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    Clinical Trial Results:
    A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects with Moderate to Severe Ulcerative Colitis, Incorporating a Response-Adaptive, Double-blind Extension Phase

    Summary
    EudraCT number
    		 2020-003556-33
    Trial protocol
    		 PL  
    Global end of trial date
    12 Jul 2022

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BBT401-UC-005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04596293
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bridge Biotherapeutics, Inc.
    Sponsor organisation address
    C’s Tower #303, 58, Pangyo-ro 255beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea, Republic of,
    Public contact
    Clinical Trials Information, Bridge Biotherapeutics, Inc., +82 31 8092 3280, clinicaltrials@bridgebiorx.com
    Scientific contact
    Clinical Trials Information, Bridge Biotherapeutics, Inc., +82 31 8092 3280, clinicaltrials@bridgebiorx.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 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to explore the efficacy of orally administered BBT-401-1S in inducing a clinical response in subjects with active UC.
    Protection of trial subjects
    A subject was free to withdraw from the study at any time. In addition, a subject was withdrawn from dosing if any of the following criteria were met: • change in compliance with any inclusion/exclusion criterion that was clinically relevant and affected subject safety as determined by the investigator (or designee) • noncompliance with the study restrictions that might have affected subject safety or study assessments/objectives, as considered applicable by the investigator (or designee) • any clinically relevant sign or symptom (including disease worsening) that, in the opinion of the investigator (or designee), warranted subject withdrawal.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Mar 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 3
    Country: Number of subjects enrolled
    Poland: 7
    Country: Number of subjects enrolled
    Ukraine: 27
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    38
    EEA total number of subjects
    7
    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)
    38
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects with: - active UC for ≥3 months prior to Day 1 - inadequate response or disease relapse despite treatment of UC based on the local standard of care (randomised at Korean sites only) - total Mayo score ≥6, an endoscopic subscore ≥2, a rectal bleeding subscore ≥1, and a stool frequency subscore ≥1, regardless of standard of care history

    Period 1
    Period 1 title
    Induction Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    • The placebo capsules were identical in appearance to BBT-401-1S. • The same number of capsules were administered at each dosing occasion. • There were the same number of dosing occasions within the induction and extension phases. • Subjects, investigators, and other members of staff involved with the study (including those involved in clinical operations and study site monitoring) remained blinded to the treatment randomisation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 12 subjects were to receive placebo twice daily.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsules were identical in appearance to BBT-401-1S capsules but with the active study drug replaced with microcrystalline cellulose. At each dosing occasion, subjects received a total of 4 capsules orally. Subjects received study drug in the morning and evening. Subjects received the first dose of study drug at the study site on Day 1 and were to self-administer the study drug away from the study site for 56 days.

    Arm title
    		 BBT-401-1S Once Daily and Placebo QD
    Arm description
    		 12 subjects were to receive 800 mg BBT-401-1S once daily (QD) and placebo QD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BBT-401-1S 800 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    BBT-401-1S was supplied as white, opaque, hydroxypropyl methylcellulose capsules for oral administration. Each capsule of BBT-401-1S contained 200 mg BBT-401-1S with excipients. Subjects received 4 capsules orally in the morning once daily. Subjects received the first dose of study drug at the study site on Day 1 and were to self-administer the study drug away from the study site for 56 days.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsules were identical in appearance to BBT-401-1S capsules but with the active study drug replaced with microcrystalline cellulose. Subjects received 4 capsules of placebo orally in the evening once daily. Subjects received the first dose of study drug at the study site on Day 1 and were to self-administer the study drug away from the study site for 56 days.

    Arm title
    		 BBT-401-1S Twice Daily
    Arm description
    		 12 subjects were to receive 800 mg BBT-401-1S twice daily (BID)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BBT-401-1S 800 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    BBT-401-1S was supplied as white, opaque, hydroxypropyl methylcellulose capsules for oral administration. Each capsule of BBT-401-1S contained 200 mg BBT-401-1S with excipients. Subjects received 4 capsules orally in the morning and 4 capsules in the evening. Subjects received the first dose of study drug at the study site on Day 1 and were to self-administer the study drug away from the study site for 56 days.

