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    Clinical Trial Results:
    A Single Arm Multiple Dose Study to Assess the Efficacy and Safety of ANB019 in Subjects with Generalized Pustular Psoriasis

    Summary
    EudraCT number
    2017-004021-33
    Trial protocol
    GB  
    Global end of trial date
    20 Jan 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Feb 2022
    First version publication date
    05 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ANB019-002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03619902
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AnaptysBio, Inc.
    Sponsor organisation address
    10770 Wateridge Circle, Suite 210, San Diego, United States, 92121
    Public contact
    AnaptysBio Clinical Trials Info, AnaptysBio Inc, 001 858 3626387, clinicaltrialinfo@anaptysbio.com
    Scientific contact
    AnaptysBio Clinical Trials Info, AnaptysBio Inc, 001 858 3626387, 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
    20 Jan 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To evaluate the efficacy of imsidolimab (ANB019) in subjects with active generalized pustular psoriasis (GPP) as measured by the Clinical Global Impression (CGI) scale according to the modified Japanese Dermatology Association (JDA) severity index total score. - To assess the safety and tolerability of imsidolimab in subjects with GPP.
    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 original protocol, protocol amendments, informed consent form (ICF), Investigator Brochure (IB), and other relevant documents (eg, advertisements) were submitted to an IRB/IEC by the investigators and reviewed and approved by the IRB/IEC before the study was initiated.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Jan 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: 5
    Country: Number of subjects enrolled
    United Kingdom: 3
    Worldwide total number of subjects
    8
    EEA total number of subjects
    5
    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)
    7
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted at 5 centers that enrolled subjects in the UK and Poland.

    Pre-assignment
    Screening details
    The study included a screening period of up to 42 days, a 12-week treatment period, and a 12-week safety follow-up period. A total of 12 subjects were screened, with 8 subjects being enrolled in the study.

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

    Arms
    Arm title
    Imsidolimab
    Arm description
    Participants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg 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/infusion
    Routes of administration
    Subcutaneous use, Intravenous use
    Dosage and administration details
    Imsidolimab was administered as a single dose of IV imsidolimab 750 mg followed by 3 doses of SC imsidolimab 100 mg administered on Days 29, 57, and 85.

    Number of subjects in period 1
    Imsidolimab
    Started
    8
    Completed
    6
    Not completed
    2
         Termination of study by investigator
    1
         Use of excluded/prohibited medication
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Imsidolimab
    Reporting group description
    Participants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg on Days 29, 57, and 85.

    Reporting group values
    Imsidolimab Total
    Number of subjects
    8 8
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    51.3 ( 14.91 ) -
    Gender categorical
    Units: Subjects
        Female
    4 4
        Male
    4 4
    Race
    Units: Subjects
        American Indian or Alaska Native
    0 0
        Asian
    1 1
        Black or African American
    0 0
        Native Hawaiian or Other Pacific Islander
    0 0
        White
    7 7
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0 0
        Not Hispanic or Latino
    8 8
    Modified Japanese Dermatological Association Severity Index (JDA-SI) Total Score
    The JDA-SI includes assessment of skin lesions (area of erythema with pustules, area of erythema total, and area of edema) and fever, white blood cell count, C-reactive protein and serum albumin levels. The total score ranges from 0 to 17 (severe).
    Units: score on a scale
        arithmetic mean (standard deviation)
    9.1 ( 2.75 ) -

    End points

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    End points reporting groups
    Reporting group title
    Imsidolimab
    Reporting group description
    Participants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg on Days 29, 57, and 85.

    Primary: Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale

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    End point title
    Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale [1]
    End point description
    Clinical response was defined as "Very much improved," "Much Improved," or "Minimally Improved" on the CGI scale according to the Modified Japanese Dermatological Association Severity Index (JDA-SI) total score. The JDA-SI includes assessment of skin lesions (area of erythema with pustules, area of erythema total, and area of edema) and fever, white blood cell count, C-reactive protein and serum albumin levels. The total score ranges from 0 to 17 (severe). CGI was assessed based on the JDA-SI according to the following: - Very Much Improved: Reduction in JDA-SI total score by 3 or > points; - Much improved: Reduction in JDA-SI total score by 1 or 2 points; - Minimally improved: No change in JDA-SI total score and area of erythema with pustules reduced by <20% or clinically meaningful improvement in at least 1 other component of the modified JDA-SI. The full analysis set (FAS) included all enrolled subjects. Participants with missing data were categorized as non-responders.
    End point type
    Primary
    End point timeframe
    Week 4 and Week 16
    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 formal hypothesis testing was performed in this single arm study.
    End point values
    Imsidolimab
    Number of subjects analysed
    8 [2]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 4
    75.0 (34.91 to 96.81)
        Week 16
    75.0 (34.91 to 96.81)
    Notes
    [2] - Full Analysis set
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Body Surface Area of Erythema with Pustules at Week 1 and Week 4

