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    Clinical Trial Results:
    A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy

    Summary
    EudraCT number
    		 2019-000328-16
    Trial protocol
    		 HU   FR   PT   GR   IT  
    Global end of trial date
    25 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Aug 2024
    First version publication date
    07 Aug 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20170588
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04058028
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, United States,
    Public contact
    Amgen (EUROPE) GmbH, IHQ Medical Info-Clinical Trials, MedInfoInternational@amgen.com
    Scientific contact
    Amgen (EUROPE) GmbH, IHQ Medical Info-Clinical Trials, MedInfoInternational@amgen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Jul 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jul 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was Evaluate the efficacy of rozibafusp alfa at Week 52 as measured by the SLE Responder Index (SRI-4).
    Protection of trial subjects
    Before participants begin participation in any study-specific activities/procedures, Amgen requires a copy of the site’s written institutional review board/independent ethics committee (IRB/IEC) approval of the protocol, informed consent form, and all other participant information as applicable. This study was conducted in accordance with the protocol and with: • Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines • Applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines • Applicable ICH laws and regulations The participant signed the IRB/IEC and Amgen approved informed consent form before starting study-specific procedures. Enrollment occurred when the investigator confirmed all eligibility criteria were met and documented this decision in the participant's medical record and enrollment case report form (CRF). If eligible at the baseline/day 1 visit, the participant was randomized to a treatment regimen. Participants failing to meet baseline/day 1 visit criteria after passing screening were considered screen fails and could rescreen up to 2 times. Each participant entering the screening period received a unique participant identification number via interactive response technology (IRT), used throughout the study. This number remained constant, unaffected by rescreening, and might differ from the randomization number.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Feb 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 30
    Country: Number of subjects enrolled
    Bulgaria: 27
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Czechia: 2
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Greece: 4
    Country: Number of subjects enrolled
    Hong Kong: 2
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Japan: 13
    Country: Number of subjects enrolled
    Korea, Republic of: 2
    Country: Number of subjects enrolled
    Mexico: 27
    Country: Number of subjects enrolled
    Poland: 52
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Russian Federation: 25
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    United States: 40
    Worldwide total number of subjects
    244
    EEA total number of subjects
    103
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    238
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants with active 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.

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

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received matching placebo SC Q2W for a maximum duration of 52 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching dose of rozibafusp alfa, administered SC.

    Arm title
    		 Rozibafusp Alfa 70mg
    Arm description
    		 Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rozibafusp alfa
    Investigational medicinal product code
    Other name
    AMG 570
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    70mg SC.

    Arm title
    		 Rozibafusp Alfa 280mg
    Arm description
    		 Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rozibafusp alfa
    Investigational medicinal product code
    Other name
    AMG 570
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    208mg SC.

    Arm title
    		 Rozibafusp Alfa 420mg
    Arm description
    		 Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rozibafusp alfa
    Investigational medicinal product code
    Other name
    AMG 570
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    420mg SC.

    Number of subjects in period 1
    		Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Started
    62
    58
    36
    88
    Completed
    36
    44
    28
    46
    Not completed
    26
    14
    8
    42
         Withdrawal of Consent from Study
    12
    8
    6
    7
         Decision by Sponsor
    13
    4
    1
    35
         Death
    -
    1
    -
    -
         Lost to follow-up
    1
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo SC Q2W for a maximum duration of 52 weeks.

    Reporting group title
    Rozibafusp Alfa 70mg
    Reporting group description
    		 Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.

    Reporting group title
    Rozibafusp Alfa 280mg
    Reporting group description
    		 Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.

    Reporting group title
    Rozibafusp Alfa 420mg
    Reporting group description
    		 Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.

    Reporting group values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg Total
    Number of subjects
    		 62 58 36 88 244
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 61 56 35 86 238
        From 65-84 years
    		 1 2 1 2 6
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.6 ( 10.3 ) 44.6 ( 12.3 ) 42.2 ( 10.5 ) 44.0 ( 10.5 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 57 56 33 82 228
        Male
    		 5 2 3 6 16
    Race/Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 24 14 5 25 68
        Not Hispanic or Latino
    		 37 44 31 63 175
        Unknown or Not Reported
    		 1 0 0 0 1
    Race/Ethnicity
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 0 2 3
        Asian
    		 3 6 2 8 19
        Black (or African American)
    		 4 4 4 5 17
        Multiple
    		 0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Unknown
    		 0 0 0 0 0
        White
    		 53 47 30 71 201
        Other
    		 2 0 0 2 4

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo SC Q2W for a maximum duration of 52 weeks.

    Reporting group title
    Rozibafusp Alfa 70mg
    Reporting group description
    		 Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.

    Reporting group title
    Rozibafusp Alfa 280mg
    Reporting group description
    		 Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.

    Reporting group title
    Rozibafusp Alfa 420mg
    Reporting group description
    		 Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.

    Primary: Number of Participants with a SLE Responder Index (SRI-4) Response at Week 52

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    End point title
    		 Number of Participants with a SLE Responder Index (SRI-4) Response at Week 52 [1]
    End point description
    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. The Full Analysis Set (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.
    End point type
    Primary
    End point timeframe
    Week 52
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    43
    51
    35
    48
    Units: Participants
        SRI-4 Response
    26
    29
    21
    35
    No statistical analyses for this end point

    Secondary: Number of Participants With a SRI-4 Response at Week 24

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    End point title
    		 Number of Participants With a SRI-4 Response at Week 24
    End point description
    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. 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.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    54
    58
    36
    66
    Units: Participants
        SRI-4 Response
    33
    30
    20
    46
    No statistical analyses for this end point

    Secondary: Number of Participants who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24

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    End point title
    		 Number of Participants who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24
    End point description
    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. 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.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    54
    58
    36
    66
    Units: Participants
        BICLA Response
    24
    19
    18
    35
    No statistical analyses for this end point

    Secondary: Number of Participants who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52

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    End point title
    		 Number of Participants who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52
    End point description
    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. 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.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    43
    51
    35
    48
    Units: Participants
        LLDAS Response
    12
    18
    6
    21
    No statistical analyses for this end point

    Secondary: 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)

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    End point title
    		 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)
    End point description
    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. FAS included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    62
    58
    36
    88
    Units: Flares/year
    number (not applicable)
        Annualized moderate and severe flare rate
    0.34
    0.52
    0.46
    0.34
        Annualized severe flare rate
    0.21
    0.24
    0.30
    0.16
    No statistical analyses for this end point

    Secondary: Number of Participants who Achieved 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

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    End point title
    		 Number of Participants who Achieved 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
    End point description
    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. 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.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    27
    16
    19
    25
    Units: Participants
    5
    1
    2
    8
    No statistical analyses for this end point

    Secondary: Number of Participants who Achieved a BICLA Response at Week 52

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    End point title
    		 Number of Participants who Achieved a BICLA Response at Week 52
    End point description
    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. 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.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    43
    51
    35
    48
    Units: Participants
        BICLA Response
    21
    20
    15
    29
    No statistical analyses for this end point

    Secondary: Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI

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    End point title
    		 Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI
    End point description
    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. FAS included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    62
    58
    36
    88
    Units: Flares/year
    number (not applicable)
        Annualized severe flare rate
    2.21
    0.24
    0.30
    0.16
    No statistical analyses for this end point

    Secondary: Annualized Flare 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

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    End point title
    		 Annualized Flare 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
    End point description
    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 FAS included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    62
    58
    36
    88
    Units: Flares/year
    number (not applicable)
        Annualized flare rate as measured by BILAG score
    0.13
    0.22
    0.30
    0.31
    No statistical analyses for this end point

    Secondary: 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

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    End point title
    		 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
    End point description
    The Cutaneous Lupus Erythematosus Disease Area and Severity Index (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.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 36, and 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    13
    10
    12
    16
    Units: Participants
        Week 12 (N = 13, 10, 12, 4)
    3
    2
    5
    4
        Week 24 (N = 10, 10, 12, 11)
    3
    3
    6
    3
        Week 36 (N = 9, 10, 12, 8)
    1
    5
    7
    2
        Week 52 (N = 8, 9, 12, 7)
    0
    4
    7
    3
    No statistical analyses for this end point

    Secondary: 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

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    End point title
    		 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
    End point description
    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. 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.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 36, and 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    34
    35
    13
    46
    Units: Participants
        Week 12 (N = 34, 35, 13, 46)
    20
    16
    8
    31
        Week 24 (N = 32, 35, 13, 39)
    23
    23
    7
    34
        Week 36 (N = 31, 34, 12, 34)
    26
    22
    10
    29
        Week 52 (N = 26, 29, 12, 30)
    19
    20
    9
    27
    No statistical analyses for this end point

    Secondary: 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

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    End point title
    		 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
    End point description
    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). The FAS included all randomized participants. Only participants with observed data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 36, 44, and 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    30
    28
    22
    43
    Units: T-score
    arithmetic mean (standard deviation)
        Week 12 (N = 30, 28, 22, 43)
    -8.40 ( 9.61 )
    -6.86 ( 5.71 )
    -4.22 ( 8.45 )
    -8.01 ( 7.60 )
        Week 24 (N = 27, 25, 14, 31)
    -6.48 ( 11.97 )
    -5.61 ( 8.54 )
    -5.86 ( 7.76 )
    -8.82 ( 6.02 )
        Week 36 (N = 22, 23, 14, 23)
    -7.26 ( 8.26 )
    -7.12 ( 8.00 )
    -3.26 ( 7.64 )
    -8.73 ( 8.98 )
        Week 44 (N = 22, 24, 17, 23)
    -4.44 ( 7.94 )
    -8.65 ( 9.75 )
    -4.47 ( 7.23 )
    -8.25 ( 10.38 )
        Week 52 (N = 19, 21, 15, 21)
    -8.57 ( 8.36 )
    -10.22 ( 8.89 )
    -6.57 ( 7.25 )
    -7.88 ( 11.88 )
    No statistical analyses for this end point

    Secondary: 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

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    End point title
    		 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
    End point description
    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. The FAS included all randomized participants. Only participants with observed data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 36, 44, and 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    51
    47
    32
    67
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 12 (N = 51, 47, 32, 67)
    4.612 ( 8.241 )
    4.261 ( 7.609 )
    4.013 ( 8.456 )
    5.409 ( 6.207 )
        Week 24 (N = 45, 46, 30, 50)
    6.055 ( 8.043 )
    5.440 ( 8.807 )
    4.570 ( 8.994 )
    5.847 ( 6.971 )
        Week 36 (N = 40, 39, 28, 44)
    6.652 ( 7.957 )
    6.536 ( 9.646 )
    5.360 ( 8.736 )
    6.833 ( 9.467 )
        Week 44 (N = 36, 36, 28, 36)
    4.881 ( 9.200 )
    7.298 ( 9.903 )
    3.508 ( 7.538 )
    7.522 ( 9.735 )
        Week 52 (N = 31, 36, 27, 35)
    7.235 ( 7.097 )
    6.598 ( 9.452 )
    5.056 ( 9.429 )
    5.456 ( 9.151 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52

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    End point title
    		 Change from Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52
    End point description
    The LupusQoL consists of 8 domains: physical health, pain, planning, intimate relationships (IR), burden to others, emotional health, body image, and fatigue. Each domain is scored on a 0-5 scale and scores are summed up for a total score range of 0 to 100. Higher scores represent better quality of life or functioning within the specific domain being measured, and lower scores signify poorer quality of life or functioning within the domain. The FAS included all randomized participants. Only participants with observed data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 36, 44, and 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    51
    46
    32
    67
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Planning: Week 12 (N = 51, 46, 32, 67)
    10.294 ( 23.368 )
    11.594 ( 24.551 )
    5.469 ( 23.817 )
    12.438 ( 22.631 )
        Planning: Week 24 (N = 45, 45, 30, 50)
    10.185 ( 23.763 )
    6.667 ( 29.226 )
    9.722 ( 24.279 )
    9.500 ( 23.988 )
        Planning: Week 36 (N = 41, 40, 27, 44)
    11.179 ( 21.214 )
    9.583 ( 23.232 )
    13.272 ( 21.836 )
    14.773 ( 29.414 )
        Planning: Week 44 (N = 36, 36, 28, 36)
    9.491 ( 26.959 )
    13.426 ( 20.919 )
    9.821 ( 19.779 )
    12.037 ( 27.418 )
        Planning: Week 52 (N = 31, 36, 27, 35)
    16.129 ( 19.357 )
    8.565 ( 23.257 )
    9.568 ( 24.428 )
    12.381 ( 22.810 )
        Physical Health: Week 12 (N = 51, 46, 32, 67)
    9.498 ( 22.989 )
    12.160 ( 15.607 )
    8.398 ( 20.992 )
    9.748 ( 16.541 )
        Physical Health: Week 24 (N = 45, 45, 30, 50)
    12.986 ( 24.461 )
    14.097 ( 21.972 )
    11.667 ( 18.856 )
    11.063 ( 16.551 )
        Physical Health: Week 36 (N = 41, 40, 27, 44)
    12.729 ( 21.678 )
    14.375 ( 22.610 )
    13.542 ( 17.313 )
    13.991 ( 21.264 )
        Physical Health: Week 44 (N = 36, 36, 28, 36)
    11.892 ( 25.253 )
    16.753 ( 22.124 )
    11.049 ( 15.625 )
    12.760 ( 17.008 )
        Physical Health: Week 52 (N = 31, 36, 27, 35)
    18.448 ( 22.827 )
    13.976 ( 19.799 )
    8.449 ( 20.156 )
    14.107 ( 18.847 )
        Pain: Week 12 (N = 51, 46, 32, 67)
    14.869 ( 27.199 )
    14.493 ( 22.800 )
    12.240 ( 26.939 )
    14.552 ( 22.349 )
        Pain: Week 24 (N = 45, 45, 30, 50)
    16.296 ( 29.460 )
    13.148 ( 22.647 )
    15.556 ( 23.947 )
    17.667 ( 20.800 )
        Pain: Week 36 (N = 41, 40, 27, 44)
    14.837 ( 26.972 )
    13.125 ( 19.327 )
    15.123 ( 23.912 )
    18.939 ( 27.159 )
        Pain: Week 44 (N = 36, 36, 28, 36)
    14.815 ( 31.755 )
    16.667 ( 23.905 )
    11.905 ( 21.328 )
    17.824 ( 24.893 )
        Pain: Week 52 (N = 31, 36, 27, 35)
    25.538 ( 23.367 )
    14.352 ( 24.929 )
    14.815 ( 28.898 )
    19.524 ( 23.565 )
        IR: Week 12 (N = 37, 32, 21, 50)
    6.76 ( 26.94 )
    3.52 ( 24.64 )
    0.60 ( 30.99 )
    4.75 ( 20.81 )
        IR: Week 24 (N = 29, 32, 18, 34)
    2.59 ( 24.86 )
    5.47 ( 28.74 )
    0.69 ( 20.77 )
    6.25 ( 23.08 )
        IR: Week 36 (N = 27, 27, 19, 29)
    4.63 ( 26.66 )
    9.26 ( 27.21 )
    -2.63 ( 20.66 )
    5.17 ( 23.27 )
        IR: Week 44 (N = 25, 25, 19, 26)
    5.00 ( 31.46 )
    8.00 ( 23.90 )
    -3.95 ( 21.67 )
    9.13 ( 31.54 )
        IR: Week 52 (N = 21, 23, 17, 27)
    11.90 ( 27.80 )
    3.26 ( 23.30 )
    -1.47 ( 18.69 )
    4.17 ( 19.61 )
        Burden to Others: Week 12 (N = 51, 46, 32, 67)
    12.092 ( 22.068 )
    5.072 ( 20.373 )
    13.281 ( 30.590 )
    9.577 ( 27.762 )
        Burden to Others: Week 24 (N = 45, 45, 30, 50)
    10.556 ( 30.896 )
    9.444 ( 27.328 )
    15.000 ( 25.931 )
    11.500 ( 27.914 )
        Burden to Others: Week 36 (N = 41, 40, 27, 44)
    16.260 ( 27.320 )
    11.042 ( 22.754 )
    18.827 ( 28.457 )
    13.447 ( 29.268 )
        Burden to Others: Week 44 (N = 36, 36, 28, 36)
    14.120 ( 28.159 )
    14.352 ( 23.955 )
    15.476 ( 26.324 )
    13.194 ( 26.902 )
        Burden to Others: Week 52 (N = 31, 36, 27, 35)
    13.710 ( 27.348 )
    8.333 ( 25.973 )
    15.741 ( 30.865 )
    17.143 ( 29.632 )
        Emotional Health: Week 12 (N = 51, 46, 32, 67)
    7.435 ( 23.940 )
    4.529 ( 15.611 )
    6.250 ( 21.997 )
    9.142 ( 19.493 )
        Emotional Health: Week 24 (N = 45, 45, 30, 50)
    8.056 ( 22.322 )
    7.963 ( 19.337 )
    7.778 ( 16.109 )
    13.083 ( 22.096 )
        Emotional Health: Week 36 (N = 41, 40, 27, 44)
    5.589 ( 19.557 )
    3.958 ( 16.150 )
    6.173 ( 20.359 )
    13.920 ( 25.903 )
        Emotional Health: Week 44 (N = 36, 36, 28, 36)
    6.134 ( 23.369 )
    9.722 ( 15.685 )
    7.292 ( 15.533 )
    13.194 ( 23.853 )
        Emotional Health: Week 52 (N = 31, 36, 27, 35)
    7.258 ( 23.545 )
    6.134 ( 19.606 )
    8.951 ( 20.888 )
    14.167 ( 21.561 )
        Body Image: Week 12 (N = 51, 46, 32, 67)
    9.2 ( 24.4 )
    3.7 ( 23.9 )
    13.1 ( 31.7 )
    10.1 ( 23.9 )
        Body Image: Week 24 (N = 45, 45, 30, 50)
    5.9 ( 26.2 )
    -0.1 ( 24.9 )
    0.2 ( 29.7 )
    14.9 ( 26.4 )
        Body Image: Week 36 (N = 41, 40, 27, 44)
    4.4 ( 25.0 )
    3.8 ( 24.3 )
    4.8 ( 27.7 )
    11.1 ( 29.2 )
        Body Image: Week 44 (N = 36, 36, 28, 36)
    11.3 ( 27.3 )
    4.6 ( 26.4 )
    12.7 ( 32.0 )
    10.4 ( 20.2 )
        Body Image: Week 52 (N = 31, 36, 27, 35)
    8.9 ( 20.2 )
    -5.0 ( 26.7 )
    7.0 ( 31.3 )
    9.6 ( 24.0 )
        Fatigue: Week 12 (N = 51, 46, 32, 67)
    10.049 ( 21.253 )
    8.424 ( 19.509 )
    6.250 ( 20.880 )
    10.541 ( 22.488 )
        Fatigue: Week 24 (N = 45, 45, 30, 50)
    9.861 ( 23.175 )
    10.972 ( 20.127 )
    6.458 ( 17.790 )
    10.625 ( 23.257 )
        Fatigue: Week 36 (N = 41, 40, 27, 44)
    9.909 ( 19.664 )
    9.219 ( 20.363 )
    7.407 ( 17.076 )
    15.057 ( 28.220 )
        Fatigue: Week 44 (N = 36, 36, 28, 36)
    10.764 ( 17.205 )
    12.153 ( 18.717 )
    9.821 ( 16.876 )
    12.500 ( 22.952 )
        Fatigue: Week 52 (N = 31, 36, 27, 35)
    12.500 ( 22.765 )
    9.722 ( 20.291 )
    9.954 ( 18.036 )
    9.464 ( 21.404 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52

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    End point title
    		 Change from Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52
    End point description
    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). The FAS included all randomized participants. Only participants with observed data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 36, 44, and 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    51
    44
    31
    65
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 12 (N = 51, 44, 31, 65)
    -0.9 ( 2.8 )
    -1.1 ( 1.9 )
    -1.8 ( 3.0 )
    -1.7 ( 2.2 )
        Week 24 (N = 45, 44, 30, 49)
    -1.9 ( 2.6 )
    -1.2 ( 2.7 )
    -1.7 ( 2.7 )
    -2.2 ( 2.1 )
        Week 36 (N = 40, 37, 28, 44)
    -2.0 ( 2.6 )
    -1.7 ( 2.5 )
    -1.6 ( 2.3 )
    -2.6 ( 2.6 )
        Week 44 (N = 36, 35, 28, 36)
    -2.1 ( 3.0 )
    -2.1 ( 2.8 )
    -2.0 ( 2.8 )
    -2.6 ( 2.3 )
        Week 52 (N = 30, 33, 27, 35)
    -2.3 ( 2.7 )
    -1.8 ( 2.5 )
    -2.6 ( 2.5 )
    -2.1 ( 2.8 )
    No statistical analyses for this end point

    Secondary: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) was any negative medical occurrence linked to an intervention in humans, regardless of its relation to the intervention. TEAEs occurred after the first intervention dose. Serious adverse events (SAEs) 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 CTCAE Version 5.0 scale: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death). Clinically significant lab 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. The Safety Analysis Set (SAS) included all randomized participants who received at least one dose of IP. Participants in this set were analyzed according to the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 68 weeks
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    62
    58
    36
    87
    Units: Number or participants
        All TEAEs
    42
    47
    23
    71
        Fatal AEs
    0
    0
    0
    0
        SAEs
    6
    7
    5
    3
    No statistical analyses for this end point

    Secondary: Serum Concentration of Rozibafusp Alfa

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    End point title
    		 Serum Concentration of Rozibafusp Alfa [2]
    End point description
    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.
    End point type
    Secondary
    End point 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
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    57
    36
    84
    Units: μg/mL
    arithmetic mean (standard deviation)
        Week 1 (N = 57, 36, 84)
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
        Week 4 (N = 49, 31, 68)
    1.29 ( 1.34 )
    20.7 ( 10.8 )
    26.2 ( 17.1 )
        Week 8 (N = 46, 29, 61)
    1.70 ( 1.93 )
    26.6 ( 15.7 )
    40.7 ( 21.8 )
        Week 12 (N = 42, 23, 66)
    2.05 ( 2.03 )
    31.3 ( 16.5 )
    46.8 ( 24.6 )
        Week 16 (N = 40, 24, 62)
    2.58 ( 2.67 )
    29.8 ( 18.9 )
    47.0 ( 28.4 )
        Week 20 (N = 40, 26, 55)
    3.42 ( 3.15 )
    35.4 ( 19.8 )
    48.9 ( 30.0 )
        Week 24 (N = 41, 27, 53)
    3.69 ( 3.37 )
    35.8 ( 19.1 )
    55.5 ( 30.6 )
        Week 36 (N = 36, 25, 43)
    3.62 ( 3.73 )
    40.5 ( 20.7 )
    54.7 ( 35.9 )
        Week 44 (N = 38, 24, 38)
    2.98 ( 3.78 )
    39.0 ( 18.6 )
    54.1 ( 38.3 )
        Week 52 (N = 35, 23, 32)
    4.15 ( 4.50 )
    43.8 ( 25.3 )
    51.6 ( 30.8 )
        Week 56 (N = 33, 18, 34)
    0.230 ( 0.495 )
    11.3 ( 8.03 )
    13.3 ( 12.4 )
        Week 60 (N = 29, 20, 34)
    0.00346 ( 0.0120 )
    3.45 ( 4.31 )
    3.08 ( 4.45 )
        Week 64 (N = 35, 23, 36)
    0.0 ( 0.0 )
    0.609 ( 1.07 )
    0.718 ( 1.41 )
        Week 68 (N = 39, 22, 36)
    0.0 ( 0.0 )
    0.0484 ( 0.125 )
    0.102 ( 0.271 )
    No statistical analyses for this end point

    Secondary: Terminal Half-life of Rozibafusp Alfa

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    End point title
    		 Terminal Half-life of Rozibafusp Alfa
    End point description
    Per the SAP, data for this outcome measure was not to be analyzed unless it could be adequately estimated.
    End point type
    Secondary
    End point timeframe
    Up to Week 68
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    Units: days
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Notes
    [3] - Data for this outcome measure was not collected.
    [4] - Data for this outcome measure was not collected.
    [5] - Data for this outcome measure was not collected.
    [6] - Data for this outcome measure was not collected.
    No statistical analyses for this end point

    Secondary: Change from Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52

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    End point title
    		 Change from Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52
    End point description
    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. The FAS included all randomized participants. Only participants with observed data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 36, 44, and 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    51
    47
    32
    67
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 12 (N = 51, 47, 32, 67)
    5.433 ( 10.477 )
    1.941 ( 8.689 )
    2.235 ( 11.754 )
    4.965 ( 9.413 )
        Week 24 (N = 45, 46, 30, 50)
    4.889 ( 10.772 )
    1.123 ( 7.767 )
    5.008 ( 8.063 )
    5.786 ( 9.278 )
        Week 36 (N = 40, 39, 28, 44)
    5.002 ( 9.405 )
    1.407 ( 10.943 )
    2.111 ( 11.263 )
    6.531 ( 10.543 )
        Week 44 (N = 36, 36, 28, 36)
    6.556 ( 12.984 )
    3.208 ( 9.125 )
    1.914 ( 9.247 )
    5.903 ( 10.847 )
        Week 52 (N = 31, 36, 27, 35)
    6.675 ( 12.074 )
    3.778 ( 9.910 )
    2.613 ( 10.841 )
    7.186 ( 9.185 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52

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    End point title
    		 Change from Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52
    End point description
    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. The FAS included all randomized participants. Only participants with observed data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 36, 44, and 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    51
    47
    32
    68
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 12 (N = 51, 47, 32, 68)
    14.019 ( 25.397 )
    11.383 ( 21.076 )
    10.000 ( 22.966 )
    12.595 ( 18.765 )
        Week 24 (N = 45, 46, 30, 51)
    15.777 ( 23.930 )
    13.043 ( 22.961 )
    13.000 ( 24.657 )
    14.048 ( 21.031 )
        Week 36 (N = 40, 39, 28, 45)
    17.752 ( 22.417 )
    15.640 ( 21.031 )
    11.608 ( 23.533 )
    16.142 ( 21.924 )
        Week 44 (N = 36, 36, 28, 37)
    15.001 ( 24.582 )
    17.222 ( 24.007 )
    8.036 ( 19.924 )
    17.200 ( 20.702 )
        Week 52 (N = 31, 36, 27, 36)
    20.807 ( 21.138 )
    15.416 ( 23.002 )
    12.778 ( 22.632 )
    16.568 ( 18.357 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52

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    End point title
    		 Change from Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52
    End point description
    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. The FAS included all randomized participants. Only participants with observed data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 36, 44, and 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    51
    47
    32
    67
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 12 (N = 51, 47, 32, 67)
    15.074 ( 25.378 )
    7.979 ( 24.090 )
    9.961 ( 21.701 )
    13.713 ( 22.957 )
        Week 24 (N = 45, 46, 30, 50)
    20.278 ( 28.240 )
    10.190 ( 28.788 )
    11.667 ( 19.609 )
    16.625 ( 27.217 )
        Week 36 (N = 40, 39, 28, 44)
    19.219 ( 24.160 )
    12.660 ( 29.991 )
    13.839 ( 23.653 )
    19.886 ( 30.863 )
        Week 44 (N = 36, 36, 28, 36)
    16.319 ( 28.554 )
    18.924 ( 28.169 )
    10.714 ( 22.876 )
    20.313 ( 32.915 )
        Week 52 (N = 31, 36, 27, 35)
    23.387 ( 22.475 )
    17.708 ( 27.730 )
    9.028 ( 23.852 )
    14.464 ( 31.933 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52

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    End point title
    		 Change from Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52
    End point description
    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. The FAS included all randomized participants. Only participants with observed data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 36, 44, and 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    51
    47
    32
    67
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 12 (N = 51, 47, 32, 67)
    15.5 ( 25.7 )
    12.0 ( 23.1 )
    10.9 ( 21.5 )
    18.4 ( 19.5 )
        Week 24 (N = 45, 46, 30, 50)
    17.5 ( 26.7 )
    14.4 ( 27.6 )
    13.5 ( 24.6 )
    18.3 ( 19.4 )
        Week 36 (N = 40, 39, 28, 44)
    18.7 ( 23.2 )
    15.9 ( 27.9 )
    14.1 ( 24.0 )
    22.1 ( 26.3 )
        Week 44 (N = 36, 36, 28, 36)
    18.9 ( 23.9 )
    19.2 ( 31.9 )
    10.7 ( 20.5 )
    26.0 ( 29.4 )
        Week 52 (N = 31, 36, 27, 35)
    19.8 ( 22.5 )
    16.7 ( 28.4 )
    16.6 ( 23.0 )
    21.8 ( 25.2 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52

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    End point title
    		 Change from Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52
    End point description
    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. The FAS included all randomized participants. Only participants with observed data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 36, 44, and 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    51
    47
    32
    68
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 12 (N = 51, 47, 32, 67)
    5.90 ( 14.71 )
    5.85 ( 16.06 )
    4.69 ( 14.87 )
    9.97 ( 14.15 )
        Week 24 (N = 45, 46, 30, 51)
    7.44 ( 15.97 )
    6.98 ( 16.11 )
    9.13 ( 14.83 )
    11.75 ( 14.11 )
        Week 36 (N = 40, 39, 28, 45)
    10.35 ( 16.43 )
    10.15 ( 16.97 )
    5.96 ( 16.28 )
    11.40 ( 17.81 )
        Week 44 (N = 36, 36, 28, 37)
    7.61 ( 19.32 )
    11.81 ( 18.99 )
    3.11 ( 16.92 )
    11.76 ( 16.74 )
        Week 52 (N = 31, 36, 27, 36)
    9.55 ( 21.62 )
    12.54 ( 18.23 )
    5.81 ( 19.60 )
    9.58 ( 18.22 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52

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    End point title
    		 Change from Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52
    End point description
    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. The FAS included all randomized participants. Only participants with observed data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 36, 44, and 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    51
    47
    32
    67
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 12 (N = 51, 47, 32, 67)
    10.662 ( 22.441 )
    8.112 ( 18.054 )
    8.594 ( 21.402 )
    11.287 ( 20.361 )
        Week 24 (N = 45, 46, 30, 50)
    10.556 ( 24.419 )
    7.880 ( 15.780 )
    12.083 ( 18.346 )
    13.125 ( 18.482 )
        Week 36 (N = 40, 39, 28, 44)
    11.094 ( 20.090 )
    10.256 ( 19.102 )
    8.036 ( 18.854 )
    15.199 ( 22.083 )
        Week 44 (N = 36, 36, 28, 36)
    7.465 ( 24.313 )
    11.632 ( 19.489 )
    5.804 ( 19.089 )
    15.104 ( 21.670 )
        Week 52 (N = 31, 36, 27, 35)
    12.903 ( 23.659 )
    11.806 ( 20.199 )
    8.796 ( 21.249 )
    11.250 ( 21.693 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52

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    End point title
    		 Change from Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52
    End point description
    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. The FAS included all randomized participants. Only participants with observed data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 36, 44, and 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    51
    47
    32
    67
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 12 (N = 51, 47, 32, 67)
    14.46 ( 22.83 )
    8.24 ( 20.40 )
    9.77 ( 24.54 )
    15.11 ( 23.89 )
        Week 24 (N = 45, 46, 30, 50)
    15.28 ( 26.23 )
    7.88 ( 25.05 )
    14.58 ( 19.72 )
    15.25 ( 21.32 )
        Week 36 (N = 40, 39, 28, 44)
    15.63 ( 25.28 )
    7.05 ( 25.78 )
    14.29 ( 23.00 )
    19.60 ( 23.72 )
        Week 44 (N = 36, 36, 28, 36)
    17.71 ( 27.61 )
    8.68 ( 27.52 )
    7.14 ( 22.16 )
    14.24 ( 23.75 )
        Week 52 (N = 31, 36, 27, 35)
    23.79 ( 25.07 )
    10.42 ( 26.98 )
    13.89 ( 23.34 )
    17.50 ( 21.90 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52

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    End point title
    		 Change from Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52
    End point description
    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. The FAS included all randomized participants. Only participants with observed data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 36, 44, and 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    51
    47
    32
    67
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 12 (N = 51, 47, 32, 67)
    13.888 ( 26.961 )
    5.141 ( 26.384 )
    2.083 ( 27.189 )
    12.935 ( 27.382 )
        Week 24 (N = 45, 46, 30, 50)
    13.888 ( 27.352 )
    5.072 ( 23.339 )
    11.111 ( 20.800 )
    15.334 ( 28.540 )
        Week 36 (N = 40, 39, 28, 44)
    15.208 ( 24.306 )
    4.058 ( 21.364 )
    6.250 ( 29.886 )
    14.773 ( 29.742 )
        Week 44 (N = 36, 36, 28, 36)
    20.139 ( 32.512 )
    8.564 ( 21.314 )
    7.441 ( 25.493 )
    16.899 ( 30.045 )
        Week 52 (N = 31, 36, 27, 35)
    18.011 ( 30.814 )
    10.647 ( 25.008 )
    6.481 ( 28.620 )
    19.762 ( 23.491 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52

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    End point title
    		 Change from Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52
    End point description
    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. The FAS included all randomized participants. Only participants with observed data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 36, 44, and 52
    End point values
    		 Placebo Rozibafusp Alfa 70mg Rozibafusp Alfa 280mg Rozibafusp Alfa 420mg
    Number of subjects analysed
    51
    47
    32
    67
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 12 (N = 51, 47, 32, 67)
    10.7 ( 21.5 )
    4.3 ( 16.2 )
    6.4 ( 21.0 )
    8.9 ( 17.1 )
        Week 24 (N = 45, 46, 30, 50)
    10.1 ( 22.7 )
    2.7 ( 15.3 )
    9.2 ( 15.1 )
    10.6 ( 18.0 )
        Week 36 (N = 40, 39, 28, 44)
    10.0 ( 18.7 )
    5.5 ( 21.8 )
    3.0 ( 20.2 )
    13.1 ( 19.3 )
        Week 44 (N = 36, 36, 28, 36)
    11.8 ( 24.3 )
    10.3 ( 16.0 )
    3.0 ( 16.1 )
    12.5 ( 20.1 )
        Week 52 (N = 31, 36, 27, 35)
    12.3 ( 21.4 )
    9.0 ( 19.0 )
    4.6 ( 17.4 )
    13.9 ( 18.3 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 68 weeks
    Adverse event reporting additional description
    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.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo SC Q2W for a maximum duration of 52 weeks

    Reporting group title
    Rozibafusp alfa 70 mg Q2W
    Reporting group description
    		 Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.

    Reporting group title
    Rozibafusp alfa 280 mg Q2W
    Reporting group description
    		 Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks.

    Reporting group title
    Rozibafusp alfa 420 mg Q2W
    Reporting group description
    		 Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.

