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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating the Efficacy and Safety of Daxdilimab in Adult Participants with Active Proliferative Lupus Nephritis

    Summary
    EudraCT number
    		 2022-001377-31
    Trial protocol
    		 ES   HR  
    Global end of trial date
    04 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2024
    First version publication date
    29 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HZNP-DAX-203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05540665
    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
    04 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jan 2024
    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 efficacy of daxdilimab in combination with standard-of-care (SOC) compared to placebo in combination with SOC in participants with active, proliferative Lupus nephritis (LN).
    Protection of trial subjects
    The trial was conducted in accordance with the protocol, International Council for Harmonisation (ICH) Good Clinical Practice (GCP), and applicable local regulations. The Principal Investigator assured that no planned deviations from, or changes to, the protocol took place without prior agreement from the Sponsor and documented approval from the institutional review board (IRB)/research ethics board (REB), except where necessary to eliminate immediate hazards to the trial participants. All personnel involved in the conduct of this study completed ICH GCP training.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Apr 2023
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 2 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 4
    Country: Number of subjects enrolled
    Brazil: 2
    Country: Number of subjects enrolled
    Malaysia: 3
    Country: Number of subjects enrolled
    Philippines: 1
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Serbia: 5
    Country: Number of subjects enrolled
    Thailand: 3
    Worldwide total number of subjects
    19
    EEA total number of subjects
    1
    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)
    19
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants with active proliferative LN were recruited from centers in Argentina, Brazil, Malaysia, the Philippines, Poland, Serbia, and Thailand between April 2023 and January 2024, when the study was terminated.

    Pre-assignment
    Screening details
    		 Participants were randomized in a 1:1:1 ratio to receive either daxdilimab 300 mg or 100 mg subcutaneously (SC) or placebo SC in addition to standard of care (SOC) background therapy for a Treatment Period of about 104 weeks. Participants were followed up for 12 weeks following last dose of investigational product (IP).

    Period 1
    Period 1 title
    Overall (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 were randomized to receive placebo SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. Thereafter, placebo was administered every 4 weeks (Q4W) through Week 52. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved either partial renal response (PRR) or complete renal response (CRR) at both Weeks 48 and 52 would have continued to receive placebo at Week 64 and every 12 weeks (Q12W) through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn’t achieve PRR or CRR at either Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and then Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.
    Arm type
    		 Placebo

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

    Arm title
    		 Daxdilimab 100 mg
    Arm description
    		 Participants were randomized to receive daxdilimab 100 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 100 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn’t achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.
    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
    100 mg SC injection

    Arm title
    		 Daxdilimab 300 mg
    Arm description
    		 Participants were randomized to receive daxdilimab 300 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn’t achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.
    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
    300 mg SC injection

    Number of subjects in period 1
    		Placebo Daxdilimab 100 mg Daxdilimab 300 mg
    Started
    6
    6
    7
    Completed
    0
    0
    0
    Not completed
    6
    6
    7
         Study terminated by sponsor
    6
    6
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive placebo SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. Thereafter, placebo was administered every 4 weeks (Q4W) through Week 52. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved either partial renal response (PRR) or complete renal response (CRR) at both Weeks 48 and 52 would have continued to receive placebo at Week 64 and every 12 weeks (Q12W) through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn’t achieve PRR or CRR at either Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and then Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

    Reporting group title
    Daxdilimab 100 mg
    Reporting group description
    		 Participants were randomized to receive daxdilimab 100 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 100 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn’t achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

    Reporting group title
    Daxdilimab 300 mg
    Reporting group description
    		 Participants were randomized to receive daxdilimab 300 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn’t achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

    Reporting group values
    		 Placebo Daxdilimab 100 mg Daxdilimab 300 mg Total
    Number of subjects
    		 6 6 7 19
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 6 6 7 19
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.2 ( 5.91 ) 31.5 ( 10.97 ) 30.3 ( 6.47 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 6 6 5 17
        Male
    		 0 0 2 2
    Race
    Units: Subjects
        Asian
    		 1 4 2 7
        White
    		 5 2 5 12
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 0 3 6
        Not Hispanic or Latino
    		 3 6 4 13

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive placebo SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. Thereafter, placebo was administered every 4 weeks (Q4W) through Week 52. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved either partial renal response (PRR) or complete renal response (CRR) at both Weeks 48 and 52 would have continued to receive placebo at Week 64 and every 12 weeks (Q12W) through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn’t achieve PRR or CRR at either Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and then Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

    Reporting group title
    Daxdilimab 100 mg
    Reporting group description
    		 Participants were randomized to receive daxdilimab 100 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 100 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn’t achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

    Reporting group title
    Daxdilimab 300 mg
    Reporting group description
    		 Participants were randomized to receive daxdilimab 300 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn’t achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

