Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis (NCT NCT03952559)

Results Overview

Percentage of participants achieving IGA of 0 or 1 with a ≥2 point improvement is presented. The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

516 participants

Primary outcome timeframe

Week 16

Results posted on

2025-04-20

Participant Flow

A total of 516 participants (33+483=516) were enrolled in the study. Of which 483 participants were randomized to one of the four double-blind treatment arms, and 33 participants received open label baricitinib as part of pharmacokinetics (PK) lead-in (not randomized).

Participant milestones

Participant milestones
Measure	Baricitinib Open Label High Dose (PK Lead-in) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Placebo Double-blind Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.
High Dose Open Label - PK Lead-in STARTED	33	0	0	0	0
High Dose Open Label - PK Lead-in Received at Least One Dose of Study Drug	33	0	0	0	0
High Dose Open Label - PK Lead-in COMPLETED	33	0	0	0	0
High Dose Open Label - PK Lead-in NOT COMPLETED	0	0	0	0	0
Double Blind Treatment Period STARTED	0	122	121	120	120
Double Blind Treatment Period Received at Least One Dose of Study Drug	0	122	120	120	120
Double Blind Treatment Period COMPLETED	0	115	116	117	119
Double Blind Treatment Period NOT COMPLETED	0	7	5	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Double-blind Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.
Double Blind Treatment Period Adverse Event	2	1	0	1
Double Blind Treatment Period Lack of Efficacy	4	1	1	0
Double Blind Treatment Period Withdrawal by Subject	1	2	2	0
Double Blind Treatment Period Inadvertently randomized	0	1	0	0

Baseline Characteristics

A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baricitinib Open Label High Dose n=33 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Placebo Double-blind n=122 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=121 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Total n=516 Participants Total of all reporting groups
Age, Continuous	11.28 years STANDARD_DEVIATION 4.296 • n=93 Participants	11.75 years STANDARD_DEVIATION 4.012 • n=4 Participants	12.35 years STANDARD_DEVIATION 4.052 • n=27 Participants	11.81 years STANDARD_DEVIATION 3.661 • n=483 Participants	11.93 years STANDARD_DEVIATION 3.829 • n=36 Participants	11.92 years STANDARD_DEVIATION 3.914 • n=10 Participants
Age, Customized 2 to <6 years	6 Participants n=93 Participants	14 Participants n=4 Participants	9 Participants n=27 Participants	8 Participants n=483 Participants	9 Participants n=36 Participants	46 Participants n=10 Participants
Age, Customized 6 to <10 years	7 Participants n=93 Participants	20 Participants n=4 Participants	24 Participants n=27 Participants	26 Participants n=483 Participants	23 Participants n=36 Participants	100 Participants n=10 Participants
Age, Customized 10 to <18 years	20 Participants n=93 Participants	88 Participants n=4 Participants	88 Participants n=27 Participants	86 Participants n=483 Participants	88 Participants n=36 Participants	370 Participants n=10 Participants
Sex: Female, Male Female	20 Participants n=93 Participants	64 Participants n=4 Participants	62 Participants n=27 Participants	63 Participants n=483 Participants	53 Participants n=36 Participants	262 Participants n=10 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	58 Participants n=4 Participants	59 Participants n=27 Participants	57 Participants n=483 Participants	67 Participants n=36 Participants	254 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants	1 Participants n=483 Participants	3 Participants n=36 Participants	9 Participants n=10 Participants
Race (NIH/OMB) Asian	19 Participants n=93 Participants	16 Participants n=4 Participants	18 Participants n=27 Participants	18 Participants n=483 Participants	21 Participants n=36 Participants	92 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	5 Participants n=483 Participants	4 Participants n=36 Participants	14 Participants n=10 Participants
Race (NIH/OMB) White	13 Participants n=93 Participants	94 Participants n=4 Participants	94 Participants n=27 Participants	93 Participants n=483 Participants	88 Participants n=36 Participants	382 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	8 Participants n=4 Participants	4 Participants n=27 Participants	2 Participants n=483 Participants	4 Participants n=36 Participants	18 Participants n=10 Participants
Region of Enrollment Argentina	0 Participants n=93 Participants	16 Participants n=4 Participants	18 Participants n=27 Participants	18 Participants n=483 Participants	18 Participants n=36 Participants	70 Participants n=10 Participants
Region of Enrollment Hungary	0 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants	2 Participants n=483 Participants	2 Participants n=36 Participants	13 Participants n=10 Participants
Region of Enrollment Czechia	0 Participants n=93 Participants	6 Participants n=4 Participants	7 Participants n=27 Participants	4 Participants n=483 Participants	5 Participants n=36 Participants	22 Participants n=10 Participants
Region of Enrollment Japan	0 Participants n=93 Participants	9 Participants n=4 Participants	10 Participants n=27 Participants	10 Participants n=483 Participants	9 Participants n=36 Participants	38 Participants n=10 Participants
Region of Enrollment United Kingdom	3 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants	0 Participants n=36 Participants	9 Participants n=10 Participants
Region of Enrollment India	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	1 Participants n=36 Participants	5 Participants n=10 Participants
Region of Enrollment Russia	0 Participants n=93 Participants	12 Participants n=4 Participants	13 Participants n=27 Participants	11 Participants n=483 Participants	9 Participants n=36 Participants	45 Participants n=10 Participants
Region of Enrollment Spain	10 Participants n=93 Participants	7 Participants n=4 Participants	6 Participants n=27 Participants	6 Participants n=483 Participants	7 Participants n=36 Participants	36 Participants n=10 Participants
Region of Enrollment Austria	0 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants	7 Participants n=10 Participants
Region of Enrollment Taiwan	18 Participants n=93 Participants	5 Participants n=4 Participants	4 Participants n=27 Participants	3 Participants n=483 Participants	11 Participants n=36 Participants	41 Participants n=10 Participants
Region of Enrollment Brazil	0 Participants n=93 Participants	7 Participants n=4 Participants	9 Participants n=27 Participants	7 Participants n=483 Participants	11 Participants n=36 Participants	34 Participants n=10 Participants
Region of Enrollment Poland	0 Participants n=93 Participants	19 Participants n=4 Participants	19 Participants n=27 Participants	25 Participants n=483 Participants	26 Participants n=36 Participants	89 Participants n=10 Participants
Region of Enrollment Mexico	0 Participants n=93 Participants	13 Participants n=4 Participants	7 Participants n=27 Participants	7 Participants n=483 Participants	7 Participants n=36 Participants	34 Participants n=10 Participants
Region of Enrollment Israel	2 Participants n=93 Participants	8 Participants n=4 Participants	11 Participants n=27 Participants	10 Participants n=483 Participants	8 Participants n=36 Participants	39 Participants n=10 Participants
Region of Enrollment Australia	0 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	6 Participants n=483 Participants	0 Participants n=36 Participants	10 Participants n=10 Participants
Region of Enrollment France	0 Participants n=93 Participants	8 Participants n=4 Participants	4 Participants n=27 Participants	2 Participants n=483 Participants	4 Participants n=36 Participants	18 Participants n=10 Participants
Region of Enrollment Germany	0 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	3 Participants n=483 Participants	0 Participants n=36 Participants	6 Participants n=10 Participants

PRIMARY outcome

Timeframe: Week 16

Population: All randomized participants in the double-blind treatment period.

Percentage of participants achieving IGA of 0 or 1 with a ≥2 point improvement is presented. The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=122 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=121 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement	16.4 Percentage of participants	18.2 Percentage of participants	25.8 Percentage of participants	41.7 Percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose

Population: All participants who received at least one dose of study drug in the PK Lead-in (PK LI) period and had evaluable PK data.

Open label Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=6 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=7 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=20 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104	63.2 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 30	40.1 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 32	50.6 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 29	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Predose; 0.25 h; 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose

Population: All participants who received at least one dose of study drug in the PK Lead-in (PK LI) period and had evaluable PK data.

