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    Clinical Trial Results:
    A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum.

    Summary
    EudraCT number
    		 2019-003596-19
    Trial protocol
    		 DE   IT   RO   DK   BG  
    Global end of trial date
    19 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Mar 2026
    First version publication date
    16 Mar 2026
    Other versions
    Summary report(s)
    		 CHS1221 Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    CHS1221
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04469686
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cristcot HCA LLC
    Sponsor organisation address
    9 Damonmill Square, Suite 4A, Concord, United States, 01742
    Public contact
    Jennifer J. Davagian, Cristcot HCA LLC, 978 2126380, jennifer.davagian@cristcot.com
    Scientific contact
    Mark C. Ensign, Cristcot HCA LLC, 978 2126380, mark.ensign@cristcot.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Sep 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Sep 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Sep 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of two dosage regimens of the study drug (hydrocortisone acetate 90 mg suppository) administered with the Sephure suppository applicator compared to placebo in the treatment of ulcerative colitis (UC) of the rectum using the Modified Mayo Score.
    Protection of trial subjects
    This study was conducted as specified in Protocol CHS1221 and in compliance with the International Council for Harmonization Good Clinical Practice (GCP) and other applicable regulatory requirements. Informed consent was obtained from a subject before enrollment into the study according to regulatory and legal requirements of the participating country. The consent form was dated and retained by the Investigator as part of the study records. The Investigator was not to perform any investigation specifically required only for the clinical study until valid consent was obtained. The date of consent was documented in the Electronic Data Capture (EDC) system. Subjects were to be given ample opportunity to inquire about the details of the study, and to make the willful decision whether or not to participate in the study. Subjects were withdrawn from the investigational product if any of the following criteria were met: • Subject experienced an AE that was considered related to the study treatment or study procedure and was severe enough in nature to warrant treatment discontinuation. The Investigator, in conjunction with the Global Medical Monitor, could decide to withdraw the subject for safety reasons. • Treatment with a prohibited medication was needed. • An increase in medication for the treatment of UC was needed. • Subject reached any safety stopping criteria (outlined in CSR).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Sep 2020
    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: 83
    Country: Number of subjects enrolled
    Romania: 106
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    Bulgaria: 8
    Country: Number of subjects enrolled
    Denmark: 14
    Country: Number of subjects enrolled
    France: 19
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Italy: 20
    Country: Number of subjects enrolled
    Georgia: 7
    Country: Number of subjects enrolled
    Hong Kong: 4
    Country: Number of subjects enrolled
    India: 79
    Country: Number of subjects enrolled
    Jordan: 24
    Country: Number of subjects enrolled
    Lebanon: 11
    Country: Number of subjects enrolled
    Moldova, Republic of: 29
    Country: Number of subjects enrolled
    Philippines: 69
    Country: Number of subjects enrolled
    Russian Federation: 15
    Country: Number of subjects enrolled
    South Africa: 14
    Country: Number of subjects enrolled
    Ukraine: 5
    Country: Number of subjects enrolled
    United States: 236
    Country: Number of subjects enrolled
    Türkiye: 20
    Country: Number of subjects enrolled
    Saudi Arabia: 3
    Country: Number of subjects enrolled
    Viet Nam: 2
    Worldwide total number of subjects
    784
    EEA total number of subjects
    266
    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)
    710
    From 65 to 84 years
    74
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date of First Consent: 24 Sep 2020 Date of Last Patient Last Visit: 19 Sep 2024 Subject Recruitment: 784 screened; 200 randomized Territories: Denmark, France, South Africa, Saudi Arabia, Bulgaria, Georgia, Jordan, Lebanon, Romania, Turkey, Moldova, Ukraine, Russia, Vietnam, India, Poland, Germany, Italy, Spain, Philippines, USA

    Pre-assignment
    Screening details
    		 For trial participation, subjects were required to meet all inclusion criteria (such as 18+ years of age, confirmed diagnosis and symptoms meeting criteria, able to sign informed consent, etc.) and were excluded if they met any of the exclusion criteria for the study (such as taking certain medications, certain medical histories, etc.).

    Pre-assignment period milestones
    Number of subjects started
    		 784
    Number of subjects completed
    		 200

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Physician decision: 584
    Period 1
    Period 1 title
    Dosing (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Arm A participants were given hydrocortisone acetate 90 mg suppositories twice a day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    hydrocortisone acetate suppository
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    Hydrocortisone acetate 90 mg rectal suppository administered twice daily, morning and evening, with the Sephure suppository applicator.

