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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Subjects With Ichthyosis

    Summary
    EudraCT number
    		 2020-003476-41
    Trial protocol
    		 PL  
    Global end of trial date
    19 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 May 2023
    First version publication date
    12 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ANB019-206
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04697056
    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
    Bruce Randazzo, AnaptysBio Inc., 001 (858) 362-6343, brandazzo@anaptysbio.com
    Scientific contact
    Bruce Randazzo, AnaptysBio Inc., 001 (858) 362-6343, brandazzo@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
    19 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Nov 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the effect of imsidolimab (ANB019) compared with placebo in adolescent and adult participants with ichthyosis as measured by Ichthyosis Area Severity Index (IASI) total score.
    Protection of trial subjects
    This study was performed in compliance with ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and the applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Jan 2021
    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
    United States: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    0
    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)
    1
    Adults (18-64 years)
    3
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants with confirmed diagnosis of ichthyosis by genetic testing of ichthyosis were enrolled into the study.

    Pre-assignment
    Screening details
    		 7 participants were screened for eligibility and 5 participants were randomized into the study.

    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, Carer, Assessor
    Blinding implementation details
    The Sponsor, Investigator, and participants were blinded to treatment assignment of imsidolimab or placebo. An unblinded pharmacist was responsible for study treatment dispensing.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Imsidolimab
    Arm description
    		 Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
    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
    Imsidolimab was administered by clinic staff trained in best practices for subcutaneous administration at starting dose of 400 mg on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85).

    Arm title
    		 Placebo
    Arm description
    		 Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
    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
    Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.

    Number of subjects in period 1
    		Imsidolimab Placebo
    Started
    4
    1
    Completed
    0
    0
    Not completed
    4
    1
         Study termination
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Imsidolimab
    Reporting group description
    		 Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.

    Reporting group values
    		 Imsidolimab Placebo Total
    Number of subjects
    		 4 1 5
    Age categorical
    Units: Subjects
    Age continuous
    99999 indicates standard deviation is not estimable because age data is reported for only 1 participant in the placebo group.
    Units: years
        arithmetic mean (standard deviation)
    		 39.0 ( 20.15 ) 66.0 ( 99999 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 0 3
        Male
    		 1 1 2
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 4 1 5
        Hispanic or Latino
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Race
    Units: Subjects
        Asian
    		 2 1 3
        Black or African American
    		 1 0 1
        White
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Imsidolimab
    Reporting group description
    		 Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.

    Primary: Change From Baseline in Ichthyosis Area Severity Index (IASI) Total Score at Week 16

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    End point title
    		 Change From Baseline in Ichthyosis Area Severity Index (IASI) Total Score at Week 16 [1]
    End point description
    IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling & percentage of body surface area (BSA) affected. Degree of erythema & scaling scored from 0 (none) to 4 (very severe) for each of 4 body regions (BR) [A1: head & neck (H&N), A2: upper limbs (UL), A3: trunk (T), A4: lower limbs (LL)]. Percentage of BSA involved for each BR (B1: % in H&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6).Total extent was determined using multiplier considering % of total BSA by each BR (C1= 0.1 for H&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-Erythema (E)= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24) IASI-Scaling (S)= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24) IASI total score= IASI-E + IASIS score ranged from 0 - 48, higher score indicated worse disease state.
    End point type
    Primary
    End point timeframe
    Baseline 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 statistical analysis was performed for the primary endpoint. Due to study termination before primary endpoint, efficacy data was not collected nor analyzed.
    End point values
    		 Imsidolimab Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [2] - Due to study termination before primary endpoint, efficacy data was not collected nor analyzed.
    [3] - Due to study termination before primary endpoint, efficacy data was not collected nor analyzed.
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in IASI Total Score at Week 16

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    End point title
    		 Percent Change From Baseline in IASI Total Score at Week 16
    End point description
    IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, & percentage of BSA affected. Degree of erythema & scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%=5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24) IASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24) IASI total score= IASI-E + IASI-S score ranged from 0 - 48, higher score indicated worse disease state.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Imsidolimab Placebo
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: percent change
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [4] - Due to study termination before primary endpoint, efficacy data was not collected nor analyzed.
    [5] - Due to study termination before primary endpoint, efficacy data was not collected nor analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving an Improvement of 50% From Baseline in IASI (IASI50) at Week 16

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    End point title
    		 Percentage of Participants Achieving an Improvement of 50% From Baseline in IASI (IASI50) at Week 16
    End point description
    IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, & percentage of BSA affected. Degree of erythema & scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%=5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24) IASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24) IASI total score= IASI-E + IASI-S score ranged from 0 - 48, higher score indicated worse disease state.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Imsidolimab Placebo
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: percentage of participants
        number (not applicable)
    Notes
    [6] - Due to study termination before primary endpoint, efficacy data was not collected nor analyzed.
    [7] - Due to study termination before primary endpoint, efficacy data was not collected nor analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in IASI-E Scores at Week 16

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    End point title
    		 Change From Baseline in IASI-E Scores at Week 16
    End point description
    IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, & percentage of BSA affected. Degree of erythema & scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%=5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 IASI-E score ranged from 0 - 24, higher score indicated worse disease state.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Imsidolimab Placebo
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [8] - Due to study termination before primary endpoint, efficacy data was not collected nor analyzed.
    [9] - Due to study termination before primary endpoint, efficacy data was not collected nor analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in IASI-S Scores at Week 16

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    End point title
    		 Change From Baseline in IASI-S Scores at Week 16
    End point description
    IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, & percentage of BSA affected. Degree of erythema & scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%=5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 IASI-S score ranged from 0 - 24, higher score indicated worse disease state.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Imsidolimab Placebo
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [10] - Due to study termination before primary endpoint, efficacy data was not collected nor analyzed.
    [11] - Due to study termination before primary endpoint, efficacy data was not collected nor analyzed.
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in IASI-E Scores at Week 16

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    End point title
    		 Percent Change From Baseline in IASI-E Scores at Week 16
    End point description
    IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, & percentage of BSA affected. Degree of erythema & scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%=5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 IASI-E score ranged from 0 - 24, higher score indicated worse disease state.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Imsidolimab Placebo
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: percent change
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [12] - Due to study termination before primary endpoint, efficacy data was not collected nor analyzed.
    [13] - Due to study termination before primary endpoint, efficacy data was not collected nor analyzed.
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in IASI-S Scores at Week 16

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    End point title
    		 Percent Change From Baseline in IASI-S Scores at Week 16
    End point description
    IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, & percentage of BSA affected. Degree of erythema & scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%=5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 IASI-S score ranged from 0 - 24, higher score indicated worse disease state.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Imsidolimab Placebo
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: percent change
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [14] - Due to study termination before primary endpoint, efficacy data was not collected nor analyzed.
    [15] - Due to study termination before primary endpoint, efficacy data was not collected nor analyzed.
    No statistical analyses for this end point

    Secondary: 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)
    End point description
    An AE was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of study treatment that did not necessarily have a causal relationship with this treatment. An AE was considered "serious" if there was any of the following outcomes: death, life-threatening adverse event, Inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. An adverse event was considered TE if the date of onset was during or after first dose of study treatment, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.
    End point type
    Secondary
    End point timeframe
    From first dose up to study termination (maximum up to 9.4 weeks)
    End point values
    		 Imsidolimab Placebo
    Number of subjects analysed
    4
    1
    Units: participants
    number (not applicable)
        Any TEAEs
    1
    1
        Serious TEAEs
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose up to study termination (maximum up to 9.4 weeks)
    Adverse event reporting additional description
    Safety analysis set included all randomized participants who received at least 1 dose of imsidolimab or placebo.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Imsidolimab
    Reporting group description
    		 Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.

    Serious adverse events
    		 Imsidolimab Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Imsidolimab Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 1 (100.00%)
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Night sweats
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Skin lesion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Inguinal mass
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Herpes simplex reactivation
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 1 (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? 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.
    As a result of insufficient recruitment of participants, this study was terminated.
    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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