Open label Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=6 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=7 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=20 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104	251 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 18	178 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 18	290 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 44	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants in the double-blind treatment period.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI75.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=122 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=121 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)	32 Percentage of participants	32.2 Percentage of participants	40 Percentage of participants	52.5 Percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants in the double-blind treatment period.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI90.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=122 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=121 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Percentage of Participants Achieving EASI90	12.3 Percentage of participants	11.6 Percentage of participants	21.7 Percentage of participants	30.0 Percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants in the double-blind treatment period and had evaluable EASI data.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs (1) erythema (2)edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score is obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). Least Square (LS) Means were calculated using a mixed model repeated measures (MMRM) model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=105 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=109 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=113 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=115 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Change From Baseline in EASI Score	-14.16 units on a scale Standard Error 1.001	-15.67 units on a scale Standard Error 0.990	-15.83 units on a scale Standard Error 0.978	-16.88 units on a scale Standard Error 0.984	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants in the double-blind treatment period.

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=122 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=121 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)	9.8 Percentage of participants	7.4 Percentage of participants	15.8 Percentage of participants	20.0 Percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants (≥10 to \<18 years old) in the double-blind treatment period and with baseline itch score \>= 4.

The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=55 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=63 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=62 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=62 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants 10 to <18 Years Old at Study Entry	16.4 Percentage of participants	17.5 Percentage of participants	25.8 Percentage of participants	35.5 Percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants in the double-blind treatment period.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI50 is defined as a ≥ 50% improvement from baseline in EASI score.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=122 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=121 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Percentage of Participants Achieving EASI50	55.7 Percentage of participants	59.5 Percentage of participants	60.8 Percentage of participants	71.7 Percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants in the double-blind treatment period.

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=122 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=121 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Percentage of Participants Achieving IGA of 0	4.1 Percentage of participants	5.0 Percentage of participants	5.0 Percentage of participants	12.5 Percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants in the double-blind treatment period and had evaluable SCORAD data.

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=103 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=107 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=112 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=112 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Change From Baseline in SCORAD	-20.93 units on a scale Standard Error 1.894	-24.82 units on a scale Standard Error 1.880	-26.08 units on a scale Standard Error 1.857	-28.55 units on a scale Standard Error 1.867	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants in the double-blind treatment period.

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=122 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=121 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Percentage of Participants Achieving SCORAD90	3.3 Percentage of participants	1.7 Percentage of participants	5.0 Percentage of participants	12.5 Percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants in the double-blind treatment period and had evaluable BSA data.

Body surface area affected by atopic dermatitis will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of atopic dermatitis. LS Means calculated using MMRM model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=105 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=109 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=113 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=115 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Change From Baseline in Body Surface Area (BSA) Affected	-20.31 percentage of body surface area Standard Error 1.622	-21.83 percentage of body surface area Standard Error 1.608	-22.06 percentage of body surface area Standard Error 1.581	-25.66 percentage of body surface area Standard Error 1.593	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants in the double-blind treatment period.

Percentage of participants developing skin infections requiring antibiotic treatment

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=122 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=121 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment	5.7 Percentage of participants	5.0 Percentage of participants	3.3 Percentage of participants	2.5 Percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline Through 16 Weeks

Population: All randomized participants in the double-blind treatment period.

Mean number of days without use of background TCS was presented. The ANOVA model includes treatment, age cohort, region, and baseline disease severity (IGA) as factors.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=122 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=121 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Mean Number of Days Without Use of Background Topical Corticosteroid (TCS)	27.74 days Standard Error 4.06	32.22 days Standard Error 4.07	30.86 days Standard Error 4.06	39.91 days Standard Error 4.10	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline through 16 Weeks

Population: All randomized participants in the double-blind treatment period.

The dispensed TCS tubes were weighed with cap (without the carton) to determine the dispensed amount of TCS in grams. Returned tubes were weighed with cap (without the carton) to determine the amount of TCS in grams used at each visit. Analysis was done via analysis of variance (ANOVA), with geographic region, baseline disease severity, and treatment as factors in the model.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=122 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=121 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=120 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Mean Gram Quantity of TCS Use (Tube Weights)	265.79 grams Standard Error 22.04	216.60 grams Standard Error 22.09	228.41 grams Standard Error 22.05	185.42 grams Standard Error 22.26	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants (10 to \<18 years) in the double-blind treatment period and had evaluable Itch NRS data.

