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NCT03899259 · FLOW

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A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata · Source last updated 2026-04-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants received two placebo tablets matched to baricitinib, administered orally once daily (QD) to maintain the blind in Period 1.
    id
    FG000
    title
    Placebo
  2. description
    Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind in Period 1.
    id
    FG001
    title
    2 mg Baricitinib
  3. description
    Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind in Period 1.
    id
    FG002
    title
    4 mg Baricitinib
  4. description
    Participants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.
    id
    FG003
    title
    Placebo/ Placebo
  5. description
    Participants who received two placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.
    id
    FG004
    title
    Placebo/ 2-mg Baricitinib
  6. description
    Participants who received two placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
    id
    FG005
    title
    Placebo/ 4-mg Baricitinib
  7. description
    Participants who received 2 mg Baricitinib at Period 1 continued to receive 2 mg Baricitinib dose administered orally QD in Period 2.
    id
    FG006
    title
    2-mg Baricitinib/ 2-mg Baricitinib
  8. description
    Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
    id
    FG007
    title
    2-mg Baricitinib/ 4-mg Baricitinib
  9. description
    Participants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
    id
    FG008
    title
    4-mg Baricitinib/ Placebo
  10. description
    Participants who received 4 mg Baricitinib at Period 1 switched to receive 2 mg Baricitinib administered orally QD in Period 2.
    id
    FG009
    title
    4-mg Baricitinib/ 2-mg Baricitinib
  11. description
    Participants who received 4 mg Baricitinib at Period 1 continued to receive 4 mg Baricitinib administered orally QD in Period 2.
    id
    FG010
    title
    4-mg Baricitinib/ 4-mg Baricitinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Pregnancy
    6. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Met Exclusion Criteria
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Lack of Adherence
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Protocol Deviation
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Randomized by Mistake and Were Not Dosed
    milestones
    1. achievements
      1. comment
        Participants who were randomized to placebo at Baseline and were not eligible for rescue to baricitinib at Week 36 (due to spontaneous remission) were rescued to baricitinib 2-mg if they are nonresponders at Week 52 or experience a loss of treatment benefit after Week 52 (\>20-point absolute worsening in SALT score).
        group Id
        FG000
        num Subjects
        173
      2. group Id
        FG001
        num Subjects
        174
      3. group Id
        FG002
        num Subjects
        259
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        171
      2. group Id
        FG001
        num Subjects
        173
      3. group Id
        FG002
        num Subjects
        258
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      comment
      All randomized participants who received at least one dose of study drug and did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit.
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        147
      2. group Id
        FG001
        num Subjects
        173
      3. group Id
        FG002
        num Subjects
        258
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      comment
      Extended safety population: Participants who were continuously treated from baseline with baricitinib 2 mg (n=173), 4 mg (n=258), or placebo (n=147) and were censored at the time of any dose change or after the permanent study drug discontinuation, whichever occurred earlier (N=578, \[173+258+147\]).
      type
      Extended Safety Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        142
      2. group Id
        FG001
        num Subjects
        151
      3. group Id
        FG002
        num Subjects
        233
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      comment
      Participants who completed Week 52
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Period 1 (Week 0 to Week 52)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        11
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        17
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        3
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        10
      7. group Id
        FG006
        num Subjects
        20
      8. group Id
        FG007
        num Subjects
        21
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        10
      11. group Id
        FG010
        num Subjects
        27
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        5
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        3
      type
      Study Terminated by Sponsor
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        1
      type
      Physician Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        1
      type
      Pregnancy
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        19
      8. group Id
        FG007
        num Subjects
        40
      9. group Id
        FG008
        num Subjects
        43
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        5
      type
      Protocol Defined Discontinuation Criteria Met at Week 76
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Lack of Adherence
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        69
      7. comment
        Participants (N=67) who were initially randomized to placebo but were not eligible for rescue to baricitinib due to spontaneous remission were later switched to baricitinib 2 mg if they were nonresponders at Week 52 or experienced a loss of treatment benefit after Week 52 per planned analysis.
        group Id
        FG006
        num Subjects
        112
      8. group Id
        FG007
        num Subjects
        106
      9. group Id
        FG008
        num Subjects
        76
      10. group Id
        FG009
        num Subjects
        47
      11. group Id
        FG010
        num Subjects
        110
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        33
      7. group Id
        FG006
        num Subjects
        50
      8. group Id
        FG007
        num Subjects
        31
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        30
      11. group Id
        FG010
        num Subjects
        60
      comment
      * Regarding participants who did not complete the study due to 'study termination by sponsor': As pre-planned in the protocol, termination could occur in a specific country or region when baricitinib became approved and reimbursed for AD, was commercially available, or when a negative regulatory opinion was received in that country or region. * Protocol Defined Discontinuation Criteria: Nonresponders (SALT \>20) at Weeks 52 and 76 were automatically discontinued from study at Week 76.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        36
      7. group Id
        FG006
        num Subjects
        62
      8. group Id
        FG007
        num Subjects
        75
      9. group Id
        FG008
        num Subjects
        70
      10. group Id
        FG009
        num Subjects
        17
      11. group Id
        FG010
        num Subjects
        50
      type
      NOT COMPLETED
    title
    Period 2 (Week 52 to Week 248)
Complete source fields
groups
  1. description
    Participants received two placebo tablets matched to baricitinib, administered orally once daily (QD) to maintain the blind in Period 1.
