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

Last Updated: 2026-04-07

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

606 participants

Primary outcome timeframe

Week 36

Results posted on

2026-04-07

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received two placebo tablets matched to baricitinib, administered orally once daily (QD) to maintain the blind in Period 1.	2 mg Baricitinib Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind in Period 1.	4 mg Baricitinib Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind in Period 1.	Placebo/ Placebo Participants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.	Placebo/ 2-mg Baricitinib Participants who received two placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.	Placebo/ 4-mg Baricitinib Participants who received two placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.	2-mg Baricitinib/ 2-mg Baricitinib Participants who received 2 mg Baricitinib at Period 1 continued to receive 2 mg Baricitinib dose administered orally QD in Period 2.	2-mg Baricitinib/ 4-mg Baricitinib Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.	4-mg Baricitinib/ Placebo Participants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.	4-mg Baricitinib/ 2-mg Baricitinib Participants who received 4 mg Baricitinib at Period 1 switched to receive 2 mg Baricitinib administered orally QD in Period 2.	4-mg Baricitinib/ 4-mg Baricitinib Participants who received 4 mg Baricitinib at Period 1 continued to receive 4 mg Baricitinib administered orally QD in Period 2.
Period 1 (Week 0 to Week 52) STARTED	173	174	259	0	0	0	0	0	0	0	0
Period 1 (Week 0 to Week 52) Safety Population	171	173	258	0	0	0	0	0	0	0	0
Period 1 (Week 0 to Week 52) Extended Safety Population	147	173	258	0	0	0	0	0	0	0	0
Period 1 (Week 0 to Week 52) COMPLETED	142	151	233	0	0	0	0	0	0	0	0
Period 1 (Week 0 to Week 52) NOT COMPLETED	31	23	26	0	0	0	0	0	0	0	0
Period 2 (Week 52 to Week 248) STARTED	0	0	0	4	2	69	112	106	76	47	110
Period 2 (Week 52 to Week 248) COMPLETED	0	0	0	4	0	33	50	31	6	30	60
Period 2 (Week 52 to Week 248) NOT COMPLETED	0	0	0	0	2	36	62	75	70	17	50

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received two placebo tablets matched to baricitinib, administered orally once daily (QD) to maintain the blind in Period 1.	2 mg Baricitinib Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind in Period 1.	4 mg Baricitinib Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind in Period 1.	Placebo/ 2-mg Baricitinib Participants who received two placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.	Placebo/ 4-mg Baricitinib Participants who received two placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.	2-mg Baricitinib/ 2-mg Baricitinib Participants who received 2 mg Baricitinib at Period 1 continued to receive 2 mg Baricitinib dose administered orally QD in Period 2.	2-mg Baricitinib/ 4-mg Baricitinib Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.	4-mg Baricitinib/ Placebo Participants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.	4-mg Baricitinib/ 2-mg Baricitinib Participants who received 4 mg Baricitinib at Period 1 switched to receive 2 mg Baricitinib administered orally QD in Period 2.	4-mg Baricitinib/ 4-mg Baricitinib Participants who received 4 mg Baricitinib at Period 1 continued to receive 4 mg Baricitinib administered orally QD in Period 2.
Period 1 (Week 0 to Week 52) Adverse Event	6	5	6	0	0	0	0	0	0	0
Period 1 (Week 0 to Week 52) Lack of Efficacy	5	1	4	0	0	0	0	0	0	0
Period 1 (Week 0 to Week 52) Lost to Follow-up	5	6	3	0	0	0	0	0	0	0
Period 1 (Week 0 to Week 52) Physician Decision	1	1	0	0	0	0	0	0	0	0
Period 1 (Week 0 to Week 52) Pregnancy	3	0	0	0	0	0	0	0	0	0
Period 1 (Week 0 to Week 52) Withdrawal by Subject	8	9	12	0	0	0	0	0	0	0
Period 1 (Week 0 to Week 52) Met Exclusion Criteria	0	1	1	0	0	0	0	0	0	0
Period 1 (Week 0 to Week 52) Lack of Adherence	1	0	0	0	0	0	0	0	0	0
Period 1 (Week 0 to Week 52) Protocol Deviation	1	0	0	0	0	0	0	0	0	0
Period 1 (Week 0 to Week 52) Randomized by Mistake and Were Not Dosed	1	0	0	0	0	0	0	0	0	0
Period 2 (Week 52 to Week 248) Adverse Event	0	0	0	0	0	4	1	1	3	5
Period 2 (Week 52 to Week 248) Lack of Efficacy	0	0	0	1	8	11	6	17	0	3
Period 2 (Week 52 to Week 248) Withdrawal by Subject	0	0	0	0	10	20	21	6	10	27
Period 2 (Week 52 to Week 248) Lost to Follow-up	0	0	0	0	1	4	6	2	1	5
Period 2 (Week 52 to Week 248) Study Terminated by Sponsor	0	0	0	0	1	3	1	1	2	3
Period 2 (Week 52 to Week 248) Physician Decision	0	0	0	0	1	1	0	0	1	1
Period 2 (Week 52 to Week 248) Pregnancy	0	0	0	0	0	0	0	0	0	1
Period 2 (Week 52 to Week 248) Protocol Defined Discontinuation Criteria Met at Week 76	0	0	0	1	14	19	40	43	0	5
Period 2 (Week 52 to Week 248) Lack of Adherence	0	0	0	0	1	0	0	0	0	0

