Trial Outcomes & Findings for Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (NCT NCT04058028)

NCT ID: NCT04058028

Last Updated: 2024-09-24

Results Overview

SRI-4 response at Week 52 is defined as a ≥ 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score, and no new British Isles Lupus Assessment Group (BILAG) 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3), and no use of more than protocol allowed therapies.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 244 participants
• Primary outcome timeframe: Week 52
• Results posted on: 2024-09-24

Participant Flow

Participants with active systemic lupus erythematosus (SLE) were recruited across 81 centers in Argentina, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Poland, Portugal, Russia, South Korea, Spain, and the United States from February 2020 to July 2023.

Response adaptive randomization was used to assign eligible participants to receive rozibafusp alfa at 70, 280, and 420 mg administered subcutaneously (SC) every 2 weeks (Q2W), or matching placebo. Randomization started with a 1:1:1:1 ratio and was subsequently adapted according to clinical efficacy.

Participant milestones

Measure	Placebo Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Overall Study STARTED	62	58	36	88
Overall Study COMPLETED	36	44	28	46
Overall Study NOT COMPLETED	26	14	8	42

Reasons for withdrawal

Measure	Placebo Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Overall Study Withdrawal of Consent from Study	12	8	6	7
Overall Study Decision by Sponsor	13	4	1	35
Overall Study Lost to Follow-up	1	1	1	0
Overall Study Death	0	1	0	0

Baseline Characteristics

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

Baseline characteristics by cohort

Measure	Placebo n=62 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=58 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=36 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=88 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.	Total n=244 Participants Total of all reporting groups
Age, Continuous	42.6 Years STANDARD_DEVIATION 10.3 • n=5 Participants	44.6 Years STANDARD_DEVIATION 12.3 • n=7 Participants	42.2 Years STANDARD_DEVIATION 10.5 • n=5 Participants	44.0 Years STANDARD_DEVIATION 10.5 • n=4 Participants	43.5 Years STANDARD_DEVIATION 10.9 • n=21 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	56 Participants n=7 Participants	33 Participants n=5 Participants	82 Participants n=4 Participants	228 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	16 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=5 Participants	14 Participants n=7 Participants	5 Participants n=5 Participants	25 Participants n=4 Participants	68 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	44 Participants n=7 Participants	31 Participants n=5 Participants	63 Participants n=4 Participants	175 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants	19 Participants n=21 Participants
Race/Ethnicity, Customized Black (or African American)	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	17 Participants n=21 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized White	53 Participants n=5 Participants	47 Participants n=7 Participants	30 Participants n=5 Participants	71 Participants n=4 Participants	201 Participants n=21 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 52

Population: The FAS included all randomized participants. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included in the analysis.

SRI-4 response at Week 52 is defined as a ≥ 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score, and no new British Isles Lupus Assessment Group (BILAG) 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3), and no use of more than protocol allowed therapies.

Outcome measures

Measure	Placebo n=43 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=51 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=35 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=48 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52	26 Participants	29 Participants	21 Participants	35 Participants

SECONDARY outcome

Timeframe: Week 24

Population: The FAS included all randomized participants. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included in the analysis.

SRI-4 response at Week 24 is defined as a ≥ 4-point decrease in the hSLEDAI score, and no new BILAG 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in PGA (scale 0 to 3), and no use of more than protocol allowed therapies.

Outcome measures

Measure	Placebo n=54 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=58 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=36 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=66 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Number of Participants With a SRI-4 Response at Week 24	33 Participants	30 Participants	20 Participants	46 Participants

SECONDARY outcome

Timeframe: Week 24

Population: The FAS included all randomized participants. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included in the analysis.

The BICLA response is defined as:

1. An improvement in baseline BILAG domain scores across all body systems with moderate (domain B) or severe disease activity (domain A)

2. No new BILAG 2004 A domain score and no > 1 new BILAG 2004 B domain scores compared with baseline

3. No worsening of the hSLEDAI score from baseline

4. No ≥ 0.3-point deterioration from baseline in PGA

5. No use of more than protocol-allowed therapies

6. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants.

Outcome measures

Measure	Placebo n=54 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=58 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=36 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=66 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Number of Participants Who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24	24 Participants	19 Participants	18 Participants	35 Participants

SECONDARY outcome

Timeframe: Week 52

Population: The FAS included all randomized participants. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included in the analysis.

LLDAS was defined as meeting all the following conditions:

1. hSLEDAI ≤ 4, with no activity in major organ system (renal, central nervous system [CNS], cardiopulmonary, vasculitis, fever) and hemolytic anemia or gastrointestinal activity

2. No new lupus disease activity as compared with the previous assessment

3. PGA ≤ 1 (on a scale of 0 to 3)

4. Current prednisone or equivalent dose of ≤ 7.5 mg/day

5. Well-tolerated standard maintenance doses of immunosuppressive drugs and approved treatments, as allowed and specified in the protocol.

Outcome measures

Measure	Placebo n=43 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=51 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=35 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=48 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52	12 Participants	18 Participants	6 Participants	21 Participants

SECONDARY outcome

Timeframe: Week 52

Population: The FAS included all randomized participants. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included in the analysis.

The BICLA response is defined as:

1. An improvement in baseline BILAG domain scores across all body systems with moderate (domain B) or severe disease activity (domain A)

2. No new BILAG 2004 A domain score and no > 1 new BILAG 2004 B domain scores compared with baseline

3. No worsening of the hSLEDAI score from baseline

4. No ≥ 0.3-point deterioration from baseline in PGA

5. No use of more than protocol-allowed therapies

6. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants.

Outcome measures

Measure	Placebo n=43 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=51 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=35 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=48 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Number of Participants Who Achieved a BICLA Response at Week 52	21 Participants	20 Participants	15 Participants	29 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: The FAS included all randomized participants. Only participants who had a baseline OCS dose ≥ 10 mg/day and had the opportunity to complete Week 52 visit by the date of the study termination were included in the analysis.

SRI-4 response is defined as a ≥ 4-point decrease in the hSLEDAI score, and no new BILAG 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in PGA (scale 0 to 3), and no use of more than protocol allowed therapies. Participants also had to meet a reduction if OCS to ≤ 7.5 mg/day by Week 44 sustained through Week 52.

Outcome measures

Measure	Placebo n=27 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=16 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=19 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=25 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Number of Participants Achieving a SRI-4 Response With a Reduction of Oral Corticosteroids (OCS) to ≤ 7.5 mg/Day by Week 44 and Sustained Through Week 52 In Participants With a Baseline OCS Dose ≥ 10 mg/Day	5 Participants	1 Participants	2 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: The FAS included all randomized participants.

The SFI, serves as a composite outcome measure incorporating the SELENA-SLEDAI score, and classifications of flares into mild, moderate, and severe, along with the PGA of disease activity. The SFI details specific clinical manifestations for each organ system and categorizes flares into mild, moderate, and severe based on treatment decisions. Moderate and severe flare: • Moderate: meeting criteria like SELENA-SLEDAI score change of 3 to 12 points, SLE symptom development, prednisone dose increase, non-steroidal anti-inflammatory drugs (NSAIDs)/hydrochloroquine addition, or PGA score increase by 1 to 2.5. • Severe: meeting criteria like SELENA-SLEDAI increase over 12 points, onset or worsening of severe symptoms, significant prednisone dose escalation, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher. Annualized flare rate was calculated as the number of flares divided by flare exposure time in days, multiplied by 365.25 for each Group.

Outcome measures

Measure	Placebo n=62 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=58 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=36 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=88 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Annualized Moderate and Severe Flare Rate Over 52 Weeks as Measured by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment [SELENA] -Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] Flare Index (SFI)	0.34 Flares/year	0.52 Flares/year	0.46 Flares/year	0.34 Flares/year

SECONDARY outcome

Timeframe: Up to Week 52

Population: The FAS included all randomized participants.

The SFI, serves as a composite outcome measure incorporating the SELENA-SLEDAI score, and classifications of flares into mild, moderate, and severe, along with the PGA of disease activity. The SFI details specific clinical manifestations for each organ system and categorizes flares into mild, moderate, and severe based on treatment decisions. Severe flare: meeting criteria like SELENA-SLEDAI increase over 12 points, onset or worsening of severe symptoms, significant prednisone dose escalation, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days, multiplied by 365.25 for each Group.

Outcome measures

Measure	Placebo n=62 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=58 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=36 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=88 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI	0.21 Flares/year	0.24 Flares/year	0.30 Flares/year	0.16 Flares/year

SECONDARY outcome

Timeframe: Up to Week 52

Population: The FAS included all randomized participants.

The BILAG flare index was derived from BILAG 2004, as measured by BILAG score designation of 'worse' or 'new' resulting in a B score in >= 2 organs or an A score in >= 1 organ.

The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days, multiplied by 365.25 for each Group.

Outcome measures

Measure	Placebo n=62 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=58 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=36 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=88 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Annualized Flares Rate Over 52 Weeks as Measured by BILAG Score Designation of "Worse" or "New" Resulting in a B-Score In ≥ 2 Organs or an A-Score in ≥ 1 Organ	0.13 Flares/year	0.22 Flares/year	0.30 Flares/year	0.31 Flares/year

SECONDARY outcome

Timeframe: Week 12, 24, 36, and 52

Population: The FAS included all randomized participants. Only participants who had ≥ 6 tender and swollen joints involving hands and wrists at baseline and had opportunity to complete the visit by the date of the study termination were included in the analysis.

The tender and swollen joint count is a physical assessment where for each swollen and tender joint a score of 1 is assigned. Scores are then summed up to provide a total score for both swollen and tender joints. Higher total score indicate a severe disease activity and a lower score indicates a lees severe disease activity.

Outcome measures

Measure	Placebo n=34 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=35 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=13 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=46 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 Week 12	20 Participants	16 Participants	8 Participants	31 Participants
Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 Week 24	23 Participants	23 Participants	7 Participants	34 Participants
Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 Week 36	26 Participants	22 Participants	10 Participants	29 Participants
Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 Week 52	19 Participants	20 Participants	9 Participants	27 Participants

SECONDARY outcome

Timeframe: Week 12, 24, 36, and 52

Population: The FAS included all randomized participants. Only participants who had CLASI activity score ≥ 8 at baseline and had the opportunity to complete the visit by the date of the study termination were included in the analysis.

The CLASI is an assessment tool consisting of two scores: one for disease activity and one for damage. Activity Score: Ranges from 0 to 70, and is assessed based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss, and non-scarring alopecia. Higher scores indicate more severe disease activity.

Damage Score: Ranges from 0 to 56, and is evaluated through dyspigmentation and scarring, including scarring alopecia. Dyspigmentation that remains visible for more than 12 months is considered permanent, and its score is doubled. Higher scores indicate greater damage.

Outcome measures

Measure	Placebo n=13 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=10 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=12 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=16 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 Week 12	3 Participants	2 Participants	5 Participants	4 Participants
Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 Week 24	3 Participants	3 Participants	6 Participants	3 Participants
Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 Week 36	1 Participants	5 Participants	7 Participants	2 Participants
Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 Week 52	0 Participants	4 Participants	7 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 12, 24, 36, 44, and 52

Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.

The PROMIS-Fatigue SF7a is a 7-item instrument that assesses the experience of fatigue as well as its impact on physical, mental and social activities. Each item is scored on a 5-point Likert scale, ranging from "1" (Never) to "5" (Always). The scores of all 7 items are summed up with a total raw score range of 7(low level of fatigue)-35(high level of fatigue). Raw scores are converted to a T-score ranging from 29.4(low level of fatigue)-83.2(high level of fatigue).

