NCT03570749 · CITED IN SOURCE DOCUMENTS

A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE2, PHASE3
Status at capture: COMPLETED
Registry last update: 2026-04-16

This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3

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outcome · POSTED

Percent Change From Baseline in SALT Score - Phase 3 Open-Label Addendum

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outcome · POSTED

Percent Change From Baseline in SALT Score - Phase 3

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outcome · POSTED

Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3

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outcome · POSTED

Time for Participants to Achieve SALT ≤ 20 at Week 36 - Phase 3

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outcome · POSTED

Percentage of Participants Achieving Clinician Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥ 2 at Baseline) - Phase 3

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outcome · POSTED

Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥ 2 at Baseline) - Phase 3

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outcome · POSTED

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 - Phase 3

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score - Phase 3

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outcome · POSTED

Mean Change From Baseline in HADS Depression Score - Phase 3

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outcome · POSTED

Percentage of Participants Achieving SALT ≤ 20 - Phase 3 Open-Label Addendum

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outcome · POSTED

Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3 Open-Label Addendum

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outcome · POSTED

Percentage of Participants Achieving ClinRO Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥ 2 at Baseline) - Phase 3 Open-Label Addendum

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outcome · POSTED

Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥ 2 at Baseline) - Phase 3 Open-Label Addendum

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outcome · POSTED

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 - Phase 3 Open-Label Addendum

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent. * Must self-identify as either Black or African American in race in the open label addenda. * Have severe or very severe AA, as determined by all of the following: * Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured by -- Severity of Alopecia Tool (SALT) Alopecia Areata (AA) Investigator Global Assessment (AA-IGA) of 3 or 4) at screening and baseline. * No spontaneous improvement over the past 6 months. * Current episode of severe or very severe AA of less than 8 years. * Male or nonpregnant, nonbreastfeeding female participants. Exclusion Criteria: * Primarily "diffuse" type of AA. * Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA. * Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment).
healthy Volunteers: false
maximum Age: 70 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants received three placebo tablets administered orally once daily (QD). Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve Severity of Alopecia Tool (SALT) ≤20 (less than or equal to 20) during the study period.
intervention Names
Drug: Baricitinib
Drug: Placebo
label
Placebo Phase 2
type
PLACEBO_COMPARATOR
description
Participants received one 1 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind through Week 12. Following the decision point at Week 12, participants were transitioned to receive one 4 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind, and continued treatment through Week 200.
intervention Names
Drug: Baricitinib
label
1 Milligram (mg) / 4 mg Baricitinib Phase 2
type
EXPERIMENTAL
description
Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
intervention Names
Drug: Baricitinib
label
2 mg Baricitinib Phase 2
type
EXPERIMENTAL
description
Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.
intervention Names
Drug: Baricitinib
label
4 mg Baricitinib Phase 2
type
EXPERIMENTAL
description
Participants received two placebo tablets administered orally QD. Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve SALT≤20 during this treatment period.
intervention Names
Drug: Baricitinib
Drug: Placebo
label
Placebo Phase 3
type
PLACEBO_COMPARATOR
description
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
intervention Names
Drug: Baricitinib
label
2 mg Baricitinib Phase 3
type
EXPERIMENTAL
description
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
intervention Names
Drug: Baricitinib
label
4 mg Baricitinib Phase 3
type
EXPERIMENTAL
description
Participants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.
intervention Names
Drug: Placebo
label
Placebo/ Placebo Phase 3
type
PLACEBO_COMPARATOR
description
Participants who received Placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.
intervention Names
Drug: Baricitinib
label
Placebo/ 2 mg Baricitinib Phase 3
type
EXPERIMENTAL
description
Participants who received Placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
intervention Names
Drug: Baricitinib
label
Placebo/ 4 mg Baricitinib Phase 3
type
EXPERIMENTAL
description
Participants who received 2 mg Baricitinib at Period 1 continued to receive 2 mg Baricitinib dose administered orally QD in Period 2.
intervention Names
Drug: Baricitinib
label
2 mg Baricitinib /2 mg Baricitinib Phase 3
type
EXPERIMENTAL
description
Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
intervention Names
Drug: Baricitinib
label
2 mg Baricitinib /4 mg Baricitinib Phase 3
type
EXPERIMENTAL

