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    Clinical Trial Results:
    A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients with Atopic Dermatitis

    Summary
    EudraCT number
    2017-000873-35
    Trial protocol
    CZ   HU   AT   ES   PL   FR   DK   IT  
    Global end of trial date

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Jun 2022
    First version publication date
    02 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I4V-MC-JAHN
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03334435
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Trial Number: 16587
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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
    Interim
    Date of interim/final analysis
    21 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Sep 2020
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis. Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    Background topical corticosteroids were permitted for use at the discretion of the investigator.
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Mar 2018
    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
    Austria: 49
    Country: Number of subjects enrolled
    France: 34
    Country: Number of subjects enrolled
    Poland: 132
    Country: Number of subjects enrolled
    Argentina: 114
    Country: Number of subjects enrolled
    Australia: 109
    Country: Number of subjects enrolled
    India: 31
    Country: Number of subjects enrolled
    Israel: 34
    Country: Number of subjects enrolled
    Japan: 244
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 107
    Country: Number of subjects enrolled
    Mexico: 107
    Country: Number of subjects enrolled
    Taiwan: 90
    Country: Number of subjects enrolled
    Czechia: 102
    Country: Number of subjects enrolled
    Germany: 196
    Country: Number of subjects enrolled
    Italy: 68
    Country: Number of subjects enrolled
    Spain: 80
    Country: Number of subjects enrolled
    Switzerland: 18
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    Hungary: 72
    Country: Number of subjects enrolled
    Russian Federation: 51
    Worldwide total number of subjects
    1645
    EEA total number of subjects
    740
    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)
    1602
    From 65 to 84 years
    43
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants who entered Study JAHN were classified as “Responders and Partial Responders (RPR): Investigator's Global Assessment (IGA) of (0,1, or 2) at entry to study JAHN and never rescued in originating study” or “Non-responders: those not meeting definition of RPR".

    Pre-assignment
    Screening details
    Participants who entered JAHN previously participated in JAHL, JAHM and JAIY and met the criteria for those studies, and, in the opinion of the investigator, there was unacceptable risk for the participants continued participation in the study. OR Participants who directly entered JAHN and met the criteria of JAHL, JAHM and JAIY.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally

    Arm title
    Bari 1- milligram (mg)
    Arm description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.
    Arm type
    Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    Other name
    LY3009104
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally

    Arm title
    Bari 2-mg
    Arm description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.
    Arm type
    Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    Other name
    LY3009104
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally

    Arm title
    Bari 4-mg
    Arm description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.
    Arm type
    Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    Other name
    LY3009104
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally

    Arm title
    Bari 2-mg Open-Label Addendum
    Arm description
    Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.
    Arm type
    Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    Other name
    LY3009104
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally

    Number of subjects in period 1
    Placebo Bari 1- milligram (mg) Bari 2-mg Bari 4-mg Bari 2-mg Open-Label Addendum
    Started
    91
    45
    519
    743
    247
    Completed
    2
    2
    12
    15
    5
    Not completed
    89
    43
    507
    728
    242
         Death
    -
    -
    -
    1
    -
         Lack of efficacy
    3
    5
    76
    140
    61
         Not specified
    -
    1
    3
    2
    1
         Ongoing as of Week 52
    70
    32
    379
    519
    146
         Adverse event, non-fatal
    2
    1
    9
    23
    13
         Consent withdrawn by subject
    11
    4
    38
    42
    20
         Lost to follow-up
    3
    -
    2
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.

    Reporting group title
    Bari 1- milligram (mg)
    Reporting group description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.

    Reporting group title
    Bari 2-mg
    Reporting group description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.

    Reporting group title
    Bari 4-mg
    Reporting group description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.

    Reporting group title
    Bari 2-mg Open-Label Addendum
    Reporting group description
    Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.

