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    Clinical Trial Results:
    Exploratory Study to Evaluate Safety, Mechanistic and Clinical Effects of MH002 in Subjects with Acute Pouchitis

    Summary
    EudraCT number
    		 2021-006656-14
    Trial protocol
    		 BE   IT  
    Global end of trial date
    14 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Mar 2025
    First version publication date
    25 Mar 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MH002-PC-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MRM Health NV
    Sponsor organisation address
    Technologiepark-Zwijnaarde 82, Zwijnaarde, Belgium, 9052
    Public contact
    MH002-FIH Information Desk, MRM Health NV, 0032 9277 08 50, MH002-FIH@mrmhealth.com
    Scientific contact
    MH002-FIH Information Desk, MRM Health NV, 0032 9277 08 50, MH002-FIH@mrmhealth.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
    12 Sep 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jun 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to assess the safety of MH002 in acute pouchitis subjects.
    Protection of trial subjects
    The study was conducted in accordance with the protocol, ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences, International Ethical Guidelines, applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) and other Guidelines, and applicable laws and regulations. The study protocol, all study protocol amendments, written study subject information, informed consent form (ICF), Investigator’s Brochure, and any other relevant documents were reviewed and approved by an independent ethics committee (IEC) at each study center. The investigator informed the subjects of the risks and benefits of the study. The subjects were informed that they could withdraw from the study at any time for any reason. Consent was obtained in writing prior to any study-related activities; the investigator retained a copy of the ICFs.
    Background therapy
    		 No
    Evidence for comparator
    		 No comparator.
    Actual start date of recruitment
    08 Sep 2022
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Italy: 8
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    13
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects with a diagnosis of active pouchitis were enrolled at study sites in Belgium and Italy. The first subject was screened on 08 September 2022; the last subject was screened on 18 October 2023. The last study contact occurred on 14 June 2024.

    Pre-assignment
    Screening details
    		 20 subjects were screened

    Pre-assignment period milestones
    Number of subjects started
    		 20 [1]
    Number of subjects completed
    		 14

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 screen failure: 6
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 6 subjects were not meeting all inclusion criteria
    Period 1
    Period 1 title
    Weeks 1-8 (treatment) + Weeks 9-34 (FU) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 MH002
    Arm description
    		 MH002 once daily dose up to Week 8
    Arm type
    		 Experimental

    Investigational medicinal product name
    MH002
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg daily with the first meal of the day (Weeks 1-8)

    Number of subjects in period 1
    		MH002
    Started
    14
    Completed
    12
    Not completed
    2
         Consent withdrawn by subject
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MH002
    Reporting group description
    		 MH002 once daily dose up to Week 8

    Reporting group values
    		 MH002 Total
    Number of subjects
    		 14 14
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 13 13
        From 65-84 years
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 41.4 (21 to 68) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 4 4
    Race
    Units: Subjects
        White
    		 13 13
        Asian
    		 1 1
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 14 14
        Hispanic or Latino
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    MH002
    Reporting group description
    		 MH002 once daily dose up to Week 8

    Subject analysis set title
    Safety Analysis Set (SAS)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who took at least 1 dose of MH002. The SAS was used for analysis of all safety outcomes.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects with a baseline assessment and at least 1 follow-up assessment who took at least 1 dose of MH002. The FAS was used for analysis of the mechanistic and clinical endpoints on disease activity.

    Subject analysis set title
    mPDAI remission - Yes
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    A subgroup of the FAS including only subjects with modified Pouchitis Disease Activity Index (mPDAI)-defined remission at Week 8. mPDAI remission: mPDAI total score <5 and a decrease in mPDAI total score ≥2 (as defined by Travis et al. NEJM 2023)

    Subject analysis set title
    mPDAI remission - No
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    A subgroup of the FAS including only subjects without modified Pouchitis Disease Activity Index (mPDAI)-defined remission at Week 8. mPDAI remission: mPDAI total score <5 and a decrease in mPDAI total score ≥2 (as defined by Travis et al. NEJM 2023)

    Primary: Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent adverse reactions

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    End point title
    		 Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent adverse reactions [1]
    End point description
    Treatment-emergent adverse events (TEAEs) are defined as AEs that first occurred or worsened in severity after the first administration of study treatment and up to the last safety phone call assessment scheduled 26 weeks after Week 8/Early Discontinuation Visit (whichever comes first). Adverse reactions were defined as AEs assessed as at least possibly related to treatment with MH002. Population: Safety Analysis Set (SAS)
    End point type
    Primary
    End point timeframe
    From first dose up to Week 34
    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 intended to be performed on for this endpoint.
    End point values
    		 MH002
    Number of subjects analysed
    14
    Units: Subjects
        With any TEAE
    11
        With any serious TEAE
    2
        With any TEAE leading to treatment discontinuation
    0
        With any TEAE leading to study discontinuation
    0
        With any TEAE leading to death
    0
    No statistical analyses for this end point

    Primary: Incidence of treatment-emergent adverse events (TEAEs) by severity

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    End point title
    		 Incidence of treatment-emergent adverse events (TEAEs) by severity [2]
    End point description
    The number of subjects with TEAEs with severity mild, moderate, or severe during the study. Population: Safety Analysis Set (SAS)
    End point type
    Primary
    End point timeframe
    From first dose up to Week 34
    Notes
    [2] - 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 intended to be performed on for this endpoint.
    End point values
    		 MH002
    Number of subjects analysed
    14
    Units: Subjects
        Any mild TEAE
    8
        Any moderate TEAE
    8
        Any severe TEAE
    0
    No statistical analyses for this end point

    Primary: Incidence of treatment-emergent adverse events (TEAEs) by relatedness

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    End point title
    		 Incidence of treatment-emergent adverse events (TEAEs) by relatedness [3]
    End point description
    The number of subjects with TEAEs considered related/unrelated as assessed by the Investigator during the study. Population: Safety Analysis Set (SAS)
    End point type
    Primary
    End point timeframe
    From first dose up to Week 34
    Notes
    [3] - 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 intended to be performed on for this endpoint.
    End point values
    		 MH002
    Number of subjects analysed
    14
    Units: Subjects
        Any unrelated TEAE
    10
        Any unlikely related TEAE
    2
        Any possibly related TEAE
    3
        Any possibly related, non-serious TEAE
    3
        Any probably related TEAE
    0
        Unknown
    1
    No statistical analyses for this end point

    Secondary: Number of subjects achieving clinical remission and response at Week 8

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    End point title
    		 Number of subjects achieving clinical remission and response at Week 8
    End point description
    Clinical remission and response were assessed using the modified Pouchitis Disease Activity Index (mPDAI) total score (0-13; best to worse); calculated from 2 subscores: 1) mPDAI symptoms subscore (0 to 7): sum of Mayo stool frequency (0=usual to postoperative stool frequency to 3=five or more stools/day>postoperative usual) and the mPDAI subscores of rectal bleeding (0=no; 1=yes); fecal urgency or abdominal cramps (0=none to 2=usual); and fever (temperature >37.8 degrees C; 0=absent and 1=present). 2) mPDAI endoscopic subscore (0 to 6; based on local assessments): sum of endoscopic inflammation findings (each scored 0 to 1); oedema, granularity, friability, loss of vascular pattern, mucous exudation, and ulceration. - Clinical remission: mPDAI total score <5, a decrease in mPDAI total score ≥2, and an mPDAI endoscopic score <2. - Clinical response: mPDAI total score <5 and a decrease in mPDAI total score ≥2 Population: Full Analysis Set (FAS)
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 MH002 Full Analysis Set (FAS)
    Number of subjects analysed
    13
    13
    Units: Subjects
        Clinical remission at Week 8
    5
    5
        Clinical response at Week 8
    6
    6
    No statistical analyses for this end point

    Secondary: Change from baseline in modified Pouchitis Disease Activity Index (mPDAI) total score at Week 8

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    End point title
    		 Change from baseline in modified Pouchitis Disease Activity Index (mPDAI) total score at Week 8
    End point description
    The mPDAI total score (0-13; best to worse) is calculated from 2 subscores: 1) mPDAI symptoms subscore (0 to 7): sum of Mayo stool frequency (0=usual to postoperative stool frequency to 3=five or more stools/day>postoperative usual) and the mPDAI subscores of rectal bleeding (0=no; 1=yes); fecal urgency or abdominal cramps (0=none to 2=usual); and fever (temperature >37.8 degrees C; 0=absent and 1=present). 2) mPDAI endoscopic subscore (0 to 6; based on local assessments): sum of endoscopic inflammation findings (each scored 0 to 1); oedema, granularity, friability, loss of vascular pattern, mucous exudation, and ulceration. A negative change from baseline indicates improvement. Population: Full Analysis Set (FAS)
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 8
    End point values
    		 MH002 Full Analysis Set (FAS)
    Number of subjects analysed
    13
    13
    Units: Score on a scale change from baseline
    arithmetic mean (confidence interval 95%)
        Baseline
    6.91 (6.15 to 7.67)
    6.91 (6.15 to 7.57)
        Week 8
    4.74 (3.03 to 6.45)
    4.74 (3.03 to 6.45)
        Change from baseline to Week 8
    -2.17 (-3.58 to -0.76)
    -2.17 (-3.58 to -0.76)
    No statistical analyses for this end point

    Secondary: Change from baseline in modified Pouchitis Disease Activity Index (mPDAI) symptoms subscore at Week 8

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    End point title
    		 Change from baseline in modified Pouchitis Disease Activity Index (mPDAI) symptoms subscore at Week 8
    End point description
    The mPDAI symptoms subscore is a sum score (0= best to 7= worse) of the Mayo stool frequency (0=usual to postoperative stool frequency to 3=five or more stools/day>postoperative usual) and the mPDAI subscores of rectal bleeding (0=no; 1=yes); fecal urgency or abdominal cramps (0=none to 2=usual); and fever (temperature >37.8 degrees C; 0=absent and 1=present). A negative change from baseline indicates improvement. Population: Full Analysis Set (FAS)
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 8
    End point values
    		 MH002 Full Analysis Set (FAS)
    Number of subjects analysed
    13
    13
    Units: Score on a scale change from baseline
    arithmetic mean (confidence interval 95%)
        Baseline
    2.98 (2.45 to 3.52)
    2.98 (2.45 to 3.52)
        Week 8
    1.74 (1.12 to 2.35)
    1.74 (1.12 to 2.35)
        Change from baseline to Week 8
    -1.25 (-1.95 to -0.54)
    -1.25 (-1.95 to -0.54)
    No statistical analyses for this end point

    Secondary: Change from baseline in modified Pouchitis Disease Activity Index (mPDAI) endoscopic subscore at Week 8

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    End point title
    		 Change from baseline in modified Pouchitis Disease Activity Index (mPDAI) endoscopic subscore at Week 8
    End point description
    The mPDAI endoscopic subscore is a sum score (0= best to 6= worse; based on local assessments) for endoscopic inflammation findings: oedema, granularity, friability, loss of vascular pattern, mucous exudation, and ulceration in mucosal biopsies. Each item is scored on a scale of 0=not present to 1=present. A negative change from baseline indicates improvement. Population: Full Analysis Set (FAS)
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 8
    End point values
    		 MH002 Full Analysis Set (FAS)
    Number of subjects analysed
    13
    13
    Units: Score on a scale change from baseline
    arithmetic mean (confidence interval 95%)
        Baseline
    3.9 (3.3 to 4.5)
    3.9 (3.3 to 4.5)
        Week 8
    3.0 (1.7 to 4.3)
    3.0 (1.7 to 4.3)
        Change from baseline to Week 8
    -0.9 (-2.0 to 0.2)
    -0.9 (-2.0 to 0.2)
    No statistical analyses for this end point

    Secondary: Change from baseline in histologic scores (Pouchitis Disease Activity Index [PDAI] and Geboes) of mucosal biopsies at Week 8

