Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03570749 · OUTCOME

Percentage of Participants Achieving PRO Measure for EB 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥ 2 at Baseline) - Phase 3

A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata · Source last updated 2026-04-16

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 participant's current appearance of eyebrows. It is comprised of 4 category response options: 0 = I have full EB on each eye; 1= I have a minimal gap(s) or a minimal amount of thinning in at least 1 of my EB; 2 = I have a large gap(s) or a large amount of thinning in at least 1 of my EB; and 3 = I have no or barely any EB hairs.

Analysis population: All randomized phase 3 participants with baseline PRO measure for EB ≥ 2 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.

Groups in this outcome

Placebo Phase 3

Participants received two placebo tablets administered orally QD.

2 mg Baricitinib Phase 3

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

4 mg Baricitinib Phase 3

Participants received one 4 mg Baricitinib tablet administered orally QD, 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
Placebo Phase 3130
2 mg Baricitinib Phase 3141
4 mg Baricitinib Phase 3184

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo Phase 33.1Not reported1.27.6Not reported
2 mg Baricitinib Phase 316.3Not reported11.123.3Not reported
4 mg Baricitinib Phase 332.1Not reported25.739.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.97
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    15.83
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.001
    param Type
    Odds Ratio (OR)
    param Value
    5.58
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    5.30
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    38.83
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    14.34
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    1.97
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    15.83
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.001
    param Type
    Odds Ratio (OR)
    param Value
    5.58
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    5.30
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    38.83
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    14.34
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.2
        upper Limit
        7.6
        value
        3.1
      2. group Id
        OG001
        lower Limit
        11.1
        upper Limit
        23.3
        value
        16.3
      3. group Id
        OG002
        lower Limit
        25.7
        upper Limit
        39.1
        value
        32.1
denoms
  1. counts
    1. group Id
      OG000
      value
      130
    2. group Id
      OG001
      value
      141
    3. group Id
      OG002
      value
      184
    units
    Participants
description
PRO is an assessment of the participant's current appearance of eyebrows. It is comprised of 4 category response options: 0 = I have full EB on each eye; 1= I have a minimal gap(s) or a minimal amount of thinning in at least 1 of my EB; 2 = I have a large gap(s) or a large amount of thinning in at least 1 of my EB; and 3 = I have no or barely any EB hairs.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received two placebo tablets administered orally QD.
    id
    OG000
    title
    Placebo Phase 3
  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 Phase 3
  3. description
    Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
    id
    OG002
    title
    4 mg Baricitinib Phase 3
param Type
NUMBER
population Description
All randomized phase 3 participants with baseline PRO measure for EB ≥ 2 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
reporting Status
POSTED
time Frame
Week 36
title
Percentage of Participants Achieving PRO Measure for EB 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥ 2 at Baseline) - Phase 3
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice