Trial Outcomes & Findings for A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (NCT NCT04761627)

Last Updated: 2024-01-11

Results Overview

AUCtau from time 0 (week 52) over the dosing interval up to week 64 is presented. Pharmacokinetic (PK) parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

494 participants

Primary outcome timeframe

Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose

Results posted on

2024-01-11

Participant Flow

Participants were enrolled at 87 study centers in 8 countries, including Canada, Estonia, Georgia, Germany, Hungary, Latvia, Poland, and the United States, and participated from 24 March 2021 to 28 February 2023.

Participants with moderate to severe plaque psoriasis were randomized at week 28 to 1 of 2 treatment groups following a run-in period. Randomization was stratified by prior biologic use for psoriasis at baseline, geographic region, and body weight group at baseline. Dosage was weight-based to ensure similar concentration by body weight received.

Participant milestones

Participant milestones
Measure	Run-in: Ustekinumab Reference Product (RP) Participants received ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) on day 1 (week 0), week 4, and week 16. At week 28, eligible participants with a 50% improvement in Psoriasis Area and Severity Index (PASI 50) response or better were randomized to the continued use group (ustekinumab RP) or the switching group (ustekinumab RP and ABP 654).	Post-randomization Switching: Ustekinumab RP and ABP 654 At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg \[baseline body weight ≤ 100 kg\] or 90 mg \[baseline body weight \> 100 kg\]) were administered by SC injection using a pre-filled syringe.	Post-randomization Continued-use: Ustekinumab RP At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.
Run-in Period STARTED	494	0	0
Run-in Period COMPLETED	453	0	0
Run-in Period NOT COMPLETED	41	0	0
Post-randomization Period STARTED	0	228	225
Post-randomization Period Full Analysis Set	0	228	225
Post-randomization Period Safety Analysis Set	0	228	224
Post-randomization Period COMPLETED	0	209	209
Post-randomization Period NOT COMPLETED	0	19	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Run-in: Ustekinumab Reference Product (RP) Participants received ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) on day 1 (week 0), week 4, and week 16. At week 28, eligible participants with a 50% improvement in Psoriasis Area and Severity Index (PASI 50) response or better were randomized to the continued use group (ustekinumab RP) or the switching group (ustekinumab RP and ABP 654).	Post-randomization Switching: Ustekinumab RP and ABP 654 At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg \[baseline body weight ≤ 100 kg\] or 90 mg \[baseline body weight \> 100 kg\]) were administered by SC injection using a pre-filled syringe.	Post-randomization Continued-use: Ustekinumab RP At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.
Run-in Period Death	1	0	0
Run-in Period Required alternative therapy	2	0	0
Run-in Period Lost to Follow-up	2	0	0
Run-in Period Protocol Violation	3	0	0
Run-in Period Abnormal liver function	1	0	0
Run-in Period Adverse Event	6	0	0
Run-in Period Withdrawal by Subject	7	0	0
Run-in Period Did not meet PASI 50	15	0	0
Run-in Period Study site closure	2	0	0
Run-in Period Pregnancy	2	0	0
Post-randomization Period Military service	0	1	0
Post-randomization Period Adverse Event	0	4	2
Post-randomization Period Lost to Follow-up	0	6	6
Post-randomization Period Withdrawal by Subject	0	7	6
Post-randomization Period Pregnancy	0	0	1
Post-randomization Period Study site closure	0	0	1
Post-randomization Period Family planning	0	1	0

Baseline Characteristics

A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Post-randomization Switching: Ustekinumab RP and ABP 654 n=228 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg \[baseline body weight ≤ 100 kg\] or 90 mg \[baseline body weight \> 100 kg\]) were administered by SC injection using a pre-filled syringe.	Post-randomization Continued-use: Ustekinumab RP n=225 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.	Total n=453 Participants Total of all reporting groups
Age, Continuous	46.9 years STANDARD_DEVIATION 13.36 • n=99 Participants	48.1 years STANDARD_DEVIATION 13.48 • n=107 Participants	47.5 years STANDARD_DEVIATION 13.42 • n=206 Participants
Sex: Female, Male Female	64 Participants n=99 Participants	83 Participants n=107 Participants	147 Participants n=206 Participants
Sex: Female, Male Male	164 Participants n=99 Participants	142 Participants n=107 Participants	306 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=99 Participants	23 Participants n=107 Participants	49 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	202 Participants n=99 Participants	201 Participants n=107 Participants	403 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized White	207 Participants n=99 Participants	214 Participants n=107 Participants	421 Participants n=206 Participants
Race/Ethnicity, Customized Asian	9 Participants n=99 Participants	3 Participants n=107 Participants	12 Participants n=206 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=99 Participants	1 Participants n=107 Participants	8 Participants n=206 Participants
Race/Ethnicity, Customized Other	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Race/Ethnicity, Customized Not allowed to collect	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants

PRIMARY outcome

Timeframe: Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose

Population: The PK parameter analysis set consisted of all randomized participants who received all 3 doses of the assigned investigational product between week 28 and week 52 and who had an evaluable ABP 654 or ustekinumab serum concentration-time profile between week 52 and week 64. Participants with data available are presented.

Outcome measures

Outcome measures
Measure	Post-randomization Switching: Ustekinumab RP and ABP 654 n=199 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg \[baseline body weight ≤ 100 kg\] or 90 mg \[baseline body weight \> 100 kg\]) were administered by SC injection using a pre-filled syringe.	Post-randomization Continued-use: Ustekinumab RP n=204 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.	Post-randomization Switching: ABP 654/Ustekinumab RP/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52.	Post-randomization Switching: ABP 654/Missing/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Missing/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52.
Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (AUCtau) Between Week 52 and Week 64	5144.40 hour*mcg/mL Geometric Coefficient of Variation 45.3	5768.45 hour*mcg/mL Geometric Coefficient of Variation 50.4	—	—	—	—

PRIMARY outcome

Timeframe: Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose

Cmax between week 52 and week 64 is presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.

Outcome measures

Outcome measures
Measure	Post-randomization Switching: Ustekinumab RP and ABP 654 n=204 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg \[baseline body weight ≤ 100 kg\] or 90 mg \[baseline body weight \> 100 kg\]) were administered by SC injection using a pre-filled syringe.	Post-randomization Continued-use: Ustekinumab RP n=205 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.	Post-randomization Switching: ABP 654/Ustekinumab RP/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52.	Post-randomization Switching: ABP 654/Missing/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Missing/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52.
Maximum Observed Serum Concentration (Cmax) Between Week 52 and Week 64	5.78 mcg/mL Geometric Coefficient of Variation 41.4	6.31 mcg/mL Geometric Coefficient of Variation 46.8	—	—	—	—

SECONDARY outcome

Timeframe: Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose

Tmax between week 52 and week 64 is presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.

Outcome measures

Outcome measures
Measure	Post-randomization Switching: Ustekinumab RP and ABP 654 n=204 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg \[baseline body weight ≤ 100 kg\] or 90 mg \[baseline body weight \> 100 kg\]) were administered by SC injection using a pre-filled syringe.	Post-randomization Continued-use: Ustekinumab RP n=205 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.	Post-randomization Switching: ABP 654/Ustekinumab RP/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52.	Post-randomization Switching: ABP 654/Missing/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Missing/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52.
Time of Maximum Serum Concentration (Tmax) Between Week 52 and Week 64	167.80 hours Interval 41.4 to 355.2	168.93 hours Interval 43.6 to 407.6	—	—	—	—

SECONDARY outcome

Timeframe: Blood samples were taken pre-dose week 28, week 40, and week 52

Ctrough,ss at weeks 28, 40, and 52 are presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.

Outcome measures

Outcome measures
Measure	Post-randomization Switching: Ustekinumab RP and ABP 654 n=204 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg \[baseline body weight ≤ 100 kg\] or 90 mg \[baseline body weight \> 100 kg\]) were administered by SC injection using a pre-filled syringe.	Post-randomization Continued-use: Ustekinumab RP n=205 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.	Post-randomization Switching: ABP 654/Ustekinumab RP/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52.	Post-randomization Switching: ABP 654/Missing/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Missing/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52.
Serum Trough Concentration at Steady-state (Ctrough,ss) at Week 28, Week 40, and Week 52 Week 28	570.46 ng/mL Geometric Coefficient of Variation 105.9	595.86 ng/mL Geometric Coefficient of Variation 110.0	—	—	—	—
Serum Trough Concentration at Steady-state (Ctrough,ss) at Week 28, Week 40, and Week 52 Week 40	537.52 ng/mL Geometric Coefficient of Variation 96.4	590.61 ng/mL Geometric Coefficient of Variation 103.9	—	—	—	—
Serum Trough Concentration at Steady-state (Ctrough,ss) at Week 28, Week 40, and Week 52 Week 52	562.51 ng/mL Geometric Coefficient of Variation 114.0	599.11 ng/mL Geometric Coefficient of Variation 108.5	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (day 1) and week 64

Population: The per-protocol efficacy analysis set included all participants who were randomized and received all 3 doses of the assigned interventional product between week 28 and week 52 and who did not experience an important protocol deviation during the study that could affect the evaluation of the efficacy endpoints. The overall number of participants analyzed includes those imputed by MI as well as those with observed data.

