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NCT03899259 · OUTCOME

Percentage of Participants With Patient-Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 With a ≥2-point Improvement From Baseline Among Participants With a Score of ≥3 at Baseline

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.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Week 36

What was measured

PRO is an assessment of the particpant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair).

Analysis population: All randomized participants with a baseline PRO scalp hair assessment score of ≥ 3 and who had evaluable data for this outcome measure.

Groups in this outcome

Placebo

Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind.

2 mg Baricitinib

Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind.

4 mg Baricitinib

Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo151
2 mg Baricitinib149
4 mg Baricitinib215

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo4.0Not reported1.88.4Not reported
2 mg Baricitinib16.1Not reported11.122.8Not reported
4 mg Baricitinib34.4Not reported28.441.0Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.77
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.74
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.001
    param Type
    Odds Ratio (OR)
    param Value
    4.36
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    5.75
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    31.10
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    13.37
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    1.77
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.74
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.001
    param Type
    Odds Ratio (OR)
    param Value
    4.36
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    5.75
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    31.10
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    13.37
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.8
        upper Limit
        8.4
        value
        4.0
      2. group Id
        OG001
        lower Limit
        11.1
        upper Limit
        22.8
        value
        16.1
      3. group Id
        OG002
        lower Limit
        28.4
        upper Limit
        41.0
        value
        34.4
denoms
  1. counts
    1. group Id
      OG000
      value
      151
    2. group Id
      OG001
      value
      149
    3. group Id
      OG002
      value
      215
    units
    Participants
description
PRO is an assessment of the particpant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair).
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind.
    id
    OG000
    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.
    id
    OG001
    title
    2 mg Baricitinib
  3. description
    Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind.
    id
    OG002
    title
    4 mg Baricitinib
param Type
NUMBER
population Description
All randomized participants with a baseline PRO scalp hair assessment score of ≥ 3 and who had evaluable data for this outcome measure.
reporting Status
POSTED
time Frame
Week 36
title
Percentage of Participants With Patient-Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 With a ≥2-point Improvement From Baseline Among Participants With a Score of ≥3 at Baseline
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice