Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata (NCT NCT03570749)

NCT ID: NCT03570749

Last Updated: 2025-10-01

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: PHASE2/PHASE3
• Target enrollment: 764 participants
• Primary outcome timeframe: Week 36
• Results posted on: 2025-10-01

Participant Flow

Study enrollment was divided into 2 stages separated by a decision point for Phase 3 dose selection, after all patients from the Phase 2 portion of the study had completed 12 weeks of treatment or had discontinued early. Approximately 100 patients were planned to be enrolled in the Phase 2 portion of the study. The remaining approximately 625 patients were planned to be enrolled into the Phase 3 portion.

After Decision Point participants randomized during Stage 1 to 1 mg Baricitinib were transitioned to the 4 mg Baricitinib. Results up to Week 36 (primary outcome) are reported here; data beyond Week 36, including open-label addenda, will be reported with the final results.

Participant milestones

Measure	Placebo Phase 2 Participants received three placebo tablets administered orally every day (QD).	1 Milligram (mg) Baricitinib Phase 2 Participants received one 1 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib Phase 2 Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.	4 mg Baricitinib Phase 2 Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.	Placebo Phase 3 Participants received two placebo tablets administered orally QD.	2 mg Baricitinib Phase 3 Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.	4 mg Baricitinib Phase 3 Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Overall Study STARTED	28	28	27	27	189	184	281
Overall Study Received at Least One Dose of Study Drug	28	28	27	27	189	183	280
Overall Study COMPLETED	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	28	28	27	27	189	184	281

Reasons for withdrawal

Measure	Placebo Phase 2 Participants received three placebo tablets administered orally every day (QD).	1 Milligram (mg) Baricitinib Phase 2 Participants received one 1 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib Phase 2 Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.	4 mg Baricitinib Phase 2 Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.	Placebo Phase 3 Participants received two placebo tablets administered orally QD.	2 mg Baricitinib Phase 3 Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.	4 mg Baricitinib Phase 3 Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Overall Study Ongoing	26	25	25	26	140	142	220
Overall Study Adverse Event	0	0	0	0	2	3	6
Overall Study Lack of Efficacy	0	0	0	0	8	2	7
Overall Study Lost to Follow-up	0	0	0	0	5	10	10
Overall Study Pregnancy	0	0	0	0	0	1	1
Overall Study Screen Fail	0	0	0	0	0	0	1
Overall Study Withdrawal by Subject	2	3	2	1	17	12	15
Overall Study Other	0	0	0	0	17	14	21

Baseline Characteristics

The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the 4 mg Baricitinib Phase 3 arm, age data for one participant was not collected and therefore couldn't be reported.