Outcome measures

Measure	Placebo n=30 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=28 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=22 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=43 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 Week 12	-8.40 T-score Standard Deviation 9.61	-6.89 T-score Standard Deviation 5.71	-4.22 T-score Standard Deviation 8.45	-8.01 T-score Standard Deviation 7.60
Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 Week 24	-6.48 T-score Standard Deviation 11.97	-5.61 T-score Standard Deviation 8.54	-5.86 T-score Standard Deviation 7.76	-8.82 T-score Standard Deviation 6.02
Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 Week 36	-7.26 T-score Standard Deviation 8.26	-7.12 T-score Standard Deviation 8.00	-3.26 T-score Standard Deviation 7.64	-8.73 T-score Standard Deviation 8.98
Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 Week 44	-4.44 T-score Standard Deviation 7.94	-8.65 T-score Standard Deviation 9.75	-4.47 T-score Standard Deviation 7.23	-8.25 T-score Standard Deviation 10.38
Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 Week 52	-8.57 T-score Standard Deviation 8.36	-10.22 T-score Standard Deviation 8.89	-6.57 T-score Standard Deviation 7.25	-7.88 T-score Standard Deviation 11.88

SECONDARY outcome

Timeframe: Week 12, 24, 36, 44, and 52

Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.

The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.

Outcome measures

Measure	Placebo n=51 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=47 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=32 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=67 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 Week 12	4.612 Score on a scale Standard Deviation 8.241	4.261 Score on a scale Standard Deviation 7.609	4.013 Score on a scale Standard Deviation 8.456	5.409 Score on a scale Standard Deviation 6.207
Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 Week 24	6.055 Score on a scale Standard Deviation 8.043	5.440 Score on a scale Standard Deviation 8.807	4.570 Score on a scale Standard Deviation 8.994	5.847 Score on a scale Standard Deviation 6.971
Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 Week 36	6.652 Score on a scale Standard Deviation 7.957	6.536 Score on a scale Standard Deviation 9.646	5.360 Score on a scale Standard Deviation 8.736	6.833 Score on a scale Standard Deviation 9.467
Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 Week 44	4.881 Score on a scale Standard Deviation 9.200	7.298 Score on a scale Standard Deviation 9.903	3.508 Score on a scale Standard Deviation 7.538	7.522 Score on a scale Standard Deviation 9.735
Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 Week 52	7.235 Score on a scale Standard Deviation 7.097	6.598 Score on a scale Standard Deviation 9.452	5.056 Score on a scale Standard Deviation 9.429	5.456 Score on a scale Standard Deviation 9.151

SECONDARY outcome

Timeframe: Week 12, 24, 36, 44, and 52

Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.

The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.

Outcome measures

Measure	Placebo n=51 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=47 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=32 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=67 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 Week 12	5.433 Score on a scale Standard Deviation 10.477	1.941 Score on a scale Standard Deviation 8.689	2.235 Score on a scale Standard Deviation 11.754	4.965 Score on a scale Standard Deviation 9.413
Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 Week 24	4.889 Score on a scale Standard Deviation 10.772	1.123 Score on a scale Standard Deviation 7.767	5.008 Score on a scale Standard Deviation 8.063	5.786 Score on a scale Standard Deviation 9.278
Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 Week 36	5.002 Score on a scale Standard Deviation 9.405	1.407 Score on a scale Standard Deviation 10.943	2.111 Score on a scale Standard Deviation 11.263	6.531 Score on a scale Standard Deviation 10.543
Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 Week 44	6.556 Score on a scale Standard Deviation 12.984	3.208 Score on a scale Standard Deviation 9.125	1.914 Score on a scale Standard Deviation 9.247	5.903 Score on a scale Standard Deviation 10.847
Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 Week 52	6.675 Score on a scale Standard Deviation 12.074	3.778 Score on a scale Standard Deviation 9.910	2.613 Score on a scale Standard Deviation 10.841	7.186 Score on a scale Standard Deviation 9.185

SECONDARY outcome

Timeframe: Week 12, 24, 36, 44, and 52

Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.

The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.

Outcome measures

Measure	Placebo n=51 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=47 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=32 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=68 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 Week 36	17.752 Score on a scale Standard Deviation 22.417	15.640 Score on a scale Standard Deviation 21.031	11.608 Score on a scale Standard Deviation 23.533	16.142 Score on a scale Standard Deviation 21.924
Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 Week 12	14.019 Score on a scale Standard Deviation 25.397	11.383 Score on a scale Standard Deviation 21.076	10.000 Score on a scale Standard Deviation 22.966	12.595 Score on a scale Standard Deviation 18.765
Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 Week 24	15.777 Score on a scale Standard Deviation 23.930	13.043 Score on a scale Standard Deviation 22.961	13.000 Score on a scale Standard Deviation 24.657	14.048 Score on a scale Standard Deviation 21.031
Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 Week 44	15.001 Score on a scale Standard Deviation 24.582	17.222 Score on a scale Standard Deviation 24.007	8.036 Score on a scale Standard Deviation 19.924	17.200 Score on a scale Standard Deviation 20.702
Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 Week 52	20.807 Score on a scale Standard Deviation 21.138	15.416 Score on a scale Standard Deviation 23.002	12.778 Score on a scale Standard Deviation 22.632	16.568 Score on a scale Standard Deviation 18.357

SECONDARY outcome

Timeframe: Week 12, 24, 36, 44, and 52

Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.

The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.