    Serious adverse events
    		 Placebo Rozibafusp alfa 70 mg Q2W Rozibafusp alfa 280 mg Q2W Rozibafusp alfa 420 mg Q2W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 62 (9.68%)
    7 / 58 (12.07%)
    5 / 36 (13.89%)
    3 / 87 (3.45%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign pancreatic neoplasm
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    0 / 36 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Upper limb fracture
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral ischaemia
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Serositis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 36 (2.78%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vocal cord thickening
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 36 (2.78%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Glomerulonephritis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 36 (2.78%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    0 / 36 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SLE arthritis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 36 (2.78%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 36 (2.78%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 36 (2.78%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Rozibafusp alfa 70 mg Q2W Rozibafusp alfa 280 mg Q2W Rozibafusp alfa 420 mg Q2W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 62 (46.77%)
    34 / 58 (58.62%)
    20 / 36 (55.56%)
    51 / 87 (58.62%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 62 (1.61%)
    3 / 58 (5.17%)
    1 / 36 (2.78%)
    3 / 87 (3.45%)
         occurrences all number
    1
    3
    1
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 62 (4.84%)
    5 / 58 (8.62%)
    3 / 36 (8.33%)
    8 / 87 (9.20%)
         occurrences all number
    6
    5
    4
    9
    Dizziness
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    1 / 36 (2.78%)
    5 / 87 (5.75%)
         occurrences all number
    1
    0
    1
    6
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 62 (1.61%)
    3 / 58 (5.17%)
    0 / 36 (0.00%)
    0 / 87 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Injection site reaction
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 36 (2.78%)
    5 / 87 (5.75%)
         occurrences all number
    3
    1
    3
    10
    Injection site erythema
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 58 (0.00%)
    3 / 36 (8.33%)
    1 / 87 (1.15%)
         occurrences all number
    9
    0
    6
    2
    Pyrexia
         subjects affected / exposed
    1 / 62 (1.61%)
    3 / 58 (5.17%)
    1 / 36 (2.78%)
    4 / 87 (4.60%)
         occurrences all number
    1
    3
    2
    4
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 58 (3.45%)
    2 / 36 (5.56%)
    1 / 87 (1.15%)
         occurrences all number
    0
    2
    2
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 62 (3.23%)
    3 / 58 (5.17%)
    1 / 36 (2.78%)
    4 / 87 (4.60%)
         occurrences all number
    2
    3
    1
    4
    Abdominal pain
         subjects affected / exposed
    0 / 62 (0.00%)
    4 / 58 (6.90%)
    2 / 36 (5.56%)
    1 / 87 (1.15%)
         occurrences all number
    0
    4
    2
    1
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    2 / 36 (5.56%)
    0 / 87 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    2 / 36 (5.56%)
    0 / 87 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Pruritus
         subjects affected / exposed
    4 / 62 (6.45%)
    0 / 58 (0.00%)
    1 / 36 (2.78%)
    6 / 87 (6.90%)
         occurrences all number
    5
    0
    1
    9
    Rash
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 58 (1.72%)
    2 / 36 (5.56%)
    1 / 87 (1.15%)
         occurrences all number
    2
    2
    3
    1
    Skin ulcer
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    2 / 36 (5.56%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    2 / 36 (5.56%)
    5 / 87 (5.75%)
         occurrences all number
    1
    1
    2
    7
    Arthralgia
         subjects affected / exposed
    1 / 62 (1.61%)
    3 / 58 (5.17%)
    2 / 36 (5.56%)
    4 / 87 (4.60%)
         occurrences all number
    1
    3
    2
    6
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 62 (4.84%)
    2 / 58 (3.45%)
    2 / 36 (5.56%)
    4 / 87 (4.60%)
         occurrences all number
    5
    2
    2
    4
    Urinary tract infection
         subjects affected / exposed
    6 / 62 (9.68%)
    9 / 58 (15.52%)
    4 / 36 (11.11%)
    13 / 87 (14.94%)
         occurrences all number
    12
    12
    7
    16
    Nasopharyngitis
         subjects affected / exposed
    0 / 62 (0.00%)
    3 / 58 (5.17%)
    1 / 36 (2.78%)
    8 / 87 (9.20%)
         occurrences all number
    0
    3
    1
    10
    Influenza
         subjects affected / exposed
    1 / 62 (1.61%)
    3 / 58 (5.17%)
    0 / 36 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    1
    3
    0
    1
    COVID-19
         subjects affected / exposed
    5 / 62 (8.06%)
    13 / 58 (22.41%)
    3 / 36 (8.33%)
    19 / 87 (21.84%)
         occurrences all number
    6
    14
    3
    19
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 62 (12.90%)
    6 / 58 (10.34%)
    6 / 36 (16.67%)
    8 / 87 (9.20%)
         occurrences all number
    8
    7
    8
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Feb 2020
    - Remove detectable SLE SOC drug levels from the inclusion criteria list. - Substitute SLEDAI 2K by hybrid SLEDAI as part of the efficacy assessment. - Simplify and reduce screening period. - Introduce home health care visits. - Add LLDAS to key secondary endpoints. - Reduce period required for OCS stable dose prior to screening visit. - Changes to OCS dose permitted between 0 to 4 weeks - from up to 20 mg/day increase in prednisone dose (or equivalent) over baseline to up to 5 mg/day increase (10 mg/day of prednisone or equivalent allowed if OCS being temporarily initiated between 0 to 4 weeks). In both cases, return to baseline dose within 2 weeks is required. - Remove body surface requirements for rash sore in SLEDAI at screening visit-rash is being evaluated through (CLASI) instrument and there is no need to impose restrictions relatively to the extension of rash (which are difficult to achieve in SLE participants). - Add language relative to management of NSAIDs and analgesic therapies throughout the study. - Substitute FACIT-Fatigue by Patient-Reported Outcome Measurement Information System (PROMIS)-Fatigue scale as part of Participant Reported outcomes (PROs) – PROMIS able to assess impact of fatigue. - Add optional sub-study for the development of a new Lupus Symptoms Questionnaire. - Revise washout period for prior biologic drugs. - Add additional lab parameters – added CRP, ESR, GGT as part of regular chemistry assessments, add lipid profile (Baseline and Week 52 only), add antiphospholipid antibodies (Baseline, Week 24 and 52), add aPTT as part of regular coagulation assessments.
    13 Oct 2020
    - Incorporate changes to the study design to enable the study to support registration, if the results are positive; these changes include: Update study from phase 2 to phase 2b, revise primary endpoint to SRI-4 response rate at Week 52 and make SRI-4 response rate at Week 24 a secondary endpoint, change all key secondary endpoints to secondary endpoints and add secondary disease flare endpoints, revise the exploratory endpoints (eg, include PGA-VAS, refine exploratory disease flares endpoints, and remove baseline SLE SOC serum drug levels since it is included as a covariate in Section 10.2.2), and revise statistical methods, including sample size estimate, planned analyses, and efficacy analyses methods for primary and secondary endpoints. - Clarify options for a participant to proceed in the study if the participant discontinues investigational product prior to Week 52. - Clarify contraceptive guidance and pregnancy and lactation information: Adjust the duration for contraceptive requirements and collection of pregnancy and lactation information to at least 10 additional weeks after the last dose of IP for female subjects of childbearing potential, specify that pregnancy testing should be performed monthly during both the treatment period and at the first 2 safety follow-up visits, and clarify the definition of females of childbearing potential. - Specify home health care visits will be centrally provided by the sponsor starting at Week 22 and will be optional for participant who have not experienced adverse effects from IP administration. - Modify the optional PRO sub-study: Revise data collection time points to every other week, and add the Patient Global Impression of Change (PGIC) and Patient Global Impression of Severity (PGIS) to the optional PRO sub-study. - Clarify initiation or increase in oral corticosteroid dosing. - Add IDMC description. - Administrative, typographical, and formatting changes were made throughout the protocol.
    24 May 2022