Baseline characteristics by cohort

Measure	Placebo Phase 2 n=28 Participants Participants received three placebo tablets administered orally every day (QD).	1 mg Baricitinib Phase 2 n=28 Participants Participants received one 1 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib Phase 2 n=27 Participants Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.	4 mg Baricitinib Phase 2 n=27 Participants Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablet administered orally QD to maintain the blind.	Placebo Phase 3 n=189 Participants Participants received two placebo tablets administered orally QD.	2 mg Baricitinib Phase 3 n=184 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 Phase 3 n=281 Participants Participants received one 4 mg Baricitinib tablet administered orally, QD and one placebo tablet QD administered orally to maintain the blind.	Total n=764 Participants Total of all reporting groups
Age, Continuous	40.5 years STANDARD_DEVIATION 14.23 • n=28 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the 4 mg Baricitinib Phase 3 arm, age data for one participant was not collected and therefore couldn't be reported.	38.6 years STANDARD_DEVIATION 11.26 • n=28 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the 4 mg Baricitinib Phase 3 arm, age data for one participant was not collected and therefore couldn't be reported.	42.5 years STANDARD_DEVIATION 13.75 • n=27 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the 4 mg Baricitinib Phase 3 arm, age data for one participant was not collected and therefore couldn't be reported.	42.4 years STANDARD_DEVIATION 14.91 • n=27 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the 4 mg Baricitinib Phase 3 arm, age data for one participant was not collected and therefore couldn't be reported.	37.4 years STANDARD_DEVIATION 12.91 • n=189 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the 4 mg Baricitinib Phase 3 arm, age data for one participant was not collected and therefore couldn't be reported.	38.0 years STANDARD_DEVIATION 12.78 • n=184 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the 4 mg Baricitinib Phase 3 arm, age data for one participant was not collected and therefore couldn't be reported.	36.3 years STANDARD_DEVIATION 13.27 • n=280 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the 4 mg Baricitinib Phase 3 arm, age data for one participant was not collected and therefore couldn't be reported.	41.0 years STANDARD_DEVIATION 13.50 • n=763 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the 4 mg Baricitinib Phase 3 arm, age data for one participant was not collected and therefore couldn't be reported.
Sex: Female, Male Female	16 Participants n=28 Participants	18 Participants n=28 Participants	23 Participants n=27 Participants	25 Participants n=27 Participants	109 Participants n=189 Participants	109 Participants n=184 Participants	165 Participants n=281 Participants	465 Participants n=764 Participants
Sex: Female, Male Male	12 Participants n=28 Participants	10 Participants n=28 Participants	4 Participants n=27 Participants	2 Participants n=27 Participants	80 Participants n=189 Participants	75 Participants n=184 Participants	116 Participants n=281 Participants	299 Participants n=764 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=28 Participants	0 Participants n=28 Participants	0 Participants n=27 Participants	1 Participants n=27 Participants	8 Participants n=189 Participants	5 Participants n=184 Participants	8 Participants n=281 Participants	22 Participants n=764 Participants
Race (NIH/OMB) Asian	3 Participants n=28 Participants	4 Participants n=28 Participants	3 Participants n=27 Participants	4 Participants n=27 Participants	78 Participants n=189 Participants	76 Participants n=184 Participants	114 Participants n=281 Participants	282 Participants n=764 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=28 Participants	0 Participants n=28 Participants	0 Participants n=27 Participants	0 Participants n=27 Participants	1 Participants n=189 Participants	1 Participants n=184 Participants	1 Participants n=281 Participants	3 Participants n=764 Participants
Race (NIH/OMB) Black or African American	4 Participants n=28 Participants	2 Participants n=28 Participants	3 Participants n=27 Participants	3 Participants n=27 Participants	17 Participants n=189 Participants	7 Participants n=184 Participants	28 Participants n=281 Participants	64 Participants n=764 Participants
Race (NIH/OMB) White	21 Participants n=28 Participants	22 Participants n=28 Participants	20 Participants n=27 Participants	19 Participants n=27 Participants	83 Participants n=189 Participants	93 Participants n=184 Participants	123 Participants n=281 Participants	381 Participants n=764 Participants
Race (NIH/OMB) More than one race	0 Participants n=28 Participants	0 Participants n=28 Participants	0 Participants n=27 Participants	0 Participants n=27 Participants	1 Participants n=189 Participants	1 Participants n=184 Participants	6 Participants n=281 Participants	8 Participants n=764 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=28 Participants	0 Participants n=28 Participants	1 Participants n=27 Participants	0 Participants n=27 Participants	1 Participants n=189 Participants	1 Participants n=184 Participants	1 Participants n=281 Participants	4 Participants n=764 Participants
Region of Enrollment South Korea	0 Participants n=28 Participants	0 Participants n=28 Participants	0 Participants n=27 Participants	0 Participants n=27 Participants	70 Participants n=189 Participants	70 Participants n=184 Participants	107 Participants n=281 Participants	247 Participants n=764 Participants
Region of Enrollment United States	25 Participants n=28 Participants	25 Participants n=28 Participants	24 Participants n=27 Participants	24 Participants n=27 Participants	103 Participants n=189 Participants	102 Participants n=184 Participants	153 Participants n=281 Participants	456 Participants n=764 Participants
Region of Enrollment Japan	3 Participants n=28 Participants	3 Participants n=28 Participants	3 Participants n=27 Participants	3 Participants n=27 Participants	0 Participants n=189 Participants	0 Participants n=184 Participants	0 Participants n=281 Participants	12 Participants n=764 Participants
Region of Enrollment Mexico	0 Participants n=28 Participants	0 Participants n=28 Participants	0 Participants n=27 Participants	0 Participants n=27 Participants	16 Participants n=189 Participants	12 Participants n=184 Participants	21 Participants n=281 Participants	49 Participants n=764 Participants

PRIMARY outcome

Timeframe: Week 36

Population: All randomized participants in Phase 3 portion, in both Stages 1 and 2.

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.

Outcome measures

Measure	Placebo Phase 3 n=189 Participants Participants received two placebo tablets administered orally every day (QD).	2 mg Baricitinib Phase 3 n=184 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 Phase 3 n=281 Participants Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3	5.3 percentage of participants Interval 2.9 to 9.5	21.7 percentage of participants Interval 16.4 to 28.2	35.2 percentage of participants Interval 29.9 to 41.0

SECONDARY outcome

Timeframe: Week 36

Population: All randomized participants in Phase 3 portion, in both Stages 1 and 2 with baseline PRO for scalp hair assessment of ≥ 3.