    Primary: Percentage of Participants who Achieved CRR at Week 48 Through Week 52

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    End point title
    		 Percentage of Participants who Achieved CRR at Week 48 Through Week 52 [1]
    End point description
    CRR was defined as meeting all of the following: • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m^2 or no worse than 15% below Baseline • 24-hour urine protein to creatinine ratio (UPCR) ≤ 0.5 mg/mg • No discontinuation of trial intervention or use of restricted medication beyond the protocol-allowed threshold before assessment
    End point type
    Primary
    End point timeframe
    Week 48 to 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 statistical analysis was pre-specified for this endpoint.
    End point values
    		 Placebo Daxdilimab 100 mg Daxdilimab 300 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: Percentage of Participants
    Notes
    [2] - Due to early termination data were not collected.
    [3] - Due to early termination data were not collected.
    [4] - Due to early termination data were not collected.
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieved Overall Renal Response (ORR) at Week 48 Through Week 52

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    End point title
    		 Percentage of Participants who Achieved Overall Renal Response (ORR) at Week 48 Through Week 52
    End point description
    CRR was defined as meeting all of the following: • EGFR ≥ 60 mL/min/1.73 m^2 or no worse than 15% below Baseline • 24-hour UPCR ≤ 0.5 mg/mg • No discontinuation of trial intervention or use of restricted medication beyond the protocol-allowed threshold before assessment PRR was defined as meeting all of the following: • EGFR ≥ 60 mL/min/1.73 m^2 or no worse than 15% below Baseline • Improvement in 24-hour UPCR: − For participants with a Baseline UPCR ≤ 3.0 mg/mg: < 1.0 mg/mg − For participants with a Baseline UPCR > 3.0 mg/mg: > 50% improvement from baseline and ≤ 3.0 mg/mg • No discontinuation of trial intervention or use of restricted medication beyond the protocol-allowed threshold before assessment
    End point type
    Secondary
    End point timeframe
    Week 48 to Week 52
    End point values
    		 Placebo Daxdilimab 100 mg Daxdilimab 300 mg
    Number of subjects analysed
    0 [5]
    0 [6]
    0 [7]
    Units: Percentage of Participants
    Notes
    [5] - Due to early termination data were not collected.
    [6] - Due to early termination data were not collected.
    [7] - Due to early termination data were not collected.
    No statistical analyses for this end point

    Secondary: Change From Baseline in eGFR at Week 52

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    End point title
    		 Change From Baseline in eGFR at Week 52
    End point description
    Change over time in the levels of eGRF present in the blood. Due to early termination data were not collected.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Placebo Daxdilimab 100 mg Daxdilimab 300 mg
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    Units: mL/min/1.73 m^2
    arithmetic mean (standard deviation)
        Baseline
    ( )
    ( )
    ( )
        Week 52 (N = 0, 0, 0)
    ( )
    ( )
    ( )
    Notes
    [8] - Due to early termination data were not collected.
    [9] - Due to early termination data were not collected.
    [10] - Due to early termination data were not collected.
    No statistical analyses for this end point

    Secondary: Proportion of Participants Achieving a Decrease in Daily Oral Corticosteroid (OCS) Dose of ≤ 2.5 mg Prednisone-Equivalent by Week 24 Maintained Through Week 52

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    End point title
    		 Proportion of Participants Achieving a Decrease in Daily Oral Corticosteroid (OCS) Dose of ≤ 2.5 mg Prednisone-Equivalent by Week 24 Maintained Through Week 52
    End point description
    Sustained reduction of OCS dose: • Prednisone-equivalent dose ≤ 2.5 mg/day by Week 24 and not exceeding this dose through Week 52 and • No discontinuation of trial intervention or use of restricted medication beyond the protocol-allowed threshold before assessment
    End point type
    Secondary
    End point timeframe
    Week 24 to Week 52
    End point values
    		 Placebo Daxdilimab 100 mg Daxdilimab 300 mg
    Number of subjects analysed
    0 [11]
    0 [12]
    0 [13]
    Units: Percentage of Participants
    Notes
    [11] - Due to early termination data were not collected.
    [12] - Due to early termination data were not collected.
    [13] - Due to early termination data were not collected.
    No statistical analyses for this end point

    Secondary: Serum Concentration of Daxdilimab

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    End point title
    		 Serum Concentration of Daxdilimab [14]
    End point description
    Levels of daxdilimab present in the blood serum at different time points. Pharmacokinetic (PK) Analysis Set: all participants who received any dose of daxdilimab and had at least 1 quantifiable PK observation following the initial dose. Value of "99999" indicates that the Standard deviation (SD) was not calculated due to the low level of observations.
    End point type
    Secondary
    End point timeframe
    Week 0 pre-dose, and 6 hours post-dose; Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 36
    Notes
    [14] - 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: This endpoint is specific to IP arms only.
    End point values
    		 Daxdilimab 100 mg Daxdilimab 300 mg
    Number of subjects analysed
    6
    7
    Units: ng/mL
    arithmetic mean (standard deviation)
        Week 0 pre-dose (N = 7, 6, 0)
    7.80 ( 0.00 )
    7.80 ( 0.00 )
        Week 0 post-dose (N = 7, 6, 0)
    689.07 ( 498.40 )
    3854.29 ( 3312.12 )
        Week 2 (N = 7, 6, 0)
    4996.67 ( 1732.21 )
    17610.00 ( 10382.53 )
        Week 4 (N = 7, 6, 0)
    8531.67 ( 3993.99 )
    22171.43 ( 9187.26 )
        Week 8 (N = 7, 6, 0)
    3533.33 ( 1727.54 )
    10330.00 ( 4167.07 )
        Week 12 (N = 6, 5, 0)
    2988.00 ( 1223.83 )
    10201.67 ( 4619.64 )
        Week 16 (N = 2, 3, 0)
    1080.33 ( 1020.32 )
    5051.50 ( 6644.68 )
        Week 20 (N = 6, 3, 0)
    240.83 ( 184.66 )
    2003.00 ( 3907.13 )
        Week 24 (N = 1, 2, 0)
    93.85 ( 94.96 )
    9660.00 ( 99999 )
        Week 36 (N = 1, 0, 0)
    0 ( 0 )
    1040.00 ( 99999 )
    No statistical analyses for this end point

