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    Clinical Trial Results:
    A Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

    Summary
    EudraCT number
    2018-000930-37
    Trial protocol
    NL   DE   GB   FR   ES   HU   IT  
    Global end of trial date
    10 Jan 2022

    Results information
    Results version number
    v2(current)
    This version publication date
    16 Apr 2023
    First version publication date
    25 Jan 2023
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Clarifying text added to Recruitment details, participant flow and arm descriptions.

    Trial information

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    Trial identification
    Sponsor protocol code
    M15-722
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03695185
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United States, SL6 4UB
    Public contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.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
    10 Jan 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to investigate the efficacy, safety, and tolerability of ravagalimab (ABBV-323) in subjects with moderate to severe ulcerative colitis (UC) who failed prior therapy.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Mar 2019
    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
    Canada: 1
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    42
    EEA total number of subjects
    27
    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)
    40
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    42 participants were enrolled in Induction Period to receive ravagalimab 600 mg intravenously (IV) then ravagalimab 300 mg subcutaneously (SC) up to Week 12. Participants who completed Induction Period and achieved clinical response per partial adapted Mayo score at Week 12 entered Maintenance Period to receive ravagalimab 300 mg SC up to Week 102.

    Pre-assignment
    Screening details
    Participants from double-blind (DB) placebo-controlled (prior to protocol version 4.0 of this study) continued their treatment as randomized in the Induction Period. No participants were enrolled in the placebo group and therefore no results are presented for this arm.

    Period 1
    Period 1 title
    Induction Period (Week 0 to Week 12)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Ravagalimab 600 mg/300 mg
    Arm description
    Subjects received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period. Subjects who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC every other week (EOW) from Week 12 through Week 102.
    Arm type
    Experimental

    Investigational medicinal product name
    Ravagalimab 600 mg
    Investigational medicinal product code
    Other name
    ABBV-323
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ravagalimab 600 mg administered by IV infusion.

    Investigational medicinal product name
    Ravagalimab 300 mg
    Investigational medicinal product code
    Other name
    ABBV-323
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Ravagalimab 300 mg administered by SC injection.

    Number of subjects in period 1
    Ravagalimab 600 mg/300 mg
    Started
    42
    Completed
    29
    Not completed
    13
         Adverse event
    1
         Withdrew consent
    2
         Lack of efficacy
    10
    Period 2
    Period 2 title
    Maintenance Period (Week 12 to Week 102)
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Ravagalimab 600 mg/300 mg
    Arm description
    Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period. Participants who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC every other week (EOW) from Week 12 through Week 102.
    Arm type
    Experimental

    Investigational medicinal product name
    Ravagalimab 600 mg
    Investigational medicinal product code
    Other name
    ABBV-323
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ravagalimab 600 mg administered by IV infusion.

    Investigational medicinal product name
    Ravagalimab 300 mg
    Investigational medicinal product code
    Other name
    ABBV-323
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Ravagalimab 300 mg administered by SC injection.

    Number of subjects in period 2
    Ravagalimab 600 mg/300 mg
    Started
    29
    Completed
    1
    Not completed
    28
         Withdrew consent
    3
         Reason not specified
    23
         Lack of efficacy
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ravagalimab 600 mg/300 mg
    Reporting group description
    Subjects received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period. Subjects who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC every other week (EOW) from Week 12 through Week 102.

    Reporting group values
    Ravagalimab 600 mg/300 mg Total
    Number of subjects
    42 42
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.3 ( 14.41 ) -
    Gender categorical
    Units: Subjects
        Female
    17 17
        Male
    25 25
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    5 5
        Not Hispanic or Latino
    37 37
        Unknown or Not Reported
    0 0
    Race
    Units: Subjects
        White
    39 39
        Non-White
    3 3

    End points

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    End points reporting groups
    Reporting group title
    Ravagalimab 600 mg/300 mg
    Reporting group description
    Subjects received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period. Subjects who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC every other week (EOW) from Week 12 through Week 102.
    Reporting group title
    Ravagalimab 600 mg/300 mg
    Reporting group description
    Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period. Participants who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC every other week (EOW) from Week 12 through Week 102.

    Primary: Percentage of Subjects with Endoscopic Improvement During Induction Period

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    End point title
    Percentage of Subjects with Endoscopic Improvement During Induction Period [1]
    End point description
    Endoscopic Improvement is defined as Mayo endoscopic subscore of 0 or 1. Mayo endoscopic score is classified as 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Higher score indicates worsening of the disease. Full Analysis Set (FAS) included all enrolled subjects who received at least 1 dose of ravagalimab. The number of responders is calculated based on the total number of subjects and estimated response rate, rounding to a nearest whole integer. Data was reported only for the Induction Period.
    End point type
    Primary
    End point timeframe
    At Week 8
    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: Only descriptive analysis was performed for this endpoint.
    End point values
    Ravagalimab 600 mg/300 mg
    Number of subjects analysed
    42
    Units: percentage of subjects
        number (not applicable)
    18.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Clinical Remission per Adapted Mayo Score During Induction Period

