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    Clinical Trial Results:
    An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Daxdilimab (HZN-7734) in Subjects with Systemic Lupus Erythematosus (RECAST SLE OLE)

    Summary
    EudraCT number
    		 2022-000855-35
    Trial protocol
    		 GR   ES   PL  
    Global end of trial date
    31 Oct 2023

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

    Trial information

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    Trial identification
    Sponsor protocol code
    HZNP-DAX-204
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05430854
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, United States,
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, 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
    31 Oct 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the long-term safety and tolerability of 200 mg every 12 weeks (Q12W) daxdilimab.
    Protection of trial subjects
    This study was conducted in accordance with the protocol and with the following: - Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and the Council for International Organizations of Medical Sciences international ethical guidelines. - Applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. - Applicable laws and regulations. The protocol, protocol amendments, informed consent form, Investigator’s brochure, and other relevant documents (e.g., advertisements) were submitted to an Institutional Review Board/Independent Ethics Committee (IRB/IEC) by the Investigator and reviewed and approved by the IRB/IEC before the study was initiated. Any protocol amendments required IRB/IEC approval before implementation, except for changes needed to eliminate an immediate hazard to study subjects. Both protocols and substantial amendments required health authority approval prior to initiation, except for changes needed to eliminate an immediate hazard. The Investigator was responsible for providing written summaries of the study status to the IRB/IEC annually or more frequently, notifying the IRB/IEC of Serious Adverse Events (SAEs) or other significant safety findings, and ensuring study conduct and compliance with 21 CFR, International Council for Harmonisation (ICH) guidelines, IRB/IEC requirements, European regulation 536/2014 for clinical studies, European Medical Device Regulation 2017/745 for clinical device research, and all other applicable local regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2022
    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
    Spain: 1
    Country: Number of subjects enrolled
    Greece: 4
    Country: Number of subjects enrolled
    India: 16
    Country: Number of subjects enrolled
    Mexico: 26
    Country: Number of subjects enrolled
    Poland: 29
    Country: Number of subjects enrolled
    Serbia: 13
    Country: Number of subjects enrolled
    Taiwan: 4
    Country: Number of subjects enrolled
    United States: 32
    Worldwide total number of subjects
    155
    EEA total number of subjects
    34
    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)
    150
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was an open-label extension (OLE) of study VIB7734.P2.S1 (NCT04925934). Eligible participants were enrolled after the completion of the VIB7734.P2.S1 study. 155 participants were enrolled at 54 centers in the United States, Argentina, Greece, India, Mexico, Poland, Serbia, Spain and Taiwan from 01 June 2022 to 31 October 2023.

    Pre-assignment
    Screening details
    		 155 participants were enrolled and received study drug.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo/Daxdilimab 200 mg Every 12 Weeks (Q12W)
    Arm description
    		 Participants who received placebo in the parent study received daxdilimab 200 mg subcutaneous (SC) injection Q12W in this OLE Study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daxdilimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    SC Q12W

    Arm title
    		 Daxdilimab 200 mg Every 4 Weeks (Q4W)/Daxdilimab 200 mg Q12W
    Arm description
    		 Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daxdilimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    SC Q12W

    Arm title
    		 Daxdilimab 200 mg Q12W/ Daxdilimab 200 mg Q12W
    Arm description
    		 Participants who received 200 mg Q12W in the parent study, and received daxdilimab 200 mg Q12W in this OLE Study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daxdilimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    SC Q12W

    Number of subjects in period 1
    		Placebo/Daxdilimab 200 mg Every 12 Weeks (Q12W) Daxdilimab 200 mg Every 4 Weeks (Q4W)/Daxdilimab 200 mg Q12W Daxdilimab 200 mg Q12W/ Daxdilimab 200 mg Q12W
    Started
    47
    57
    51
    Completed
    8
    4
    5
    Not completed
    39
    53
    46
         Consent withdrawn by subject
    -
    3
    -
         Trial terminated by Sponsor
    39
    50
    46

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo/Daxdilimab 200 mg Every 12 Weeks (Q12W)
    Reporting group description
    		 Participants who received placebo in the parent study received daxdilimab 200 mg subcutaneous (SC) injection Q12W in this OLE Study.

    Reporting group title
    Daxdilimab 200 mg Every 4 Weeks (Q4W)/Daxdilimab 200 mg Q12W
    Reporting group description
    		 Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.

    Reporting group title
    Daxdilimab 200 mg Q12W/ Daxdilimab 200 mg Q12W
    Reporting group description
    		 Participants who received 200 mg Q12W in the parent study, and received daxdilimab 200 mg Q12W in this OLE Study.

    Reporting group values
    		 Placebo/Daxdilimab 200 mg Every 12 Weeks (Q12W) Daxdilimab 200 mg Every 4 Weeks (Q4W)/Daxdilimab 200 mg Q12W Daxdilimab 200 mg Q12W/ Daxdilimab 200 mg Q12W Total
    Number of subjects
    		 47 57 51 155
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.3 ( 10.3 ) 44.8 ( 12.8 ) 45.9 ( 11.2 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 44 52 46 142
        Male
    		 3 5 5 13
    Race
    Units: Subjects
        American Indian or Alaskan Native
    		 1 2 0 3
        Asian
    		 7 5 8 20
        Black or African American
    		 3 5 6 14
        White
    		 35 39 35 109
        Other
    		 1 6 2 9
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 19 24 16 59
        Not Hispanic or Latino
    		 28 33 35 96

    End points

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    End points reporting groups
    Reporting group title
    Placebo/Daxdilimab 200 mg Every 12 Weeks (Q12W)
    Reporting group description
    		 Participants who received placebo in the parent study received daxdilimab 200 mg subcutaneous (SC) injection Q12W in this OLE Study.

    Reporting group title
    Daxdilimab 200 mg Every 4 Weeks (Q4W)/Daxdilimab 200 mg Q12W
    Reporting group description
    		 Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.

    Reporting group title
    Daxdilimab 200 mg Q12W/ Daxdilimab 200 mg Q12W
    Reporting group description
    		 Participants who received 200 mg Q12W in the parent study, and received daxdilimab 200 mg Q12W in this OLE Study.

    Primary: 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) [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP, whether or not considered related to the IP. A TEAE is defined as any AE with an onset date on or after the first dose date in the OLE study. OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study.
    End point type
    Primary
    End point timeframe
    Up to approximately 56 weeks
    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/Daxdilimab 200 mg Every 12 Weeks (Q12W) Daxdilimab 200 mg Every 4 Weeks (Q4W)/Daxdilimab 200 mg Q12W Daxdilimab 200 mg Q12W/ Daxdilimab 200 mg Q12W
    Number of subjects analysed
    47
    57
    51
    Units: Participants
    25
    31
    31
    No statistical analyses for this end point

    Primary: Number of Participants who Experienced Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants who Experienced Serious Adverse Events (SAEs) [2]
    End point description
    An AE is considered “serious” if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: - Death - A life-threatening AE - Inpatient hospitalization or prolongation of existing hospitalization - Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions - A congenital abnormality/birth defect - Important medical events judged to jeopardize the participant(s). OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study.
    End point type
    Primary
    End point timeframe
    Up to approximately 56 weeks
    Notes
    [2] - 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/Daxdilimab 200 mg Every 12 Weeks (Q12W) Daxdilimab 200 mg Every 4 Weeks (Q4W)/Daxdilimab 200 mg Q12W Daxdilimab 200 mg Q12W/ Daxdilimab 200 mg Q12W
    Number of subjects analysed
    47
    57
    51
    Units: Participants
    3
    5
    5
    No statistical analyses for this end point

    Primary: Number of Participants who Experienced AEs of Special Interest (AESI)

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    End point title
    		 Number of Participants who Experienced AEs of Special Interest (AESI) [3]
    End point description
    An AESI is an AE of scientific and medical interest specific to understanding of the IP and may require close monitoring and collection of additional information by the Investigator. In this study, AESIs were: - Hypersensitivity reaction, including anaphylaxis - Severe (Grade 3 or higher) viral infections/reactivations - Opportunistic infections - Malignancy (except non-melanoma skin cancer). OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study.
    End point type
    Primary
    End point timeframe
    Up to approximately 56 weeks
    Notes
    [3] - 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/Daxdilimab 200 mg Every 12 Weeks (Q12W) Daxdilimab 200 mg Every 4 Weeks (Q4W)/Daxdilimab 200 mg Q12W Daxdilimab 200 mg Q12W/ Daxdilimab 200 mg Q12W
    Number of subjects analysed
    47
    57
    51
    Units: Participants
        Participants with at least 1 AESI
    1
    2
    1
    No statistical analyses for this end point

