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    Clinical Trial Results:
    A Phase 2, Randomized, Placebo-controlled, Double-blind, Multiple Dose Study to Evaluate the Efficacy and Safety of ANB019 in Subjects with Palmoplantar Pustulosis

    Summary
    EudraCT number
    2017-004022-15
    Trial protocol
    DE  
    Global end of trial date
    23 Apr 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    21 May 2022
    First version publication date
    21 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ANB019-003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03633396
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AnaptysBio, Inc.
    Sponsor organisation address
    10770 Wateridge Circle, Suite 210, San Diego, CA, United States, 92121
    Public contact
    AnaptysBio Clinical Trials Info, AnaptysBio Inc, 001 8583626387, clinicaltrialinfo@anaptysbio.com
    Scientific contact
    AnaptysBio Clinical Trials Info, AnaptysBio Inc, 001 8583626387, clinicaltrialinfo@anaptysbio.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
    23 Apr 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To determine the effect of imsidolimab (ANB019) compared with placebo in participants with palmoplantar pustulosis (PPP) as measured by the Palmoplantar Pustulosis Psoriasis Area Severity Index 50 (PPPASI50). - To assess the safety and tolerability of imsidolimab in subjects with PPP.
    Protection of trial subjects
    This study was conducted in compliance with the protocol, the International Council for Harmonisation (ICH) Guidance for Industry E6(R2) Good Clinical Practice (GCP): Consolidated Guidance, the Declaration of Helsinki, institutional review board (IRB)/independent ethics committee (IEC) requirements, and all applicable national and local regulatory requirements. The investigator or his/her representative explained the nature of the study to the participant or his/her legally authorized representative and answered all questions regarding the study. Written informed consent was obtained before the participant was enrolled in the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Apr 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 22
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    United States: 16
    Worldwide total number of subjects
    59
    EEA total number of subjects
    36
    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)
    54
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled in this trial at 36 sites located within North America and Europe.

    Pre-assignment
    Screening details
    Participants were randomized equally to one of two treatment groups. Randomization was stratified based on the participant's history of plaque psoriasis, to ensure that the number of participants enrolled with plaque psoriasis did not exceed 50%.

    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 placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.
    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
    Administered by subcutaneous injection once a month.

    Arm title
    Imsidolimab
    Arm description
    Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
    Arm type
    Experimental

    Investigational medicinal product name
    Imsidolimab
    Investigational medicinal product code
    ANB019
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection once a month.

    Number of subjects in period 1
    Placebo Imsidolimab
    Started
    29
    30
    Completed
    23
    24
    Not completed
    6
    6
         Consent withdrawn by subject
    4
    4
         Adverse event, non-fatal
    1
    1
         Coronavirus disease 2019 (COVID-19) restrictions
    -
    1
         Lack of efficacy
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.

    Reporting group title
    Imsidolimab
    Reporting group description
    Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.

    Reporting group values
    Placebo Imsidolimab Total
    Number of subjects
    29 30 59
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    47.7 ( 10.59 ) 52.3 ( 12.10 ) -
    Gender categorical
    Units: Subjects
        Female
    24 22 46
        Male
    5 8 13
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    3 0 3
        Not Hispanic or Latino
    26 30 56
    Race
    Units: Subjects
        American Indian or Alaska Native
    0 0 0
        Asian
    0 0 0
        Native Hawaiian or Other Pacific Islander
    1 1 2
        Black or African American
    3 1 4
        White
    25 28 53
    History of Plaque Psoriasis
    Units: Subjects
        Yes
    7 7 14
        No
    22 23 45
    Palmoplantar Pustulosis Psoriasis Area Severity Index Score
    The Palmoplantar Pustulosis Area and Severity Index (PPPASI) is used to assess the severity of palmoplantar pustulosis lesions. The glabrous skin of both palms and soles are assessed for erythema, pustules and desquamation (scaling) on a scale from 0 (none) to 4 (very severe). The area affected of each palm and sole is scored from 0 (0%) to 6 (90-100%). The PPPASI total score ranges from 0 to 72. A higher score indicates more severe disease.
    Units: score on a scale
        arithmetic mean (standard deviation)
    19.47 ( 11.633 ) 16.18 ( 8.045 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.

    Reporting group title
    Imsidolimab
    Reporting group description
    Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.

    Primary: Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI)