    Reporting group values
    Placebo Bari 1- milligram (mg) Bari 2-mg Bari 4-mg Bari 2-mg Open-Label Addendum Total
    Number of subjects
    91 45 519 743 247 1645
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    35.2 ± 14.06 33.5 ± 8.49 34.2 ± 12.69 35.6 ± 12.85 34.9 ± 12.98 -
    Gender categorical
    Units: Subjects
        Female
    44 16 206 239 112 617
        Male
    47 29 313 504 135 1028
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    6 4 10 6 16 42
        Asian
    32 7 174 282 13 508
        Native Hawaiian or Other Pacific Islander
    0 0 1 0 0 1
        Black or African American
    0 0 1 1 1 3
        White
    48 32 315 429 211 1035
        More than one race
    5 2 18 23 6 54
        Unknown or Not Reported
    0 0 0 2 0 2
    Region of Enrollment
    Units: Subjects
        Argentina
    6 2 36 46 24 114
        Hungary
    7 2 15 21 27 72
        Czechia
    3 3 22 46 28 102
        Japan
    11 3 89 141 0 244
        Switzerland
    0 1 5 9 3 18
        India
    5 0 7 19 0 31
        Spain
    2 1 27 26 24 80
        Russia
    0 1 9 13 28 51
        Austria
    2 0 12 23 12 49
        South Korea
    9 1 39 58 0 107
        Taiwan
    8 2 30 50 0 90
        Denmark
    0 0 0 0 7 7
        Poland
    10 7 45 70 0 132
        Italy
    7 4 16 26 15 68
        Mexico
    9 5 29 21 43 107
        Israel
    1 0 16 13 4 34
        France
    0 0 15 19 0 34
        Australia
    4 1 30 42 32 109
        Germany
    7 12 77 100 0 196

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.

    Reporting group title
    Bari 1- milligram (mg)
    Reporting group description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.

    Reporting group title
    Bari 2-mg
    Reporting group description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.

    Reporting group title
    Bari 4-mg
    Reporting group description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.

    Reporting group title
    Bari 2-mg Open-Label Addendum
    Reporting group description
    Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.

    Subject analysis set title
    RPR-Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Responders or partial responders (RPR) [Investigator's Global Assessment (IGA) of (0,1, or 2) at entry to study JAHN and never rescued in originating study] participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally.

    Subject analysis set title
    RPR-Bari 1-mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.

    Subject analysis set title
    RPR-Bari 2-mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally.

    Subject analysis set title
    RPR-Bari 4-mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.

    Subject analysis set title
    Bari 2 mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.

    Subject analysis set title
    Bari 4 mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.ly.

    Subject analysis set title
    NR: Bari 1 mg to 2 mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Non-responder (NR) [those not meeting definition of RPR] participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.

    Subject analysis set title
    NR: Bari 1 mg to 4 mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.

    Subject analysis set title
    NR: Bari 2 mg to 2 mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.

    Subject analysis set title
    NR: Bari 2 mg to 4 mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.

    Subject analysis set title
    NR: Bari 4 mg to 4 mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.

    Subject analysis set title
    NR: Placebo to Bari 2 mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.

    Subject analysis set title
    NR: Placebo to Bari 4 mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.

    Subject analysis set title
    Bari 2-mg Open-Label Addendum
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.

    Subject analysis set title
    Bari 1 mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.

    Primary: Responder and Partial Responders (RPR): Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1

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    End point title
    Responder and Partial Responders (RPR): Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 [1]
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall RPR population.
    End point type
    Primary
    End point timeframe
    Weeks 16, 36 and 52
    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: The results were analyzed using non-responder imputation (NRI).
    End point values
    RPR-Placebo RPR-Bari 1-mg RPR-Bari 2-mg RPR-Bari 4-mg
    Number of subjects analysed
    52
    45
    54
    70
    Units: participants
    number (not applicable)
        Week 16
    19
    21
    32
    34
        Week 36
    12
    14
    34
    26
        Week 52
    15
    16
    27
    28
    No statistical analyses for this end point

    Primary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

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    End point title
    RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 [2]
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall RPR population.
    End point type
    Primary
    End point timeframe
    Weeks 16, 36, and 52
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The results were analyzed using non-responder imputation (NRI).
    End point values
    RPR-Placebo RPR-Bari 2-mg RPR-Bari 4-mg
    Number of subjects analysed
    34
    53
    63
    Units: participants
    number (not applicable)
        Week 16
    16
    24
    20
        Week 36
    14
    13
    19
        Week 52
    10
    16
    20
    No statistical analyses for this end point

    Secondary: RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

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    End point title
    RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall RPR population.
    End point type
    Secondary
    End point timeframe
    Weeks 16, 36, and 52
    End point values
    RPR-Placebo RPR-Bari 1-mg RPR-Bari 2-mg RPR-Bari 4-mg
    Number of subjects analysed
    52
    45
    54
    70
    Units: participants
    number (not applicable)
        Week 16
    36
    35
    44
    51
        Week 36
    25
    27
    44
    41
        Week 52
    24
    24
    39
    41
    No statistical analyses for this end point

    Secondary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2

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    End point title
    RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall RPR population.
    End point type
    Secondary
    End point timeframe
    Weeks 16, 36, and 52
    End point values
    Placebo Bari 2 mg Bari 4 mg
    Number of subjects analysed
    34
    53
    63
    Units: participants
    number (not applicable)
        Week 16
    24
    39
    40
        Week 36
    19
    26
    33
        Week 52
    17
    29
    33
    No statistical analyses for this end point

    Secondary: Non Responders (NR): Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

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    End point title
    Non Responders (NR): Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Weeks 16, 36 and 52
    End point values
    NR: Bari 1 mg to 2 mg NR: Bari 1 mg to 4 mg NR: Bari 2 mg to 2 mg NR: Bari 2 mg to 4 mg NR: Bari 4 mg to 4 mg
    Number of subjects analysed
    87
    81
    84
    78
    156
    Units: participants
    number (not applicable)
        Week 16
    40
    45
    40
    34
    63
        Week 36
    35
    35
    37
    38
    61
        Week 52
    27
    39
    37
    30
    64
    No statistical analyses for this end point

    Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2

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    End point title
    NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Weeks 16, 36, and 52
    End point values
    NR: Bari 2 mg to 2 mg NR: Bari 2 mg to 4 mg NR: Bari 4 mg to 4 mg
    Number of subjects analysed
    20
    21
    39
    Units: participants
    number (not applicable)
        Week 16
    7
    12
    12
        Week 36
    8
    9
    8
        Week 52
    9
    9
    11
    No statistical analyses for this end point

    Secondary: NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1

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    End point title
    NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Weeks 16, 36, 52
    End point values
    NR: Bari 1 mg to 2 mg NR: Bari 1 mg to 4 mg NR: Bari 2 mg to 2 mg NR: Bari 2 mg to 4 mg NR: Bari 4 mg to 4 mg
    Number of subjects analysed
    87
    81
    84
    78
    156
    Units: participants
    number (not applicable)
        Week 16
    12
    19
    13
    14
    16
        Week 36
    12
    10
    9
    13
    26
        Week 52
    11
    10
    16
    12
    32
    No statistical analyses for this end point

    Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

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    End point title
    NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Weeks 16, 36, and 52
    End point values
    NR: Bari 2 mg to 2 mg NR: Bari 2 mg to 4 mg NR: Bari 4 mg to 4 mg
    Number of subjects analysed
    20
    21
    39
    Units: participants
    number (not applicable)
        Week 16
    2
    6
    2
        Week 36
    3
    5
    6
        Week 52
    3
    4
    2
    No statistical analyses for this end point

    Secondary: RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75

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    End point title
    RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall RPR population.
    End point type
    Secondary
    End point timeframe
    Weeks 16, 36, and 52
    End point values
    RPR-Placebo RPR-Bari 1-mg RPR-Bari 2-mg RPR-Bari 4-mg
    Number of subjects analysed
    52
    45
    54
    70
    Units: participants
    number (not applicable)
        Week 16
    22
    28
    38
    45
        Week 36
    23
    21
    40
    36
        Week 52
    20
    23
    35
    36
    No statistical analyses for this end point

    Secondary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

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    End point title
    RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall RPR population.
    End point type
    Secondary
    End point timeframe
    Weeks 16, 36, and 52
    End point values
    RPR-Placebo RPR-Bari 2-mg RPR-Bari 4-mg
    Number of subjects analysed
    34
    53
    63
    Units: participants
    number (not applicable)
        Week 16
    19
    36
    35
        Week 36
    16
    25
    28
        Week 52
    13
    28
    27
    No statistical analyses for this end point

    Secondary: NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75

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    End point title
    NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Weeks 16, 36, and 52
    End point values
    NR: Bari 1 mg to 2 mg NR: Bari 1 mg to 4 mg NR: Bari 2 mg to 2 mg NR: Bari 2 mg to 4 mg NR: Bari 4 mg to 4 mg
    Number of subjects analysed
    87
    81
    84
    78
    156
    Units: participants
    number (not applicable)
        Week 16
    29
    35
    32
    30
    42
        Week 36
    28
    25
    26
    35
    48
        Week 52
    25
    29
    29
    27
    52
    No statistical analyses for this end point

    Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

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    End point title
    NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Weeks 16, 36, and 52
    End point values
    NR: Bari 2 mg to 2 mg NR: Bari 2 mg to 4 mg NR: Bari 4 mg to 4 mg
    Number of subjects analysed
    20
    21
    39
    Units: participants
    number (not applicable)
        Week 16
    4
    12
    11
        Week 36
    5
    6
    9
        Week 52
    4
    6
    11
    No statistical analyses for this end point