    Arm title
    		 Arm B
    Arm description
    		 Arm B participants were only given hydrocortisone acetate 90 mg suppositories once a day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    hydrocortisone acetate suppository
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    Hydrocortisone acetate 90 mg rectal suppository administered once daily, in the morning, with the Sephure suppository applicator and a placebo dose, given in a double-dummy manner, in the evening.

    Arm title
    		 Arm C
    Arm description
    		 Arm C participants were only given a placebo suppository.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo suppository
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    Arm C participants were given placebo suppositories twice a day (morning and evening) administered with the Sephure suppository applicator.

    Number of subjects in period 1 [1]
    		Arm A Arm B Arm C
    Started
    67
    67
    66
    Completed
    57
    56
    58
    Not completed
    10
    11
    8
         Physician decision
    1
    3
    2
         Consent withdrawn by subject
    1
    1
    2
         Adverse event, non-fatal
    4
    2
    3
         Randomization problem
    -
    1
    -
         Pregnancy
    -
    -
    1
         geopolitical tension
    1
    -
    -
         Lost to follow-up
    1
    4
    -
         Protocol deviation
    2
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The pre-assignment period (screening) included 784 subjects. The baseline period (dosing) included 200 randomized subjects.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Arm A participants were given hydrocortisone acetate 90 mg suppositories twice a day.

    Reporting group title
    Arm B
    Reporting group description
    		 Arm B participants were only given hydrocortisone acetate 90 mg suppositories once a day.

    Reporting group title
    Arm C
    Reporting group description
    		 Arm C participants were only given a placebo suppository.

    Reporting group values
    		 Arm A Arm B Arm C Total
    Number of subjects
    		 67 67 66 200
    Age categorical
    Units: Subjects
    Age continuous
    As the ITT population differs from the FAS by only a single subject and the Safety Set differs from the FAS by the treatment attribution of a single subject, tabular summaries of the demographics and baseline characteristics in these analysis sets have not been prepared. Additionally, no programmatic outputs are provided for the mITT Set.
    Units: years
        arithmetic mean (standard deviation)
    		 45.3 ( 19.76 ) 41.0 ( 18.80 ) 41.0 ( 19.73 ) -
    Gender categorical
    As the ITT population differs from the FAS by only a single subject and the Safety Set differs from the FAS by the treatment attribution of a single subject, tabular summaries of the demographics and baseline characteristics in these analysis sets have not been prepared. Additionally, no programmatic outputs are provided for the mITT Set.
    Units: Subjects
        Female
    		 37 37 35 109
        Male
    		 30 30 31 91
    Subject analysis sets

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set includes all randomized subjects who received at least one dose of study treatment. Subjects were included in the analysis according to the treatment received.

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set includes all randomized subjects following the principle of intent-to-treat (ITT).

    Subject analysis set title
    ITT Analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Set includes all randomized subjects who were randomized using the IRT system.

    Subject analysis set title
    Modified ITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The mITT Set includes all subjects in the ITT Set who did not have endocrinology intercurrent events

    Subject analysis sets values
    		 Safety Set Full Analysis Set ITT Analysis Modified ITT
    Number of subjects
    200
    200
    199
    174
    Age categorical
    Units: Subjects
    Age continuous
    As the ITT population differs from the FAS by only a single subject and the Safety Set differs from the FAS by the treatment attribution of a single subject, tabular summaries of the demographics and baseline characteristics in these analysis sets have not been prepared. Additionally, no programmatic outputs are provided for the mITT Set.
    Units: years
        arithmetic mean (standard deviation)
    ( )
    43.1 ( 14.90 )
    ( )
    ( )
    Gender categorical
    As the ITT population differs from the FAS by only a single subject and the Safety Set differs from the FAS by the treatment attribution of a single subject, tabular summaries of the demographics and baseline characteristics in these analysis sets have not been prepared. Additionally, no programmatic outputs are provided for the mITT Set.
    Units: Subjects
        Female
    109
        Male
    91

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Arm A participants were given hydrocortisone acetate 90 mg suppositories twice a day.

    Reporting group title
    Arm B
    Reporting group description
    		 Arm B participants were only given hydrocortisone acetate 90 mg suppositories once a day.

    Reporting group title
    Arm C
    Reporting group description
    		 Arm C participants were only given a placebo suppository.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set includes all randomized subjects who received at least one dose of study treatment. Subjects were included in the analysis according to the treatment received.