Outcome measures

Measure	Placebo n=51 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=47 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=32 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=67 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 Week 12	15.074 Score on a scale Standard Deviation 25.378	7.979 Score on a scale Standard Deviation 24.090	9.961 Score on a scale Standard Deviation 21.701	13.713 Score on a scale Standard Deviation 22.957
Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 Week 24	20.278 Score on a scale Standard Deviation 28.240	10.190 Score on a scale Standard Deviation 28.788	11.667 Score on a scale Standard Deviation 19.609	16.625 Score on a scale Standard Deviation 27.217
Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 Week 36	19.219 Score on a scale Standard Deviation 24.160	12.660 Score on a scale Standard Deviation 29.991	13.839 Score on a scale Standard Deviation 23.653	19.886 Score on a scale Standard Deviation 30.863
Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 Week 44	16.319 Score on a scale Standard Deviation 28.554	18.924 Score on a scale Standard Deviation 28.169	10.714 Score on a scale Standard Deviation 22.876	20.313 Score on a scale Standard Deviation 32.915
Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 Week 52	23.387 Score on a scale Standard Deviation 22.475	17.708 Score on a scale Standard Deviation 27.730	9.028 Score on a scale Standard Deviation 23.852	14.464 Score on a scale Standard Deviation 31.933

SECONDARY outcome

Timeframe: Week 12, 24, 36, 44, and 52

Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.

The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.

Outcome measures

Measure	Placebo n=51 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=47 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=32 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=67 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 Week 12	15.5 Score on a scale Standard Deviation 25.7	12.0 Score on a scale Standard Deviation 23.1	10.9 Score on a scale Standard Deviation 21.5	18.4 Score on a scale Standard Deviation 19.5
Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 Week 24	17.5 Score on a scale Standard Deviation 26.7	14.4 Score on a scale Standard Deviation 27.6	13.5 Score on a scale Standard Deviation 24.6	18.3 Score on a scale Standard Deviation 19.4
Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 Week 36	18.7 Score on a scale Standard Deviation 23.2	15.9 Score on a scale Standard Deviation 27.9	14.1 Score on a scale Standard Deviation 24.0	22.1 Score on a scale Standard Deviation 26.3
Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 Week 44	18.9 Score on a scale Standard Deviation 23.9	19.2 Score on a scale Standard Deviation 31.9	10.7 Score on a scale Standard Deviation 20.5	26.0 Score on a scale Standard Deviation 29.4
Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 Week 52	19.8 Score on a scale Standard Deviation 22.5	16.7 Score on a scale Standard Deviation 28.4	16.6 Score on a scale Standard Deviation 23.0	21.8 Score on a scale Standard Deviation 25.2

SECONDARY outcome

Timeframe: Week 12, 24, 36, 44, and 52

Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.

The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.

Outcome measures

Measure	Placebo n=51 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=47 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=32 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=68 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 Week 12	5.90 Score on a scale Standard Deviation 14.71	5.85 Score on a scale Standard Deviation 16.06	4.69 Score on a scale Standard Deviation 14.87	9.97 Score on a scale Standard Deviation 14.15
Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 Week 24	7.44 Score on a scale Standard Deviation 15.97	6.98 Score on a scale Standard Deviation 16.11	9.13 Score on a scale Standard Deviation 14.83	11.75 Score on a scale Standard Deviation 14.11
Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 Week 36	10.35 Score on a scale Standard Deviation 16.43	10.15 Score on a scale Standard Deviation 16.97	5.96 Score on a scale Standard Deviation 16.28	11.40 Score on a scale Standard Deviation 17.81
Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 Week 44	7.61 Score on a scale Standard Deviation 19.32	11.81 Score on a scale Standard Deviation 18.99	3.11 Score on a scale Standard Deviation 16.92	11.76 Score on a scale Standard Deviation 16.74
Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 Week 52	9.55 Score on a scale Standard Deviation 21.62	12.54 Score on a scale Standard Deviation 18.23	5.81 Score on a scale Standard Deviation 19.60	9.58 Score on a scale Standard Deviation 18.22

SECONDARY outcome

Timeframe: Week 12, 24, 36, 44, and 52

Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.

The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.

Outcome measures

Measure	Placebo n=51 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=47 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=32 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=67 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 Week 12	10.662 Score on a scale Standard Deviation 22.441	8.112 Score on a scale Standard Deviation 18.054	8.594 Score on a scale Standard Deviation 21.402	11.287 Score on a scale Standard Deviation 20.361
Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 Week 24	10.556 Score on a scale Standard Deviation 24.419	7.880 Score on a scale Standard Deviation 15.780	12.083 Score on a scale Standard Deviation 18.346	13.125 Score on a scale Standard Deviation 18.482
Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 Week 36	11.094 Score on a scale Standard Deviation 20.090	10.256 Score on a scale Standard Deviation 19.102	8.036 Score on a scale Standard Deviation 18.854	15.199 Score on a scale Standard Deviation 22.083
Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 Week 44	7.465 Score on a scale Standard Deviation 24.313	11.632 Score on a scale Standard Deviation 19.489	5.804 Score on a scale Standard Deviation 19.089	15.104 Score on a scale Standard Deviation 21.670
Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 Week 52	12.903 Score on a scale Standard Deviation 23.659	11.806 Score on a scale Standard Deviation 20.199	8.796 Score on a scale Standard Deviation 21.249	11.250 Score on a scale Standard Deviation 21.693

SECONDARY outcome

Timeframe: Week 12, 24, 36, 44, and 52

Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.

The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.

Outcome measures

Measure	Placebo n=51 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=47 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=32 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=67 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 Week 44	17.71 Score on a scale Standard Deviation 27.61	8.68 Score on a scale Standard Deviation 27.52	7.14 Score on a scale Standard Deviation 22.16	14.24 Score on a scale Standard Deviation 23.75
Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 Week 12	14.46 Score on a scale Standard Deviation 22.83	8.24 Score on a scale Standard Deviation 20.40	9.77 Score on a scale Standard Deviation 24.54	15.11 Score on a scale Standard Deviation 23.89
Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 Week 24	15.28 Score on a scale Standard Deviation 26.23	7.88 Score on a scale Standard Deviation 25.05	14.58 Score on a scale Standard Deviation 19.72	15.25 Score on a scale Standard Deviation 21.32
Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 Week 36	15.63 Score on a scale Standard Deviation 25.28	7.05 Score on a scale Standard Deviation 25.78	14.29 Score on a scale Standard Deviation 23.00	19.60 Score on a scale Standard Deviation 23.72
Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 Week 52	23.79 Score on a scale Standard Deviation 25.07	10.42 Score on a scale Standard Deviation 26.98	13.89 Score on a scale Standard Deviation 23.34	17.50 Score on a scale Standard Deviation 21.90

SECONDARY outcome

Timeframe: Week 12, 24, 36, 44, and 52

Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.