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

Outcome measures

Measure	Placebo Phase 3 n=181 Participants Participants received two placebo tablets administered orally every day (QD).	2 mg Baricitinib Phase 3 n=175 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 Phase 3 n=275 Participants Participants received one 4 mg Baricitinib tablet administered orally, every day QD, 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 - Phase 3	5.0 percentage of participants Interval 2.6 to 9.2	16.0 percentage of participants Interval 11.3 to 22.2	33.1 percentage of participants Interval 27.8 to 38.9

SECONDARY outcome

Timeframe: Week 36

Population: All randomized participants in Phase 3 portion, in both Stages 1 and 2 with baseline PRO measure for EB ≥ 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

Measure	Placebo Phase 3 n=130 Participants Participants received two placebo tablets administered orally every day (QD).	2 mg Baricitinib Phase 3 n=141 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 Phase 3 n=184 Participants Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
Percentage of Participants Achieving PRO Measure for EB 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥ 2 at Baseline) - Phase 3	3.1 percentage of participants Interval 1.2 to 7.6	16.3 percentage of participants Interval 11.1 to 23.3	32.1 percentage of participants Interval 25.7 to 39.1

SECONDARY outcome

Timeframe: Week 36

Population: All randomized participants in Phase 3 portion, in both Stages 1 and 2 with baseline PRO measure for EL ≥ 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

Measure	Placebo Phase 3 n=100 Participants Participants received two placebo tablets administered orally every day (QD).	2 mg Baricitinib Phase 3 n=112 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 Phase 3 n=161 Participants Participants received one 4 mg Baricitinib tablet administered orally, every day QD, 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) - Phase 3	2.0 percentage of participants Interval 0.6 to 7.0	19.6 percentage of participants Interval 13.3 to 28.0	29.8 percentage of participants Interval 23.3 to 37.3

SECONDARY outcome

Timeframe: Week 36

Population: All randomized participants in Phase 3 portion, in both Stages 1 and 2 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

Measure	Placebo Phase 3 n=124 Participants Participants received two placebo tablets administered orally every day (QD).	2 mg Baricitinib Phase 3 n=136 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 Phase 3 n=188 Participants Participants received one 4 mg Baricitinib tablet administered orally, every day QD, 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) - Phase 3	3.2 percentage of participants Interval 1.3 to 8.0	19.1 percentage of participants Interval 13.4 to 26.5	31.4 percentage of participants Interval 25.2 to 38.3

SECONDARY outcome

Timeframe: Week 36

Population: All randomized participants in Phase 3 portion, in both Stages 1 and 2 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

Measure	Placebo Phase 3 n=96 Participants Participants received two placebo tablets administered orally every day (QD).	2 mg Baricitinib Phase 3 n=111 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 Phase 3 n=167 Participants Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
Percentage of Participants Achieving ClinRO Measure for Eye Lash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥ 2 at Baseline) - Phase 3	3.1 percentage of participants Interval 1.1 to 8.8	13.5 percentage of participants Interval 8.4 to 21.1	33.5 percentage of participants Interval 26.8 to 41.0

SECONDARY outcome

Timeframe: Baseline, Week 36

Population: All randomized participants in Phase 3 portion, Stages 1 and 2 with a nonmissing baseline and least one postbaseline measures. A modified last observation carried forward (mLOCF) imputation technique was used to replace missing data with the most recent non-missing post-baseline assessment.

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 worse 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

Measure	Placebo Phase 3 n=185 Participants Participants received two placebo tablets administered orally every day (QD).	2 mg Baricitinib Phase 3 n=180 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 Phase 3 n=278 Participants Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
Percent Change From Baseline in SALT Score - Phase 3	-8.13 percent change Standard Error 3.100	-31.23 percent change Standard Error 3.157	-45.79 percent change Standard Error 2.663

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants in Phase 3 portion, in both Stages 1 and 2.

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.

Outcome measures

Measure	Placebo Phase 3 n=189 Participants Participants received two placebo tablets administered orally every day (QD).	2 mg Baricitinib Phase 3 n=184 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 Phase 3 n=281 Participants Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3	4.8 percentage of participants Interval 2.5 to 8.8	9.8 percentage of participants Interval 6.3 to 14.9	21.7 percentage of participants Interval 17.3 to 26.9

SECONDARY outcome

Timeframe: Week 52

Time for participants to achieve SALT ≤ 20

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 36

Population: All randomized participants in Phase 3 portion, Stages 1 and 2 with a nonmissing baseline and at least one postbaseline measure. The method used to handle missing data will be mLOCF which used the most recent nonmissing postbaseline assessment.

The Hospital Anxiety Depression Scale (HADS) is a 14 item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (e.g., 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.

LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.

