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    Clinical Trial Results:
    Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Mechanistic Effects, and Effects on Disease Activity of MH002 in Subjects with Mild to Moderate Ulcerative Colitis: A First-in-human Study

    Summary
    EudraCT number
    		 2020-004355-33
    Trial protocol
    		 BE   CZ   PL  
    Global end of trial date
    23 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jun 2024
    First version publication date
    05 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MH002-UC-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, Ghent, Belgium, B-9052
    Public contact
    MH002-FIH Information Desk, MRM Health NV, +32 92411188, MH002-FIH@mrmhealth.com
    Scientific contact
    MH002-FIH Information Desk, MRM Health NV, +32 92411188, 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
    23 Aug 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    23 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate the safety and tolerability of MH002 in subjects with mild to moderate ulcerative colitis (UC)
    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
    		 Yes
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Aug 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 36
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Czechia: 5
    Worldwide total number of subjects
    45
    EEA total number of subjects
    45
    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)
    42
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at study sites in Poland, Belgium and Czechia. The first ICF was signed on 03 November 2021. The last study visit occurred on 23 May 2023.

    Pre-assignment
    Screening details
    		 75 subjects were screened.

    Period 1
    Period 1 title
    Period 1: Weeks 1-8 (randomized phase)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MH002
    Arm description
    		 MH002 during Weeks 1-8 (randomized phase); responders and non-responders received MH002 during Weeks 9-16 (extension phase).
    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

    Arm title
    		 Placebo
    Arm description
    		 Placebo during Weeks 1–8 (randomized phase); responders (based on Modified Mayo Score using locally read colonoscopy or Physician’s Global Assessment in case of missing data) remained on Placebo until Week 16, while non-responders were automatically (blindly) allocated to MH002 400 mg daily during Weeks 9-16 (extension phase).
    Arm type
    		 Placebo

    Investigational medicinal product name
    MH002-matching Placebo
    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

    Number of subjects in period 1
    		MH002 Placebo
    Started
    31
    14
    Completed
    28
    14
    Not completed
    3
    0
         Consent withdrawn by subject
    1
    -
         Physician decision
    1
    -
         Significant relapse or worsening UC
    1
    -
    Period 2
    Period 2 title
    Period 2: Weeks 9-16 (extension phase)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MH002-MH002
    Arm description
    		 MH002 during Weeks 1-8 (randomized phase); responders and non-responders received MH002 during Weeks 9-16 (extension phase). Note: One subject completed study period 1, but did not start study period 2 due to withdrawal of consent.
    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

    Arm title
    		 Placebo-Placebo (Placebo responders)
    Arm description
    		 Placebo during Weeks 1–8 (randomized phase); responders (based on Modified Mayo Score using locally read colonoscopy or Physician’s Global Assessment in case of missing data) remained on Placebo until Week 16, while non-responders were automatically (blindly) allocated to MH002 400 mg daily during Weeks 9-16 (extension phase). Note: One subject completed study period 1, but did not start study period 2 due to withdrawal of consent.
    Arm type
    		 Placebo

    Investigational medicinal product name
    MH002-matching Placebo
    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

    Arm title
    		 Placebo-MH002 (Placebo non-responders)
    Arm description
    		 Placebo during Weeks 1–8 (randomized phase); non-responders were automatically (blindly) allocated to MH002 400 mg daily during Weeks 9–16 (extension phase).
    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

    Number of subjects in period 2 [1]
    		MH002-MH002 Placebo-Placebo (Placebo responders) Placebo-MH002 (Placebo non-responders)
    Started
    27
    6
    7
    Completed
    26
    6
    6
    Not completed
    1
    0
    1
         Adverse event, non-fatal
    -
    -
    1
         Protocol deviation
    1
    -
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: MH002-MH002: one subject completed study period 1, but did not start study period 2 due to withdrawal of consent. Placebo-Placebo: one subject completed study period 1, but did not start study period 2 due to withdrawal of consent.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MH002
    Reporting group description
    		 MH002 during Weeks 1-8 (randomized phase); responders and non-responders received MH002 during Weeks 9-16 (extension phase).

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo during Weeks 1–8 (randomized phase); responders (based on Modified Mayo Score using locally read colonoscopy or Physician’s Global Assessment in case of missing data) remained on Placebo until Week 16, while non-responders were automatically (blindly) allocated to MH002 400 mg daily during Weeks 9-16 (extension phase).