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    End point title
    Percent Change from Baseline in Body Surface Area of Erythema with Pustules at Week 1 and Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, and Week 4
    End point values
    Imsidolimab
    Number of subjects analysed
    8 [3]
    Units: percent change
    arithmetic mean (standard deviation)
        Week 1
    -59.63 ( 39.895 )
        Week 4
    -94.17 ( 10.737 )
    Notes
    [3] - FAS; N=6 at Week 4
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4 and Week 16

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    End point title
    Percent Change from Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4 and Week 16
    End point description
    The area of erythema with pustules, area of total erythema and area of edema were assessed by the Investigator and scored from 0 to 3 on the following scale: 0: 0% body surface area (BSA); 1: > 0%, < 10% BSA; 2: ≥ 10%, < 50% BSA; 3: ≥ 50% BSA. The JDA-SI Total Skin Lesions Score is the sum of the area of erythema with pustules score, area of total erythema score and area of edema score and ranges between 0 and 9.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, Week 4, and Week 16
    End point values
    Imsidolimab
    Number of subjects analysed
    8 [4]
    Units: percent change
    arithmetic mean (standard deviation)
        Week 1
    -25.74 ( 26.369 )
        Week 4
    -55.65 ( 27.157 )
        Week 16
    -62.20 ( 29.757 )
    Notes
    [4] - FAS; N=6 at Week 4 and Week 16
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician’s Global Assessment (GPPPGA) Score of 0 or 1 at Week 1 and Week 4

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    End point title
    Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician’s Global Assessment (GPPPGA) Score of 0 or 1 at Week 1 and Week 4
    End point description
    The GPPPGA scale was used to assess the impact and severity of GPP on the following scale: 0: Clear (normal skin or post-inflammatory hyperpigmentation, no visible pustules, no scaling or crusting). 1: Almost clear (faint, diffuse pink or slight red erythema, low density occasional small discrete pustules (noncoalescent), superficial focal scaling or crusting restricted to periphery of lesions). 2: Mild (light red erythema, moderate density grouped discrete small pustules (noncoalescent), predominantly fine scaling or crusting). 3: Moderate (bright red erythema, high density pustules with some coalescence, moderate scaling or crusting covering most or all lesions). 4: Severe (deep fiery red erythema, very high density pustules with pustular lakes, severe scaling or crusting covering most or all lesions).
    End point type
    Secondary
    End point timeframe
    Week 1 and Week 4
    End point values
    Imsidolimab
    Number of subjects analysed
    5 [5]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 1
    0.0 (0.00 to 52.18)
        Week 4
    50.0 (6.76 to 93.24)
    Notes
    [5] - Subjects with any GPPPGA assessment; N=4 at Week 4
    No statistical analyses for this end point

    Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16

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    End point title
    Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16
    End point description
    The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that their skin problem has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 1, Week 4, and Week 16
    End point values
    Imsidolimab
    Number of subjects analysed
    8 [6]
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 1
    -0.9 ( 3.56 )
        Week 4
    -6.0 ( 9.08 )
        Week 16
    -10.7 ( 9.16 )
    Notes
    [6] - FAS; N= 6 at Week 4 and Week 16
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study treatment up to end of follow-up period; 24 weeks.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Imsidolimab
    Reporting group description
    Participants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg on Days 29, 57, and 85.