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    End point title
    Percentage of Subjects with Clinical Remission per Adapted Mayo Score During Induction Period
    End point description
    Clinical remission per Adapted Mayo score is defined as stool frequency subscore (SFS) <=1, and not greater than baseline, rectal bleeding subscore (RBS) = 0, and endoscopic subscore <=1. Adapted Mayo Score is composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal), Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed), Endoscopic subscore confirmed by central reader, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). Overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. FAS included all enrolled subjects who received at least 1 dose of ravagalimab. Number of responders is calculated based on the total number of subjects and estimated response rate, rounding to nearest whole integer. Data was reported only for the Induction Period.
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    Ravagalimab 600 mg/300 mg
    Number of subjects analysed
    42
    Units: percentage of subjects
        number (not applicable)
    9.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Clinical Response Per Adapted Mayo Score During Induction Period

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    End point title
    Percentage of Subjects With Clinical Response Per Adapted Mayo Score During Induction Period
    End point description
    Clinical response per Adapted Mayo score is defined as the decrease from Baseline ≥2 points and ≥30%, PLUS a decrease in RBS ≥1 or an absolute RBS ≤1. The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed), Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 with higher scores representing more severe disease. FAS included all enrolled subjects who received at least 1 dose of ravagalimab. The number of responders is calculated based on the total number of subjects and estimated response rate, rounding to a nearest whole integer. Data was reported only for the Induction Period.
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    Ravagalimab 600 mg/300 mg
    Number of subjects analysed
    42
    Units: percentage of subjects
        number (not applicable)
    40.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Clinical Response Per Partial Adapted Mayo Score During Induction Period

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    End point title
    Percentage of Subjects With Clinical Response Per Partial Adapted Mayo Score During Induction Period
    End point description
    Clinical response per Partial Adapted Mayo Score is defined as a decrease in Partial Adapted Mayo score ≥1 point and ≥30% from Baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1. The Partial Adapted Mayo Score is a composite score of UC disease activity based on the following 2 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Adapted Mayo score ranges from 0 to 6 with higher scores representing more severe disease. FAS included all enrolled subjects who received at least 1 dose of ravagalimab. The number of responders is calculated based on the total number of subjects and estimated response rate, rounding to a nearest whole integer. Data was reported only for the Induction Period.
    End point type
    Secondary
    End point timeframe
    Up to Week 8
    End point values
    Ravagalimab 600 mg/300 mg
    Number of subjects analysed
    42
    Units: percentage of subjects
        number (not applicable)
    57.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Clinical Remission per Full Mayo Score During Induction Period in Subjects With a Full Mayo Score of 6 to 12 at Baseline

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    End point title
    Percentage of Subjects With Clinical Remission per Full Mayo Score During Induction Period in Subjects With a Full Mayo Score of 6 to 12 at Baseline
    End point description
    Clinical Remission per full Mayo score (FMS) is defined as Full Mayo score <=2 with no subscore >1. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to the nearest whole integer. FAS included all enrolled subjects who received at least 1 dose of ravagalimab. Subjects analysed are the number of subjects available for analyses. Data was reported only for the Induction Period.
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    Ravagalimab 600 mg/300 mg
    Number of subjects analysed
    40
    Units: percentage of subjects
        number (not applicable)
    7.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Endoscopic Remission During Induction Period

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    End point title
    Percentage of Subjects with Endoscopic Remission During Induction Period
    End point description
    Endoscopic remission is defined as Mayo endoscopic subscore = 0. Mayo endoscopic subscore is classified as 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Higher score indicates worsening of the disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to the nearest whole integer. FAS included all enrolled subjects who received at least 1 dose of ravagalimab. Data was reported only for the Induction Period.
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    Ravagalimab 600 mg/300 mg
    Number of subjects analysed
    42
    Units: percentage of subjects
        number (not applicable)
    0.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to safety follow up visit (up to approximately 116 weeks)
    Adverse event reporting additional description
    Safety Analysis Set included all subjects who received at least 1 dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Maintenance Period: Ravagalimab 300 mg
    Reporting group description
    Subjects who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC EOW from Week 12 through Week 102.

    Reporting group title
    Induction Period: Ravagalimab 600 mg/300 mg
    Reporting group description
    Subjects received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period.

