Trial Outcomes & Findings for A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (NCT NCT04607980)

Last Updated: 2024-12-12

Results Overview

The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale \[0 = clear; 1-4 = increasing severity\]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

563 participants

Primary outcome timeframe

Baseline (Day 1 [Week 0]) and Week 12

Results posted on

2024-12-12

Participant Flow

This study was conducted at 84 centers in Canada, Estonia, Germany, Hungary, Latvia, Lithuania, Poland, and the United States between 11 November 2020 and 03 June 2022.

Of the 648 participants screened, 563 participants were enrolled and randomized in a 1:1 ratio to receive ABP 654 or ustekinumab.

Participant milestones

Participant milestones
Measure	Treatment Group A (ABP 654) Participants received SC injection of ABP 654, 45 mg (Baseline body weight \[BW\] less than or equal to \[\<=\] 100 kg) or 90 mg (Baseline BW greater than \[\>\] 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) every 12 weeks (Q12W) at Weeks 28 and 40 or depending on Psoriasis Area and Severity Index (PASI) score, received dose intensification every 8 weeks (Q8W) at Weeks 28, 36, and 44 (as per protocol).	Treatment Group B (Ustekinumab) Participants received SC injection of ustekinumab, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol).
Overall Study STARTED	281	282
Overall Study Treated	280	282
Overall Study Re-randomized to ABP 654 at Week 28	247	117
Overall Study Re-randomized to Ustekinumab at Week 28	0	116
Overall Study Not Re-randomized at Week 28 and Dose Intensified	25	34
Overall Study COMPLETED	269	261
Overall Study NOT COMPLETED	12	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Group A (ABP 654) Participants received SC injection of ABP 654, 45 mg (Baseline body weight \[BW\] less than or equal to \[\<=\] 100 kg) or 90 mg (Baseline BW greater than \[\>\] 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) every 12 weeks (Q12W) at Weeks 28 and 40 or depending on Psoriasis Area and Severity Index (PASI) score, received dose intensification every 8 weeks (Q8W) at Weeks 28, 36, and 44 (as per protocol).	Treatment Group B (Ustekinumab) Participants received SC injection of ustekinumab, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol).
Overall Study Adverse Event	3	4
Overall Study Death	0	1
Overall Study Withdrawal by Subject	2	5
Overall Study Lost to Follow-up	4	8
Overall Study Protocol Violation	0	3
Overall Study Other	3	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group A (ABP 654) n=281 Participants Participants received SC injection of ABP 654, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) Q12W at Weeks 28 and 40 or, depending on PASI score, received dose intensification Q8W at Weeks 28, 36, and 44 (as per protocol).	Treatment Group B (Ustekinumab) n=282 Participants Participants received SC injection of ustekinumab, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol).	Total n=563 Participants Total of all reporting groups
Age, Continuous	43.7 years STANDARD_DEVIATION 14.15 • n=5 Participants	45.0 years STANDARD_DEVIATION 12.58 • n=7 Participants	44.4 years STANDARD_DEVIATION 13.39 • n=5 Participants
Age, Customized In utero	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Preterm newborn infants (gestational age < 37 wks)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Newborns (0-27 days)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Infants and toddlers (28 days-23 months)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Children (2-11 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Adolescents (12-17 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Adults (18-64 years)	257 Participants n=5 Participants	261 Participants n=7 Participants	518 Participants n=5 Participants
Age, Customized From 65-84 years	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Age, Customized 85 years and over	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	104 Participants n=5 Participants	91 Participants n=7 Participants	195 Participants n=5 Participants
Sex: Female, Male Male	177 Participants n=5 Participants	191 Participants n=7 Participants	368 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	20 Participants n=5 Participants	25 Participants n=7 Participants	45 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	250 Participants n=5 Participants	247 Participants n=7 Participants	497 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Not allowed to collect	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	248 Participants n=5 Participants	252 Participants n=7 Participants	500 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Static Physician Global Assessment of Psoriasis (sPGA) Score 0 (clear)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Static Physician Global Assessment of Psoriasis (sPGA) Score 1 (almost clear)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Static Physician Global Assessment of Psoriasis (sPGA) Score 2 (mild)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Static Physician Global Assessment of Psoriasis (sPGA) Score 3 (moderate)	130 Participants n=5 Participants	154 Participants n=7 Participants	284 Participants n=5 Participants
Static Physician Global Assessment of Psoriasis (sPGA) Score 4 (severe)	132 Participants n=5 Participants	114 Participants n=7 Participants	246 Participants n=5 Participants
Static Physician Global Assessment of Psoriasis (sPGA) Score 5 (very severe)	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
PASI	21.50 Score on a scale STANDARD_DEVIATION 8.855 • n=5 Participants	20.35 Score on a scale STANDARD_DEVIATION 7.850 • n=7 Participants	20.92 Score on a scale STANDARD_DEVIATION 8.379 • n=5 Participants
Psoriasis Body Surface Area (BSA)	26.5 Percentage of BSA STANDARD_DEVIATION 15.25 • n=5 Participants	24.9 Percentage of BSA STANDARD_DEVIATION 15.05 • n=7 Participants	25.7 Percentage of BSA STANDARD_DEVIATION 15.16 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1 [Week 0]) and Week 12