    Serious adverse events
    Imsidolimab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 8 (25.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nosocomial infection
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Imsidolimab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 8 (75.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    General disorders and administration site conditions
    Peripheral swelling
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Swelling face
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Investigations
    Blood folate decreased
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Blood glucose increased
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    C-reactive protein increased
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    White blood cell count increased
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Cardiac disorders
    Mitral valve prolapse
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Myxomatous mitral valve degeneration
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Skin haemorrhage
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypokalemia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jan 2018
    Changes included the following: -Revised to indicate a minimum three-hour observation period after the first and second subcutaneous injections (from no such limit for study center observation after SC administration). - Revised Inclusion Criteria to specify that in addition to prohibition on sperm donation for the specified duration, ova donation for assisted reproduction is also prohibited. The duration for males was revised to 220 days (from 6 months).
    26 Jul 2018
    Changes included the following: - Overall Design revised to remove a minimum of 7 days screening period requirement and updated 'up to 28 days', and updated the number of Investigators and number of study centers from 3 to 5. - Updated Background to reflect Phase I Study results (ANB019-001). - Inclusion Criteria: Added SI and conventional units for hemoglobin, white blood cell count, platelets, and serum creatinine. - Exclusion Criteria: Text revised to clarify the requirement to stop all systemic conventional therapies (eg. cyclosporine, methotrexate, and retinoid) the day the study drug is administered and remove definition of regular alcohol consumption and excessive smoking. - Removed Meals and Dietary Restrictions. - included guidance for using rescue medication in the form of topical corticosteroids (eg. betamethasone valerate ointment and cream, mometasone furoate ointment and cream) and guidance for adding any systemic psoriasis medication that is likely to impact psoriasis signs and symptoms (eg. cyclosporine, methotrexate, retinoid). - Removed the section 8.1.4 describing assessment of body surface area affected by GPP. - Updated timing of bidirectional posterior-anterior and lateral view chest X-ray. - Added text regarding follow-up visits in case of early discontinuation. - Added text to indicate that a minimum 3 hour observation period is required after the first and second SC injections. - Storage duration of biomarker samples and immunogenicity samples was updated to 5 years from 1 year. - Added text to indicate that “only samples within the stability window of the assay will be analyzed”.
    03 Apr 2019
    Changes included the following: - Updated the number of Investigators and number of study centers from 5 to 8-10. - Added an additional secondary endpoint to assess the proportion of subjects achieving a score of 0 or 1 on the Generalized Pustular Psoriasis Physician’s Global Assessment scale. Additional wording added to the secondary endpoints for PK analysis; moved immunogenicity objective (to assess ADA) from exploratory to secondary endpoint; retitled tertiary/exploratory endpoints section to exploratory endpoints. - Revised the screening period from "up to 28 days" to "up to 42 days (Week -0)." - Added Table to detail the sample collection and time points for PK and ADA testing. - Inclusion Criteria revised to to increase the upper age limit from 65 to 75, define the limit of ALT and AST to ≤ 2 × ULN, and revise disease criteria for study entry. - Exclusion criteria revised to remove 2 examples of other forms of psoriasis that were excluded from participation. - Added wording to clarify that study treatment may be interrupted only once before being permanently discontinued. - New section added to describe the GPPPGA scale. - Clarified that ECGs will be reviewed by the central laboratory "for quality and interpretation" and that ECG data would not be entered into EDC with the exception of clinical significance. Photography language was revised to describe a standardized approach for collection of photographs and the process for transfer and quality review. - Added a clarification that Investigator may review laboratory assessments to make a decision about safety or to determine subject eligibility for the study. - Genetics language revised to characterize additional DNA/RNA testing and optional pharmacogenomic testing. - Text added to better characterize the presentation of statistical data for ADA status and efficacy and safety endpoints - Added 3 references - Added new appendix to support added secondary endpoint of the GPPPGA assessment.
    30 Aug 2019
    Changes included the following: - Revised the secondary objectives to remove change from Baseline in GPPPGA score at all study visits and to assess change in Dermatology Life Quality Index (DLQI) total score instead of improvement in DLQI total score at all visits. Exploratory endpoint was revised for skin biopsies to assess IL-8 dendritic cells, not IL-6 dendritic cells. Removed references to logistic regression model using logit link. - Added one paragraph in Benefit/Risk Assessment about an SAE of sepsis that has been reported during the study for 1 subject. - Inclusion Criteria that specified the enrollment of subjects with or without a history of PP and PsA was removed. A statement was added that any laboratory values that are out-of-range at Screening will be left to the Investigator’s discretion as to whether or not a subject is eligible. - Exclusion Criteria modified to include squamous cell carcinoma deemed fully treatable by the Investigator as permissible. - Clarified the language around dose administration and to state that infusions may be slowed for subjects experiencing infusion-related reactions. - Revised the statement on collection of AEs to include any occurring through End of Study. - Clarified PK sample collection and documentation. - Removed the ITT Analysis Set and replaced with Full Analysis Set (FAS). Removed any references to randomization. The PPS will now be based on the FAS instead of the ITT set. Additional text was added to clarify use of the PK analysis set. - Added a clarification on the analysis of clinical response and Clinical Global Impression (CGI) score. - Clarified that secondary endpoints will be analyzed at all study visits through Week 16 for modified JDA SI score, descriptive statistics, GPPPGA score, and PASI. - Included a statement that summary statistics will be provided for average DLQI scores instead of absolute scores, in addition to the percent change from Baseline through Week 16.
    29 Oct 2019
    Changes included the following: - The sentence permitting the Investigator to assess eligibility in consultation with the Medical Monitor and the Sponsor, for those subject who fail to meet laboratory screening criteria, has been removed.

    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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    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
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