The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=65 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=69 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=78 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=79 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Change From Baseline in Itch NRS for Participants 10 to <18 Years at Study Entry	-1.15 units on a scale Standard Deviation 0.276	-1.80 units on a scale Standard Deviation 0.266	-1.65 units on a scale Standard Deviation 0.261	-2.25 units on a scale Standard Deviation 0.258	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants (2 to \<10 years old) in the double-blind treatment period and had evaluable PRISM data.

The Parent-Reported Itch Severity Measure (PRISM) is a single-item, parent/caregiver administered scale that reports the overall severity of their child's itching. Parent/Caregiver's report the overall severity of their child's itching based on observed actions of the child in the past 24 hours. Response options range include "No Itch," "Mild," "Moderate," "Severe," and "Very Severe." The PRISM will be completed for participants \<10 years old by the parent/caregiver. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=31 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=29 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=27 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=21 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Change From Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants 2 to <10 Years at Study Entry	-0.02 units on a scale Standard Error 0.139	-0.24 units on a scale Standard Error 0.146	-0.49 units on a scale Standard Error 0.145	-0.37 units on a scale Standard Error 0.158	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants in the double-blind treatment period and had evaluable POEM data.

The POEM is a simple, 7-item, patient-administered scale that assesses disease severity in children and adults. Participants respond to questions about the frequency of 7 symptoms (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) over the last week on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). Scores range from 0-28 with higher total scores indicating greater disease severity. LS Means were calculated using MMRM model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=104 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=107 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=112 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=112 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Change From Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score	-3.02 units on a scale Standard Error 0.708	-3.93 units on a scale Standard Error 0.704	-4.58 units on a scale Standard Error 0.696	-4.58 units on a scale Standard Error 0.702	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants (10 to \<18 years old) in the double-blind treatment period and had evaluable PGI-S-AD data.

The PGI-S-AD is a single-item question asked to the participants on how they would rate their overall atopic dermatitis symptoms over the past 24 hours to evaluate the severity of the disease at that point in time. The 5 categories of responses range from "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe". LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=65 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=68 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=78 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=79 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Change From Baseline in Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score for Participants 10 to <18 Years at Study Entry	-0.33 units on a scale Standard Error 0.115	-0.56 units on a scale Standard Error 0.112	-0.64 units on a scale Standard Error 0.109	-0.83 units on a scale Standard Error 0.108	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants (5 to \<18 years old) in the double-blind treatment period and had evaluable (PROMIS) - Pediatric Depression data. LS Means were calculated using MMRM model, which includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline-by-visit-interaction as fixed continuous effects.

PROMIS is a set of person-centered measures that evaluates and monitors physical, mental and social health in adults and children. The PROMIS Depression item bank assesses self-reported negative mood (sadness, guilt), views on self (self-criticism, worthlessness), social cognition (loneliness, interpersonal alienation), decreased positive affect and engagement (loss of interest, meaning, and purpose). The PROMIS Depression Short Form (8a v2.0 and 6a v2.0) is available in pediatric self-report (ages 8 to \<18 years) and for parents/caregivers serving as proxy reporters for children (ages 5 to \<8 years). Children aged \<5 years will not complete assessment. Both pediatric self-report and proxy-report versions assess depression "in past seven days." Response options range from 1 = Never;2 = Rarely;3 = Sometimes;4 = Often; to 5 = Almost always. Total raw scores were converted to T-Scores (mean= 50 and a standard deviation = 10) with higher scores representing greater depression.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=93 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=102 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=106 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=107 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Pediatric Depression for Participants 5 to <18 Years at Study Entry 5 to <8 years old	-3.95 T-score Standard Error 2.629	-2.54 T-score Standard Error 2.138	-7.07 T-score Standard Error 2.644	-2.83 T-score Standard Error 2.033	—	—	—	—	—
Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Pediatric Depression for Participants 5 to <18 Years at Study Entry 8 to <18 years old	-3.60 T-score Standard Error 1.190	-3.42 T-score Standard Error 1.343	-4.68 T-score Standard Error 1.034	-5.30 T-score Standard Error 1.436	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants (5 to \<18 years old) in the double-blind treatment period and had evaluable (PROMIS) - Pediatric Anxiety data. LS Means were calculated using the MMRM model, which includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline-by-visit-interaction as fixed continuous effects.

PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS Anxiety item bank assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The PROMIS Anxiety Short Form (8 questions, 8a v2.0) is available in a pediatric self-report (ages 8 to \<18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages 5 to \<8 years old). Children aged \<5 years will not complete this assessment. Both pediatric self-report and proxy-report versions assess anxiety "in the past seven days." Response options range from 1= Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=93 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=102 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=106 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=107 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Change From Baseline in the PROMIS-Pediatric Anxiety for Participants 5 to <18 Years at Study Entry 5 to <8 years old	-4.65 T-score Standard Error 2.864	-3.03 T-score Standard Error 2.318	-5.09 T-score Standard Error 2.931	-3.15 T-score Standard Error 2.214	—	—	—	—	—
Change From Baseline in the PROMIS-Pediatric Anxiety for Participants 5 to <18 Years at Study Entry 8 to <18 years old	-4.40 T-score Standard Error 1.223	-4.09 T-score Standard Error 1.394	-5.44 T-score Standard Error 1.064	-6.81 T-score Standard Error 1.486	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants (4 to \<18 years old) in the double-blind treatment period and had evaluable CDLQI data.

CDLQI is a validated 10 question tool to measure impact of skin disease on QOL in children by assessing how much the skin problem has affected the subjects over past week. Nine questions were scored as follows: Very much = 3, Quite a lot = 2, Only a little = 1, Not at all or unanswered = 0. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question (max. = 30, min. = 0). Higher the score, the greater the impact on QOL. A negative change from baseline indicated improvement. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=97 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=105 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=111 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=111 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Change From Baseline in the Children's Dermatology Life Quality Index (CDLQI) at Week 16 for Participants 4 to <18 Years at Study Entry	-3.06 Score on a Scale Standard Error 0.480	-3.73 Score on a Scale Standard Error 0.465	-3.70 Score on a Scale Standard Error 0.451	-3.36 Score on a Scale Standard Error 0.459	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants (2 to \<4 years old) in the double-blind treatment period and had evaluable IDQOL data.

Infants' Dermatitis Quality of Life Index (IDQOL) is used to evaluate quality of life for subjects of age less than 4 years. IDQOL questionnaires were designed for infants (below the age of 4 years) with atopic dermatitis. The IDQOL was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. A negative change from baseline indicated improvement. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=5 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=2 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=1 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=1 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry	-1.40 units on a scale Standard Error 1.743	3.87 units on a scale Standard Error 4.423	3.33 units on a scale Standard Error 3.752	-6.40 units on a scale Standard Error 3.601	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants in the double-blind treatment period and who had at least 1 post-baseline WPAI measure.