    Reporting group values
    		 MH002 Placebo Total
    Number of subjects
    		 31 14 45
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 29 13 42
        From 65-84 years
    		 2 1 3
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 41.8 (20 to 67) 44.9 (20 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 13 5 18
        Male
    		 18 9 27
    Race
    Units: Subjects
        White
    		 31 14 45
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 31 14 45

    End points

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    End points reporting groups
    Reporting group title
    MH002
    Reporting group description
    		 MH002 during Weeks 1-8 (randomized phase); responders and non-responders received MH002 during Weeks 9-16 (extension phase).

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo during Weeks 1–8 (randomized phase); responders (based on Modified Mayo Score using locally read colonoscopy or Physician’s Global Assessment in case of missing data) remained on Placebo until Week 16, while non-responders were automatically (blindly) allocated to MH002 400 mg daily during Weeks 9-16 (extension phase).
    Reporting group title
    MH002-MH002
    Reporting group description
    		 MH002 during Weeks 1-8 (randomized phase); responders and non-responders received MH002 during Weeks 9-16 (extension phase). Note: One subject completed study period 1, but did not start study period 2 due to withdrawal of consent.

    Reporting group title
    Placebo-Placebo (Placebo responders)
    Reporting group description
    		 Placebo during Weeks 1–8 (randomized phase); responders (based on Modified Mayo Score using locally read colonoscopy or Physician’s Global Assessment in case of missing data) remained on Placebo until Week 16, while non-responders were automatically (blindly) allocated to MH002 400 mg daily during Weeks 9-16 (extension phase). Note: One subject completed study period 1, but did not start study period 2 due to withdrawal of consent.

    Reporting group title
    Placebo-MH002 (Placebo non-responders)
    Reporting group description
    		 Placebo during Weeks 1–8 (randomized phase); non-responders were automatically (blindly) allocated to MH002 400 mg daily during Weeks 9–16 (extension phase).

    Primary: Incidence of Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Incidence of Treatment-emergent Adverse Events (TEAEs) [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 prior to 30 days after the last administration of study treatment, or up to the last safety phone call assessment scheduled 21 days (or up to 28 days) after Week 16/Early Discontinuation Visit (whichever comes first). Population: Safety Analysis Set; all subjects who enrolled in the study and received at least 1 dose of study treatment. For subjects who were randomized to Placebo in the randomized phase and who switched at Week 8 to MH002 in the extension phase, TEAEs that first occurred or worsened after initiation of MH002 were identified and summarized separately. Notes: No statistical analyses have been specified for this primary endpoint. Justification: no statistical analysis was intended to be performed for this endpoint.
    End point type
    Primary
    End point timeframe
    From first dose up to Week 19 (20).
    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: Primary endpoint: safety and tolerability. No formal hypothesis testing was planned, any statistical testing is to be considered exploratory and descriptive in this study. The sample size is not based on statistical considerations but practical ones.
    End point values
    		 MH002 Placebo
    Number of subjects analysed
    31
    14
    Units: Percent subjects with at least 1 TEAE
    35
    57
    No statistical analyses for this end point

    Secondary: Change from baseline in Modified Mayo Score (MMS) at Week 8

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    End point title
    		 Change from baseline in Modified Mayo Score (MMS) at Week 8
    End point description
    The 3-item Modified Mayo Score (MMS) is a composite scoring index based on sum of the Mayo symptom subscores for stool frequency and rectal bleeding, and centrally assessed Mayo Endoscopic Score (MES), ie, without the Physician’s Global Assessment of disease activity (0-9: normal to severe UC). Population: Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Observed Cases (OC).
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 MH002 Placebo
    Number of subjects analysed
    24
    13
    Units: Score on a scale change from baseline
        arithmetic mean (standard deviation)
    -1.86 ( 1.916 )
    -1.41 ( 1.837 )
    Statistical analysis title
    		 CFBL in Modified Mayo Score (MMS)
    Statistical analysis description
    Changes from baseline (CFBL) were compared between MH002 and Placebo. Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Observed Cases (OC).
    Comparison groups
    MH002 v Placebo
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2457
    Method
    		 t-test, 1-sided
    Confidence interval

    Secondary: Change from baseline in Mayo symptom subscore for stool frequency at Week 8

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    End point title
    		 Change from baseline in Mayo symptom subscore for stool frequency at Week 8
    End point description
    Patient-reported disease symptom assessment of stool frequency (0-3: none to most frequent). Population: Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Last Observation Carried Forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 MH002 Placebo
    Number of subjects analysed
    30
    14
    Units: score on a scale change from baseline
        arithmetic mean (standard deviation)
    -0.73 ( 1.029 )
    -0.57 ( 1.215 )
    Statistical analysis title
    		 CFBL in Mayo subscore for stool frequency
    Statistical analysis description
    Changes from baseline (CFBL) were compared between MH002 and Placebo. Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Last Observation Carried Forward (LOCF).
    Comparison groups
    MH002 v Placebo
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3233
    Method
    		 t-test, 1-sided
    Confidence interval