    Secondary: RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement Itch Numeric Rating Scale (NRS)

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    End point title
    RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement Itch Numeric Rating Scale (NRS)
    End point description
    The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from the previous Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall RPR population.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    RPR-Placebo RPR-Bari 1-mg RPR-Bari 2-mg RPR-Bari 4-mg
    Number of subjects analysed
    43
    31
    43
    61
    Units: participants
        number (not applicable)
    14
    8
    14
    25
    No statistical analyses for this end point

    Secondary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

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    End point title
    RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
    End point description
    The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall RPR population.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Bari 2 mg Bari 4 mg
    Number of subjects analysed
    32
    48
    56
    Units: participants
        number (not applicable)
    12
    22
    26
    No statistical analyses for this end point

    Secondary: NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS

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    End point title
    NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS
    End point description
    The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    NR: Bari 1 mg to 2 mg NR: Bari 1 mg to 4 mg NR: Bari 2 mg to 2 mg NR: Bari 2 mg to 4 mg NR: Bari 4 mg to 4 mg
    Number of subjects analysed
    80
    62
    70
    71
    138
    Units: participants
        number (not applicable)
    16
    24
    17
    22
    31
    No statistical analyses for this end point

    Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

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    End point title
    NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
    End point description
    The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    NR: Bari 2 mg to 2 mg NR: Bari 2 mg to 4 mg NR: Bari 4 mg to 4 mg
    Number of subjects analysed
    19
    19
    35
    Units: participants
        number (not applicable)
    6
    7
    11
    No statistical analyses for this end point

    Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

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    End point title
    NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 16, 24, 52
    End point values
    NR: Placebo to Bari 2 mg NR: Placebo to Bari 4 mg
    Number of subjects analysed
    180
    194
    Units: participants
    number (not applicable)
        Week 4
    104
    130
        Week 16
    102
    122
        Week 24
    100
    111
        Week 52
    91
    91
    No statistical analyses for this end point

    Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2

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    End point title
    NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 16, 24, 52
    End point values
    NR: Placebo to Bari 2 mg NR: Placebo to Bari 4 mg
    Number of subjects analysed
    34
    28
    Units: participants
    number (not applicable)
        Week 4
    17
    13
        Week 16
    16
    13
        Week 24
    13
    11
        Week 52
    9
    7
    No statistical analyses for this end point

    Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1

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    End point title
    NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 16, 24, 52
    End point values
    NR: Placebo to Bari 2 mg NR: Placebo to Bari 4 mg
    Number of subjects analysed
    180
    194
    Units: participants
    number (not applicable)
        Week 4
    41
    50
        Week 16
    40
    58
        Week 24
    40
    54
        Week 52
    37
    46
    No statistical analyses for this end point

    Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

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    End point title
    NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 16, 24, 52
    End point values
    NR: Placebo to Bari 2 mg NR: Placebo to Bari 4 mg
    Number of subjects analysed
    34
    28
    Units: participants
    number (not applicable)
        Week 4
    0
    4
        Week 16
    2
    7
        Week 24
    4
    5
        Week 52
    2
    3
    No statistical analyses for this end point

    Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75

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    End point title
    NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 16, 24, 52
    End point values
    NR: Placebo to Bari 2 mg NR: Placebo to Bari 4 mg
    Number of subjects analysed
    180
    194
    Units: participants
    number (not applicable)
        Week 4
    70
    91
        Week 16
    79
    104
        Week 24
    81
    88
        Week 52
    74
    75
    No statistical analyses for this end point

    Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

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    End point title
    NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 16, 24, 52
    End point values
    NR: Placebo to Bari 2 mg NR: Placebo to Bari 4 mg
    Number of subjects analysed
    34
    28
    Units: participants
    number (not applicable)
        Week 4
    8
    11
        Week 16
    13
    11
        Week 24
    11
    9
        Week 52
    9
    9
    No statistical analyses for this end point

    Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS

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    End point title
    NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS
    End point description
    The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    NR: Placebo to Bari 2 mg NR: Placebo to Bari 4 mg
    Number of subjects analysed
    165
    171
    Units: participants
        number (not applicable)
    56
    61
    No statistical analyses for this end point

    Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

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    End point title
    NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
    End point description
    The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    NR: Placebo to Bari 2 mg NR: Placebo to Bari 4 mg
    Number of subjects analysed
    34
    26
    Units: participants
        number (not applicable)
    7
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through Week 52
    Adverse event reporting additional description
    All participants who received at least one dose of IP. The participants from open label arm were included in the Baricitinib 2-mg arm while reporting the safety data. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    Bari-2mg
    Reporting group description
    -