The Atopic Dermatitis Caregiver (WPAI-AD-CG) assesses the effect of a child's atopic dermatitis on the parent/caregiver's work productivity during the past 7 days. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, Scores are calculated as impairment percentages with higher scores indicating greater impairment and less productivity. LS Mean were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=96 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=104 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=106 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=109 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Change From Baseline on the Work Productivity and Activity Impairment: Atopic Dermatitis - Caregiver (WPAI-AD-CG) Score Absenteeism	3.99 score on a scale Standard Error 2.367	2.39 score on a scale Standard Error 2.135	2.14 score on a scale Standard Error 2.107	-0.94 score on a scale Standard Error 2.387	—	—	—	—	—
Change From Baseline on the Work Productivity and Activity Impairment: Atopic Dermatitis - Caregiver (WPAI-AD-CG) Score Presenteeism	-4.69 score on a scale Standard Error 2.719	-5.62 score on a scale Standard Error 2.452	-9.99 score on a scale Standard Error 2.451	-11.44 score on a scale Standard Error 2.797	—	—	—	—	—
Change From Baseline on the Work Productivity and Activity Impairment: Atopic Dermatitis - Caregiver (WPAI-AD-CG) Score Overall Work Impairment	0.38 score on a scale Standard Error 3.473	-3.80 score on a scale Standard Error 3.119	-5.86 score on a scale Standard Error 3.086	-11.15 score on a scale Standard Error 3.515	—	—	—	—	—
Change From Baseline on the Work Productivity and Activity Impairment: Atopic Dermatitis - Caregiver (WPAI-AD-CG) Score Activity Impairment	-7.03 score on a scale Standard Error 2.372	-11.45 score on a scale Standard Error 2.318	-11.90 score on a scale Standard Error 2.293	-14.05 score on a scale Standard Error 2.311	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants (4 to \<18 years old) in the double-blind treatment period with week 16 EQ-5D-Y data.

The EQ-5D-Y questionnaire is health status related and self-completed for pediatric participants ≥8 years old and completed by parents/caregivers for children 4 to \<8 years old. Health state profile assessed health in 5 dimensions (Mobility,selfcare,usual activities,pain/discomfort, anxiety/depression) to obtain index score, each with three levels of response (no problems,some problems,a lot of problems). Participants indicated their health state by choosing appropriate level from each dimension. Visual analog scale on which participant rates their perceived health state from 0 ("worst health you can imagine") to 100 ("best health you can imagine") is presented.Higher the score the better the health status. LS Means uses MMRM model which includes treatment,age cohort,region,baseline disease severity(IGA),visit,treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=98 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=105 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=110 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=110 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Change From Baseline on the European Quality of Life-5 Dimensions-Youth (EQ-5D-Y) for Participants 4 to <18 Years at Study Entry	3.15 score on a scale Standard Error 2.090	5.12 score on a scale Standard Error 2.025	5.16 score on a scale Standard Error 1.969	7.67 score on a scale Standard Error 2.000	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants (10 to \<18 years old) in the double-blind treatment period with week 16 ADSS Item 2 (frequency of waking) data.

Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=65 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=68 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=78 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=79 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) for Participants 10 to <18 Years at Study Entry	-0.42 score on a scale Standard Error 0.130	-0.35 score on a scale Standard Error 0.126	-0.43 score on a scale Standard Error 0.123	-0.55 score on a scale Standard Error 0.122	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants (10 to \<18 years old) in the double-blind treatment period with Week 16 Skin Pain NRS data.

Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours. LS Means were calculated using a MMRM model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=65 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=68 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=78 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=79 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Change From Baseline in Skin Pain NRS for Participants 10 to <18 Years at Study Entry	-1.15 score on a scale Standard Error 0.267	-1.23 score on a scale Standard Error 0.259	-1.56 score on a scale Standard Error 0.254	-1.77 score on a scale Standard Error 0.251	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 2

Population: All PK lead-in participants (2 to \<10 years old) with data for suspension acceptability and palatability assessment at given time point.

The questionnaire for Suspension acceptability and palatability assessed the participants ability to swallow the oral suspension product, experience relating to the taste, smell and ease of administering and taking the suspension. The questionnaire contained following Questions: Question 1) How did you (your child) like the taste of the medicine? Question 2) How did you (your child) like the smell of the medicine? Question 3) How easy was it for you (your child) to take the medicine today? Question 4) How easy was it for you to use the oral syringe to give your child the dose today? Responses: Liked Very Much, Liked, Neither Liked nor Disliked, Disliked, Disliked Very Much, Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=13 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 1- Liked Very Much:	8 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 1- Liked	1 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 1- Neither Liked nor Disliked	3 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 1- Disliked	1 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 1- Disliked Very Much	0 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 2- Liked Very Much:	6 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 2- Liked	1 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 2- Neither Liked nor Disliked	6 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 2- Disliked	0 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 2- Disliked Very Much	0 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 3- Very Easy	8 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 3- Easy	5 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 3- Neither Easy nor Hard	0 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 3- Difficult (or Hard)	0 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 3- Very Difficult (or Hard)	0 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 4- Very Easy	9 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 4- Easy	4 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 4- Neither Easy nor Hard	0 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 4- Difficult (or Hard)	0 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry Question 4- Very Difficult (or Hard)	0 Participant responses	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 2

Population: All PK Lead-In participants \>=10 years old, who had data for tablet acceptability and palatability at given time point.