    Number of subjects in period 1
    		Placebo BBT-401-1S Once Daily and Placebo QD BBT-401-1S Twice Daily
    Started
    13
    12
    13
    ITT Population
    11
    11
    11
    Completed
    11
    11
    10
    Not completed
    2
    1
    3
         Clinical progression
    1
    1
    -
         Consent withdrawn by subject
    -
    -
    2
         Adverse event, non-fatal
    1
    -
    -
         Other
    -
    -
    1
    Period 2
    Period 2 title
    Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    The placebo capsules were identical in appearance to BBT-401-1S. • The same number of capsules were administered at each dosing occasion. • There were the same number of dosing occasions within the induction and extension phases. • Subjects, investigators, and other members of staff involved with the study (including those involved in clinical operations and study site monitoring) remained blinded to the treatment randomisation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects were to receive placebo twice daily. Subjects who agreed to participate in the extension phase were to continue study drug administration while awaiting their clinical remission status from the local reader. Subjects were assigned to the treatment for the extension phase on receipt of their clinical remission status. - Subjects who achieved clinical remission in the induction phase were to continue the same treatment. - Subjects who did not achieve clinical remission in the induction phase and: 1) who received placebo BID were to receive 800 mg BBT-401-1S QD and placebo QD 2) who received 800 mg BBT-401-1S QD and placebo QD were to receive 800 mg BBT-401-1S BID 3) who received 800 mg BBT-401-1S BID were to continue the same treatment.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsules were identical in appearance to BBT-401-1S capsules but with the active study drug replaced with microcrystalline cellulose. At each dosing occasion, subjects received a total of 4 capsules orally. Subjects received study drug in the morning and evening.

    Arm title
    		 BBT-401-1S Once Daily and Placebo QD
    Arm description
    		 Subjects were to receive 800 mg BBT-401-1S once daily (QD) and placebo QD. Subjects who agreed to participate in the extension phase were to continue study drug administration while awaiting their clinical remission status from the local reader. Subjects were assigned to the treatment for the extension phase on receipt of their clinical remission status. - Subjects who achieved clinical remission in the induction phase were to continue the same treatment. - Subjects who did not achieve clinical remission in the induction phase and: 1) who received placebo BID were to receive 800 mg BBT-401-1S QD and placebo QD 2) who received 800 mg BBT-401-1S QD and placebo QD were to receive 800 mg BBT-401-1S BID 3) who received 800 mg BBT-401-1S BID were to continue the same treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BBT-401-1S 800 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    BBT-401-1S was supplied as white, opaque, hydroxypropyl methylcellulose capsules for oral administration. Each capsule of BBT-401-1S contained 200 mg BBT-401-1S with excipients. Subjects received 4 capsules orally in the morning once daily.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsules were identical in appearance to BBT-401-1S capsules but with the active study drug replaced with microcrystalline cellulose. Subjects received 4 capsules of placebo orally in the evening once daily.

    Arm title
    		 BBT-401-1S Twice Daily
    Arm description
    		 Subjects were to receive 800 mg BBT-401-1S twice daily (BID). Subjects who agreed to participate in the extension phase were to continue study drug administration while awaiting their clinical remission status from the local reader. Subjects were assigned to the treatment for the extension phase on receipt of their clinical remission status. - Subjects who achieved clinical remission in the induction phase were to continue the same treatment. - Subjects who did not achieve clinical remission in the induction phase and: 1) who received placebo BID were to receive 800 mg BBT-401-1S QD and placebo QD 2) who received 800 mg BBT-401-1S QD and placebo QD were to receive 800 mg BBT-401-1S BID 3) who received 800 mg BBT-401-1S BID were to continue the same treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BBT-401-1S 800 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    BBT-401-1S was supplied as white, opaque, hydroxypropyl methylcellulose capsules for oral administration. Each capsule of BBT-401-1S contained 200 mg BBT-401-1S with excipients. Subjects received 4 capsules orally in the morning and 4 capsules in the evening.

    Number of subjects in period 2
    		Placebo BBT-401-1S Once Daily and Placebo QD BBT-401-1S Twice Daily
    Started
    11
    11
    10
    Completed
    11
    10
    8
    Not completed
    0
    1
    2
         Consent withdrawn by subject
    -
    1
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 12 subjects were to receive placebo twice daily.