    Reporting group title
    Bari-4mg
    Reporting group description
    -

    Reporting group title
    Bari-1mg
    Reporting group description
    -

    Serious adverse events
    Placebo Bari-2mg Bari-4mg Bari-1mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 91 (5.49%)
    33 / 766 (4.31%)
    40 / 743 (5.38%)
    1 / 45 (2.22%)
         number of deaths (all causes)
    0
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    thrombophlebitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    2 / 743 (0.27%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vasculitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    anaplastic large cell lymphoma t- and null-cell types
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bladder neoplasm
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rectal cancer
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    squamous cell carcinoma
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    anaphylactic reaction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    uterine haemorrhage
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed [1]
    1 / 44 (2.27%)
    0 / 318 (0.00%)
    0 / 239 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    ankle fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    contusion
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 766 (0.00%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    facial bones fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    foot fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    joint dislocation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ligament sprain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    limb injury
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    meniscus injury
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    multiple injuries
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    road traffic accident
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tibia fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    myocarditis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sinus tachycardia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    supraventricular tachycardia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ventricular extrasystoles
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    epistaxis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    retinal detachment
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    retinopathy proliferative
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rhegmatogenous retinal detachment
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    tinnitus
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    colitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    intestinal obstruction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancreatic failure
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancreatitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    calculus urinary
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal colic
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal failure
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    drug-induced liver injury
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 766 (0.00%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hepatic failure
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    dermatitis atopic
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 91 (1.10%)
    11 / 766 (1.44%)
    9 / 743 (1.21%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    3 / 15
    6 / 12
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dermatitis exfoliative
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    parakeratosis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 766 (0.00%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urticaria
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    bursitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    compartment syndrome
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteonecrosis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    dairy intolerance
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    abscess jaw
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    appendicitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    0 / 743 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    arthritis infective
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bacteraemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bronchitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    2 / 743 (0.27%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diverticulitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    eczema herpeticum
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    2 / 766 (0.26%)
    6 / 743 (0.81%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    5 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    endophthalmitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    erysipelas
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    influenza
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteomyelitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    otitis externa
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    parainfluenzae virus infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 766 (0.00%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    postoperative wound infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 766 (0.00%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    psoas abscess
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyelonephritis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    0 / 743 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sinusitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    skin bacterial infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 766 (0.13%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    staphylococcal bacteraemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    staphylococcal skin infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    superinfection bacterial
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    2 / 743 (0.27%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    syphilis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 766 (0.00%)
    1 / 743 (0.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The denominator was adjusted because it was a gender-specific event for females.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Bari-2mg Bari-4mg Bari-1mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 91 (24.18%)
    229 / 766 (29.90%)
    243 / 743 (32.71%)
    16 / 45 (35.56%)
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    7 / 91 (7.69%)
    48 / 766 (6.27%)
    22 / 743 (2.96%)
    1 / 45 (2.22%)
         occurrences all number
    7
    60
    37
    1
    General disorders and administration site conditions
    pyrexia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 91 (0.00%)
    19 / 766 (2.48%)
    19 / 743 (2.56%)
    3 / 45 (6.67%)
         occurrences all number
    0
    20
    20
    3
    Infections and infestations
    herpes simplex
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 91 (5.49%)
    20 / 766 (2.61%)
    34 / 743 (4.58%)
    1 / 45 (2.22%)
         occurrences all number
    5
    31
    41
    1
    nasopharyngitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    11 / 91 (12.09%)
    110 / 766 (14.36%)
    128 / 743 (17.23%)
    10 / 45 (22.22%)
         occurrences all number
    13
    147
    180
    18
    oral herpes
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 91 (2.20%)
    34 / 766 (4.44%)
    41 / 743 (5.52%)
    1 / 45 (2.22%)
         occurrences all number
    3
    49
    55
    2
    upper respiratory tract infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 91 (3.30%)
    44 / 766 (5.74%)
    45 / 743 (6.06%)
    1 / 45 (2.22%)
         occurrences all number
    3
    66
    57
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Nov 2019
    Substantial Amendment (c): - Included an additional six visits to reflect the 2-year extension to the study. - Updated discontinuation criteria for VTEs requiring permanent discontinuation after one VTE instead of two. - Added discontinuation criteria to reflect the possibility of study termination following potential approval or dismissal of Baricitinib for atopic dermatitis within a given country. - Removed leukotriene inhibitors and allergen immunotherapy from prohibited medications.

    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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