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set includes all randomized subjects following the principle of intent-to-treat (ITT).

    Subject analysis set title
    ITT Analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Set includes all randomized subjects who were randomized using the IRT system.

    Subject analysis set title
    Modified ITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The mITT Set includes all subjects in the ITT Set who did not have endocrinology intercurrent events

    Primary: Primary Efficacy Variable

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    End point title
    		 Primary Efficacy Variable
    End point description
    proportion of subjects with clinical remission at the End of Treatment visit (Day 29). Clinical remission is defined as the Modified Mayo Score of 0 to 2, with stool frequency subscore of 0 or 1 (minimum 1 point decrease from a Baseline score of 1 or 2), rectal bleeding subscore of 0, and endoscopic subscore of 0 or 1.
    End point type
    Primary
    End point timeframe
    29 days
    End point values
    		 Arm A Arm B Arm C ITT Analysis
    Number of subjects analysed
    67
    66
    66
    199
    Units: 0-8
    67
    66
    66
    199
    Statistical analysis title
    		 Primary Endpoint - End of Treatment
    Statistical analysis description
    A logistic regression model in which treatment, sex, concomitant ulcerative colitis medication use (user vs. nonuser), and geographical region are included as covariate terms (and remain in the model regardless of their significance) was used for the primary analysis.
    Comparison groups
    Arm A v Arm C
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0105
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    8.9331
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 1.3126
         upper limit
    		 60.7941
    Statistical analysis title
    		 Primary Endpoint - End of Treatment
    Statistical analysis description
    A logistic regression model in which treatment, sex, concomitant ulcerative colitis medication use (user vs. nonuser), and geographical region are included as covariate terms (and remain in the model regardless of their significance) was used for the primary analysis.
    Comparison groups
    Arm B v Arm C
    Number of subjects included in analysis
    132
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0061
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    10.2893
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 1.5305
         upper limit
    		 69.1744

    Secondary: Secondary Efficacy Variable - Rectal Bleeding

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    End point title
    		 Secondary Efficacy Variable - Rectal Bleeding
    End point description
    The following secondary endpoint was evaluated hierarchically with Baseline (Day 1) compared to End of Treatment (Day 29) and then Follow-up (Day 15): • proportion of subjects with a rectal bleeding subscore of 0. The secondary endpoints were evaluated as measured by the Modified Mayo Score according to the following: • Change in rectal bleeding from Baseline (Day 1) to End of Treatment (Day 29). • Change in rectal bleeding from Baseline (Day 1) to Follow-up (Day 15).
    End point type
    Secondary
    End point timeframe
    29 days
    End point values
    		 Arm A Arm B Arm C ITT Analysis
    Number of subjects analysed
    67
    66
    66
    199
    Units: 0-3
    67
    66
    66
    199
    Statistical analysis title
    		 Secondary - Rectal Bleeding, End of treatment B/C
    Statistical analysis description
    The secondary efficacy endpoints were evaluated using the same logistic regression test as the primary efficacy analysis. Odds ratios and risk differences with two-sided 97.5% confidence intervals are reported with the placebo group as the reference group. The proportions of subjects in each HCA 90 mg Suppository treatment group meeting the criteria defined were also compared with placebo using a one-sided Fisher Exact Test, similar to the primary efficacy analysis.
    Comparison groups
    Arm B v Arm C
    Number of subjects included in analysis
    132
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.082
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 1.831
         upper limit
    		 14.106
    Statistical analysis title
    		 Secondary - Rectal Bleeding Follow- up B/C
    Statistical analysis description
    The secondary efficacy endpoints were evaluated using the same logistic regression test as the primary efficacy analysis. Odds ratios and risk differences with two-sided 97.5% confidence intervals are reported with the placebo group as the reference group. The proportions of subjects in each HCA 90 mg Suppository treatment group meeting the criteria defined were also compared with placebo using a one-sided Fisher Exact Test, similar to the primary efficacy analysis.
    Comparison groups
    Arm B v Arm C
    Number of subjects included in analysis
    132
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0107
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.176
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 1.151
         upper limit
    		 8.761
    Statistical analysis title
    		 Secondary - Rectal Bleeding, End of treatment A/C
    Comparison groups
    Arm A v Arm C
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.836
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 2.098
         upper limit
    		 16.232
    Statistical analysis title
    		 Secondary - Rectal Bleeding Follow- up A/C
    Comparison groups
    Arm A v Arm C
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0456
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.524
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.894
         upper limit
    		 7.13