    Reporting group title
    BBT-401-1S Once Daily and Placebo QD
    Reporting group description
    		 12 subjects were to receive 800 mg BBT-401-1S once daily (QD) and placebo QD.

    Reporting group title
    BBT-401-1S Twice Daily
    Reporting group description
    		 12 subjects were to receive 800 mg BBT-401-1S twice daily (BID)

    Reporting group values
    		 Placebo BBT-401-1S Once Daily and Placebo QD BBT-401-1S Twice Daily Total
    Number of subjects
    		 13 12 13 38
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 13 12 13 38
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.1 ± 11.3 34.4 ± 9.7 42.1 ± 8.7 -
    Gender categorical
    Units: Subjects
        Female
    		 6 5 5 16
        Male
    		 7 7 8 22
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        Native Hawaiian or Other Pacific Inlander
    		 0 0 0 0
        White
    		 12 11 12 35
        Asian
    		 1 1 1 3
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 1 1
        Not Hispanic or Latino
    		 13 12 12 37
    Weight (kg) [b]
    Units: kg
        arithmetic mean (standard deviation)
    		 69.81 ± 14.17 74.08 ± 20.08 72.40 ± 11.49 -
    Subject analysis sets

    Subject analysis set title
    Placebo ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) population included all subjects who received at least 1 dose of study drug, and who had a partial Mayo score recorded on Day 1 and at least 1 post-baseline Mayo score recorded.

    Subject analysis set title
    BBT-401-1S Once Daily + Placebo Once Daily ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) population included all subjects who received at least 1 dose of study drug, and who had a partial Mayo score recorded on Day 1 and at least 1 post-baseline Mayo score recorded.

    Subject analysis set title
    BBT-401-1S Twice Daily ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) population included all subjects who received at least 1 dose of study drug, and who had a partial Mayo score recorded on Day 1 and at least 1 post-baseline Mayo score recorded.

    Subject analysis sets values
    		 Placebo ITT BBT-401-1S Once Daily + Placebo Once Daily ITT BBT-401-1S Twice Daily ITT
    Number of subjects
    11
    11
    11
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    11
    11
    11
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    47.0 ± 9.6
    35.0 ± 9.9
    42.1 ± 9.1
    Gender categorical
    Units: Subjects
        Female
    4
    4
    5
        Male
    7
    7
    6
    Race
    Units: Subjects
        American Indian or Alaska Native
    0
    0
    0
        Black or African American
    0
    0
    0
        Native Hawaiian or Other Pacific Inlander
    0
    0
    0
        White
    11
    10
    10
        Asian
    0
    1
    1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0
    0
    1
        Not Hispanic or Latino
    11
    11
    10
    Weight (kg) [b]
    Units: kg
        arithmetic mean (standard deviation)
    72.14 ± 14.15
    75.72 ± 20.20
    70.47 ± 10.15

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 12 subjects were to receive placebo twice daily.

    Reporting group title
    BBT-401-1S Once Daily and Placebo QD
    Reporting group description
    		 12 subjects were to receive 800 mg BBT-401-1S once daily (QD) and placebo QD.

    Reporting group title
    BBT-401-1S Twice Daily
    Reporting group description
    		 12 subjects were to receive 800 mg BBT-401-1S twice daily (BID)
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were to receive placebo twice daily. Subjects who agreed to participate in the extension phase were to continue study drug administration while awaiting their clinical remission status from the local reader. Subjects were assigned to the treatment for the extension phase on receipt of their clinical remission status. - Subjects who achieved clinical remission in the induction phase were to continue the same treatment. - Subjects who did not achieve clinical remission in the induction phase and: 1) who received placebo BID were to receive 800 mg BBT-401-1S QD and placebo QD 2) who received 800 mg BBT-401-1S QD and placebo QD were to receive 800 mg BBT-401-1S BID 3) who received 800 mg BBT-401-1S BID were to continue the same treatment.

    Reporting group title
    BBT-401-1S Once Daily and Placebo QD
    Reporting group description
    		 Subjects were to receive 800 mg BBT-401-1S once daily (QD) and placebo QD. Subjects who agreed to participate in the extension phase were to continue study drug administration while awaiting their clinical remission status from the local reader. Subjects were assigned to the treatment for the extension phase on receipt of their clinical remission status. - Subjects who achieved clinical remission in the induction phase were to continue the same treatment. - Subjects who did not achieve clinical remission in the induction phase and: 1) who received placebo BID were to receive 800 mg BBT-401-1S QD and placebo QD 2) who received 800 mg BBT-401-1S QD and placebo QD were to receive 800 mg BBT-401-1S BID 3) who received 800 mg BBT-401-1S BID were to continue the same treatment.

    Reporting group title
    BBT-401-1S Twice Daily
    Reporting group description
    		 Subjects were to receive 800 mg BBT-401-1S twice daily (BID). Subjects who agreed to participate in the extension phase were to continue study drug administration while awaiting their clinical remission status from the local reader. Subjects were assigned to the treatment for the extension phase on receipt of their clinical remission status. - Subjects who achieved clinical remission in the induction phase were to continue the same treatment. - Subjects who did not achieve clinical remission in the induction phase and: 1) who received placebo BID were to receive 800 mg BBT-401-1S QD and placebo QD 2) who received 800 mg BBT-401-1S QD and placebo QD were to receive 800 mg BBT-401-1S BID 3) who received 800 mg BBT-401-1S BID were to continue the same treatment.

    Subject analysis set title
    Placebo ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) population included all subjects who received at least 1 dose of study drug, and who had a partial Mayo score recorded on Day 1 and at least 1 post-baseline Mayo score recorded.

    Subject analysis set title
    BBT-401-1S Once Daily + Placebo Once Daily ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) population included all subjects who received at least 1 dose of study drug, and who had a partial Mayo score recorded on Day 1 and at least 1 post-baseline Mayo score recorded.

    Subject analysis set title
    BBT-401-1S Twice Daily ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) population included all subjects who received at least 1 dose of study drug, and who had a partial Mayo score recorded on Day 1 and at least 1 post-baseline Mayo score recorded.

    Primary: The clinical response at Day 57, as measured by a reduction of ≥3 points and ≥30% improvement from baseline of total Mayo score, which included a decrease in rectal bleeding subscope of ≥1 point or an absolute rectal bleeding subscore ≤1.

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    End point title
    		 The clinical response at Day 57, as measured by a reduction of ≥3 points and ≥30% improvement from baseline of total Mayo score, which included a decrease in rectal bleeding subscope of ≥1 point or an absolute rectal bleeding subscore ≤1.
    End point description
    The primary efficacy endpoint was the clinical response rate at Day 57, as measured by a reduction of ≥3 points and ≥30% improvement from baseline of total Mayo score, which included a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore ≤1.
    End point type
    Primary
    End point timeframe
    Baseline to Day 57.
    End point values
    		 Placebo ITT BBT-401-1S Once Daily + Placebo Once Daily ITT BBT-401-1S Twice Daily ITT
    Number of subjects analysed
    11
    11
    11
    Units: participants
        Clinical response rate at Day 57
    7
    6
    6
    Statistical analysis title
    		 Clinical response rate: BBT-401-1S QD + Placebo QD
    Comparison groups
    Placebo ITT v BBT-401-1S Once Daily + Placebo Once Daily ITT
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 23.4
         upper limit
    		 83.3
    Statistical analysis title
    		 Clinical response rate: BBT-401-1S BID
    Comparison groups
    BBT-401-1S Twice Daily ITT v Placebo ITT
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 23.4
         upper limit
    		 83.3

    Secondary: Clinical remission at Day 57, as measured by a total Mayo score of ≤2 points, with no individual subscore exceeding 1 point