    Secondary: Serum Concentration of Daxdilimab

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    End point title
    		 Serum Concentration of Daxdilimab
    End point description
    Serum concentration of daxdilimab refers to the amount of daxdilimab present in the blood serum at a given time. Blood samples were collected via venipuncture at the specified time frames. Week 0 corresponds to the last day of the treatment period in the parent study and Day 1 of the treatment period in the OLE study. PK Analysis Set: all participants who received any dose of daxdilimab in OLE study and had at least 1 measurable PK concentration post dose. Number analyzed represents the number of participants with available data at that time point.
    End point type
    Secondary
    End point timeframe
    Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56
    End point values
    		 Placebo/Daxdilimab 200 mg Every 12 Weeks (Q12W) Daxdilimab 200 mg Every 4 Weeks (Q4W)/Daxdilimab 200 mg Q12W Daxdilimab 200 mg Q12W/ Daxdilimab 200 mg Q12W
    Number of subjects analysed
    47
    57
    51
    Units: ug/mL
    arithmetic mean (standard deviation)
        Week 0 (N = 0, 55, 50)
    0 ( 0 )
    5.527 ( 4.412 )
    0.458 ( 0.614 )
        Week 12 (N = 47, 57, 51)
    0.291 ( 0.390 )
    0.502 ( 0.740 )
    0.400 ( 0.520 )
        Week 24 (N = 47, 56, 50)
    0.414 ( 0.575 )
    0.398 ( 0.531 )
    0.437 ( 0.437 )
        Week 36 (N = 27, 26, 25)
    0.508 ( 0.616 )
    0.464 ( 0.467 )
    1.002 ( 1.404 )
        Week 48 (N = 11, 10, 11)
    0.813 ( 1.044 )
    0.380 ( 0.395 )
    0.815 ( 0.759 )
        Week 56 ( 5, 2, 5)
    0.399 ( 0.251 )
    0.146 ( 0.009 )
    0.997 ( 0.898 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count

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    End point title
    		 Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count
    End point description
    PDCs count refers to the number of pDCs present in a blood sample. Blood samples were collected via venipuncture at the specified time frames. Week 0 corresponds to the last day of the treatment period in the parent study and Day 1 of the treatment period in the OLE study. OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. The overall number of participants analzyed represents the number of participants contributing data to any individual timepoint within the table.
    End point type
    Secondary
    End point timeframe
    Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56
    End point values
    		 Placebo/Daxdilimab 200 mg Every 12 Weeks (Q12W) Daxdilimab 200 mg Every 4 Weeks (Q4W)/Daxdilimab 200 mg Q12W Daxdilimab 200 mg Q12W/ Daxdilimab 200 mg Q12W
    Number of subjects analysed
    23
    36
    33
    Units: Percentage change in pDCs count
    arithmetic mean (standard deviation)
        Week 0 (N = 24, 32, 30)
    70.59 ( 225.39 )
    -58.37 ( 36.19 )
    -30.40 ( 50.67 )
        Week 12 (N = 23, 36, 33)
    1.33 ( 142.08 )
    13.57 ( 158.14 )
    -21.25 ( 66.97 )
        Week 24 (N = 22, 33, 29)
    -14.39 ( 164.63 )
    -24.98 ( 79.85 )
    -19.86 ( 77.23 )
        Week 36 (N = 12, 12, 15)
    13.64 ( 255.67 )
    -41.36 ( 41.29 )
    -51.11 ( 35.28 )
        Week 48 (N = 8, 5, 6)
    -49.47 ( 34.54 )
    -58.65 ( 43.33 )
    -4.44 ( 74.93 )
        Week 56 (N = 3, 2, 3)
    -75.22 ( 14.11 )
    -43.13 ( 49.49 )
    4.15 ( 96.43 )
    No statistical analyses for this end point

    Secondary: Number of Participants Expressing Anti-drug Antibodies (ADA)