The questionnaire for tablet acceptability and palatability assessed the participants ability to swallow the tablet. The questionnaire contained the question 1) How easy was it for you (your child) to swallow the medicine today? Responses: Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=18 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old at Study Entry Question 1- Very Easy	18 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old at Study Entry Question 1- Easy	0 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old at Study Entry Question 1- Neither Easy nor Hard	0 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old at Study Entry Question 1- Difficult (or Hard)	0 Participant responses	—	—	—	—	—	—	—	—
Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old at Study Entry Question 1- Very Difficult (or Hard)	0 Participant responses	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 124 Weeks

Height, Weight and BMI Growth Rate will be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline Through End of Study Completion

Number of participants with change of IgG titers for tetanus vaccine and pneumococcal conjugate will be presented. A primary immune response was assessed in participants who had never received tetanus or pneumococcal conjugate vaccines previously and secondary/booster responses were assessed if the participants had previously received the vaccines. For pneumococcal conjugate vaccine, number of participants with \>= 2-fold increase in \>=6 pneumococcal serotypes from pre-vaccination timepoint to specified post-vaccination timepoints through the end of the study will be presented. For tetanus vaccine, number of participants with \>= 2-fold increase in participants with baseline titer \>=0.1 IU/mL from pre-vaccination timepoint to specified post-vaccination timepoints through the end of the study will be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose

Population: All participants who received at least one dose of study drug in the open-label PK lead-in and double-blind treatment period and had evaluable PK data.

Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=9 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=8 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=15 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=24 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) n=26 Participants Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) n=30 Participants Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) n=87 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) n=86 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) n=108 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Pop PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104	18.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 29	35.1 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 21	64.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 22	11.6 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 29	23.1 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 23	44.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41	13.2 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 34	27.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 34	50.7 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 28

SECONDARY outcome

Timeframe: Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose

Population: All participants who received at least one dose of study drug in the open-label PK lead-in and double-blind treatment period and had evaluable PK data.

Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.

Outcome measures

Outcome measures
Measure	Placebo Double-blind n=9 Participants Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=8 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Medium Dose n=15 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=24 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib (1 mg): Medium Dose (6 to <10 Years) n=26 Participants Participants 6 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.	Baricitinib (2 mg): High Dose (6 to <10 Years) n=30 Participants Participants 6 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.	Baricitinib (1 mg): Low Dose (10 to <18 Years) n=87 Participants Participants 10 to \< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.	Baricitinib (2 mg): Medium Dose (10 to <18 Years) n=86 Participants Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.	Baricitinib (4 mg): High Dose (10 to <18 Years) n=108 Participants Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104	94.3 hournanogram per milliliter (hng/ mL) Geometric Coefficient of Variation 108	200 hournanogram per milliliter (hng/ mL) Geometric Coefficient of Variation 63	298 hournanogram per milliliter (hng/ mL) Geometric Coefficient of Variation 51	74.8 hournanogram per milliliter (hng/ mL) Geometric Coefficient of Variation 64	155 hournanogram per milliliter (hng/ mL) Geometric Coefficient of Variation 65	276 hournanogram per milliliter (hng/ mL) Geometric Coefficient of Variation 76	109 hournanogram per milliliter (hng/ mL) Geometric Coefficient of Variation 63	222 hournanogram per milliliter (hng/ mL) Geometric Coefficient of Variation 66	383 hournanogram per milliliter (hng/ mL) Geometric Coefficient of Variation 61

