Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata (NCT NCT03899259)

Last Updated: 2025-01-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

546 participants

Primary outcome timeframe

Week 36

Results posted on

2025-01-31

Participant Flow

Results for maximum extended enrollment (MEE) participants will be posted after the study completion.

Participant milestones

Participant milestones
Measure	Placebo Participants received two placebo tablets 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 blind.	4 mg Baricitinib Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.
Overall Study STARTED	156	156	234
Overall Study Received at Least One Dose of Study Drug	155	156	234
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	156	156	234

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received two placebo tablets 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 blind.	4 mg Baricitinib Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.
Overall Study Adverse Event	5	4	6
Overall Study Lack of Efficacy	5	0	2
Overall Study Pregnancy	3	0	1
Overall Study Physician Decision	0	1	0
Overall Study Protocol Deviation	1	1	1
Overall Study Withdrawal by Subject	8	10	12
Overall Study Lost to Follow-up	5	6	2
Overall Study Lack of Adherence	1	0	0
Overall Study Screen Failure	1	0	0
Overall Study Ongoing Study Participation	127	134	210

Baseline Characteristics

One participant was randomized inadvertently but not dosed and age was not obtained.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=156 Participants Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=156 Participants Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind..	4 mg Baricitinib n=234 Participants Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.	Total n=546 Participants Total of all reporting groups
Age, Continuous	37.10 years STANDARD_DEVIATION 12.35 • n=155 Participants • One participant was randomized inadvertently but not dosed and age was not obtained.	39.00 years STANDARD_DEVIATION 12.99 • n=156 Participants • One participant was randomized inadvertently but not dosed and age was not obtained.	38.00 years STANDARD_DEVIATION 12.65 • n=234 Participants • One participant was randomized inadvertently but not dosed and age was not obtained.	38.00 years STANDARD_DEVIATION 12.66 • n=545 Participants • One participant was randomized inadvertently but not dosed and age was not obtained.
Sex: Female, Male Female	98 Participants n=156 Participants	103 Participants n=156 Participants	144 Participants n=234 Participants	345 Participants n=546 Participants
Sex: Female, Male Male	58 Participants n=156 Participants	53 Participants n=156 Participants	90 Participants n=234 Participants	201 Participants n=546 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=156 Participants	0 Participants n=156 Participants	0 Participants n=234 Participants	0 Participants n=546 Participants
Race (NIH/OMB) Asian	51 Participants n=156 Participants	49 Participants n=156 Participants	67 Participants n=234 Participants	167 Participants n=546 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=156 Participants	1 Participants n=156 Participants	0 Participants n=234 Participants	1 Participants n=546 Participants
Race (NIH/OMB) Black or African American	16 Participants n=156 Participants	12 Participants n=156 Participants	18 Participants n=234 Participants	46 Participants n=546 Participants
Race (NIH/OMB) White	85 Participants n=156 Participants	92 Participants n=156 Participants	144 Participants n=234 Participants	321 Participants n=546 Participants
Race (NIH/OMB) More than one race	4 Participants n=156 Participants	2 Participants n=156 Participants	5 Participants n=234 Participants	11 Participants n=546 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=156 Participants	0 Participants n=156 Participants	0 Participants n=234 Participants	0 Participants n=546 Participants
Region of Enrollment Argentina	15 Participants n=156 Participants	11 Participants n=156 Participants	20 Participants n=234 Participants	46 Participants n=546 Participants
Region of Enrollment Australia	17 Participants n=156 Participants	17 Participants n=156 Participants	20 Participants n=234 Participants	54 Participants n=546 Participants
Region of Enrollment Brazil	14 Participants n=156 Participants	13 Participants n=156 Participants	24 Participants n=234 Participants	51 Participants n=546 Participants
Region of Enrollment China	2 Participants n=156 Participants	2 Participants n=156 Participants	6 Participants n=234 Participants	10 Participants n=546 Participants
Region of Enrollment Israel	14 Participants n=156 Participants	19 Participants n=156 Participants	25 Participants n=234 Participants	58 Participants n=546 Participants
Region of Enrollment Japan	10 Participants n=156 Participants	11 Participants n=156 Participants	20 Participants n=234 Participants	41 Participants n=546 Participants
Region of Enrollment South Korea	23 Participants n=156 Participants	17 Participants n=156 Participants	26 Participants n=234 Participants	66 Participants n=546 Participants
Region of Enrollment Taiwan	7 Participants n=156 Participants	12 Participants n=156 Participants	11 Participants n=234 Participants	30 Participants n=546 Participants
Region of Enrollment United States	54 Participants n=156 Participants	54 Participants n=156 Participants	82 Participants n=234 Participants	190 Participants n=546 Participants
Baseline Disease Severity of Alopecia Tool (SALT) Score	85 units on a scale STANDARD_DEVIATION 17.79 • n=156 Participants	85.6 units on a scale STANDARD_DEVIATION 18.08 • n=156 Participants	84.8 units on a scale STANDARD_DEVIATION 18.08 • n=234 Participants	85.1 units on a scale STANDARD_DEVIATION 17.97 • n=546 Participants

PRIMARY outcome

Timeframe: Week 36

Population: All randomized participants.