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    End point title
    		 Clinical remission at Day 57, as measured by a total Mayo score of ≤2 points, with no individual subscore exceeding 1 point
    End point description
    Clinical remission at Day 57, as measured by a total Mayo score of ≤2 points, with no individual subscore exceeding 1 point
    End point type
    Secondary
    End point timeframe
    Baseline to Day 57
    End point values
    		 Placebo ITT BBT-401-1S Once Daily + Placebo Once Daily ITT BBT-401-1S Twice Daily ITT
    Number of subjects analysed
    11
    11
    11
    Units: participants with clinical remission
        Clinical remission at Day 57
    4
    2
    1
    Statistical analysis title
    		 Clinical Remission at Day 57: BBT-401-1S QD + Plac
    Comparison groups
    Placebo ITT v BBT-401-1S Once Daily + Placebo Once Daily ITT
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.6351
    Method
    		 Fisher exact
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.3
         upper limit
    		 51.8
    Statistical analysis title
    		 Clinical Remission at Day 57: BBT-401-1S BID
    Comparison groups
    Placebo ITT v BBT-401-1S Twice Daily ITT
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.3108
    Method
    		 Fisher exact
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 41.3

    Secondary: Achievement of endoscopic remission at Day 57, as measured by a Mayo endoscopic subscore of 0 or 1.

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    End point title
    		 Achievement of endoscopic remission at Day 57, as measured by a Mayo endoscopic subscore of 0 or 1.
    End point description
    Achievement of endoscopic remission at Day 57, as measured by a Mayo endoscopic subscore of 0 or 1.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 57
    End point values
    		 Placebo ITT BBT-401-1S Once Daily + Placebo Once Daily ITT BBT-401-1S Twice Daily ITT
    Number of subjects analysed
    11
    11
    11
    Units: participants
        Achievement of Endoscopic Remission at Day 57
    5
    4
    3
    Statistical analysis title
    		 Achievement of Endoscopic Remission: BBT-401-1S QD
    Comparison groups
    Placebo ITT v BBT-401-1S Once Daily + Placebo Once Daily ITT
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.9
         upper limit
    		 69.2
    Statistical analysis title
    		 Achievement of Endoscopic Remission: BBT-401-1S BI
    Comparison groups
    Placebo ITT v BBT-401-1S Twice Daily ITT
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.6594
    Method
    		 Fisher exact
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6
         upper limit
    		 61

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening (up to 28 days prior to Day 1) to follow-up visit (Day 71, +/- 7 days)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    BBT-401-1S Once Daily and Placebo Once Daily
    Reporting group description
    		 -

    Reporting group title
    BBT-401-1S Twice Daily
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo BBT-401-1S Once Daily and Placebo Once Daily BBT-401-1S Twice Daily
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Surgical and medical procedures
    Abscess drainage
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
    Additional description: Occurred between the induction and extension phases
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo BBT-401-1S Once Daily and Placebo Once Daily BBT-401-1S Twice Daily
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 13 (15.38%)
    4 / 12 (33.33%)
    7 / 13 (53.85%)
    Investigations
    Lipase increased
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Blood glucose increased
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Coagulation factor decreased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Gamma-glutamyl transferase increased
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    0
    Leukocytosis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Joint stiffness
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    0
    2
    0
    Sinusitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Apr 2021
    Version 4.1, Korea • Added that subjects must have had an inadequate response or disease relapse (despite treatment for ulcerative colitis according to the local standard of care) for inclusion in the study. • Added that over-the-counter and prescription antidiarrhoeals and probiotics were excluded from 2 weeks prior to screening and for the duration of the study. • Added that colonic dysplasia was exclusionary. • Added that the presence or a history of cancer that had not been in full remission for ≥5 years are exclusionary, except for completely resected or treated squamous cell or basal cell carcinomas of the skin. • Added that hypersensitivity to any of the active ingredients or excipients of BBT-401-1S or placebo was exclusionary. • Added an additional visit on Day 126 in the extension phase for safety monitoring. • Clarified the duration of the induction phase for subjects who subsequently progress into the extension phase.
    02 Aug 2021
    Version 5.0 • Updated that rectally administered 5-aminosalicylic acid that had been stable for <5 weeks was exclusionary. • Clarified that concomitant medications for ulcerative colitis should have been maintained at a stable dose until the last dose of study drug. • Added that over-the-counter and prescription antidiarrhoeals and probiotics are excluded for the duration of the study. • Added guidelines for performing assessments and procedures during the coronavirus disease-2019 pandemic.
    02 Aug 2021
    Version 5.1, Korea • Updated that rectally administered 5-aminosalicylic acid that had been stable for <5 weeks was exclusionary. • Clarified that concomitant medications for ulcerative colitis should have been maintained at a stable dose until the last dose of study drug.

    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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