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    End point title
    Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI)
    End point description
    The Palmoplantar Pustulosis Area and Severity Index (PPPASI) is used to assess the severity of palmoplantar pustulosis lesions and their response to therapy. The glabrous skin of both palms and both soles are assessed for erythema, pustules, and desquamation (scaling), each on a scale from 0 (none) to 4 (very severe). The area affected of each palm and sole is scored from 0 (0%) to 6 (90-100%). Scores for the 3 characteristics of PPP are summed and adjusted for the area affected, and the scores for each palm and sole are added to calculate the total score. The PPPASI total score ranges from 0 to 72. A higher score indicates more severe disease, and a negative change from Baseline indicates improvement.
    End point type
    Primary
    End point timeframe
    Baseline to Week 16
    End point values
    Placebo Imsidolimab
    Number of subjects analysed
    24 [1]
    24 [2]
    Units: score on a scale
        least squares mean (standard error)
    -6.0 ( 1.48 )
    -6.1 ( 1.46 )
    Notes
    [1] - Intent-to-treat analysis set with available data
    [2] - Intent-to-treat analysis set with available data
    Statistical analysis title
    Analysis of Change in PPPASI Score
    Statistical analysis description
    The change from Baseline in PPPASI at Week 16 was analyzed using a a general linear mixed model for repeated measures (MMRM). The model included fixed effects for treatment, history of plaque psoriasis (Yes/No), visit, treatment by visit interaction, and Baseline PPPASI score as covariate.
    Comparison groups
    Placebo v Imsidolimab
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.944 [3]
    Method
    Mixed-model Repeated Measures (MMRM)
    Parameter type
    Least Squares (LS) Mean Difference
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.05
         upper limit
    3.77
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.98
    Notes
    [3] - MMRM including fixed effects of treatment, history of plaque psoriasis, visit, treatment by visit interaction, and Baseline PPPASI score as covariate.

    Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

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    End point title
    Number of Participants With Treatment-emergent Adverse Events (TEAEs) [4]
    End point description
    Clinical safety was evaluated by reporting incidence of adverse events up to Week 24. TEAEs are defined as new events that occured during or after first dose of study drug or any event that worsens after first dose of study drug. A serious AE (SAE) is defined as any untoward medical occurrence that resulted in death, was life-threatening, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or an important medical event that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above. Severity was assessed by the Investigator as mild (easily tolerated, causing minimal discomfort and not interfering with everyday activities), moderate (causes sufficient discomfort and interferes with normal everyday activities) or severe (prevents normal everyday activities). The Investigator assessed the relationship between study treatment and each AE based on clinical judgement.
    End point type
    Primary
    End point timeframe
    From first dose of any study drug to Week 24
    Notes
    [4] - 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: There were no statistical comparisons between the treatment groups for safety data.
    End point values
    Placebo Imsidolimab
    Number of subjects analysed
    29 [5]
    30 [6]
    Units: participants
        Any treatment-emergent adverse event (TEAE)
    20
    21
        TEAE related to study drug
    3
    6
        Severe TEAE
    1
    0
        Serious TEAE
    1
    0
        TEAE of special interest
    1
    0
        TEAE leading to discontinuation of study treatment
    2
    1
        TEAE leading to study discontinuation
    1
    1
        TEAE leading to death
    0
    0
        TEAE related to injection site reaction
    0
    0
        Disease related TEAE
    6
    2
    Notes
    [5] - Safety analysis set
    [6] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved 50% Reduction (Improvement) From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index Score (PPPASI 50)

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    End point title
    Percentage of Participants Who Achieved 50% Reduction (Improvement) From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index Score (PPPASI 50)
    End point description
    The Palmoplantar Pustulosis Area and Severity Index (PPPASI) is used to assess the severity of palmoplantar pustulosis lesions and their response to therapy. The glabrous skin of both palms and both soles are assessed for erythema, pustules, and desquamation (scaling), each on a scale from 0 (none) to 4 (very severe). The area affected of each palm and sole is scored from 0 (0%) to 6 (90-100%). Scores for the 3 characteristics of PPP are summed and adjusted for the area affected, and the scores for each palm and sole are added to calculate the total score. The PPPASI total score ranges from 0 to 72. A higher score indicates more severe disease.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    Placebo Imsidolimab
    Number of subjects analysed
    24 [7]
    24 [8]
    Units: percentage of participants
        number (confidence interval 95%)
    50.0 (29.12 to 70.88)
    45.8 (25.55 to 67.18)
    Notes
    [7] - Intent-to-treat analysis set with available data
    [8] - Intent-to-treat analysis set with available data
    Statistical analysis title
    Analysis of PPPASI 50 Response
    Statistical analysis description
    Response was analyzed using a logistic regression model including treatment as fixed effect, and history of plaque psoriasis (Yes/No) and Baseline PPPASI score as covariates. Missing PPPASI scores were imputed using multiple imputation while deriving PPPASI50 responses for executing the logistic regression model to obtain the odds ratio and the CI.
    Comparison groups
    Imsidolimab v Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.879
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.288
         upper limit
    2.686

    Secondary: Percentage of Participants Who Achieved a Clear or Almost Clear PPPIGA Score at Week 16