Outcome measures

Outcome measures
Measure	Placebo n=156 Participants Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=156 Participants Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.	4 mg Baricitinib n=234 Participants Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20	2.6 percentage of participants Interval 1.0 to 6.4	17.3 percentage of participants Interval 12.2 to 24.0	32.5 percentage of participants Interval 26.8 to 38.7

SECONDARY outcome

Timeframe: Baseline, Week 36

Population: All randomized participants with nonmissing baseline and at least one postbaseline measure. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.

SALT uses a visual aid showing the division of the scalp hair into4 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. 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.

Outcome measures

Outcome measures
Measure	Placebo n=153 Participants Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=151 Participants Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.	4 mg Baricitinib n=230 Participants Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.
Percent Change From Baseline in SALT Score at Week 36	-2.96 percentage of change Standard Error 2.723	-28.21 percentage of change Standard Error 2.770	-47.45 percentage of change Standard Error 2.229

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants.

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. SALT50 indicates at least a 50 % improvement from baseline in the SALT score.

Outcome measures

Outcome measures
Measure	Placebo n=156 Participants Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=156 Participants Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.	4 mg Baricitinib n=234 Participants Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.
Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50)	2.6 percentage of participants Interval 1.0 to 6.4	10.9 percentage of participants Interval 6.9 to 16.8	23.5 percentage of participants Interval 18.5 to 29.3

SECONDARY outcome

Timeframe: Week 36

Population: All randomized participants with baseline PRO for scalp hair assessment score of ≥ 3.

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).

Outcome measures

Outcome measures
Measure	Placebo n=151 Participants Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=149 Participants Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.	4 mg Baricitinib n=215 Participants Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.
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	4.0 percentage of participants Interval 1.8 to 8.4	16.1 percentage of participants Interval 11.1 to 22.8	34.4 percentage of participants Interval 28.4 to 41.0

SECONDARY outcome

Timeframe: Week 52

Time for participants to achieve SALT ≤ 20

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 36

Population: All randomized participants with baseline ClinRO measure for EB hair loss ≥ 2.

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.

Outcome measures

Outcome measures
Measure	Placebo n=112 Participants Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=104 Participants Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.	4 mg Baricitinib n=161 Participants Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.
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)	4.5 percentage of participants Interval 1.9 to 10.0	11.5 percentage of participants Interval 6.7 to 19.1	34.8 percentage of participants Interval 27.9 to 42.4

SECONDARY outcome

Timeframe: Week 36

Population: All randomized participants with baseline ClinRO measure for EL hair loss ≥ 2.

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.

Outcome measures

Outcome measures
Measure	Placebo n=90 Participants Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=89 Participants Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.	4 mg Baricitinib n=140 Participants Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.
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)	5.6 percentage of participants Interval 2.4 to 12.4	10.1 percentage of participants Interval 5.4 to 18.1	34.3 percentage of participants Interval 26.9 to 42.5

SECONDARY outcome

Timeframe: Week 36

Population: All randomized participants with baseline PRO measures for EB hair loss ≥2.

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.

Outcome measures

Outcome measures
Measure	Placebo n=107 Participants Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=108 Participants Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.	4 mg Baricitinib n=165 Participants Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.
Percentage of Participants Achieving Patient-Reported Outcome (PRO) Measure for EB 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥2 at Baseline)	4.7 percentage of participants Interval 2.0 to 10.5	14.8 percentage of participants Interval 9.3 to 22.7	35.8 percentage of participants Interval 28.8 to 43.3

SECONDARY outcome

Timeframe: Week 36

Population: All randomized participants with baseline PRO Measure EL hair loss ≥2.

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.

Outcome measures

Outcome measures
Measure	Placebo n=89 Participants Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=90 Participants Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.	4 mg Baricitinib n=133 Participants Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.
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)	1.1 percentage of participants Interval 0.2 to 6.1	18.9 percentage of participants Interval 12.1 to 28.2	34.6 percentage of participants Interval 27.0 to 43.0

SECONDARY outcome

Timeframe: Baseline, Week 36

Population: All randomized participants with baseline and at least one postbaseline Skindex-16 AA Symptoms Domain Score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.

Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life. LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (\<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=146 Participants Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=147 Participants Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.	4 mg Baricitinib n=227 Participants Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.
Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score	1.17 score on a scale Standard Error 1.415	-1.85 score on a scale Standard Error 1.425	-3.04 score on a scale Standard Error 1.138

SECONDARY outcome

Timeframe: Baseline, Week 36

Population: All randomized participants with baseline and at least one postbaseline Skindex-16 AA emotions domain score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.

Outcome measures

Outcome measures
Measure	Placebo n=146 Participants Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=147 Participants Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.	4 mg Baricitinib n=227 Participants Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.
Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36	-11.98 score on a scale Standard Error 2.154	-18.73 score on a scale Standard Error 2.171	-25.40 score on a scale Standard Error 1.732

SECONDARY outcome

Timeframe: Baseline, Week 36

Population: All randomized participants with baseline and at least one postbaseline Skindex-16 AA functioning domain score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.

Outcome measures

Outcome measures
Measure	Placebo n=146 Participants Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=147 Participants Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.	4 mg Baricitinib n=227 Participants Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.
Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36	-9.67 score on a scale Standard Error 1.913	-14.05 score on a scale Standard Error 1.925	-18.00 score on a scale Standard Error 1.535

SECONDARY outcome

Timeframe: Baseline, Week 36

Population: All randomized participants with baseline and at least one postbaseline HADS anxiety score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.

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 (for example, 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.

Outcome measures

Outcome measures
Measure	Placebo n=146 Participants Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=147 Participants Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.	4 mg Baricitinib n=227 Participants Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36	-0.47 score on a scale Standard Error 0.225	-0.67 score on a scale Standard Error 0.227	-1.19 score on a scale Standard Error 0.181

SECONDARY outcome

Timeframe: Baseline,Week 36

Population: All randomized participants with baseline and at least one postbaseline HADS depression score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.

Outcome measures

Outcome measures
Measure	Placebo n=144 Participants Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=156 Participants Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.	4 mg Baricitinib n=234 Participants Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.
Mean Change From Baseline in HADS Depression Score at Week 36	0.29 score on a scale Standard Error 0.208	-0.22 score on a scale Standard Error 0.210	-0.39 score on a scale Standard Error 0.167

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

2 mg Baricitinib

Serious events: 4 serious events

Other events: 39 other events

Deaths: 0 deaths

4 mg Baricitinib

Serious events: 8 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=154 participants at risk Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=155 participants at risk Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.	4 mg Baricitinib n=233 participants at risk Participants received one 4 mg Baricitinib tablet administered orally QD, one placebo tablet administered orally QD to maintain blind.
Cardiac disorders Cardiac failure congestive	0.00% 0/154 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.65% 1/155 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/233 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Inguinal hernia	0.00% 0/154 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/155 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.43% 1/233 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Strangulated umbilical hernia	0.65% 1/154 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/155 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/233 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis acute	0.65% 1/154 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.65% 1/155 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.43% 1/233 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Covid-19 pneumonia	0.00% 0/154 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.65% 1/155 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/233 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pyelonephritis	0.00% 0/154 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.65% 1/155 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.43% 1/233 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/154 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.65% 1/155 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/233 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/154 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/155 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.43% 1/233 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Sars-cov-2 test positive	0.00% 0/154 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/155 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.43% 1/233 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/154 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/155 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.43% 1/233 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.8% 1/57 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/89 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Product Issues Device dislocation	0.00% 0/154 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/155 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.43% 1/233 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypertension	0.00% 0/154 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/155 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.43% 1/233 • Number of events 1 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Other adverse events

Other adverse events
Measure	Placebo n=154 participants at risk Participants received two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib n=155 participants at risk Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.	4 mg Baricitinib n=233 participants at risk Participants received one 4 mg Baricitinib tablet administered orally QD, one placebo tablet administered orally QD to maintain blind.
Infections and infestations Nasopharyngitis	4.5% 7/154 • Number of events 7 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 2/155 • Number of events 3 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.4% 15/233 • Number of events 19 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	7.1% 11/154 • Number of events 12 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 12/155 • Number of events 13 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.4% 15/233 • Number of events 16 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	1.3% 2/154 • Number of events 2 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 12/155 • Number of events 14 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 11/233 • Number of events 14 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Headache	6.5% 10/154 • Number of events 11 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 12/155 • Number of events 15 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.0% 21/233 • Number of events 28 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Acne	1.9% 3/154 • Number of events 4 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.8% 9/155 • Number of events 10 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 11/233 • Number of events 11 • Baseline Up to 36 Weeks 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. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-595-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60