    - Remove requirement for a separate blinded joint assessor - Clarify that the same investigator must perform all efficacy assessments at every time point for a given subject. In order to ensure consistency, it is clarified that the same investigator/assessor should perform the assessments throughout the study for a given participant - Clarify data collection process - Improve clarity of the definition of SRI-4 response in section 9.2.2.11 and BILAG-based BICLA response in section 9.2.2.12. - Clarify events that classify joints as non-evaluable - Clarify that SRI-4 response cannot be achieved regardless of protocol deviations, since the Important Protocol Deviation list is now used to define 'more than protocol-allowed therapies' - Remove language defining SRI-4 response from the Objectives/Endpoints table, as it is described in detail in other sections of the protocol - Endpoint for secondary objective aiming to evaluate efficacy of AMG 570 on joint count was updated to clarify that the combined tenderness and swelling of joint count will be conducted for joints in hands and wrists - Clarify that the endpoint for secondary objective aiming to describe efficacy of AMG 570 using patient-reported outcomes includes the 2 component measures of physical and mental health to be assessed by the Medical Outcomes Short Form 36 version 2 Questionnaire - Clarify that one of exploratory objectives aim is to evaluate the pharmacodynamic effects of AMG 570 - Addition of a new exploratory objective endpoint to evaluate the efficacy of AMG 570 on joint count, assessing tenderness and swelling in all 28 joints evaluable
    24 May 2022
    - Timing of sample collection for PK and anti-AMG 570 antibody assessments during safety follow-up was described for clarity purposes - Additionally, for simplification and improved clarity, information pertaining to safety follow-up was removed from protocol synopsis, overall design description, and treatment period - Clarification of when an individual participants is considered to have completed the study - Clarification of when an individual participants is considered to have completed the study - Clarify within the table for Analyses Schedule that after the 7th interim analysis, additional interim analyses are planned after every 32 subjects are randomized and have had the opportunity to complete the week 24 assessment until full enrollment - Interim analysis language was updated to remove details related to the hypothetical Phase 3 study as they do not impact the conduct of this study and will be pre-specified in the study data monitoring committee charter, statistical analysis plan, and simulation report, as appropriate - Clarify that the adjudication reviews occur at study entry to determine eligibility and throughout the study period on blinded endpoint data from enrollment to week 52 for all randomized participants and for all visits - Clarify that participants taking more that protocol-allowed therapies are considered treatment failures for the primary efficacy endpoint analyses but will be allowed to continue investigational product and/or the study at the investigator’s discretion except those initiating specific treatments with immunosuppressant/immunomodulators - Title of section 9.2.6.1 was changed to Biomarker Assessment During the Study given that not all biomarkers listed in that section have established pharmacodynamic activity.
    24 May 2022
    - Specify that all participants who at the end of study visit have clinical sequelae considered potentially related to an anti-AMG 570 antibody response will be asked to return for additional testing. Additionally, it was clarified that follow-up results will be communicated to sites after database is locked to prevent potential risk of unblinding the sites for treatment assignment - Clarify what is included in baseline covariates - Clarify inclusion criterion 105 by re-organizing SLE treatments that participants must be taking to meet protocol-specific rules applied during screening. One treatment was included to this criterion, leflunomide - For consistency, criterion 208 was updated to align with the updates made to Schedule of Activities regarding monitoring of viral load frequency to evaluate hepatitis B and C - Add thalidomide treatment within 4 weeks prior to screening to the treatment listed in exclusion criterion 212. For consistency, thalidomide was also added as an excluded treatment during study period - Decreased washout period for Janus kinase (JAK) inhibitor from 3 to 1 month prior to screening based on information available for the PK/pharmacodynamic (PD) profile of these drugs (criterion 213). - Clarify criterion 215 by adding immunosuppressive or immunomodulatory activity to treatment with a biologic agent, reduce washout period for abatacept to 3 months prior to screening based on its PK/PD profile, and clarify that PD activity of other biologics at screening should be considered when evaluating washout periods - Clarify the timeframe within which a subject must not plan to receive a live vaccine
    24 May 2022
    - Revise washout period for treatment with an investigational product or device to consider the PK and PD profile of those products at screening - Include Gilbert’s Syndrome as an exception for presence of laboratory abnormalities during screening in serum total bilirubin since these patients present non clinically relevant elevated bilirubin levels (criterion 221) - Clarify that serum pregnancy test is required at screening and urine pregnancy test is required at day 1 visit (criterion 225) - Clarify that this table applies for the subset of participants that completed the planned 52-week treatment period and emphasize that participants are required to attend as many visits as necessary to ensure a minimum of 16 weeks of safety follow-up after last dose of the investigational product - Clarify that safety follow-up visits should be scheduled in relation to last administration of the investigational product and not visit week 52 - Add frequency for monitoring viral load to evaluate hepatitis B and C o Remove urine pregnancy tests from the last two safety follow-up visits - Minor updates were included in the footnotes of the Schedule of Activities Treatment Period to clarify information regarding starting time of home health care visits, the option of conducting a QuantiFERON-TB test locally, assessment frequency of serum viral DNA and RNA for hepatitis B and C, and lymphocyte subset analysis. Additionally, for clarity purposes details no longer relevant to the assessments were removed - Accountability instructions for AMG 570 was updated to remove requirement to record the amount used in AMG 570 preparation on the electronic case report form for each participant - Simplify language around disease flares as a possible reason to discontinue protocol-required investigational product or procedural assessments (section 8.1) - The description of AMG 570 was updated (section 3.2.2)
    24 May 2022
    - For rescreening, it was clarified that tuberculosis tests and serologies for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus (HIV) are not required to be repeated when rescreening occurs within 12 months of screening visit, provided that those test results were negative and there is no patient’s medical/epidemiological history suggestive of infection or recent exposure to cases of infection (section 9.1.1) - Clarify the types of corticosteroid treatments that are allowed in the study and specify that participants requiring such treatments can continue the investigational product at the investigator’s discretion (section 7.1.4.2). - Simplify Treatment Period section by removing information outside the scope of this section (section 9.1.2) - Include the option for local laboratory to conduct the QuantiFERON-TB test for eligibility using a local kit procured by the site (section 9.2.4.3.2) - Clarify the rating scale used for patient global assessment of disease activity (section 9.2.10.4) - Information collected for screen failure was updated to remove medical history and prior therapies as these are not considered required forms for screen failure per electronic case report form standard instructions (section 6.5) - Remove the efficacy analysis set (section 10.2.1.2) - Include a footnote in Analyte Listing table to instruct that local lab testing may be conducted if central lab testing is unavailable and add that QuantiFERON-TB test can also be conducted locally. For clarity purposes, details no longer relevant to the analyte listing were removed - Add a clarification note that clinical assessments to evaluate hepatoxicity in participants for whom investigational product is withheld due to potential drug-induced liver injury can be performed locally as required per investigator discretion (section 12.7)
    24 May 2022
    - Updates have been implemented to align collection and reporting of safety events with current procedures - Clarify that tapering of oral corticosteroids is allowed before week 24 at the investigator’s discretion (sections 1.1 and 7.1.4.2) - Anti-drug Antibody Testing Procedures section was updated to remove sentence describing that follow-up testing will not be required where it is established that the participant did not receive AMG 570 (section 9.2.8). - The definition of the alphabetical score used to evaluate disease activity in 9 separate organ system was updated only for D by replacing stable with no activity (section 9.2.2.2) - Administrative, typographical, abbreviations, and formatting changes were made throughout the protocol.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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