The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling), each graded on a 0 to 4 scale of the lesions, weighted by the area of involvement. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI percent improvement is defined as 100 x (value at baseline - value at post-baseline visit) / value at baseline. A positive value indicates PASI improvement. Baseline data were derived based on observed data and at week 64 were derived based on multiple imputation (MI) data. Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.

Outcome measures

Outcome measures
Measure	Post-randomization Switching: Ustekinumab RP and ABP 654 n=216 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg \[baseline body weight ≤ 100 kg\] or 90 mg \[baseline body weight \> 100 kg\]) were administered by SC injection using a pre-filled syringe.	Post-randomization Continued-use: Ustekinumab RP n=215 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.	Post-randomization Switching: ABP 654/Ustekinumab RP/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52.	Post-randomization Switching: ABP 654/Missing/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Missing/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52.
PASI Percent Improvement From Baseline at Week 64	88.80 Percentage change Standard Deviation 18.066	88.72 Percentage change Standard Deviation 16.128	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (day 1) and week 64

The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling), each graded on a 0 to 4 scale of the lesions, weighted by the area of involvement. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI response was defined as a participant meeting or surpassing a pre-specified threshold for percent improvement in PASI score compared to the baseline PASI score. An improvement of at least 75% qualified a participant as being a PASI 75 responder. Missing PASI 75 responses at week 64 were imputed by non-responder imputation (NRI). Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.

Outcome measures

Outcome measures
Measure	Post-randomization Switching: Ustekinumab RP and ABP 654 n=216 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg \[baseline body weight ≤ 100 kg\] or 90 mg \[baseline body weight \> 100 kg\]) were administered by SC injection using a pre-filled syringe.	Post-randomization Continued-use: Ustekinumab RP n=215 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.	Post-randomization Switching: ABP 654/Ustekinumab RP/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52.	Post-randomization Switching: ABP 654/Missing/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Missing/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52.
PASI 75 Response at Week 64	83.3 Percentage of responders Interval 78.4 to 88.3	82.8 Percentage of responders Interval 77.8 to 87.8	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (day 1) and week 64

The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling), each graded on a 0 to 4 scale of the lesions, weighted by the area of involvement. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI response was defined as a participant meeting or surpassing a pre-specified threshold for percent improvement in PASI score compared to the baseline PASI score. An improvement of 100% qualified a participant as being a PASI 100 responder. Missing PASI 100 responses at week 64 were imputed by NRI. Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.

Outcome measures

Outcome measures
Measure	Post-randomization Switching: Ustekinumab RP and ABP 654 n=216 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg \[baseline body weight ≤ 100 kg\] or 90 mg \[baseline body weight \> 100 kg\]) were administered by SC injection using a pre-filled syringe.	Post-randomization Continued-use: Ustekinumab RP n=215 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.	Post-randomization Switching: ABP 654/Ustekinumab RP/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52.	Post-randomization Switching: ABP 654/Missing/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Missing/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52.
PASI 100 Response at Week 64	36.1 Percentage of responders Interval 29.7 to 42.5	35.8 Percentage of responders Interval 29.4 to 42.2	—	—	—	—

SECONDARY outcome

Timeframe: Week 28 to week 64

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

TEAEs during the post-randomization period were defined as AEs that started on or after the first dose of investigational product post-randomization and prior to the end of study. The number of participants who experienced any TEAE, and who experienced a serious TEAE are presented. A serious TEAE was defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: resulted in death (fatal), was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly/birth defect, or other medically important serious event.