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    End point title
    		 Change from baseline in histologic scores (Pouchitis Disease Activity Index [PDAI] and Geboes) of mucosal biopsies at Week 8
    End point description
    Histologic scoring tools to assess histologic inflammation of the mucosa. The PDAI histologic subscore is a sum score (0= best to 6= worse) for findings of polymorphic nuclear leukocyte infiltration (0=none to 3=severe plus crypt abscess), and ulceration per low power field [mean] (0=0% to 3= >50%). Geboes score: 0 to 22; no to most severe histological inflammation. A negative change from baseline (CFBL) indicates improvement. Population: Full Analysis Set (FAS)
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 8
    End point values
    		 MH002 Full Analysis Set (FAS)
    Number of subjects analysed
    13
    13
    Units: Score on a scale change from baseline
    arithmetic mean (confidence interval 95%)
        PDAI histologic score - Baseline
    2.0 (1.1 to 2.9)
    2.0 (1.1 to 2.9)
        PDAI histologic score - Week 8
    1.5 (0.7 to 2.2)
    1.5 (0.7 to 2.2)
        PDAI histologic score - CFBL
    -0.5 (-1.2 to 0.1)
    -0.5 (-1.2 to 0.1)
        Geboes score - Baseline
    10.0 (7.7 to 12.3)
    10.0 (7.7 to 12.3)
        Geboes score - Week 8
    7.5 (5.5 to 9.5)
    7.5 (5.5 to 9.5)
        Geboes score - CFBL
    -2.5 (-4.3 to -0.7)
    -2.5 (-4.3 to -0.7)
    No statistical analyses for this end point

    Secondary: Change from baseline in Pouchitis Disease Activity Index (PDAI) total score at Week 8

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    End point title
    		 Change from baseline in Pouchitis Disease Activity Index (PDAI) total score at Week 8
    End point description
    The PDAI total score (0-18; best to worse) is calculated from 3 subscores: 1) mPDAI symptoms subscore (0 to 6): sum of mPDAI subscores of stool frequency (0=usual to postoperative stool frequency to 2=three or more stools/day>postoperative usual); rectal bleeding (0=no; 1=yes); fecal urgency or abdominal cramps (0=none to 2=usual); and fever (temperature >37.8 degrees C; 0=absent and 1=present). 2) mPDAI endoscopic subscore (0 to 6; based on local assessments): sum of endoscopic inflammation findings (each scored 0 to 1); oedema, granularity, friability, loss of vascular pattern, mucous exudation, and ulceration. 3) mPDAI histologic score (0 to 6): sum of polymorphic nuclear leukocyte infiltration findings (0 to 3), and ulceration per low power field [mean] (0 to 3). A negative change from baseline indicates improvement. Population: Full Analysis Set (FAS)
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 8
    End point values
    		 MH002 Full Analysis Set (FAS)
    Number of subjects analysed
    13
    13
    Units: Score on a scale change from baseline
    arithmetic mean (confidence interval 95%)
        Baseline
    8.91 (7.65 to 10.17)
    8.91 (7.65 to 10.17)
        Week 8
    6.20 (4.10 to 8.30)
    6.20 (4.10 to 8.30)
        Change from baseline at Week 8
    -2.71 (-4.54 to -0.88)
    -2.71 (-4.54 to -0.88)
    No statistical analyses for this end point

    Secondary: Change from baseline in severity of fecal urgency at Week 8

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    End point title
    		 Change from baseline in severity of fecal urgency at Week 8
    End point description
    Fecal urgency was measured using the 11-item Urgency Scoring Scale (USS) ranging from 0 (no urgency) to 10 (worst possible urgency) assessing the severity of urgency to have a bowel movement in the past 24 hours. A negative change from baseline indicates improvement. Population: Full Analysis Set (FAS)
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 8
    End point values
    		 MH002 Full Analysis Set (FAS)
    Number of subjects analysed
    13
    13
    Units: Score on a scale change from baseline
    arithmetic mean (confidence interval 95%)
        Baseline
    4.51 (3.18 to 5.83)
    4.51 (3.18 to 5.83)
        Week 8
    3.20 (1.81 to 4.59)
    3.20 (1.81 to 4.59)
        Change from baseline to Week 8
    -1.31 (-2.35 to -0.26)
    -1.31 (-2.35 to -0.26)
    No statistical analyses for this end point

    Secondary: Change from baseline in number of ulcerations at Week 8 (local and central assessments)