The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.

Outcome measures

Measure	Placebo n=51 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=47 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=32 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=67 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 Week 12	13.888 Score on a scale Standard Deviation 26.961	5.141 Score on a scale Standard Deviation 26.384	2.083 Score on a scale Standard Deviation 27.189	12.935 Score on a scale Standard Deviation 27.382
Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 Week 24	13.888 Score on a scale Standard Deviation 27.352	5.072 Score on a scale Standard Deviation 23.339	11.111 Score on a scale Standard Deviation 20.800	15.334 Score on a scale Standard Deviation 28.540
Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 Week 36	15.208 Score on a scale Standard Deviation 24.306	4.058 Score on a scale Standard Deviation 21.364	6.250 Score on a scale Standard Deviation 29.886	14.773 Score on a scale Standard Deviation 29.742
Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 Week 44	20.139 Score on a scale Standard Deviation 32.512	8.564 Score on a scale Standard Deviation 21.314	7.441 Score on a scale Standard Deviation 25.493	16.899 Score on a scale Standard Deviation 30.045
Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 Week 52	18.011 Score on a scale Standard Deviation 30.814	10.647 Score on a scale Standard Deviation 25.008	6.481 Score on a scale Standard Deviation 28.620	19.762 Score on a scale Standard Deviation 23.491

SECONDARY outcome

Timeframe: Week 12, 24, 36, 44, and 52

Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.

The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.

Outcome measures

Measure	Placebo n=51 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=47 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=32 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=67 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 Week 12	10.7 Score on a scale Standard Deviation 21.5	4.3 Score on a scale Standard Deviation 16.2	6.4 Score on a scale Standard Deviation 21.0	8.9 Score on a scale Standard Deviation 17.1
Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 Week 24	10.1 Score on a scale Standard Deviation 22.7	2.7 Score on a scale Standard Deviation 15.3	9.2 Score on a scale Standard Deviation 15.1	10.6 Score on a scale Standard Deviation 18.0
Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 Week 36	10.0 Score on a scale Standard Deviation 18.7	5.5 Score on a scale Standard Deviation 21.8	3.0 Score on a scale Standard Deviation 20.2	13.1 Score on a scale Standard Deviation 19.3
Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 Week 44	11.8 Score on a scale Standard Deviation 24.3	10.3 Score on a scale Standard Deviation 16.0	3.0 Score on a scale Standard Deviation 16.1	12.5 Score on a scale Standard Deviation 20.1
Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 Week 52	12.3 Score on a scale Standard Deviation 21.4	9.0 Score on a scale Standard Deviation 19.0	4.6 Score on a scale Standard Deviation 17.4	13.9 Score on a scale Standard Deviation 18.3

SECONDARY outcome

Timeframe: Week 12, 24, 36, 44, and 52

Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.

The LupusQoL questionnaire consists of 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Each item in the questionnaire is scored on a 5 point scale and items within a given domain are summed and converted to a 0-100 scale. Each domain is scored 0-100 with higher scores representing better quality of life in the specific domain. Lower scores signify poorer quality of life within the domain.