Population: Results are presented for the FAS with available data; observed data was used for summary statistics.

Outcome measures

Outcome measures
Measure	Treatment Group A (ABP 654) n=272 Participants Participants received SC injection of ABP 654, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) Q12W at Weeks 28 and 40 or, depending on PASI score, received dose intensification Q8W at Weeks 28, 36, and 44 (as per protocol).	Treatment Group B (Ustekinumab) n=276 Participants Participants received SC injection of ustekinumab, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol).	Post Week 28: ABP 654/ ABP 654 All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40.	Post Week 28: Ustekinumab/ ABP 654 All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40.	Post Week 28: Ustekinumab/ Ustekinumab All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40.	Post Week 28: ABP 654 Dose Intensification All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification Q8W at Weeks 28, 36, and 44.	Post Week 28: Ustekinumab Dose Intensification All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44.
PASI Percent Change From Baseline to Week 12	81.92 Percent Change in PASI score Standard Deviation 19.872 • Interval 19.872 to	81.91 Percent Change in PASI score Standard Deviation 19.611 • Interval 19.611 to	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 [Week 0]), Weeks 4, 16, 28, 36 (dose intensification only), 40 (re-randomized FAS only), 44 (dose intensification only) and Week 52 (End of Study [EOS])

Population: Through Week 28 results are presented for the FAS with available data; last observation carried forward (LOCF) imputation was used. Post Week 28 results are presented for dose intensification participants with available observed data and re-randomized FAS participants with available data (LOCF imputation was used).