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    End point title
    Percentage of Participants Who Achieved a Clear or Almost Clear PPPIGA Score at Week 16
    End point description
    The Investigator rated the severity of participants' disease on the following 5-point scale: - 0: Clear - No signs of palmoplantar pustulosis; no scaling or crusts or pustules remain; - 1: Almost clear - Slight scaling and/or erythema and/or slight crusts; very few (yellow) and/or old (brown) pustules; - 2: Mild - Scaling and/or erythema and/or crusts; visible new (yellow) and/or old (brown) pustules of limited number and extent; - 3: Moderate - Prominent scaling and/or erythema and/or crusting; prominent new (yellow) and/or old (brown) pustules covering most of the area involved; - 4: Severe - Severe scaling and/or erythema and/or crusting; numerous new (yellow) and/or old (brown) pustules with / without major confluence, covering the entire area of at least 2 palmoplantar sites.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Imsidolimab
    Number of subjects analysed
    24 [9]
    24 [10]
    Units: percentage of participants
        number (confidence interval 95%)
    12.5 (2.66 to 32.36)
    20.8 (7.13 to 42.15)
    Notes
    [9] - Intent-to-treat analysis set with available data
    [10] - Intent-to-treat analysis set with available data
    Statistical analysis title
    Analysis of PPPIGA Response
    Statistical analysis description
    Response was analyzed with a logistic regression model including treatment as fixed effect, and history of psoriasis (Yes/No) and Baseline PPPIGA score as covariates.
    Comparison groups
    Imsidolimab v Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.5
         upper limit
    13.9

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of any study drug to Week 24.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.

    Reporting group title
    Imsidolimab
    Reporting group description
    Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.

    Serious adverse events
    Placebo Imsidolimab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Abortion early
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Placebo Imsidolimab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 29 (68.97%)
    21 / 30 (70.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Fatigue
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    3
    Reproductive system and breast disorders
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Panic attack
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Blood pressure increased
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Blood triglycerides increased
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 30 (6.67%)
         occurrences all number
    8
    2
    Nerve compression
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Anosmia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Intercostal neuralgia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Neuralgia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Sciatica
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Eye disorders
    Blepharospasm
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    3
    Dental caries
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Duodenogastric reflux
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    4 / 29 (13.79%)
    0 / 30 (0.00%)
         occurrences all number
    4
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Diffuse alopecia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Palmoplantar pustulosis
         subjects affected / exposed
    5 / 29 (17.24%)
    1 / 30 (3.33%)
         occurrences all number
    6
    1
    Skin lesion
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Eczema asteatotic
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Pustular psoriasis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Myalgia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    Neck pain
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    Osteoarthritis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 30 (3.33%)
         occurrences all number
    2
    2
    Arthralgia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Spinal pain
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 29 (13.79%)
    4 / 30 (13.33%)
         occurrences all number
    6
    4
    Pharyngitis
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    3
    COVID-19
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 30 (3.33%)
         occurrences all number
    3
    1
    Otitis externa
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Tinea pedis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Bacterial pyelonephritis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Bronchitis viral
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Folliculitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Impetigo
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    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 Oct 2019
    Changes included: - Moved immunogenicity endpoint to secondary objectives. - Increased the screening period from 28 days (4 weeks) to 48 days. - Removed the reference to the Patient Global Assessment (PGA) of disease activity and replaced with Patient Assessment of Palmoplantar Pustulosis Disease Activity. - Increased the number of study centers from 10 to 25. - Increased the upper age limit of subjects from 70 years to 75 years. - Inclusion Criteria, criterion 3, revised to remove reference to lack of response to prior topical or corticosteroid therapy. - Added a caveat that out-of-range screening values may be assessed by the Investigator and subjects may be enrolled at the discretion of the Investigator following consultation with the Medical Monitor and Sponsor. Removed the clause allowing one repeat test for abnormal laboratory results. - Exclusion Criteria, criterion 13 revised to allow squamous cell carcinoma as determined by the Investigator to be fully treatable. - Added a criterion to exclude subjects for inability to tolerate SC drug administration. - Clarified the appearance description of ANB019 and placebo. - Added a paragraph to describe the study procedures for early withdrawal. - Added an additional urine pregnancy text collection at the Week 20 study visit. - For FSH collection, removed the criteria in the definition of postmenopausal that stated women must be 45 years of age. - Added the endpoint for ADA assessment.
    19 Dec 2019
    Changes included: - Revised the duration allowed for previous chest x-ray from 6 months to 12 months. - Removed the following sentence: “If any laboratory results are outside the upper or lower limits listed above, final determination of eligibility will be after Investigator assessment following consultation with the Medical Monitor and Sponsor. - Administrative changes for consistency with other AnaptysBio protocols.
    23 Jun 2020
    Changes included: - Removed Week 4 from the primary analysis of PPASI50. - Revised text describing primary efficacy analysis with respect to analysis factors and use of 2-sided exact 95% test for the analysis of treatment differences. - Revised the wording of the exclusion criteria to permit enrollment of subjects with localized oral and genital herpes simplex that is well controlled. - Revised description of logistic regression model to identify factors used for analysis of 2 secondary efficacy endpoints (proportion of subjects achieving PPPASI50 and PPPASI75 at all study centers and proportion of patients with clear or almost clear assessment score on PPPIGA at all study center visits).
    11 Aug 2020
    Changes included: - Updated Benefit/Risk Assessment to include ANB019-005 final TEAE results and 26-week toxicology study in cynomolgus monkeys
    29 Oct 2020
    Changes included: - Changed the primary endpoint to mean change from Baseline in PPPASI at Week 16. Moved proportion of subjects achieving PPPASI50 at Week 16 from primary to secondary objective. - Changed description of statistical methods for analysis of primary efficacy endpoint. - Minor editorial changes for accuracy and formatting.

    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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