Outcome measures

Measure	Placebo n=51 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=46 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=32 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=67 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Fatigue: Week 36	9.909 Score on a scale Standard Deviation 19.664	9.219 Score on a scale Standard Deviation 20.363	7.407 Score on a scale Standard Deviation 17.076	15.057 Score on a scale Standard Deviation 28.220
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Burden to Others: Week 52	13.710 Score on a scale Standard Deviation 27.348	8.333 Score on a scale Standard Deviation 25.973	15.741 Score on a scale Standard Deviation 30.865	17.143 Score on a scale Standard Deviation 29.632
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Body Image: Week 44	11.3 Score on a scale Standard Deviation 27.3	4.6 Score on a scale Standard Deviation 26.4	12.7 Score on a scale Standard Deviation 32.0	10.4 Score on a scale Standard Deviation 20.2
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Body Image: Week 52	8.9 Score on a scale Standard Deviation 20.2	-5.0 Score on a scale Standard Deviation 26.7	7.0 Score on a scale Standard Deviation 31.3	9.6 Score on a scale Standard Deviation 24.0
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Fatigue: Week 12	10.049 Score on a scale Standard Deviation 21.253	8.424 Score on a scale Standard Deviation 19.509	6.250 Score on a scale Standard Deviation 20.880	10.541 Score on a scale Standard Deviation 22.488
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Fatigue: Week 24	9.861 Score on a scale Standard Deviation 23.175	10.972 Score on a scale Standard Deviation 20.127	6.458 Score on a scale Standard Deviation 17.790	10.625 Score on a scale Standard Deviation 23.257
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Fatigue: Week 44	10.764 Score on a scale Standard Deviation 17.205	12.153 Score on a scale Standard Deviation 18.717	9.821 Score on a scale Standard Deviation 16.876	12.500 Score on a scale Standard Deviation 22.952
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Fatigue: Week 52	12.500 Score on a scale Standard Deviation 22.765	9.722 Score on a scale Standard Deviation 20.291	9.954 Score on a scale Standard Deviation 18.036	9.464 Score on a scale Standard Deviation 21.404
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Emotional Health: Week 12	7.435 Score on a scale Standard Deviation 23.940	4.529 Score on a scale Standard Deviation 15.611	6.250 Score on a scale Standard Deviation 21.997	9.142 Score on a scale Standard Deviation 19.493
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Planning: Week 12	10.294 Score on a scale Standard Deviation 23.368	11.594 Score on a scale Standard Deviation 21.551	5.469 Score on a scale Standard Deviation 23.817	12.438 Score on a scale Standard Deviation 22.631
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Planning: Week 24	10.185 Score on a scale Standard Deviation 23.763	6.667 Score on a scale Standard Deviation 29.226	9.722 Score on a scale Standard Deviation 24.279	9.500 Score on a scale Standard Deviation 23.988
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Planning: Week 36	11.179 Score on a scale Standard Deviation 21.214	9.583 Score on a scale Standard Deviation 23.232	13.272 Score on a scale Standard Deviation 21.836	14.773 Score on a scale Standard Deviation 29.414
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Planning: Week 44	9.491 Score on a scale Standard Deviation 26.959	13.426 Score on a scale Standard Deviation 20.919	9.821 Score on a scale Standard Deviation 19.779	12.037 Score on a scale Standard Deviation 27.418
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Planning: Week 52	16.129 Score on a scale Standard Deviation 19.357	8.565 Score on a scale Standard Deviation 23.527	9.568 Score on a scale Standard Deviation 24.428	12.381 Score on a scale Standard Deviation 22.810
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Physical Health: Week 12	9.498 Score on a scale Standard Deviation 22.989	12.160 Score on a scale Standard Deviation 15.607	8.398 Score on a scale Standard Deviation 20.992	9.748 Score on a scale Standard Deviation 16.541
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Physical Health: Week 24	12.986 Score on a scale Standard Deviation 24.461	14.097 Score on a scale Standard Deviation 21.972	11.667 Score on a scale Standard Deviation 18.856	11.063 Score on a scale Standard Deviation 16.551
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Physical Health: Week 36	12.729 Score on a scale Standard Deviation 21.678	14.375 Score on a scale Standard Deviation 22.610	13.542 Score on a scale Standard Deviation 17.313	13.991 Score on a scale Standard Deviation 21.264
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Physical Health: Week 44	11.892 Score on a scale Standard Deviation 25.253	16.753 Score on a scale Standard Deviation 22.124	11.049 Score on a scale Standard Deviation 15.625	12.760 Score on a scale Standard Deviation 17.008
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Physical Health: Week 52	18.448 Score on a scale Standard Deviation 22.827	13.976 Score on a scale Standard Deviation 19.799	8.449 Score on a scale Standard Deviation 20.156	14.107 Score on a scale Standard Deviation 18.847
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Pain: Week 12	14.869 Score on a scale Standard Deviation 27.199	14.493 Score on a scale Standard Deviation 22.800	12.240 Score on a scale Standard Deviation 26.939	14.552 Score on a scale Standard Deviation 22.349
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Pain: Week 24	16.296 Score on a scale Standard Deviation 29.460	13.148 Score on a scale Standard Deviation 22.647	15.556 Score on a scale Standard Deviation 23.947	17.667 Score on a scale Standard Deviation 20.800
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Pain: Week 36	14.837 Score on a scale Standard Deviation 26.972	13.125 Score on a scale Standard Deviation 19.327	15.123 Score on a scale Standard Deviation 23.912	18.939 Score on a scale Standard Deviation 27.159
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Pain: Week 44	14.815 Score on a scale Standard Deviation 31.755	16.667 Score on a scale Standard Deviation 23.905	11.905 Score on a scale Standard Deviation 21.328	17.824 Score on a scale Standard Deviation 24.893
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Pain: Week 52	25.538 Score on a scale Standard Deviation 23.367	14.352 Score on a scale Standard Deviation 24.929	14.815 Score on a scale Standard Deviation 28.898	19.524 Score on a scale Standard Deviation 23.565
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Intimate Relationship: Week 12	6.76 Score on a scale Standard Deviation 26.94	3.52 Score on a scale Standard Deviation 24.64	0.60 Score on a scale Standard Deviation 30.99	4.75 Score on a scale Standard Deviation 20.81
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Intimate Relationship: Week 24	2.59 Score on a scale Standard Deviation 24.86	5.47 Score on a scale Standard Deviation 28.74	0.69 Score on a scale Standard Deviation 20.77	6.25 Score on a scale Standard Deviation 23.08
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Intimate Relationship: Week 36	4.63 Score on a scale Standard Deviation 26.66	9.26 Score on a scale Standard Deviation 27.21	-2.63 Score on a scale Standard Deviation 20.66	5.17 Score on a scale Standard Deviation 23.27
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Intimate Relationship: Week 44	5.00 Score on a scale Standard Deviation 31.46	8.00 Score on a scale Standard Deviation 23.90	-3.95 Score on a scale Standard Deviation 21.67	9.13 Score on a scale Standard Deviation 31.54
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Intimate Relationship: Week 52	11.90 Score on a scale Standard Deviation 27.80	3.26 Score on a scale Standard Deviation 23.30	-1.47 Score on a scale Standard Deviation 18.69	4.17 Score on a scale Standard Deviation 19.61
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Burden to Others: Week 12	12.092 Score on a scale Standard Deviation 22.068	5.072 Score on a scale Standard Deviation 20.373	13.281 Score on a scale Standard Deviation 30.590	9.577 Score on a scale Standard Deviation 27.762
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Burden to Others: Week 24	10.556 Score on a scale Standard Deviation 30.896	9.444 Score on a scale Standard Deviation 27.328	15.000 Score on a scale Standard Deviation 25.931	11.500 Score on a scale Standard Deviation 27.914
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Burden to Others: Week36	16.260 Score on a scale Standard Deviation 27.320	11.042 Score on a scale Standard Deviation 22.754	18.827 Score on a scale Standard Deviation 28.457	13.447 Score on a scale Standard Deviation 29.268
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Burden to Others: Week 44	14.120 Score on a scale Standard Deviation 28.159	14.352 Score on a scale Standard Deviation 23.955	15.476 Score on a scale Standard Deviation 26.324	13.194 Score on a scale Standard Deviation 26.902
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Emotional Health: Week 24	8.056 Score on a scale Standard Deviation 22.322	7.963 Score on a scale Standard Deviation 19.337	7.778 Score on a scale Standard Deviation 16.109	13.083 Score on a scale Standard Deviation 22.096
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Emotional Health: Week 36	5.589 Score on a scale Standard Deviation 19.557	3.958 Score on a scale Standard Deviation 16.150	6.173 Score on a scale Standard Deviation 20.359	13.920 Score on a scale Standard Deviation 25.903
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Emotional Health: Week 44	6.134 Score on a scale Standard Deviation 23.369	9.722 Score on a scale Standard Deviation 15.685	7.292 Score on a scale Standard Deviation 15.533	13.194 Score on a scale Standard Deviation 23.853
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Emotional Health: Week 52	7.258 Score on a scale Standard Deviation 23.545	6.134 Score on a scale Standard Deviation 19.606	8.951 Score on a scale Standard Deviation 20.888	14.167 Score on a scale Standard Deviation 21.561
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Body Image: Week 12	9.2 Score on a scale Standard Deviation 24.4	3.7 Score on a scale Standard Deviation 23.9	13.1 Score on a scale Standard Deviation 31.7	10.1 Score on a scale Standard Deviation 23.9
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Body Image: Week 24	5.9 Score on a scale Standard Deviation 26.2	-0.1 Score on a scale Standard Deviation 24.9	0.2 Score on a scale Standard Deviation 29.7	14.9 Score on a scale Standard Deviation 26.4
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 Body Image: Week 36	4.4 Score on a scale Standard Deviation 25.0	3.8 Score on a scale Standard Deviation 24.3	4.8 Score on a scale Standard Deviation 27.7	11.1 Score on a scale Standard Deviation 29.2