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    End point title
    		 Change from baseline in number of ulcerations at Week 8 (local and central assessments)
    End point description
    The total number of ulcerations in pouch biopsies was recorded. The local assessments only included the number of ulcerations, while the central assessments included the number of ulcerations and erosions. A negative change from baseline (CFBL) indicates improvement. Population: Full Analysis Set (FAS)
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 8
    End point values
    		 MH002 Full Analysis Set (FAS)
    Number of subjects analysed
    13 [4]
    13 [5]
    Units: Number
    arithmetic mean (confidence interval 95%)
        Local assessment - baseline
    3.7 (1.8 to 5.5)
    3.7 (1.8 to 5.5)
        Local assessment - Week 8
    2.8 (1.2 to 4.3)
    2.8 (1.2 to 4.3)
        Local assessment - CFBL
    -0.9 (-3.2 to 1.4)
    -0.9 (-3.2 to 1.4)
        Central assessment - baseline
    31.9 (9.4 to 54.4)
    31.9 (9.4 to 54.4)
        Central assessment - Week 8
    36.8 (9.1 to 64.4)
    36.8 (9.1 to 64.4)
        Central assessment - CFBL
    3.4 (-11.0 to 17.8)
    3.4 (-11.0 to 17.8)
    Notes
    [4] - Local: n= 13 at baseline and Week 8 Central: n=13 at baseline and n= 12 at Week 8
    [5] - Local: n= 13 at baseline and Week 8 Central: n= 13 at baseline and n= 12 at Week 8
    No statistical analyses for this end point

    Secondary: Number of subjects with no, mild, moderate, or severe disease per Physician's Global Assessment (PGA)

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    End point title
    		 Number of subjects with no, mild, moderate, or severe disease per Physician's Global Assessment (PGA)
    End point description
    The Investigator scored the overall severity of pouchitis using the 4-item PGA scale ranging from 0 (absent) to 3 (most severe). Population: Full Analysis Set (FAS)
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 8
    End point values
    		 MH002 Full Analysis Set (FAS)
    Number of subjects analysed
    13
    13
    Units: Subjects
        Baseline - absent
    0
    0
        Baseline - mild
    3
    3
        Baseline - moderate
    10
    10
        Baseline - severe
    0
    0
        Week 8 - absent
    2
    2
        Week 8 - mild
    10
    10
        Week 8 - moderate
    1
    1
        Week 8 - severe
    0
    0
    No statistical analyses for this end point

    Secondary: Change from baseline in daily (24-hour) stool count at Week 8

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    End point title
    		 Change from baseline in daily (24-hour) stool count at Week 8
    End point description
    The number of stools was recorded in the last 24 hours. A negative change from baseline (CFBL) indicates improvement. Population: Full Analysis Set (FAS)
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    End point values
    		 MH002 Full Analysis Set (FAS)
    Number of subjects analysed
    13
    13
    Units: Number of stools
    arithmetic mean (confidence interval 95%)
        Baseline
    9.13 (7.07 to 11.19)
    9.13 (7.07 to 11.19)
        Week 8
    7.21 (5.83 to 8.59)
    7.21 (5.83 to 8.59)
        Change from baseline to Week 8
    -1.92 (-3.20 to -0.64)
    -1.92 (-3.20 to -0.64)
    No statistical analyses for this end point

    Secondary: Change from baseline in faecal calprotectin concentration at Week 8

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    End point title
    		 Change from baseline in faecal calprotectin concentration at Week 8
    End point description
    Faecal calprotectin is a clinically relevant marker of intestinal inflammation and is recommended in daily clinical practice for follow-up of patients with inflammatory bowel disease and to guide treatment decisions. Lower values indicate a better outcome. Population: Full Analysis Set (FAS)
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 8
    End point values
    		 MH002 Full Analysis Set (FAS)
    Number of subjects analysed
    13 [6]
    13 [7]
    Units: mg/kg
    median (confidence interval 95%)
        Baseline
    391.0 (187.0 to 864.0)
    391.0 (187.0 to 864.0)
        Change from baseline to Week 2
    -51.5 (-457.0 to 766.0)
    -51.5 (-457.0 to 766.0)
        Change from baseline to Week 4
    -163.0 (-493.0 to 500.5)
    -163.0 (-493.0 to 500.5)
        Change from baseline to Week 8
    56.0 (-539.0 to 230.5)
    56.0 (-539.0 to 230.5)
    Notes
    [6] - Baseline: 13 Week 2: 12 Week 4: 12 Week 8: 12
    [7] - Baseline: 13 Week 2: 12 Week 4: 12 Week 8: 12
    No statistical analyses for this end point