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=173 Participants * Week 0 to Week 52: Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind (Period 1). * Week 52 to Week 248: Participants continued to receive the same placebo or switched to either 2 mg or 4 mg Baricitinib dose administered orally QD (Period 2).	2 mg Baricitinib n=174 Participants * Week 0 to Week 52: Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind (Period 1). * Week 52 to Week 248: Participants continued to receive the same 2 mg dose or switched to an uptitrated 4 mg Baricitinib dose administered orally QD (Period 2).	4 mg Baricitinib n=259 Participants * Week 0 to Week 52: Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind (Period 1). * Week 52 to Week 248: Participants continued to receive the same 4 mg dose or switched to a downtitrated 2 mg Baricitinib dose, or receive placebo tablets matched to Baricitinib administered orally QD (Period 2).	Total n=606 Participants Total of all reporting groups
Age, Continuous	36.0 years STANDARD_DEVIATION 12.24 • n=172 Participants • One participant was randomized inadvertently but not dosed and age was not obtained.	38.2 years STANDARD_DEVIATION 12.96 • n=174 Participants • One participant was randomized inadvertently but not dosed and age was not obtained.	37.2 years STANDARD_DEVIATION 12.47 • n=259 Participants • One participant was randomized inadvertently but not dosed and age was not obtained.	37.2 years STANDARD_DEVIATION 12.55 • n=605 Participants • One participant was randomized inadvertently but not dosed and age was not obtained.
Sex: Female, Male Female	108 Participants n=173 Participants	111 Participants n=174 Participants	161 Participants n=259 Participants	380 Participants n=606 Participants
Sex: Female, Male Male	65 Participants n=173 Participants	63 Participants n=174 Participants	98 Participants n=259 Participants	226 Participants n=606 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=173 Participants	0 Participants n=174 Participants	0 Participants n=259 Participants	0 Participants n=606 Participants
Race (NIH/OMB) Asian	68 Participants n=173 Participants	67 Participants n=174 Participants	92 Participants n=259 Participants	227 Participants n=606 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=173 Participants	1 Participants n=174 Participants	0 Participants n=259 Participants	1 Participants n=606 Participants
Race (NIH/OMB) Black or African American	16 Participants n=173 Participants	12 Participants n=174 Participants	18 Participants n=259 Participants	46 Participants n=606 Participants
Race (NIH/OMB) White	85 Participants n=173 Participants	92 Participants n=174 Participants	144 Participants n=259 Participants	321 Participants n=606 Participants
Race (NIH/OMB) More than one race	4 Participants n=173 Participants	2 Participants n=174 Participants	5 Participants n=259 Participants	11 Participants n=606 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=173 Participants	0 Participants n=174 Participants	0 Participants n=259 Participants	0 Participants n=606 Participants
Region of Enrollment Argentina	15 Participants n=173 Participants	11 Participants n=174 Participants	20 Participants n=259 Participants	46 Participants n=606 Participants
Region of Enrollment Australia	17 Participants n=173 Participants	17 Participants n=174 Participants	20 Participants n=259 Participants	54 Participants n=606 Participants
Region of Enrollment Brazil	14 Participants n=173 Participants	13 Participants n=174 Participants	24 Participants n=259 Participants	51 Participants n=606 Participants
Region of Enrollment China	19 Participants n=173 Participants	20 Participants n=174 Participants	31 Participants n=259 Participants	70 Participants n=606 Participants
Region of Enrollment Israel	14 Participants n=173 Participants	19 Participants n=174 Participants	25 Participants n=259 Participants	58 Participants n=606 Participants
Region of Enrollment Japan	10 Participants n=173 Participants	11 Participants n=174 Participants	20 Participants n=259 Participants	41 Participants n=606 Participants
Region of Enrollment South Korea	23 Participants n=173 Participants	17 Participants n=174 Participants	26 Participants n=259 Participants	66 Participants n=606 Participants
Region of Enrollment Taiwan	7 Participants n=173 Participants	12 Participants n=174 Participants	11 Participants n=259 Participants	30 Participants n=606 Participants
Region of Enrollment United States	54 Participants n=173 Participants	54 Participants n=174 Participants	82 Participants n=259 Participants	190 Participants n=606 Participants
Baseline Disease Severity of Alopecia Tool (SALT) Score	84.6 units on a scale STANDARD_DEVIATION 17.75 • n=173 Participants	85.3 units on a scale STANDARD_DEVIATION 18.30 • n=174 Participants	84.9 units on a scale STANDARD_DEVIATION 18.03 • n=259 Participants	85.0 units on a scale STANDARD_DEVIATION 18.00 • n=606 Participants