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    End point title
    		 Number of Participants Expressing Anti-drug Antibodies (ADA)
    End point description
    ADA incidence is the number of the participants with ADA positive post-Baseline only or boosted their preexisting ADA during the trial. Persistent positive was defined as ADA positive at ≥ 2 post-Baseline assessments (with ≥ 16 weeks between first and last positive) or positive at last post-Baseline assessment. Transient positive was defined as ADA post-Baseline positive but did not fulfill the criteria of persistent positive. Analysis Set: all participants who received at least 1 dose of daxdilimab in parent study or OLE study.
    End point type
    Secondary
    End point timeframe
    Up to approximately 56 weeks
    End point values
    		 Placebo/Daxdilimab 200 mg Every 12 Weeks (Q12W) Daxdilimab 200 mg Every 4 Weeks (Q4W)/Daxdilimab 200 mg Q12W Daxdilimab 200 mg Q12W/ Daxdilimab 200 mg Q12W
    Number of subjects analysed
    47
    57
    51
    Units: Participants
        ADA Incidence
    7
    6
    4
        ADA not detected
    34
    48
    44
        Only Baseline positive
    0
    3
    0
        Only post-Baseline positive
    6
    3
    3
        Both Baseline and post-Baseline positive
    7
    3
    2
        Persistent positive
    4
    3
    2
        Transient positive
    9
    3
    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 56 weeks
    Adverse event reporting additional description
    Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Placebo/Daxdilimab 200 mg Q12W
    Reporting group description
    		 Participants who received placebo in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.

    Reporting group title
    Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W
    Reporting group description
    		 Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.

    Reporting group title
    Daxdilimab 200 mg Q4W in Parent Study
    Reporting group description
    		 Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.

    Serious adverse events
    		 Placebo/Daxdilimab 200 mg Q12W Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W Daxdilimab 200 mg Q4W in Parent Study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 47 (6.38%)
    5 / 51 (9.80%)
    5 / 57 (8.77%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colorectal adenocarcinoma
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 51 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 51 (1.96%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial ischaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 51 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 51 (1.96%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 51 (1.96%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 51 (1.96%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 51 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Glomerulonephritis minimal lesion
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 51 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 51 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cytomegalovirus nephritis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 51 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 51 (1.96%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 51 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 51 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 51 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo/Daxdilimab 200 mg Q12W Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W Daxdilimab 200 mg Q4W in Parent Study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 47 (25.53%)
    19 / 51 (37.25%)
    19 / 57 (33.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 47 (8.51%)
    2 / 51 (3.92%)
    1 / 57 (1.75%)
         occurrences all number
    4
    2
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 51 (1.96%)
    3 / 57 (5.26%)
         occurrences all number
    4
    1
    3
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 47 (0.00%)
    3 / 51 (5.88%)
    0 / 57 (0.00%)
         occurrences all number
    0
    5
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 47 (0.00%)
    4 / 51 (7.84%)
    1 / 57 (1.75%)
         occurrences all number
    0
    6
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 51 (0.00%)
    3 / 57 (5.26%)
         occurrences all number
    0
    0
    3
    Depression
         subjects affected / exposed
    0 / 47 (0.00%)
    3 / 51 (5.88%)
    2 / 57 (3.51%)
         occurrences all number
    0
    3
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 47 (2.13%)
    3 / 51 (5.88%)
    2 / 57 (3.51%)
         occurrences all number
    1
    3
    2
    Osteoarthritis
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 51 (1.96%)
    4 / 57 (7.02%)
         occurrences all number
    2
    1
    4
    Infections and infestations
    COVID-19
         subjects affected / exposed
    4 / 47 (8.51%)
    2 / 51 (3.92%)
    0 / 57 (0.00%)
         occurrences all number
    4
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 51 (1.96%)
    3 / 57 (5.26%)
         occurrences all number
    1
    1
    3
    Sinusitis
         subjects affected / exposed
    1 / 47 (2.13%)
    3 / 51 (5.88%)
    2 / 57 (3.51%)
         occurrences all number
    1
    3
    2
    Urinary tract infection
         subjects affected / exposed
    1 / 47 (2.13%)
    5 / 51 (9.80%)
    0 / 57 (0.00%)
         occurrences all number
    1
    6
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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