    Secondary: Change from baseline in C-reactive protein at Week 8

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    End point title
    		 Change from baseline in C-reactive protein at Week 8
    End point description
    C-reactive Protein is an acute-phase protein produced by the liver in response to various acute and chronic inflammatory conditions and is a widely used serum indicator of inflammation in inflammatory bowel disease. Lower values indicate a better outcome. Population: Safety Analysis Set (SAS)
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    End point values
    		 MH002 Safety Analysis Set (SAS)
    Number of subjects analysed
    13 [8]
    13 [9]
    Units: mg/L
    arithmetic mean (confidence interval 95%)
        Baseline
    11.31 (0.5 to 64.3)
    11.31 (0.5 to 64.3)
        Week 8
    8.78 (0.5 to 62.1)
    8.78 (0.5 to 62.1)
        Change from baseline to Week 8
    -1.58 (-5.1 to 0.5)
    -1.58 (-5.1 to 0.5)
    Notes
    [8] - n=13 due to an early discontinuation of 1 subject
    [9] - n= 13 due to an early discontinuation of 1 subject
    No statistical analyses for this end point

    Post-hoc: Number of subjects achieving mPDAI-based clinical remission, clinical response, symptomatic response, endoscopic response, and histologic response at Week 8

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    End point title
    		 Number of subjects achieving mPDAI-based clinical remission, clinical response, symptomatic response, endoscopic response, and histologic response at Week 8
    End point description
    Post-hoc analysis: mPDAI-based remission/response as in vedolizumab trial 2015-003472-78; symptomatic, endoscopic, and histologic response as in tofacitinib trial 2020-002695-12. mPDAI total score (0-12; best to worse); calculated from 2 subscores: 1) mPDAI symptoms subscore (0 to 6): sum of mPDAI subscores of stool frequency (0 to 2); rectal bleeding (0 or 1); fecal urgency or abdominal cramps (0 to 2); and fever (0 or 1). 2) endoscopic subscore (0 to 6): sum of endoscopic inflammation findings (each 0 to 1); oedema, granularity, friability, loss of vascular pattern, mucous exudation, and ulceration. - Clinical remission: mPDAI total score <5 & decrease in mPDAI total score ≥2 - Clinical response: decrease in mPDAI total score ≥2 - Symptomatic response: decrease of ≥2 points in mPDAI symptom subscore - Endoscopic response: decrease of ≥2 points in mPDAI endoscopic subscore - Histologic response: decrease of ≥2 points in PDAI histologic subscore
    End point type
    Post-hoc
    End point timeframe
    Week 8
    End point values
    		 MH002 Full Analysis Set (FAS) mPDAI remission - Yes mPDAI remission - No
    Number of subjects analysed
    13
    13
    6
    7
    Units: Subjects
        mPDAI clinical remission at Week 8
    6
    6
    6
    0
        mPDAI clinical response at Week 8
    6
    6
    6
    0
        Symptomatic response at Week 8
    5
    5
    3
    2
        Endoscopic response at Week 8
    5
    5
    5
    0
        Histologic response at Week 8
    2
    2
    2
    0
    No statistical analyses for this end point

    Post-hoc: Number of subjects achieving PDAI-based clinical remission and clinical response at Week 8

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    End point title
    		 Number of subjects achieving PDAI-based clinical remission and clinical response at Week 8
    End point description
    Post-hoc analysis with PDAI total score-based remission and response definitions as in vedolizumab trial 2015-003472-78. PDAI total score (0-18; best to worse); calculated from 3 subscores: 1) mPDAI symptom subscore (0 to 6) sum of mPDAI subscores of stool frequency (0 to 2); rectal bleeding (0 or 1); fecal urgency or abdominal cramps (0 to 2); and fever (0 or 1). 2) Endoscopic subscore (0 to 6); sum of endoscopic inflammation findings (each scored 0 to 1); oedema, granularity, friability, loss of vascular pattern, mucous exudation, and ulceration. 3) Histologic subscore (0 to 6): sum of polymorphic nuclear leukocyte infiltration findings (0 to 3), and ulceration per low power field [mean] (0 to 3). - PDAI clinical remission: PDAI score of ≤6 and a decrease of ≥3 points in the PDAI total score. - PDAI clinical response: a decrease of ≥3 points in the PDAI total score.
    End point type
    Post-hoc
    End point timeframe
    Week 8
    End point values
    		 MH002 Full Analysis Set (FAS) mPDAI remission - Yes mPDAI remission - No
    Number of subjects analysed
    13
    13
    6
    7
    Units: Subjects
        PDAI clinical remission at Week 8
    5
    5
    5
    0
        PDAI clinical response at Week 8
    5
    5
    5
    0
    No statistical analyses for this end point

    Post-hoc: Number of subjects achieving Robarts' Histopathology Index (RHI) based remission and response at Week 8

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    End point title
    		 Number of subjects achieving Robarts' Histopathology Index (RHI) based remission and response at Week 8
    End point description
    Robarts' Histopathology Index (RHI) is a histologic scoring tool to assess histopathological disease activity in patients with inflammatory bowel disease; scores 0-33; no to most severe disease activity. - RHI-based remission: RHI score <3. - RHI-based response: RHI score <5.
    End point type
    Post-hoc
    End point timeframe
    Week 8
    End point values
    		 MH002 Full Analysis Set (FAS) mPDAI remission - Yes mPDAI remission - No
    Number of subjects analysed
    13
    13
    6
    7
    Units: Subjects
        RHI-based remission at Week 8
    1
    1
    1
    0
        RHI-based response at Week 8
    2
    2
    2
    0
    No statistical analyses for this end point

    Post-hoc: Number of subjects with normalisation in faecal calprotectin levels

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    End point title
    		 Number of subjects with normalisation in faecal calprotectin levels
    End point description
    Faecal calprotectin (FCP) is a clinically relevant marker of intestinal inflammation and is recommended in daily clinical practice for follow-up of patients with inflammatory bowel disease and to guide treatment decisions. Lower values indicate better outcome. FCP normalisation is defined as a concentration ≤250 mg/kg.
    End point type
    Post-hoc
    End point timeframe
    Week 8
    End point values
    		 MH002 mPDAI remission - Yes mPDAI remission - No
    Number of subjects analysed
    13 [10]
    6 [11]
    7
    Units: Subjects
        Normal FCP (≤250 mg/kg) at baseline
    7
    3
    4
        Normal FCP (≤250 mg/kg) at Week 8
    4
    3
    1
    Notes
    [10] - n=13 at baseline n=12 at Week 8
    [11] - n=6 at Baseline n=5 at Week 8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events that occurred or worsened from first study drug administration up to 26 weeks after last dose (up to Week 34)
    Adverse event reporting additional description
    Adverse Events: Safety Analysis Set for the study included all subjects who took at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    MH002
    Reporting group description
    		 Subjects received MH002 once daily up to Week 8, and were followed up to 26 weeks after last dose for safety (up to Week 34).

    Serious adverse events
    		 MH002
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 14 (14.29%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Anal abscess
    Additional description: Event occurred during the safety follow-up period
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MH002
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 14 (78.57%)
    Investigations
    Blood uric acid increased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Haemoglobin decreased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Colitis ulcerative
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Flatulence
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    3
    Reproductive system and breast disorders
    Female genital tract fistula
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pelvic pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Vulvovaginal swelling
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Excessive granulation tissue
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    COVID-19
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Clostridium difficile infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Coronavirus infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Cryptosporidiosis infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Influenza
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Viral infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Iron deficiency
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Vitamin D deficiency
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1

    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.
    This trial with relative small sample size was primarily intended to assess the safety and tolerability of MH002 in subjects with acute pouchitis. Endpoints related to disease activity were exploratory in nature.
    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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