    Serious adverse events
    Maintenance Period: Ravagalimab 300 mg Induction Period: Ravagalimab 600 mg/300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 42 (4.76%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    COLITIS ULCERATIVE
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 42 (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
    PERIRECTAL ABSCESS
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LARGE INTESTINE INFECTION
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    Maintenance Period: Ravagalimab 300 mg Induction Period: Ravagalimab 600 mg/300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 29 (65.52%)
    15 / 42 (35.71%)
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    4 / 29 (13.79%)
    2 / 42 (4.76%)
         occurrences all number
    4
    2
    PARAESTHESIA
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 42 (2.38%)
         occurrences all number
    4
    1
    General disorders and administration site conditions
    FATIGUE
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 42 (4.76%)
         occurrences all number
    3
    7
    PYREXIA
         subjects affected / exposed
    4 / 29 (13.79%)
    2 / 42 (4.76%)
         occurrences all number
    5
    2
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 42 (2.38%)
         occurrences all number
    2
    1
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 42 (0.00%)
         occurrences all number
    2
    0
    HAEMORRHOIDS
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 42 (7.14%)
         occurrences all number
    1
    3
    NAUSEA
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 42 (7.14%)
         occurrences all number
    1
    3
    Skin and subcutaneous tissue disorders
    ECZEMA
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 42 (0.00%)
         occurrences all number
    2
    0
    RASH
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 42 (7.14%)
         occurrences all number
    1
    3
    PRURITUS
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 42 (2.38%)
         occurrences all number
    3
    1
    SKIN LESION
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 42 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    6 / 29 (20.69%)
    0 / 42 (0.00%)
         occurrences all number
    7
    0
    BACK PAIN
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 42 (2.38%)
         occurrences all number
    3
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 42 (0.00%)
         occurrences all number
    3
    0
    TOOTH ABSCESS
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 42 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    IRON DEFICIENCY
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 42 (2.38%)
         occurrences all number
    2
    1
    VITAMIN D DEFICIENCY
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 42 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Aug 2018
    The following changes were implemented with Amendment 1: -Clarified where dose and duration requirements was specified in the body text. -Highlighted key secondary endpoints and moved the rest to exploratory endpoints. -Rescreening was added. -"Systemic hypersensitivity reactions" was changed to "anaphylaxis," and text was added in regards to the types of tests to be carried out in the event of a suspected anaphylaxis. -Revised text to remove the requirement of additional consent for the use of biopsy samples for biomarker research. -Specified the only samples that are optional are blood samples and where the biopsies are taken from. -Added text to clarify that the initiation and/or increase of oral aminosalicylates, immunomodulators, IV or oral corticosteroids, and/or UC-related antibiotics is prohibited through Week 12 specifically, and that the initiation and/or increase of the aforementioned drugs is permissible after discussion with the AbbVie TA MD starting at Week 12. -Provided more detailed text around timing of Day 1 and subsequent serum ABBV-323 and anti-drug antibody (ADA)/ neutalizing antibody (nAb) collection.
    13 Feb 2019
    The following changes were implemented with Amendment 2: -Deleted secondary objectives and updated the overall objective. -Clarified that primary and secondary endpoints are efficacy endpoints and changed the terminology of "safety assessments" to "safety endpoints". -Updated language regarding optional continuation from the induction period into the maintenance period. -Included text regarding the provision of a separate study drug administration guideline. -Updated Primary Analysis text for clarification. -Revised wording to clarify that the subject must understand all aspects of the study and personally sign the informed consent. -Revised wording to further clarify that sites should avoid administration of two consecutive doses of ABBV-323 sooner than 7 days apart. -Updated text regarding golimumab induction regimen. -Updated the footnote 'Lab assessments will only need to be repeated at Baseline if the time between Screening and Baseline is greater than 14 days, or if the subject's health status has changed to warrant a repeat test'. -Changed steroid tapering after Week 12 and during the Maintenance Period from mandatory to optional. -Updated the biomarker lab activities to indicate the exact parameters that will be analyzed at each visit.
    29 May 2019
    The following changes were implemented with Amendment 3: -Changed the study design from randomized, double-blind, placebo-controlled to open-label.
    06 May 2020
    The following changes were implemented with Amendment 4: -Expanded the maintenance period by an additional 52 weeks with similar, although reduced study procedures as during Week 12 through Week 52.
    04 Dec 2020
    The following changes were implemented with Amendment 5: -Added ustekinumab to approved therapies list for key eligibility criteria. -Removed text from key eligibility criterion requiring open-label (OL) use of tofacitinib if received in a clinical trial. -Clarified endpoint definitions. -Removed discussion of the data monitoring committee (DMC) from the study design. -Clarified text regarding primary and interim analysis and the timing of termination of study enrollment, and explicitly permit additional statistical analysis if needed. -Update eligibility criterion, with details regarding subject eligibility with regards to COVID-19 (coronavirus SARS-CoV-2) infection, to remove requirement for tofacitinib and ustekinumab to have been given in open label fashion if received in a clinical trial, and corrected language on, prohibiting pregnancy and breastfeeding. -Clarified discontinuation of study drug as well as study participation. -Clarified that active tuberculosis (TB) is an adverse event of special interest. -Removed sensitivity analysis for the primary efficacy endpoint. -Added Hepatitis B screening, Hepatitis C screening, HIV test, and SARSCoV-2 molecular test to the list of clinical tests which may be performed during the study.

    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
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