    Secondary: Number of Participants with Detectable Anti-Drug Antibodies (ADA) Against Daxdilimab

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    End point title
    		 Number of Participants with Detectable Anti-Drug Antibodies (ADA) Against Daxdilimab
    End point description
    Assessed via blood test at multiple time points throughout the duration of the study.
    End point type
    Secondary
    End point timeframe
    Up to approximately 36 weeks
    End point values
    		 Placebo Daxdilimab 100 mg Daxdilimab 300 mg
    Number of subjects analysed
    6
    6
    7
    Units: Participants
        ADA Negative
    6
    6
    7
    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 AE was any untoward medical occurrence in a participant or clinical subject who was administered a pharmaceutical product, which may or may not have been causally related to the treatment. A serious AE (SAE) was any AE resulting in death, life-threatening situations, inpatient hospitalization or its prolongation, persistent/significant disability/incapacity, congenital abnormality/birth defect, or other significant medical events that may have jeopardized the participant or required medical/surgical intervention to prevent the outcomes listed above. Treatment-emergent AEs of special interest (AESI) included hypersensitivity reactions (e.g., anaphylaxis), severe viral infections/reactivations (Common Terminology for Adverse Events [CTCAE] Grade 3+), herpes zoster, opportunistic infections, and malignancies.
    End point type
    Secondary
    End point timeframe
    Up to approximately 36 weeks
    End point values
    		 Placebo Daxdilimab 100 mg Daxdilimab 300 mg
    Number of subjects analysed
    6
    6
    7
    Units: Participants
        All TEAEs
    2
    2
    5
        All SAEs
    0
    0
    1
        All ≥ Grade 3 AESI
    0
    0
    0
        Fatal AEs
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 36 weeks
    Adverse event reporting additional description
    All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Daxdilimab 100 mg
    Reporting group description
    		 Participants were randomized to receive daxdilimab 100 mg SC at baseline, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 100 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn’t achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

    Reporting group title
    Daxdilimab 300 mg
    Reporting group description
    		 Participants were randomized to receive daxdilimab 300 mg SC at baseline, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn’t achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive placebo SC at baseline, Week 2, and Week 4. Thereafter, placebo was administered Q4W through Week 52. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved either partial renal response (PRR) or complete renal response (CRR) at both Weeks 48 and 52 would have continued to receive placebo at Week 64 and every 12 weeks (Q12W) through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn’t achieve PRR or CRR at either Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and then Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

    Reporting group title
    Total
    Reporting group description
    		 -

    Reporting group title
    Daxdilimab Total
    Reporting group description
    		 All participants who were exposed to daxdilimab.

    Serious adverse events
    		 Daxdilimab 100 mg Daxdilimab 300 mg Placebo Total Daxdilimab Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 19 (5.26%)
    1 / 13 (7.69%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Gastrointestinal infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 19 (5.26%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Daxdilimab 100 mg Daxdilimab 300 mg Placebo Total Daxdilimab Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 6 (33.33%)
    5 / 7 (71.43%)
    2 / 6 (33.33%)
    9 / 19 (47.37%)
    7 / 13 (53.85%)
    Investigations
    Urinary sediment abnormal
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 19 (5.26%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 19 (5.26%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    1
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 19 (5.26%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    1
    Abdominal pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 19 (5.26%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 19 (5.26%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 19 (5.26%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    1
    Butterfly rash
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 19 (5.26%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    1
    Rash
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 19 (5.26%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    1
    Rash erythematous
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 19 (5.26%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    1
    Endocrine disorders
    Cushingoid
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 19 (5.26%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 19 (5.26%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 19 (5.26%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 19 (5.26%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 19 (5.26%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 May 2022
    - Updated eligibility criteria to clarify eligibility for participants unable to understand the informed consent form; the use of digital pathology images for adjudication of diagnosis; to clarify review of screening data. - Updated exploratory objectives and endpoints . - Updated clinical safety laboratory tests for consistency with eligibility criteria and clinical evaluation. - Clarified details in the schedule of assessments.

    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.
    The study was terminated early following a sponsor decision.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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