PRIMARY outcome

Timeframe: Week 36

Population: All randomized participants who had evaluable data for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=156 Participants Participants received two placebo tablets matched to baricitinib, 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 the blind.	4 mg Baricitinib n=234 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the 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 who had evaluable data for this outcome 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 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. 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 matched to baricitinib, 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 the blind.	4 mg Baricitinib n=230 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the 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 who had evaluable data for this outcome measure.

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 matched to baricitinib, 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 the blind.	4 mg Baricitinib n=234 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the 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 a baseline PRO scalp hair assessment score of ≥ 3 and who had evaluable data for this outcome measure.

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 matched to baricitinib, 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 the blind.	4 mg Baricitinib n=215 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the 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 36

Population: All randomized participants who had evaluable data for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=156 Participants Participants received two placebo tablets matched to baricitinib, 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 the blind.	4 mg Baricitinib n=234 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind.
Time for Participants to Achieve SALT ≤ 20 at Week 36.	NA Days Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events.	NA Days Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events.	NA Days Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Week 36

Population: All randomized participants with baseline ClinRO measure for EB hair loss ≥ 2 and who had evaluable data for this outcome measure.

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 matched to baricitinib, 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 the blind.	4 mg Baricitinib n=161 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the 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 and who had evaluable data for this outcome measure.

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 matched to baricitinib, 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 the blind.	4 mg Baricitinib n=140 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the 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 and who had evaluable data for this outcome measure.

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 matched to baricitinib, 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 the blind.	4 mg Baricitinib n=165 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the 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 and who had evaluable data for this outcome measure.

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 matched to baricitinib, 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 the blind.	4 mg Baricitinib n=133 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the 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 who had evaluable data for this outcome measure. 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 matched to baricitinib, 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 the blind.	4 mg Baricitinib n=227 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the 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 who had evaluable data for this outcome measure. 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 matched to baricitinib, 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 the blind.	4 mg Baricitinib n=227 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the 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 who had evaluable data for this outcome measure. 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 matched to baricitinib, 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 the blind.	4 mg Baricitinib n=227 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the 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 who had evaluable data for this outcome measure. 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 matched to baricitinib, 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 the blind.	4 mg Baricitinib n=227 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the 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 who had evaluable data for this outcome measure. 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 matched to baricitinib, 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 the blind.	4 mg Baricitinib n=234 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the 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: 44 other events

