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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis

    Summary
    EudraCT number
    		 2021-003029-31
    Trial protocol
    		 DE   CZ   HU  
    Global end of trial date
    06 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jun 2023
    First version publication date
    30 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RIST4721-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05194839
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aristea Therapeutics Inc.
    Sponsor organisation address
    12770 High Bluff Drive, San Diego, United States, 92130
    Public contact
    Aristea Therapeutics Inc., Aristea Therapeutics Inc., +1 858-465-6142, info@aristeatx.com
    Scientific contact
    Aristea Therapeutics Inc., Aristea Therapeutics Inc., +1 858-465-6142, info@aristeatx.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
    06 Mar 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Feb 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Mar 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of RIST4721 in the treatment of subjects with moderate to severe PPP
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice (GCP) and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jan 2022
    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: 10
    Country: Number of subjects enrolled
    Czechia: 8
    Country: Number of subjects enrolled
    Germany: 33
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    United States: 13
    Country: Number of subjects enrolled
    Canada: 7
    Worldwide total number of subjects
    79
    EEA total number of subjects
    59
    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)
    63
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects must have at least a 6-month history of PPP and have moderate or severe PPP.

    Period 1
    Period 1 title
    Blinded Treatment Period (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
    		 RIST4721 400mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    RIST4721
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RIST4721 tablets, 100 mg (4 x 100 mg tablet) once daily.

    Arm title
    		 RIST4721 200mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    RIST4721
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RIST4721 tablets, 100 mg (2 x 100 mg tablet and 2 placebo tablets) once daily.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo (4 placebo tablets) once daily.

    Number of subjects in period 1
    		RIST4721 400mg RIST4721 200mg Placebo
    Started
    27
    26
    26
    Completed
    12
    13
    12
    Not completed
    15
    13
    14
         Consent withdrawn by subject
    2
    1
    1
         Adverse event, non-fatal
    2
    2
    1
         Other
    -
    -
    1
         Study Terminated by Sponsor
    11
    10
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RIST4721 400mg
    Reporting group description
    		 -

    Reporting group title
    RIST4721 200mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 RIST4721 400mg RIST4721 200mg Placebo Total
    Number of subjects
    		 27 26 26 79
    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)
    		 21 22 20 63
        From 65-84 years
    		 6 4 6 16
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 23 23 19 65
        Male
    		 4 3 7 14

    End points

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    End points reporting groups
    Reporting group title
    RIST4721 400mg
    Reporting group description
    		 -

    Reporting group title
    RIST4721 200mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    RIST4721 400mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who completed Week 12

    Subject analysis set title
    RIST4721 200mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who completed Week 12

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who completed Week 12

    Primary: Proportion of Subjects Achieving 50% Reduction in PPPASI Score at Week 12

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    End point title
    		 Proportion of Subjects Achieving 50% Reduction in PPPASI Score at Week 12 [1]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12
    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 statistical hypothesis testing was conducted due to early study termination. Descriptive statistics were used to summarize the primary endpoint.
    End point values
    		 RIST4721 400mg RIST4721 200mg Placebo
    Number of subjects analysed
    12
    13
    12
    Units: Number of Subjects
    6
    3
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through end of Week 12 (blinded treatment) and follow-up.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    RIST4721 400mg
    Reporting group description
    		 -

    Reporting group title
    RIST4721 200mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 RIST4721 400mg RIST4721 200mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic lesion
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 RIST4721 400mg RIST4721 200mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 27 (66.67%)
    17 / 26 (65.38%)
    18 / 26 (69.23%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    2
    0
    1
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    1
    Pyrexia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Xerosis
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchitis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Cough
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 26 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    0
    2
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 26 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    0
    2
    0
    Urine leukocyte esterase positive
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    White blood cell count increased
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Ligament rupture
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Bundle branch block left
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dysaesthesia
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    3
    1
    1
    Vertigo
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia macrocytic
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Neutropenia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Blepharitis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Vision blurred
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    0
    Abnormal faeces
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    4 / 27 (14.81%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    4
    1
    0
    Dry mouth
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Flatulence
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    1
    0
    Vomiting
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Diffuse alopecia
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Hand dermatitis
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Palmoplantar pustulosis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Petechiae
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Psoriasis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    1
    0
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Urine odor abnormal
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 26 (11.54%)
    0 / 26 (0.00%)
         occurrences all number
    1
    3
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Back pain
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    2
    Invertebral disc protrusion
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Asymptomatic COVID-19
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Asymptomatic bacteriuria
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Bacterial vaginosis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    COVID-19
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    1
    0
    1
    Cystitis bacterial
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Fungal skin infection
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Furuncle
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 26 (11.54%)
    4 / 26 (15.38%)
         occurrences all number
    1
    3
    4
    Periodontitis
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    1
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    1
    Viral diarrhoea
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Nov 2021
    The primary purpose of this amendment was to provide additional guidance/clarification regarding the SARs-CoV-2 vaccine and inclusion criteria regarding SARs-CoV-2 vaccination, to amend contact in case of SAE/pregnancy if the electronic system is not available, and other minor edits and clarifications.
    05 Apr 2022
    The primary purpose of this amendment was to incorporate open-label extension as well as other minor edits and clarifications.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    13 Jan 2023
    Study RIST4721-202 was terminated due to safety findings.
    -

    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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