interventions

arm Group Labels
1 Milligram (mg) / 4 mg Baricitinib Phase 2
2 mg Baricitinib /2 mg Baricitinib Phase 3
2 mg Baricitinib /4 mg Baricitinib Phase 3
2 mg Baricitinib Phase 2
2 mg Baricitinib Phase 3
4 mg Baricitinib /4 mg Baricitinib Phase 3
4 mg Baricitinib Phase 2
4 mg Baricitinib Phase 3
4 mg Baricitinib Phase 3 Open-Label Addendum
Placebo Phase 2
Placebo Phase 3
Placebo/ 2 mg Baricitinib Phase 3
description
Administered orally.
name
Baricitinib
other Names
LY3009104
type
DRUG
arm Group Labels
2 mg Baricitinib / Placebo Phase 3
4 mg Baricitinib / Placebo Phase 3
Placebo Phase 2
Placebo Phase 3
Placebo/ Placebo Phase 3
description
Administered orally.
name
Placebo
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: DOUBLE
who Masked: PARTICIPANT
INVESTIGATOR

primary Purpose

TREATMENT

Enrollment

count: 784
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.
measure
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3
time Frame
Week 36
description
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100, with lower score indicating better health outcomes.
measure
Percent Change From Baseline in SALT Score - Phase 3 Open-Label Addendum
time Frame
Baseline, Week 52

secondary Outcomes

description
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100, with lower score indicating better health outcomes. Least Squares Mean (LSM) was calculated using analysis of covariance (ANCOVA) with geographic region duration of current episode at baseline (\< 4 years versus ≥4 years), treatment group, and baseline value in the model.
measure
Percent Change From Baseline in SALT Score - Phase 3
time Frame
Baseline, Week 36
description
SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process . The SALT score will range from 0% to 100%. with lower score indicating better health outcomes.
measure
Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3
time Frame
Week 12
description
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. Kaplan-Meier method was used for analysis. Time for participants to achieve salt ≤ 20 at week 36 were reported in this outcome measure.
measure
Time for Participants to Achieve SALT ≤ 20 at Week 36 - Phase 3
time Frame
Week 36
description
ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB.
measure
Percentage of Participants Achieving Clinician Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥ 2 at Baseline) - Phase 3
time Frame
Week 36
description
ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL.
measure
Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥ 2 at Baseline) - Phase 3
time Frame
Week 36
description
PRO is an assessment of the participant'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).
measure
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 - Phase 3
time Frame
Week 36
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.
measure
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
time Frame
Week 36
description
PRO assessment of the participant's current appearance of EL. It is comprised of 4 category response options: 0 = I have full EL on each eyelid; 1 = I have a minimal gap or minimal gaps along the eyelids; 2 = I have a large gap or large gaps along the eyelids; and 3 = I have no or barely any EL hair.
measure
Percentage of Participants Achieving PRO Measure for EL 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With PRO Measure EL ≥2 at Baseline) - Phase 3
time Frame
Week 36
description
The Hospital Anxiety Depression Scale (HADS) is a 14 item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (e.g., 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression. LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (\<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.
measure
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score - Phase 3
time Frame
Baseline, Week 36
description
The HADS is a 14 item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (e.g., 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression. LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (\<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.
measure
Mean Change From Baseline in HADS Depression Score - Phase 3
time Frame
Baseline, Week 36
description
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.
measure
Percentage of Participants Achieving SALT ≤ 20 - Phase 3 Open-Label Addendum
time Frame
Week 52
description
SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process . The SALT score will range from 0% to 100%. with lower score indicating better health outcomes.
measure
Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3 Open-Label Addendum
time Frame
Week 52

Full study description

brief Summary: This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.

Source references

references

citation
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pmid
40214720
type
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citation
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citation
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citation
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35334197
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