    Secondary: Change from baseline in Mayo symptom subscore for rectal bleeding at Week 8

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    End point title
    		 Change from baseline in Mayo symptom subscore for rectal bleeding at Week 8
    End point description
    Patient-reported disease symptom assessment of rectal bleeding (0-3: none to most severe). Population: Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Last Observation Carried Forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 MH002 Placebo
    Number of subjects analysed
    30
    14
    Units: Score on a scale change from baseline
        arithmetic mean (standard deviation)
    -0.7 ( 1.02 )
    -0.8 ( 0.89 )
    Statistical analysis title
    		 CFBL in Mayo subscore for rectal bleeding
    Statistical analysis description
    Changes from baseline (CFBL) were compared between MH002 and Placebo. Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Last Observation Carried Forward (LOCF).
    Comparison groups
    MH002 v Placebo
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5373
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change from baseline in Mayo Endoscopic Score (MES) (overall) at Week 8

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    End point title
    		 Change from baseline in Mayo Endoscopic Score (MES) (overall) at Week 8
    End point description
    The Mayo Endoscopic Score (MES) is a well-established endoscopic scoring index (centrally assessed; 0-3: normal to severe disease). Population: Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Observed Cases (OC).
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 MH002 Placebo
    Number of subjects analysed
    28
    14
    Units: Score on a scale change from baseline
        arithmetic mean (standard deviation)
    -0.3 ( 0.66 )
    0.1 ( 0.62 )
    Statistical analysis title
    		 CFBL in Mayo Endoscopic Score (MES)
    Statistical analysis description
    Changes from baseline (CFBL) were compared between MH002 and Placebo. Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Observed Cases (OC).
    Comparison groups
    MH002 v Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0543
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Rate of Modified Mayo Score (MMS) Clinical Response at Week 8

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    End point title
    		 Rate of Modified Mayo Score (MMS) Clinical Response at Week 8
    End point description
    Clinical Response is a composite scoring index and defined as a decrease of ≥3 points on the Modified Mayo Score (MMS) and/or a decrease of ≥1 point on the Mayo symptom subscore for stool frequency and a decrease of ≥1 point on the Mayo symptom subscore for rectal bleeding, and/or meeting the definition of clinical remission. Population: Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Observed Cases (OC).
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 MH002 Placebo
    Number of subjects analysed
    28
    14
    Units: Percentage of subjects
    46
    50
    Statistical analysis title
    		 Rate of Clinical Response
    Statistical analysis description
    Percentage rates were compared between MH002 and Placebo. The Cochran-Mantel-Haenszel (CMH) test was stratified by concomitant corticosteroid use and included continuity correction. Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Observed Cases (OC).
    Comparison groups
    MH002 v Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5943
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Rate of Modified Mayo Score (MMS) Clinical Remission at Week 8

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    End point title
    		 Rate of Modified Mayo Score (MMS) Clinical Remission at Week 8
    End point description
    Clinical Remission is a composite scoring index and defined as Modified Mayo Score (MMS) ≤2.0 and with all MMS subscores ≤1 and a Mayo symptom subscore for rectal bleeding of 0. Population: Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Observed Cases (OC).
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 MH002 Placebo
    Number of subjects analysed
    28
    14
    Units: Percentage of subjects
    14
    7
    Statistical analysis title
    		 Rate of Clinical Remission
    Statistical analysis description
    Percentage rates were compared between MH002 and Placebo. The Cochran-Mantel-Haenszel (CMH) test was stratified by concomitant corticosteroid use and included continuity correction. Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Observed Cases (OC).
    Comparison groups
    MH002 v Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4597
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Changes from baseline in histologic scores (Nancy Index, Geboes Score, and Robarts' Histopathology Index) of colonic biopsies at Week 8

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    End point title
    		 Changes from baseline in histologic scores (Nancy Index, Geboes Score, and Robarts' Histopathology Index) of colonic biopsies at Week 8
    End point description
    Histologic scoring tools to assess histopathological disease activity in patients with Ulcerative Colitis; scores define histological inflammation and remission of the mucosa. Nancy Index: grades 0-4; least to most severe disease. Geboes Score: grades 0.0-5.4; no to most severe histological inflammation. Robarts' Histopathology Index (RHI): 0-33; no to most severe disease activity. Population: Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Observed Cases (OC).
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 MH002 Placebo
    Number of subjects analysed
    27
    14
    Units: Score on a scale change from baseline
    arithmetic mean (standard deviation)
        Nancy Index
    -0.4 ( 1.55 )
    -0.6 ( 1.15 )
        Geboes Score
    -0.7 ( 5.24 )
    -1.1 ( 5.90 )
        Robarts' Histopathology Index
    -1.3 ( 9.79 )
    -3.9 ( 9.08 )
    Statistical analysis title
    		 CFBL in histologic score: Nancy Index
    Statistical analysis description
    Changes from baseline (CFBL) were compared between MH002 and Placebo. Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Observed Cases (OC).
    Comparison groups
    MH002 v Placebo
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6431
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 CFBL in histologic score: Geboes Score
    Statistical analysis description
    Changes from baseline (CFBL) were compared between MH002 and Placebo. Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Observed Cases (OC).
    Comparison groups
    MH002 v Placebo
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5724
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 CFBL in histologic score: RHI
    Statistical analysis description
    Changes from baseline (CFBL) were compared between MH002 and Placebo. Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Observed Cases (OC).
    Comparison groups
    MH002 v Placebo
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.796
    Method
    		 t-test, 1-sided
    Confidence interval

    Secondary: Change from baseline in stool consistency (Bristol Stool Form Scale) at Week 8

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    End point title
    		 Change from baseline in stool consistency (Bristol Stool Form Scale) at Week 8
    End point description
    The Bristol Stool Form Scale (BSFS) is a 7-point scale used for stool consistency measurement (1-7: hard to watery). Population: Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Last Observation Carried Forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 MH002 Placebo
    Number of subjects analysed
    28
    12
    Units: score on a scale change from baseline
        arithmetic mean (standard deviation)
    -0.78 ( 0.994 )
    -0.53 ( 1.259 )
    Statistical analysis title
    		 CFBL in stool consistency (BSFS)
    Statistical analysis description
    Changes from baseline were compared between MH002 and Placebo. Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Last Observation Carried Forward (LOCF).
    Comparison groups
    MH002 v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2485
    Method
    		 t-test, 1-sided
    Confidence interval

    Secondary: Change from baseline in faecal calprotectin at Week 8

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    End point title
    		 Change from baseline in faecal calprotectin 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 Ulcerative Colitis and to guide treatment decisions. Population: Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Observed Cases (OC).
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 MH002 Placebo
    Number of subjects analysed
    28
    13
    Units: percent
        median (full range (min-max))
    -41.753 (-99.77 to 3106.34)
    -18.342 (-89.80 to 1634.62)
    Statistical analysis title
    		 CFBL in faecal calprotectin
    Statistical analysis description
    Changes from baseline (CFBL) were compared between MH002 and Placebo. Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Observed Cases (OC).
    Comparison groups
    MH002 v Placebo
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2043
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Changes from baseline in C-reactive protein (CRP) at Week 8

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    End point title
    		 Changes from baseline in C-reactive protein (CRP) at Week 8
    End point description
    C-reactive Protein (CRP) 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 Ulcerative Colitis.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 MH002 Placebo
    Number of subjects analysed
    31
    14
    Units: mg/L
        arithmetic mean (standard deviation)
    -1.7 ( 9.91 )
    13.6 ( 51.55 )
    Statistical analysis title
    		 CFBL in C-reactive Protein (CRP)
    Statistical analysis description
    Changes from baseline (CFBL) were compared between MH002 and Placebo. Full Analysis Set; all subjects randomly assigned to study treatment. Analysis by Observed Cases (OC).
    Comparison groups
    MH002 v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1899
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first study drug administration up to Week 19 (20).
    Adverse event reporting additional description
    Adverse Events: Safety Analysis Set for the study included all subjects who took at least 1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    MH002
    Reporting group description
    		 All subjects who were randomized to MH002 on Day 1 and who were allocated to MH002 during Weeks 1-16.

    Reporting group title
    Placebo
    Reporting group description
    		 All subjects who were randomized to Placebo on Day 1 and who were allocated to Placebo during Weeks 1–8 (randomized phase); with responders remaining on Placebo until Week 16. For subjects who were randomized to Placebo in the randomized phase and who switched at Week 8 to MH002 in the extension phase (Placebo non-responders), TEAEs that first occurred or worsened after initiation of MH002 were identified and summarized separately.

    Serious adverse events
    		 MH002 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 14 (7.14%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Immune system disorders
    Drug hypersensitivity
    Additional description: allergic reaction to insulin
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MH002 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 31 (16.13%)
    7 / 14 (50.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Thrombocytosis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 14 (14.29%)
         occurrences all number
    2
    2
    Abdominal distension
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Large intestine polyp
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Influenza
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    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 mild-to-moderate Ulcerative Colitis. Endpoints related to disease activity were exploratory in nature.
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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
    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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