    Secondary: Secondary Efficacy Variable - Reduction in Stool Frequency

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    End point title
    		 Secondary Efficacy Variable - Reduction in Stool Frequency
    End point description
    The following secondary endpoint was evaluated hierarchically with Baseline (Day 1) compared to End of Treatment (Day 29) and then Follow-up (Day 15): • proportion of subjects with a reduction of stool frequency. Treatment response was defined as a score of 0 or 1, with at least a 1-point decrease from Baseline (Day 1) The secondary endpoints were evaluated as measured by the Modified Mayo Score according to the following: • Change in stool frequency from Baseline (Day 1) to End of Treatment (Day 29). • Change in stool frequency from Baseline (Day 1) to Follow-up (Day 15).
    End point type
    Secondary
    End point timeframe
    29 days
    End point values
    		 Arm A Arm B Arm C ITT Analysis
    Number of subjects analysed
    67
    66
    66
    199
    Units: 0-3
    67
    66
    66
    199
    Statistical analysis title
    		 Secondary - Stool Frequency, End of treatment B/C
    Statistical analysis description
    The secondary efficacy endpoints were evaluated using the same logistic regression test as the primary efficacy analysis. Odds ratios and risk differences with two-sided 97.5% confidence intervals are reported with the placebo group as the reference group. The proportions of subjects in each HCA 90 mg Suppository treatment group meeting the criteria defined were also compared with placebo using a one-sided Fisher Exact Test, similar to the primary efficacy analysis
    Comparison groups
    Arm B v Arm C
    Number of subjects included in analysis
    132
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0523
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.007
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.898
         upper limit
    		 4.486
    Statistical analysis title
    		 Secondary - Stool Frequency, Follow up B/C
    Statistical analysis description
    The secondary efficacy endpoints were evaluated using the same logistic regression test as the primary efficacy analysis. Odds ratios and risk differences with two-sided 97.5% confidence intervals are reported with the placebo group as the reference group. The proportions of subjects in each HCA 90 mg Suppository treatment group meeting the criteria defined were also compared with placebo using a one-sided Fisher Exact Test, similar to the primary efficacy analysis.
    Comparison groups
    Arm B v Arm C
    Number of subjects included in analysis
    132
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0802
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.903
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.835
         upper limit
    		 4.337
    Statistical analysis title
    		 Secondary - Stool Frequency, End of treatment A/C
    Comparison groups
    Arm A v Arm C
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1728
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.631
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 3.646
    Statistical analysis title
    		 Secondary - Stool Frequency, Follow up A/C
    Comparison groups
    Arm A v Arm C
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.17
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.679
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 3.912

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from time of subject screening (24 September 2020) and recruitment until end of trial (19 September 2024).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Arm B
    Reporting group description
    		 -

    Reporting group title
    Arm A
    Reporting group description
    		 -

    Reporting group title
    Arm C
    Reporting group description
    		 -

    Serious adverse events
    		 Arm B Arm A Arm C
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 66 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Arm B Arm A Arm C
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 67 (13.43%)
    10 / 67 (14.93%)
    8 / 66 (12.12%)
    Investigations
    Blood glucose increased
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 67 (2.99%)
    0 / 66 (0.00%)
         occurrences all number
    0
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 67 (2.99%)
    3 / 66 (4.55%)
         occurrences all number
    1
    2
    4
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 67 (2.99%)
    2 / 66 (3.03%)
         occurrences all number
    0
    2
    2
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 67 (2.99%)
    0 / 66 (0.00%)
         occurrences all number
    0
    2
    0
    Abdominal pain
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 67 (2.99%)
    2 / 66 (3.03%)
         occurrences all number
    2
    3
    2
    Flatulence
         subjects affected / exposed
    3 / 67 (4.48%)
    2 / 67 (2.99%)
    0 / 66 (0.00%)
         occurrences all number
    3
    3
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 67 (2.99%)
    2 / 66 (3.03%)
         occurrences all number
    0
    2
    2
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 67 (2.99%)
    0 / 66 (0.00%)
         occurrences all number
    1
    3
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    2
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Sep 2021
    Amendment to screening period and laboratory testing.
    09 May 2022
    Amendment to endoscopy screening procedure.
    18 Jul 2023
    Removal of interim analyses, and amendment to statistical analyses, diary, scoring inclusion, and screening procedures.
    08 Sep 2023
    Amendment to statistical analyses and DMC.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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