Outcome measures

Outcome measures
Measure	Treatment Group A (ABP 654) n=280 Participants Participants received SC injection of ABP 654, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) Q12W at Weeks 28 and 40 or, depending on PASI score, received dose intensification Q8W at Weeks 28, 36, and 44 (as per protocol).	Treatment Group B (Ustekinumab) n=281 Participants Participants received SC injection of ustekinumab, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol).	Post Week 28: ABP 654/ ABP 654 n=247 Participants All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40.	Post Week 28: Ustekinumab/ ABP 654 n=117 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40.	Post Week 28: Ustekinumab/ Ustekinumab n=116 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40.	Post Week 28: ABP 654 Dose Intensification All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification Q8W at Weeks 28, 36, and 44.	Post Week 28: Ustekinumab Dose Intensification All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44.
PASI Percent Change at Other Timepoints Week 36	75.53 Percent Change in PASI score Standard Deviation 11.038	74.12 Percent Change in PASI score Standard Deviation 13.826	—	—	—	—	—
PASI Percent Change at Other Timepoints Week 40	—	—	93.60 Percent Change in PASI score Standard Deviation 9.738	94.22 Percent Change in PASI score Standard Deviation 8.296	95.10 Percent Change in PASI score Standard Deviation 8.529	—	—
PASI Percent Change at Other Timepoints Week 44	75.33 Percent Change in PASI score Standard Deviation 15.563	78.42 Percent Change in PASI score Standard Deviation 14.733	—	—	—	—	—
PASI Percent Change at Other Timepoints Week 4	44.15 Percent Change in PASI score Standard Deviation 23.587	42.40 Percent Change in PASI score Standard Deviation 24.536	—	—	—	—	—
PASI Percent Change at Other Timepoints Week 16	85.88 Percent Change in PASI score Standard Deviation 18.704	85.86 Percent Change in PASI score Standard Deviation 19.953	—	—	—	—	—
PASI Percent Change at Other Timepoints Week 28	89.41 Percent Change in PASI score Standard Deviation 14.228	88.18 Percent Change in PASI score Standard Deviation 18.771	—	—	—	—	—
PASI Percent Change at Other Timepoints Week 52	77.80 Percent Change in PASI score Standard Deviation 14.760	77.46 Percent Change in PASI score Standard Deviation 18.109	92.54 Percent Change in PASI score Standard Deviation 11.808	93.90 Percent Change in PASI score Standard Deviation 8.987	93.23 Percent Change in PASI score Standard Deviation 16.029	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 [Week 0]), Weeks 4, 16, 28, 36 (dose intensification only), 40 (re-randomized FAS only), 44 (dose intensification only) and Week 52 (EOS)

Population: Through Week 28 FAS results are presented for the FAS with available data; non-responder imputation (NRI) was used. Post Week 28 results are presented for dose intensification participants with available observed data and re-randomized FAS participants with available data (NRI was used).

Reduction in disease was measured by PASI score. The PASI 75 response is a 75% or greater improvement (reduction in disease \[PASI 75\]) from baseline in PASI score. The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale \[0 = clear; 1-4 = increasing severity\]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity.

Outcome measures

Outcome measures
Measure	Treatment Group A (ABP 654) n=281 Participants Participants received SC injection of ABP 654, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) Q12W at Weeks 28 and 40 or, depending on PASI score, received dose intensification Q8W at Weeks 28, 36, and 44 (as per protocol).	Treatment Group B (Ustekinumab) n=282 Participants Participants received SC injection of ustekinumab, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol).	Post Week 28: ABP 654/ ABP 654 n=247 Participants All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40.	Post Week 28: Ustekinumab/ ABP 654 n=117 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40.	Post Week 28: Ustekinumab/ Ustekinumab n=116 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40.	Post Week 28: ABP 654 Dose Intensification All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification Q8W at Weeks 28, 36, and 44.	Post Week 28: Ustekinumab Dose Intensification All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44.
Percentage of Participants With PASI 75 Response Throughout the Study Week 4	11.4 Percentage of participants Interval 7.67 to 15.1	10.3 Percentage of participants Interval 6.74 to 13.83	—	—	—	—	—
Percentage of Participants With PASI 75 Response Throughout the Study Week 16	80.8 Percentage of participants Interval 76.18 to 85.39	80.1 Percentage of participants Interval 75.49 to 84.8	—	—	—	—	—
Percentage of Participants With PASI 75 Response Throughout the Study Week 12	69.8 Percentage of participants Interval 64.38 to 75.12	70.2 Percentage of participants Interval 64.88 to 75.55	—	—	—	—	—
Percentage of Participants With PASI 75 Response Throughout the Study Week 28	85.8 Percentage of participants Interval 81.68 to 89.85	82.3 Percentage of participants Interval 77.81 to 86.73	—	—	—	—	—
Percentage of Participants With PASI 75 Response Throughout the Study Week 36	52.0 Percentage of participants Interval 32.42 to 71.58	55.9 Percentage of participants Interval 39.19 to 72.57	—	—	—	—	—
Percentage of Participants With PASI 75 Response Throughout the Study Week 40	—	—	94.7 Percentage of participants Interval 91.95 to 97.52	95.7 Percentage of participants Interval 92.06 to 99.39	94.0 Percentage of participants Interval 89.63 to 98.3	—	—
Percentage of Participants With PASI 75 Response Throughout the Study Week 44	48.0 Percentage of participants Interval 28.42 to 67.58	64.7 Percentage of participants Interval 48.64 to 80.77	—	—	—	—	—
Percentage of Participants With PASI 75 Response Throughout the Study Week 52	64.0 Percentage of participants Interval 45.18 to 82.82	58.8 Percentage of participants Interval 42.28 to 75.37	89.5 Percentage of participants Interval 85.65 to 93.3	92.3 Percentage of participants Interval 87.48 to 97.14	92.2 Percentage of participants Interval 87.37 to 97.11	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 [Week 0]), Weeks 4, 16, 28, 36 (dose intensification only), 40 (re-randomized FAS only), 44 (dose intensification only) and Week 52 (EOS)