    id
    FG000
    title
    Placebo
  2. description
    Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind in Period 1.
    id
    FG001
    title
    2 mg Baricitinib
  3. description
    Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind in Period 1.
    id
    FG002
    title
    4 mg Baricitinib
  4. description
    Participants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.
    id
    FG003
    title
    Placebo/ Placebo
  5. description
    Participants who received two placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.
    id
    FG004
    title
    Placebo/ 2-mg Baricitinib
  6. description
    Participants who received two placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
    id
    FG005
    title
    Placebo/ 4-mg Baricitinib
  7. description
    Participants who received 2 mg Baricitinib at Period 1 continued to receive 2 mg Baricitinib dose administered orally QD in Period 2.
    id
    FG006
    title
    2-mg Baricitinib/ 2-mg Baricitinib
  8. description
    Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
    id
    FG007
    title
    2-mg Baricitinib/ 4-mg Baricitinib
  9. description
    Participants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
    id
    FG008
    title
    4-mg Baricitinib/ Placebo
  10. description
    Participants who received 4 mg Baricitinib at Period 1 switched to receive 2 mg Baricitinib administered orally QD in Period 2.
    id
    FG009
    title
    4-mg Baricitinib/ 2-mg Baricitinib
  11. description
    Participants who received 4 mg Baricitinib at Period 1 continued to receive 4 mg Baricitinib administered orally QD in Period 2.
    id
    FG010
    title
    4-mg Baricitinib/ 4-mg Baricitinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Pregnancy
    6. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Met Exclusion Criteria
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Lack of Adherence
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Protocol Deviation
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Randomized by Mistake and Were Not Dosed
    milestones
    1. achievements
      1. comment
        Participants who were randomized to placebo at Baseline and were not eligible for rescue to baricitinib at Week 36 (due to spontaneous remission) were rescued to baricitinib 2-mg if they are nonresponders at Week 52 or experience a loss of treatment benefit after Week 52 (\>20-point absolute worsening in SALT score).
        group Id
        FG000
        num Subjects
        173
      2. group Id
        FG001
        num Subjects
        174
      3. group Id
        FG002
        num Subjects
        259
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        171
      2. group Id
        FG001
        num Subjects
        173
      3. group Id
        FG002
        num Subjects
        258
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      comment
      All randomized participants who received at least one dose of study drug and did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit.
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        147
      2. group Id
        FG001
        num Subjects
        173
      3. group Id
        FG002
        num Subjects
        258
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      comment
      Extended safety population: Participants who were continuously treated from baseline with baricitinib 2 mg (n=173), 4 mg (n=258), or placebo (n=147) and were censored at the time of any dose change or after the permanent study drug discontinuation, whichever occurred earlier (N=578, \[173+258+147\]).
      type
      Extended Safety Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        142
      2. group Id
        FG001
        num Subjects
        151
      3. group Id
        FG002
        num Subjects
        233
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      comment
      Participants who completed Week 52
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Period 1 (Week 0 to Week 52)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        11
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        17
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        3
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        10
      7. group Id
        FG006
        num Subjects
        20
      8. group Id
        FG007
        num Subjects
        21
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        10
      11. group Id
        FG010
        num Subjects
        27
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        5
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        3
      type
      Study Terminated by Sponsor
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        1
      type
      Physician Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        1
      type
      Pregnancy
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        19
      8. group Id
        FG007
        num Subjects
        40
      9. group Id
        FG008
        num Subjects
        43
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        5
      type
      Protocol Defined Discontinuation Criteria Met at Week 76
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Lack of Adherence
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        69
      7. comment
        Participants (N=67) who were initially randomized to placebo but were not eligible for rescue to baricitinib due to spontaneous remission were later switched to baricitinib 2 mg if they were nonresponders at Week 52 or experienced a loss of treatment benefit after Week 52 per planned analysis.
        group Id
        FG006
        num Subjects
        112
      8. group Id
        FG007
        num Subjects
        106
      9. group Id
        FG008
        num Subjects
        76
      10. group Id
        FG009
        num Subjects
        47
      11. group Id
        FG010
        num Subjects
        110
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        33
      7. group Id
        FG006
        num Subjects
        50
      8. group Id
        FG007
        num Subjects
        31
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        30
      11. group Id
        FG010
        num Subjects
        60
      comment
      * Regarding participants who did not complete the study due to 'study termination by sponsor': As pre-planned in the protocol, termination could occur in a specific country or region when baricitinib became approved and reimbursed for AD, was commercially available, or when a negative regulatory opinion was received in that country or region. * Protocol Defined Discontinuation Criteria: Nonresponders (SALT \>20) at Weeks 52 and 76 were automatically discontinued from study at Week 76.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        36
      7. group Id
        FG006
        num Subjects
        62
      8. group Id
        FG007
        num Subjects
        75
      9. group Id
        FG008
        num Subjects
        70
      10. group Id
        FG009
        num Subjects
        17
      11. group Id
        FG010
        num Subjects
        50
      type
      NOT COMPLETED
    title
    Period 2 (Week 52 to Week 248)

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Preserved source evidence · Not medical advice