Adverse Events

Placebo Double-blind

Serious events: 5 serious events

Other events: 42 other events

Deaths: 0 deaths

Baricitinib Double-blind Low Dose

Serious events: 2 serious events

Other events: 39 other events

Deaths: 0 deaths

Baricitinib Double-blind Mid Dose

Serious events: 1 serious events

Other events: 44 other events

Deaths: 0 deaths

Baricitinib Double-blind High Dose

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

Baricitinib Open-label High Dose PK Lead-in

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Double-blind n=122 participants at risk Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=120 participants at risk Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Mid Dose n=120 participants at risk Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=120 participants at risk Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Open-label High Dose PK Lead-in n=33 participants at risk Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.
Infections and infestations Corneal abscess	0.00% 0/122 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Covid-19	0.82% 1/122 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Impetigo	0.82% 1/122 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Ophthalmic herpes simplex	0.00% 0/122 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Vertigo cns origin	0.00% 0/122 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Suicide attempt	0.82% 1/122 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/122 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis atopic	2.5% 3/122 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Other adverse events

Other adverse events
Measure	Placebo Double-blind n=122 participants at risk Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.	Baricitinib Double-blind Low Dose n=120 participants at risk Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind Mid Dose n=120 participants at risk Participants 10 to \< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Double-blind High Dose n=120 participants at risk Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.	Baricitinib Open-label High Dose PK Lead-in n=33 participants at risk Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/122 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 3/120 • Number of events 4 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	2.5% 3/122 • Number of events 4 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 3/120 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 5/120 • Number of events 6 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.0% 6/120 • Number of events 6 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	0.82% 1/122 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/120 • Number of events 2 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/120 • Number of events 4 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.3% 4/120 • Number of events 5 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	1.6% 2/122 • Number of events 2 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/120 • Number of events 2 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 5/120 • Number of events 7 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Vomiting	2.5% 3/122 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/120 • Number of events 2 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/120 • Number of events 2 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pyrexia	0.82% 1/122 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 3/120 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 2 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/120 • Number of events 2 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bronchitis	0.82% 1/122 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.0% 6/120 • Number of events 6 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 3/120 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Covid-19	2.5% 3/122 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 5/120 • Number of events 5 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 5/120 • Number of events 5 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 3/120 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis	0.00% 0/122 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/120 • Number of events 2 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 3/120 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Impetigo	2.5% 3/122 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/120 • Number of events 2 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Influenza	2.5% 3/122 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Molluscum contagiosum	2.5% 3/122 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/120 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Nasopharyngitis	4.9% 6/122 • Number of events 6 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.3% 4/120 • Number of events 4 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 5/120 • Number of events 5 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 5/120 • Number of events 6 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.1% 2/33 • Number of events 2 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pharyngitis	0.82% 1/122 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 3/120 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 3/120 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Rhinitis	1.6% 2/122 • Number of events 2 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 3/120 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/120 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	0.82% 1/122 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 3/120 • Number of events 4 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.3% 4/120 • Number of events 4 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 5/120 • Number of events 6 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection	4.9% 6/122 • Number of events 7 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/120 • Number of events 2 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/122 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 3/120 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/122 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.3% 4/120 • Number of events 4 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/120 • Number of events 2 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dizziness	0.00% 0/122 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Headache	8.2% 10/122 • Number of events 10 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.8% 7/120 • Number of events 9 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.2% 11/120 • Number of events 20 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.0% 6/120 • Number of events 6 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Dysmenorrhoea	3.1% 2/64 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/62 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 2/63 • Number of events 5 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/53 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Asthma	3.3% 4/122 • Number of events 7 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 3/120 • Number of events 5 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	2.5% 3/122 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/120 • Number of events 2 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/120 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Acne	4.1% 5/122 • Number of events 5 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 3/120 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.3% 4/120 • Number of events 4 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.0% 6/120 • Number of events 6 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis atopic	2.5% 3/122 • Number of events 3 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.83% 1/120 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Chapped lips	0.00% 0/122 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Nausea	0.00% 0/122 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Folliculitis	0.00% 0/122 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Oral herpes	0.00% 0/122 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hair growth abnormal	0.00% 0/122 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/122 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/120 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up to 16 Weeks All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-595-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60