Population: Through Week 28 FAS results are presented for the FAS with available data; NRI was used. Post Week 28 results are presented for dose intensification participants with available observed data and re-randomized FAS participants with available data (NRI was used).

Reduction in disease was measured by PASI score. The PASI 100 response is a 100% improvement (reduction in disease \[PASI 100\]) from baseline in PASI score. The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale \[0 = clear; 1-4 = increasing severity\]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity.

Outcome measures

Outcome measures
Measure	Treatment Group A (ABP 654) n=281 Participants Participants received SC injection of ABP 654, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) Q12W at Weeks 28 and 40 or, depending on PASI score, received dose intensification Q8W at Weeks 28, 36, and 44 (as per protocol).	Treatment Group B (Ustekinumab) n=282 Participants Participants received SC injection of ustekinumab, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol).	Post Week 28: ABP 654/ ABP 654 n=247 Participants All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40.	Post Week 28: Ustekinumab/ ABP 654 n=117 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40.	Post Week 28: Ustekinumab/ Ustekinumab n=116 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40.	Post Week 28: ABP 654 Dose Intensification All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification Q8W at Weeks 28, 36, and 44.	Post Week 28: Ustekinumab Dose Intensification All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44.
Percentage of Participants With PASI 100 Response Throughout the Study Week 12	20.6 Percentage of participants Interval 15.91 to 25.37	19.1 Percentage of participants Interval 14.56 to 23.74	—	—	—	—	—
Percentage of Participants With PASI 100 Response Throughout the Study Week 4	0.4 Percentage of participants Interval 0.0 to 1.05	0.7 Percentage of participants Interval 0.0 to 1.69	—	—	—	—	—
Percentage of Participants With PASI 100 Response Throughout the Study Week 16	29.9 Percentage of participants Interval 24.54 to 35.25	26.2 Percentage of participants Interval 21.11 to 31.38	—	—	—	—	—
Percentage of Participants With PASI 100 Response Throughout the Study Week 28	34.5 Percentage of participants Interval 28.96 to 40.08	31.6 Percentage of participants Interval 26.14 to 36.98	—	—	—	—	—
Percentage of Participants With PASI 100 Response Throughout the Study Week 36	0 Percentage of participants CIs were not estimable as there were no PASI responses.	0 Percentage of participants CIs were not estimable as there were no PASI responses.	—	—	—	—	—
Percentage of Participants With PASI 100 Response Throughout the Study Week 40	—	—	44.5 Percentage of participants Interval 38.34 to 50.73	41.9 Percentage of participants Interval 32.94 to 50.82	46.6 Percentage of participants Interval 37.47 to 55.63	—	—
Percentage of Participants With PASI 100 Response Throughout the Study Week 44	4.0 Percentage of participants Interval 0.0 to 11.68	2.9 Percentage of participants Interval 0.0 to 8.62	—	—	—	—	—
Percentage of Participants With PASI 100 Response Throughout the Study Week 52	4.0 Percentage of participants Interval 0.0 to 11.68	14.7 Percentage of participants Interval 2.8 to 26.61	47.0 Percentage of participants Interval 40.74 to 53.19	42.7 Percentage of participants Interval 33.77 to 51.7	44.8 Percentage of participants Interval 35.78 to 53.88	—	—

SECONDARY outcome

Timeframe: Week 12 and Week 52 (EOS)

Population: Week 12 results are presented for the FAS with available data; NRI was used. Week 52 results are presented for dose intensification participants with available data and re-randomized FAS participants with available data (NRI was used).