Outcome measures

Measure	Placebo Phase 3 n=177 Participants Participants received two placebo tablets administered orally every day (QD).	2 mg Baricitinib Phase 3 n=174 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 Phase 3 n=272 Participants Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score - Phase 3	-0.40 score on a scale Standard Error 0.234	-1.22 score on a scale Standard Error 0.236	-0.93 score on a scale Standard Error 0.199

SECONDARY outcome

Timeframe: Baseline, Week 36

Population: All randomized participants in Phase 3 portion, Stages 1 and 2 with a nonmissing baseline and at least one postbaseline measure. The method used to handle missing data will be 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 (e.g., 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.

LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.

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Outcome measures

Measure	Placebo Phase 3 n=177 Participants Participants received two placebo tablets administered orally every day (QD).	2 mg Baricitinib Phase 3 n=174 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 Phase 3 n=272 Participants Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
Mean Change From Baseline in HADS Depression Score - Phase 3	0.04 score on a scale Standard Error 0.210	-0.38 score on a scale Standard Error 0.213	-0.28 score on a scale Standard Error 0.179

Adverse Events

Placebo Phase 2

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

1 mg Baricitinib Phase 2

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

2 mg Baricitinib Phase 2

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

4 mg Baricitinib Phase 2

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo Phase 3

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

2 mg Baricitinib Phase 3

Serious events: 4 serious events

Other events: 28 other events

Deaths: 0 deaths

4 mg Baricitinib Phase 3

Serious events: 6 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo Phase 2 n=28 participants at risk Participants received three placebo tablets administered QD.	1 mg Baricitinib Phase 2 n=28 participants at risk Participants received one 1 mg Baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib Phase 2 n=27 participants at risk Participants received one 2 mg Baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind.	4 mg Baricitinib Phase 2 n=27 participants at risk Participants received one 4 mg Baricitinib tablet administered orally QD, and two placebo tablets QD administered orally to maintain the blind.	Placebo Phase 3 n=189 participants at risk Participants received two placebo tablets administered orally QD.	2 mg Baricitinib Phase 3 n=183 participants at risk Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.	4 mg Baricitinib Phase 3 n=280 participants at risk Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Cardiac disorders Acute myocardial infarction	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.55% 1/183 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Ventricular tachycardia	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.36% 1/280 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Food poisoning	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.36% 1/280 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Asthenia	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.55% 1/183 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Chest pain	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.36% 1/280 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.55% 1/183 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.36% 1/280 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.55% 1/183 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Guillain-barre syndrome	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.36% 1/280 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.00% 0/16 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/23 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/108 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.61% 1/164 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Nephrolithiasis	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.55% 1/183 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.

Other adverse events

Measure	Placebo Phase 2 n=28 participants at risk Participants received three placebo tablets administered QD.	1 mg Baricitinib Phase 2 n=28 participants at risk Participants received one 1 mg Baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind.	2 mg Baricitinib Phase 2 n=27 participants at risk Participants received one 2 mg Baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind.	4 mg Baricitinib Phase 2 n=27 participants at risk Participants received one 4 mg Baricitinib tablet administered orally QD, and two placebo tablets QD administered orally to maintain the blind.	Placebo Phase 3 n=189 participants at risk Participants received two placebo tablets administered orally QD.	2 mg Baricitinib Phase 3 n=183 participants at risk Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.	4 mg Baricitinib Phase 3 n=280 participants at risk Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Blood and lymphatic system disorders Neutropenia	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Nausea	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 3 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Bronchitis	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Herpes simplex	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Influenza	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Nasopharyngitis	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.3% 12/189 • Number of events 12 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.6% 12/183 • Number of events 14 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.5% 21/280 • Number of events 28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Onychomycosis	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Oral herpes	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 3 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 3/27 • Number of events 3 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	17.9% 5/28 • Number of events 8 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 3/27 • Number of events 3 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	18.5% 5/27 • Number of events 5 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.3% 10/189 • Number of events 13 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 9/183 • Number of events 12 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.5% 21/280 • Number of events 29 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/16 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/23 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/108 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/164 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Vulvovaginal mycotic infection	6.2% 1/16 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/23 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/108 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/164 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypercholesterolaemia	3.6% 1/28 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 2/28 • Number of events 2 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	10.7% 3/28 • Number of events 3 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Depression	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Endometriosis	6.2% 1/16 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/23 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/108 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/164 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Menorrhagia	0.00% 0/16 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/23 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/108 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/164 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Acne	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 3/27 • Number of events 3 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.5% 10/183 • Number of events 10 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.7% 16/280 • Number of events 18 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/183 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/280 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood creatine phosphokinase increased	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/189 • Number of events 4 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/183 • Number of events 3 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.7% 16/280 • Number of events 20 • Baseline up to Week 36 * All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. * Gender specific events occurring only 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: ClinicalTrials.gov@lilly.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60