SECONDARY outcome

Timeframe: Week 12, 24, 36, 44, and 52

Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.

The PtGA assesses disease activity on a 10 cm numeric rating scale (NRS; 0 to 10 cm). The scale for the assessment ranges from "very well" (0) to "very poor" (10).

Outcome measures

Measure	Placebo n=51 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=44 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=31 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=65 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 Week 12	-0.9 Score on a scale Standard Deviation 2.8	-1.1 Score on a scale Standard Deviation 1.9	-1.8 Score on a scale Standard Deviation 3.0	-1.7 Score on a scale Standard Deviation 2.2
Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 Week 24	-1.9 Score on a scale Standard Deviation 2.6	-1.2 Score on a scale Standard Deviation 2.7	-1.7 Score on a scale Standard Deviation 2.7	-2.2 Score on a scale Standard Deviation 2.1
Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 Week 36	-2.0 Score on a scale Standard Deviation 2.6	-1.7 Score on a scale Standard Deviation 2.5	-1.6 Score on a scale Standard Deviation 2.3	-2.6 Score on a scale Standard Deviation 2.6
Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 Week 44	-2.1 Score on a scale Standard Deviation 3.0	-2.1 Score on a scale Standard Deviation 2.8	-2.0 Score on a scale Standard Deviation 2.8	-2.6 Score on a scale Standard Deviation 2.3
Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 Week 52	-2.3 Score on a scale Standard Deviation 2.7	-1.8 Score on a scale Standard Deviation 2.5	-2.6 Score on a scale Standard Deviation 2.5	-2.1 Score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: Up to approximately 68 weeks

Population: The Safety Analysis Set (SAS) included all randomized participants who received at least 1 dose of investigational product (IP).

An adverse event (AE) was any negative medical occurrence linked to an intervention in humans, regardless of its relation to the intervention. Treatment-emergent AEs (TEAEs) were those that occurred after the first intervention dose. A serious adverse event (SAE) included outcomes such as death, life-threatening situations, hospitalization or an extended hospital stay, significant incapacity, congenital defects, or other crucial medical events. AE severity followed the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 scale: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death). Clinically significant laboratory results or other assessments (e.g., ECGs, scans, vital signs) that worsened from baseline and were deemed important by the investigator, independent of disease progression, were also considered.

Outcome measures

Measure	Placebo n=62 Participants Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=58 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=36 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=87 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) All TEAEs	42 Participants	47 Participants	23 Participants	71 Participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) Fatal AEs	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) SAEs	6 Participants	7 Participants	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 36, Week 44, Week 52, Week 56, Week 60, Week 64, and Week 68

Population: The pharmacokinetic (PK) concentration analysis set contained all participants who received at least one dose of IP and had at least one quantifiable PK sample collected. PK concentration data was analyzed according to the actual treatment received.