The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response was defined as a sPGA value of clear (score 0) or almost clear (score 1). Higher scores represent worse symptom severity.

Outcome measures

Outcome measures
Measure	Treatment Group A (ABP 654) n=281 Participants Participants received SC injection of ABP 654, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) Q12W at Weeks 28 and 40 or, depending on PASI score, received dose intensification Q8W at Weeks 28, 36, and 44 (as per protocol).	Treatment Group B (Ustekinumab) n=282 Participants Participants received SC injection of ustekinumab, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol).	Post Week 28: ABP 654/ ABP 654 n=247 Participants All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40.	Post Week 28: Ustekinumab/ ABP 654 n=117 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40.	Post Week 28: Ustekinumab/ Ustekinumab n=116 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40.	Post Week 28: ABP 654 Dose Intensification All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification Q8W at Weeks 28, 36, and 44.	Post Week 28: Ustekinumab Dose Intensification All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44.
Percentage of Participants With sPGA Responses (0/1) at Week 12 and Week 52 Week 12	55.2 Percentage of participants Interval 49.35 to 60.98	52.8 Percentage of participants Interval 47.01 to 58.66	—	—	—	—	—
Percentage of Participants With sPGA Responses (0/1) at Week 12 and Week 52 Week 52	24.0 Percentage of participants Interval 7.26 to 40.74	35.3 Percentage of participants Interval 19.23 to 51.36	71.3 Percentage of participants Interval 65.61 to 76.9	70.9 Percentage of participants Interval 62.71 to 79.17	78.4 Percentage of participants Interval 70.97 to 85.93	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 [Week 0]), Week 12 and Week 52 (EOS)

Population: Week 12 results are presented for the FAS with available data; LOCF imputation was used. Week 52 results are presented for dose intensification participants with available observed data and re-randomized FAS participants with available data (LOCF imputation was used).

The percentage of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represents roughly 1% of the body's surface.

Outcome measures

Outcome measures
Measure	Treatment Group A (ABP 654) n=280 Participants Participants received SC injection of ABP 654, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) Q12W at Weeks 28 and 40 or, depending on PASI score, received dose intensification Q8W at Weeks 28, 36, and 44 (as per protocol).	Treatment Group B (Ustekinumab) n=281 Participants Participants received SC injection of ustekinumab, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol).	Post Week 28: ABP 654/ ABP 654 n=247 Participants All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40.	Post Week 28: Ustekinumab/ ABP 654 n=117 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40.	Post Week 28: Ustekinumab/ Ustekinumab n=116 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40.	Post Week 28: ABP 654 Dose Intensification All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification Q8W at Weeks 28, 36, and 44.	Post Week 28: Ustekinumab Dose Intensification All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44.
Change From Baseline in Percentage of BSA Affected With Psoriasis at Week 12 and Week 52 Week 52	-20.6 Percentage of BSA Standard Deviation 14.72	-21.6 Percentage of BSA Standard Deviation 16.89	-24.7 Percentage of BSA Standard Deviation 14.81	-22.8 Percentage of BSA Standard Deviation 13.86	-22.5 Percentage of BSA Standard Deviation 14.11	—	—
Change From Baseline in Percentage of BSA Affected With Psoriasis at Week 12 and Week 52 Week 12	-17.8 Percentage of BSA Standard Deviation 14.32	-17.2 Percentage of BSA Standard Deviation 14.51	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)

Population: Through Week 28 results are presented for the Safety Analysis Set. Post Week 28 results are presented for the re-randomized Safety Analysis Set and the dose intensification participants.

TEAEs were summarized by actual treatment received. For each category, participants were included only once, even if they experienced multiple events in that category.