Deaths: 0 deaths

2 mg Baricitinib

Serious events: 5 serious events

Other events: 85 other events

Deaths: 0 deaths

4 mg Baricitinib

Serious events: 16 serious events

Other events: 133 other events

Deaths: 0 deaths

All Baricitinib- Extended

Serious events: 34 serious events

Other events: 321 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=171 participants at risk * Week 0 to Week 52: Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind (Period 1). * Week 52 to Week 248: Participants continued to receive the same placebo or switched to either 2 mg or 4 mg Baricitinib dose administered orally QD (Period 2).	2 mg Baricitinib n=173 participants at risk * Week 0 to Week 52: Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind (Period 1). * Week 52 to Week 248: Participants continued to receive the same 2 mg dose or switched to an uptitrated 4 mg Baricitinib dose administered orally QD (Period 2).	4 mg Baricitinib n=258 participants at risk * Week 0 to Week 52: Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind (Period 1). * Week 52 to Week 248: Participants continued to receive the same 4 mg dose or switched to a downtitrated 2 mg Baricitinib dose, or receive placebo tablets matched to Baricitinib administered orally QD (Period 2).	All Baricitinib- Extended n=578 participants at risk * The extended safety population (All Baricitinib- Extended) included participants who were continuously treated from baseline with baricitinib 2 mg, baricitinib 4 mg, or placebo and were censored at the time of any dose change or after the permanent study drug discontinuation, whichever occurred earlier. * In addition, the population included an "All Baricitinib" group, including all participants who received at least one dose of baricitinib (2 mg or 4 mg) at any time during the treatment period.
Infections and infestations Covid-19	0.58% 1/171 • Number of events 1 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	10.4% 18/173 • Number of events 20 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	17.4% 45/258 • Number of events 52 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	25.6% 148/578 • Number of events 178 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Infections and infestations Nasopharyngitis	4.7% 8/171 • Number of events 8 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	5.2% 9/173 • Number of events 12 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	11.6% 30/258 • Number of events 43 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	9.3% 54/578 • Number of events 80 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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	7.6% 13/171 • Number of events 16 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	13.9% 24/173 • Number of events 29 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	12.0% 31/258 • Number of events 45 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	13.3% 77/578 • Number of events 107 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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	2.3% 4/171 • Number of events 4 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	10.4% 18/173 • Number of events 24 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	7.8% 20/258 • Number of events 29 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	10.4% 60/578 • Number of events 84 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Investigations Blood cholesterol increased	1.8% 3/171 • Number of events 3 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	4.0% 7/173 • Number of events 7 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	5.0% 13/258 • Number of events 14 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	3.6% 21/578 • Number of events 23 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Investigations Blood creatine phosphokinase increased	0.58% 1/171 • Number of events 1 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.7% 3/173 • Number of events 5 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	6.6% 17/258 • Number of events 25 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	5.5% 32/578 • Number of events 49 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Investigations Weight increased	0.58% 1/171 • Number of events 1 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	5.2% 9/173 • Number of events 9 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.2% 3/258 • Number of events 5 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	3.3% 19/578 • Number of events 21 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Metabolism and nutrition disorders Hypercholesterolaemia	1.2% 2/171 • Number of events 2 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	4.6% 8/173 • Number of events 10 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	3.9% 10/258 • Number of events 12 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	5.4% 31/578 • Number of events 40 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	4.7% 8/171 • Number of events 8 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	2.3% 4/173 • Number of events 4 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	5.0% 13/258 • Number of events 15 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	4.5% 26/578 • Number of events 29 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Nervous system disorders Headache	5.8% 10/171 • Number of events 12 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	9.8% 17/173 • Number of events 37 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	13.6% 35/258 • Number of events 45 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	12.8% 74/578 • Number of events 119 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	2.9% 5/171 • Number of events 5 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	2.3% 4/173 • Number of events 5 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	5.4% 14/258 • Number of events 16 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	5.4% 31/578 • Number of events 36 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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	1.8% 3/171 • Number of events 4 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	6.4% 11/173 • Number of events 13 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	6.2% 16/258 • Number of events 17 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	6.9% 40/578 • Number of events 44 • Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately). (continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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