Outcome measures

Measure	Placebo Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70mg n=57 Participants Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280mg n=36 Participants Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420mg n=84 Participants Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Serum Concentration of Rozibafusp Alfa Week 4	—	1.29 μg/mL Standard Deviation 1.34	20.7 μg/mL Standard Deviation 10.8	26.2 μg/mL Standard Deviation 17.1
Serum Concentration of Rozibafusp Alfa Week 1	—	0.0 μg/mL Standard Deviation 0.0	0.0 μg/mL Standard Deviation 0.0	0.0 μg/mL Standard Deviation 0.0
Serum Concentration of Rozibafusp Alfa Week 8	—	1.70 μg/mL Standard Deviation 1.93	26.6 μg/mL Standard Deviation 15.7	40.7 μg/mL Standard Deviation 21.8
Serum Concentration of Rozibafusp Alfa Week 12	—	2.05 μg/mL Standard Deviation 2.03	31.3 μg/mL Standard Deviation 16.5	46.8 μg/mL Standard Deviation 24.6
Serum Concentration of Rozibafusp Alfa Week 16	—	2.58 μg/mL Standard Deviation 2.67	29.8 μg/mL Standard Deviation 18.9	47.0 μg/mL Standard Deviation 28.4
Serum Concentration of Rozibafusp Alfa Week 20	—	3.42 μg/mL Standard Deviation 3.15	35.4 μg/mL Standard Deviation 19.8	48.9 μg/mL Standard Deviation 30.0
Serum Concentration of Rozibafusp Alfa Week 24	—	3.69 μg/mL Standard Deviation 3.37	35.8 μg/mL Standard Deviation 19.1	55.5 μg/mL Standard Deviation 30.6
Serum Concentration of Rozibafusp Alfa Week 36	—	3.62 μg/mL Standard Deviation 3.73	40.5 μg/mL Standard Deviation 20.7	54.7 μg/mL Standard Deviation 35.9
Serum Concentration of Rozibafusp Alfa Week 44	—	2.98 μg/mL Standard Deviation 3.78	39.0 μg/mL Standard Deviation 18.6	54.1 μg/mL Standard Deviation 38.3
Serum Concentration of Rozibafusp Alfa Week 52	—	4.15 μg/mL Standard Deviation 4.50	43.8 μg/mL Standard Deviation 25.3	51.6 μg/mL Standard Deviation 30.8
Serum Concentration of Rozibafusp Alfa Week 56	—	0.230 μg/mL Standard Deviation 0.495	11.3 μg/mL Standard Deviation 8.03	13.3 μg/mL Standard Deviation 12.4
Serum Concentration of Rozibafusp Alfa Week 60	—	0.00346 μg/mL Standard Deviation 0.0120	3.45 μg/mL Standard Deviation 4.31	3.08 μg/mL Standard Deviation 4.45
Serum Concentration of Rozibafusp Alfa Week 64	—	0.0 μg/mL Standard Deviation 0.0	0.609 μg/mL Standard Deviation 1.07	0.718 μg/mL Standard Deviation 1.41
Serum Concentration of Rozibafusp Alfa Week 68	—	0.0 μg/mL Standard Deviation 0.0	0.0484 μg/mL Standard Deviation 0.125	0.102 μg/mL Standard Deviation 0.271

SECONDARY outcome

Timeframe: Up to Week 68

Population: Per the SAP, data for this outcome measure was not to be analyzed unless it could be adequately estimated.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 29 other events

Deaths: 0 deaths

Rozibafusp Alfa 70 mg

Serious events: 7 serious events

Other events: 34 other events

Deaths: 1 deaths

Rozibafusp Alfa 280 mg

Serious events: 5 serious events

Other events: 20 other events

Deaths: 0 deaths

Rozibafusp Alfa 420 mg

Serious events: 3 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=62 participants at risk Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70 mg n=58 participants at risk Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280 mg n=36 participants at risk Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420 mg n=87 participants at risk Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Gastrointestinal disorders Abdominal pain	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.7% 1/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Serositis	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.7% 1/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis chronic	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations COVID-19	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.7% 1/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations COVID-19 pneumonia	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.8% 1/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.1% 1/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.8% 1/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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 Upper limb fracture	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.7% 1/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.7% 1/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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 SLE arthritis	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.8% 1/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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 Systemic lupus erythematosus	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.7% 1/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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) Benign pancreatic neoplasm	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.7% 1/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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) Gastric cancer	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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) Uterine leiomyoma	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.1% 1/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Glomerulonephritis	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.8% 1/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.1% 1/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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 Bronchial hyperreactivity	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.7% 1/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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 Chronic obstructive pulmonary disease	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.8% 1/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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 Haemoptysis	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.7% 1/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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 Pulmonary oedema	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.7% 1/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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 Vocal cord thickening	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.8% 1/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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 Drug eruption	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Peripheral ischaemia	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Other adverse events

Measure	Placebo n=62 participants at risk Participants received matching placebo for a maximum duration of 52 weeks.	Rozibafusp Alfa 70 mg n=58 participants at risk Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 280 mg n=36 participants at risk Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.	Rozibafusp Alfa 420 mg n=87 participants at risk Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.4% 2/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.6% 2/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.1% 1/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	6.9% 4/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.6% 2/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.1% 1/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	3.2% 2/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.2% 3/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.8% 1/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.6% 4/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Injection site erythema	3.2% 2/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	8.3% 3/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.1% 1/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Injection site reaction	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.7% 1/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.8% 1/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.7% 5/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Oedema peripheral	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.2% 3/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Pyrexia	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.2% 3/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.8% 1/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.6% 4/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bronchitis	4.8% 3/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.4% 2/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.6% 2/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.6% 4/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations COVID-19	8.1% 5/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	22.4% 13/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	8.3% 3/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	21.8% 19/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Influenza	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.2% 3/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.1% 1/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.2% 3/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.8% 1/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	9.2% 8/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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	12.9% 8/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	10.3% 6/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 6/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	9.2% 8/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	9.7% 6/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	15.5% 9/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	11.1% 4/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.9% 13/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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 Arthralgia	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.2% 3/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.6% 2/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.6% 4/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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 Back pain	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.7% 1/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.6% 2/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.7% 5/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dizziness	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.8% 1/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.7% 5/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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	4.8% 3/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	8.6% 5/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	8.3% 3/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	9.2% 8/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.6% 2/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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 Dry skin	0.00% 0/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.6% 2/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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 Pruritus	6.5% 4/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.8% 1/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	6.9% 6/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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 Rash	3.2% 2/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.7% 1/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.6% 2/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.1% 1/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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 Skin ulcer	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.7% 1/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.6% 2/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypertension	1.6% 1/62 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.2% 3/58 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.8% 1/36 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.4% 3/87 • Up to approximately 68 weeks The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent 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: medinfo@amgen.com

Results disclosure agreements

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

Restriction type: OTHER