Outcome measures

Outcome measures
Measure	Post-randomization Switching: Ustekinumab RP and ABP 654 n=217 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg \[baseline body weight ≤ 100 kg\] or 90 mg \[baseline body weight \> 100 kg\]) were administered by SC injection using a pre-filled syringe.	Post-randomization Continued-use: Ustekinumab RP n=216 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.	Post-randomization Switching: ABP 654/Ustekinumab RP/Missing n=8 Participants Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing n=5 Participants Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52.	Post-randomization Switching: ABP 654/Missing/Missing n=3 Participants Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Missing/Missing n=3 Participants Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52.
Number of Participants With Treatment-emergent Adverse Events (TEAEs): Post-randomization Period Any TEAE	97 Participants	108 Participants	4 Participants	1 Participants	3 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs): Post-randomization Period Any serious TEAE	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 28 to week 64

Population: Participants in the safety analysis set who completed all planned doses of investigational product in the post-randomization period up to week 52. The safety analysis set included all randomized participants who received at least 1 dose of investigational product post randomization.

The treatment-emergent EOIs prespecified for this study included serious systemic hypersensitivity reactions, facial palsy, pustular psoriasis, erythrodermic psoriasis, serious infections (including mycobacterial and salmonella infections), malignancy, cardiovascular events, reversible posterior leukoencephalopathy syndrome (RPLS), serious depression including suicidality, and venous thromboembolism.

Outcome measures

Outcome measures
Measure	Post-randomization Switching: Ustekinumab RP and ABP 654 n=217 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg \[baseline body weight ≤ 100 kg\] or 90 mg \[baseline body weight \> 100 kg\]) were administered by SC injection using a pre-filled syringe.	Post-randomization Continued-use: Ustekinumab RP n=216 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.	Post-randomization Switching: ABP 654/Ustekinumab RP/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52.	Post-randomization Switching: ABP 654/Missing/Missing Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Missing/Missing Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52.
Number of Participants With Events of Interest (EOI): Post-randomization Period Any EOI	6 Participants	7 Participants	—	—	—	—
Number of Participants With Events of Interest (EOI): Post-randomization Period Cardiovascular events	2 Participants	3 Participants	—	—	—	—
Number of Participants With Events of Interest (EOI): Post-randomization Period RPLS	2 Participants	0 Participants	—	—	—	—
Number of Participants With Events of Interest (EOI): Post-randomization Period Serious infections	1 Participants	2 Participants	—	—	—	—
Number of Participants With Events of Interest (EOI): Post-randomization Period Malignancy	1 Participants	1 Participants	—	—	—	—
Number of Participants With Events of Interest (EOI): Post-randomization Period Serious depression	0 Participants	1 Participants	—	—	—	—
Number of Participants With Events of Interest (EOI): Post-randomization Period Serious systemic hypersensitivity reactions	0 Participants	0 Participants	—	—	—	—
Number of Participants With Events of Interest (EOI): Post-randomization Period Facial palsy	0 Participants	0 Participants	—	—	—	—
Number of Participants With Events of Interest (EOI): Post-randomization Period Pustular psoriasis	0 Participants	0 Participants	—	—	—	—
Number of Participants With Events of Interest (EOI): Post-randomization Period Erythrodermic psoriasis	0 Participants	0 Participants	—	—	—	—
Number of Participants With Events of Interest (EOI): Post-randomization Period Venous thromboembolism	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (pre-dose day 1), week 4, week 16, week 28, week 40, week 52 and week 64

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

The number of participants developing binding or neutralizing ADAs during the post-randomization period is defined as the number of participants in the safety analysis set who had a positive result post-randomization and had never tested positive (i.e., negative or no results) prior to the first dose of post-randomization investigational product and who have at least one ADA result post randomization. A transient antibody results was defined as a positive result during the post-randomization period with a negative result at the participant's last visit tested within the respective study period. Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.

Outcome measures

Outcome measures
Measure	Post-randomization Switching: Ustekinumab RP and ABP 654 n=217 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg \[baseline body weight ≤ 100 kg\] or 90 mg \[baseline body weight \> 100 kg\]) were administered by SC injection using a pre-filled syringe.	Post-randomization Continued-use: Ustekinumab RP n=216 Participants At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.	Post-randomization Switching: ABP 654/Ustekinumab RP/Missing n=8 Participants Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing n=5 Participants Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52.	Post-randomization Switching: ABP 654/Missing/Missing n=3 Participants Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Missing/Missing n=3 Participants Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52.
Number of Participants With Antidrug Antibodies (ADAs): Post-randomization Period Participants with post-baseline result post-randomization	217 Participants	216 Participants	8 Participants	5 Participants	3 Participants	1 Participants
Number of Participants With Antidrug Antibodies (ADAs): Post-randomization Period Binding antibody negative/no result prior to first dose post-randomization	136 Participants	134 Participants	5 Participants	4 Participants	3 Participants	1 Participants
Number of Participants With Antidrug Antibodies (ADAs): Post-randomization Period Binding antibody positive with negative/no result prior to first dose post-randomization	7 Participants	11 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Antidrug Antibodies (ADAs): Post-randomization Period Transient binding antibody positive with negative/no result prior to first dose post-randomization	4 Participants	5 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Antidrug Antibodies (ADAs): Post-randomization Period Neutralizing antibody negative/no result prior to first dose post-randomization	190 Participants	188 Participants	6 Participants	5 Participants	3 Participants	1 Participants
Number of Participants With Antidrug Antibodies (ADAs): Post-randomization Period Neutralizing antibody positive with negative/no result prior to first dose post-randomization	8 Participants	6 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Antidrug Antibodies (ADAs): Post-randomization Period Transient neutralizing antibody positive with negative/no result prior first dose post-randomization	6 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Run-in: Ustekinumab RP

Serious events: 14 serious events

Other events: 116 other events

Deaths: 2 deaths

Post-randomization Switching: Ustekinumab RP and ABP 654

Serious events: 3 serious events

Other events: 55 other events

Deaths: 0 deaths

Post-randomization Continued-use: Ustekinumab RP

Serious events: 2 serious events

Other events: 58 other events

Deaths: 0 deaths

Post-randomization Switching: ABP 654/Ustekinumab RP/Missing

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Post-randomization Switching: ABP 654/Missing/Missing

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Post-randomization Continued-use: Ustekinumab RP/Missing/Missing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Run-in: Ustekinumab RP n=494 participants at risk Participants received ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) on day 1 (week 0), week 4, and week 16.	Post-randomization Switching: Ustekinumab RP and ABP 654 n=217 participants at risk Participants were randomized to the switching group at week 28 and completed all planned doses of ABP 654 and ustekinumab RP up to week 52, including ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP n=216 participants at risk Participants were randomized to the continued-use group at week 28 and completed all planned doses of ustekinumab RP up to week 52, including 3 doses at weeks 28, 40, and 52.	Post-randomization Switching: ABP 654/Ustekinumab RP/Missing n=8 participants at risk Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing n=5 participants at risk Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52.	Post-randomization Switching: ABP 654/Missing/Missing n=3 participants at risk Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Missing/Missing n=3 participants at risk Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52.
Cardiac disorders Atrial fibrillation	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Supraventricular tachycardia	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Vision blurred	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis acute	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.46% 1/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Death	0.40% 2/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	0.00% 0/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.46% 1/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis acute	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholelithiasis	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Otitis media chronic	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia viral	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fibula fracture	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Tibia fracture	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.46% 1/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.46% 1/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebrovascular accident	0.00% 0/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.46% 1/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Facial paralysis	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Dermatillomania	0.00% 0/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.46% 1/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal turbinate hypertrophy	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Erythrodermic psoriasis	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Run-in: Ustekinumab RP n=494 participants at risk Participants received ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight \> 100 kg) on day 1 (week 0), week 4, and week 16.	Post-randomization Switching: Ustekinumab RP and ABP 654 n=217 participants at risk Participants were randomized to the switching group at week 28 and completed all planned doses of ABP 654 and ustekinumab RP up to week 52, including ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP n=216 participants at risk Participants were randomized to the continued-use group at week 28 and completed all planned doses of ustekinumab RP up to week 52, including 3 doses at weeks 28, 40, and 52.	Post-randomization Switching: ABP 654/Ustekinumab RP/Missing n=8 participants at risk Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing n=5 participants at risk Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52.	Post-randomization Switching: ABP 654/Missing/Missing n=3 participants at risk Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52.	Post-randomization Continued-use: Ustekinumab RP/Missing/Missing n=3 participants at risk Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52.
Infections and infestations COVID-19	13.2% 65/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.4% 27/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	11.6% 25/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	5.5% 27/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.5% 12/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	7.4% 16/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Sinusitis	1.2% 6/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.46% 1/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.4% 3/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	3.6% 18/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	6.5% 14/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	6.5% 14/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Abdominal wall wound	0.00% 0/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.92% 2/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.93% 2/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.20% 1/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.46% 1/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.93% 2/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm benign	0.00% 0/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Headache	1.8% 9/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.3% 5/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.46% 1/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Scleroedema	0.00% 0/494 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/217 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/216 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

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