 7/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Skin and subcutaneous tissue disorders Rash	5.3% 3/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 3/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	13.2% 7/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	18.9% 10/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Skin and subcutaneous tissue disorders Urticaria	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	3.8% 2/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	5.7% 3/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Gastrointestinal disorders Dry mouth	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 1/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Gastrointestinal disorders Flatulence	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 1/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Gastrointestinal disorders Oral hyperaesthesia	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 1/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Infections and infestations Eye infection	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 1/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Metabolism and nutrition disorders Metabolic acidosis	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 1/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Musculoskeletal and connective tissue disorders Neck pain	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 1/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 1/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Skin and subcutaneous tissue disorders Dry skin	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 1/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	1.9% 1/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.
Vascular disorders Varicose vein	1.8% 1/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	7.1% 1/14 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/42 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/57 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.	0.00% 0/53 • All-cause mortality: From enrollment until the end of study (EOS); median (min, max) time on study was 22.49 (2.85, 83.14) weeks. Serious AEs and other AEs: From first dose of study drug until the EOS; median (min, max) duration was 22.49 (2.85, 83.14) weeks. All-cause mortality is reported for all randomized participants; serious and other AEs are reported for all participants who received at least one dose of study drug. One participant who was a Week 12 responder was excluded from the Placebo Q2W in the LTT, and did not receive placebo in the LTT.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

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

Restriction type: OTHER