Outcome measures

Outcome measures
Measure	Treatment Group A (ABP 654) n=280 Participants Participants received SC injection of ABP 654, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) Q12W at Weeks 28 and 40 or, depending on PASI score, received dose intensification Q8W at Weeks 28, 36, and 44 (as per protocol).	Treatment Group B (Ustekinumab) n=282 Participants Participants received SC injection of ustekinumab, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol).	Post Week 28: ABP 654/ ABP 654 n=247 Participants All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40.	Post Week 28: Ustekinumab/ ABP 654 n=117 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40.	Post Week 28: Ustekinumab/ Ustekinumab n=116 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40.	Post Week 28: ABP 654 Dose Intensification n=25 Participants All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification Q8W at Weeks 28, 36, and 44.	Post Week 28: Ustekinumab Dose Intensification n=34 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE	106 Participants	99 Participants	85 Participants	44 Participants	40 Participants	12 Participants	9 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any Serious TEAE	7 Participants	5 Participants	1 Participants	1 Participants	3 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)

Population: Through Week 28 results are presented for the Safety Analysis Set. Post Week 28 results are presented for the re-randomized Safety Analysis Set.

The EOIs pre-specified 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, serious depression including suicidality, and venous thromboembolism.

Outcome measures

Outcome measures
Measure	Treatment Group A (ABP 654) n=280 Participants Participants received SC injection of ABP 654, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) Q12W at Weeks 28 and 40 or, depending on PASI score, received dose intensification Q8W at Weeks 28, 36, and 44 (as per protocol).	Treatment Group B (Ustekinumab) n=282 Participants Participants received SC injection of ustekinumab, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol).	Post Week 28: ABP 654/ ABP 654 n=247 Participants All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40.	Post Week 28: Ustekinumab/ ABP 654 n=117 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40.	Post Week 28: Ustekinumab/ Ustekinumab n=116 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40.	Post Week 28: ABP 654 Dose Intensification All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification Q8W at Weeks 28, 36, and 44.	Post Week 28: Ustekinumab Dose Intensification All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44.
Number of Participants With Events of Interests (EOIs)	5 Participants	7 Participants	3 Participants	0 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: Baseline; Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)

Population: Through Week 28 results are presented for the Safety Analysis Set with available ADA data. Post Week 28 results are presented for the re-randomized Safety Analysis Set and dose intensification participants with available ADA data.

A participant was considered to have developed ADAs if they: * had a positive post-baseline binding or neutralizing antibody result with a negative or no result at Baseline or * had a positive post-baseline binding or neutralizing antibody result with a negative or no result prior to the first dose in the post Week 28 study period.

Outcome measures

Outcome measures
Measure	Treatment Group A (ABP 654) n=279 Participants Participants received SC injection of ABP 654, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) Q12W at Weeks 28 and 40 or, depending on PASI score, received dose intensification Q8W at Weeks 28, 36, and 44 (as per protocol).	Treatment Group B (Ustekinumab) n=280 Participants Participants received SC injection of ustekinumab, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol).	Post Week 28: ABP 654/ ABP 654 n=246 Participants All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40.	Post Week 28: Ustekinumab/ ABP 654 n=116 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40.	Post Week 28: Ustekinumab/ Ustekinumab n=115 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40.	Post Week 28: ABP 654 Dose Intensification n=25 Participants All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification Q8W at Weeks 28, 36, and 44.	Post Week 28: Ustekinumab Dose Intensification n=34 Participants All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44.
Number of Participants Developing Anti-drug Antibodies (ADAs) to ABP 654 Binding antibody	52 Participants	104 Participants	11 Participants	4 Participants	2 Participants	0 Participants	2 Participants
Number of Participants Developing Anti-drug Antibodies (ADAs) to ABP 654 Neutralizing antibody	24 Participants	50 Participants	5 Participants	1 Participants	1 Participants	0 Participants	1 Participants

Adverse Events

Through Week 28: ABP 654

Serious events: 7 serious events

Other events: 21 other events

Deaths: 0 deaths

Through Week 28: Ustekinumab

Serious events: 5 serious events

Other events: 15 other events

Deaths: 1 deaths

Post Week 28: ABP 654 / ABP 654

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Post Week 28: Ustekinumab / ABP654

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Post Week 28: Ustekinumab / Ustekinumab

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Post Week 28: ABP 654 Dose Intensification

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Post Week 28: Ustekinumab Dose Intensification

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Through Week 28: ABP 654 n=280 participants at risk All participants who were randomized to receive SC injection of ABP 654, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16.	Through Week 28: Ustekinumab n=282 participants at risk All participants who were randomized to receive SC injection of ustekinumab, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16.	Post Week 28: ABP 654 / ABP 654 n=247 participants at risk All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40.	Post Week 28: Ustekinumab / ABP654 n=117 participants at risk All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40.	Post Week 28: Ustekinumab / Ustekinumab n=116 participants at risk All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40.	Post Week 28: ABP 654 Dose Intensification n=25 participants at risk All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification Q8W at Weeks 28, 36, and 44.	Post Week 28: Ustekinumab Dose Intensification n=34 participants at risk All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44.
Cardiac disorders Acute myocardial infarction	0.00% 0/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.86% 1/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Cardiac disorders Cardiac failure congestive	0.00% 0/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.35% 1/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.35% 1/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Hepatobiliary disorders Cholelithiasis	0.36% 1/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Immune system disorders Anaphylactic reaction	0.36% 1/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Infections and infestations COVID-19	0.00% 0/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.35% 1/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.86% 1/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Infections and infestations COVID-19 pneumonia	0.36% 1/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Infections and infestations Cellulitis	0.00% 0/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.35% 1/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Infections and infestations Infected cyst	0.00% 0/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.86% 1/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Infections and infestations Postoperative wound infection	0.00% 0/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.86% 1/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Infections and infestations Sepsis	0.00% 0/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.86% 1/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Injury, poisoning and procedural complications Femoral neck fracture	0.36% 1/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.85% 1/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.35% 1/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.36% 1/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.40% 1/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.35% 1/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.36% 1/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Psychiatric disorders Bipolar I disorder	0.00% 0/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.86% 1/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Vascular disorders Hypertension	0.36% 1/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Congenital, familial and genetic disorders Developmental hip dysplasia	0.00% 0/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	4.0% 1/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.

Other adverse events

Other adverse events
Measure	Through Week 28: ABP 654 n=280 participants at risk All participants who were randomized to receive SC injection of ABP 654, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16.	Through Week 28: Ustekinumab n=282 participants at risk All participants who were randomized to receive SC injection of ustekinumab, 45 mg (Baseline BW \<= 100 kg) or 90 mg (Baseline BW \> 100 kg) at Weeks 0, 4, and 16.	Post Week 28: ABP 654 / ABP 654 n=247 participants at risk All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40.	Post Week 28: Ustekinumab / ABP654 n=117 participants at risk All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40.	Post Week 28: Ustekinumab / Ustekinumab n=116 participants at risk All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40.	Post Week 28: ABP 654 Dose Intensification n=25 participants at risk All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification Q8W at Weeks 28, 36, and 44.	Post Week 28: Ustekinumab Dose Intensification n=34 participants at risk All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44.
Infections and infestations COVID-19	2.1% 6/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	1.4% 4/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	9.3% 23/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	12.8% 15/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	8.6% 10/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	20.0% 5/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	2.9% 1/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Infections and infestations Nasopharyngitis	2.5% 7/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	1.1% 3/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	3.6% 9/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.85% 1/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	6.0% 7/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	8.0% 2/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Infections and infestations Upper respiratory tract infection	2.1% 6/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	2.5% 7/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	2.4% 6/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	5.1% 6/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	2.6% 3/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	2.9% 1/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
Renal and urinary disorders Proteinuria	0.71% 2/280 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.35% 1/282 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.40% 1/247 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	1.7% 2/117 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/116 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	8.0% 2/25 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.	0.00% 0/34 • Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.

Additional Information

Study Director

Amgen Inc.

Phone: 8665726436

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