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Clinical Trial Results:
A Phase 3, Multicenter, Randomized, Double blind, Placebo controlled, Parallel group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients with Moderate to Severe Atopic Dermatitis

Summary
EudraCT number	2018-000349-38
Trial protocol	GB DE FR ES CZ AT PL HU
Global end of trial date

Results information
Results version number	v1(current)
This version publication date	10 May 2023
First version publication date	10 May 2023
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

I4V-MC-JAIP

ISRCTN number

US NCT number

NCT03952559

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 16966

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-001220-PIP03-16

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Interim

Date of interim/final analysis

24 Apr 2022

Is this the analysis of the primary completion data?

Yes

Primary completion date

24 Apr 2022

Global end of trial reached?

Main objective of the trial

The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

24 May 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 70

Country: Number of subjects enrolled

Hungary: 13

Country: Number of subjects enrolled

Czechia: 22

Country: Number of subjects enrolled

Japan: 38

Country: Number of subjects enrolled

United Kingdom: 9

Country: Number of subjects enrolled

India: 5

Country: Number of subjects enrolled

Russian Federation: 45

Country: Number of subjects enrolled

Spain: 36

Country: Number of subjects enrolled

Austria: 7

Country: Number of subjects enrolled

Taiwan: 41

Country: Number of subjects enrolled

Brazil: 34

Country: Number of subjects enrolled

Poland: 89

Country: Number of subjects enrolled

Mexico: 34

Country: Number of subjects enrolled

Israel: 39

Country: Number of subjects enrolled

Australia: 10

Country: Number of subjects enrolled

France: 18

Country: Number of subjects enrolled

Germany: 6

Worldwide total number of subjects

516

EEA total number of subjects

191

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

239

Adolescents (12-17 years)

277

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Participants were randomized to one of the four double-blind treatment arms.

Screening details

A separate group of 33 participants received open label baricitinib as part of Pharmacokinetics (PK) lead-in (not randomized).

Period 1 title

Baseline period (Overall) (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Blinding implementation details

The PK lead-in was non-randomized and open-label.

Are arms mutually exclusive

Yes

Placebo Double-blind

Arm description

Participants 10 to < 18 years received placebo tablets. Participants 2 to < 10 years received placebo as oral suspension.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants 10 to < 18 years received placebo tablets.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Participants 2 to < 10 years received placebo as oral suspension.

Baricitinib Double-blind Low Dose

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Baricitinib

Investigational medicinal product code

Other name

LY3009104

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants 10 to < 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.

Investigational medicinal product name

Baricitinib

Investigational medicinal product code

Other name

LY3009104

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Baricitinib

Investigational medicinal product code

Other name

LY3009104

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants 10 to < 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.

Investigational medicinal product name

Baricitinib

Investigational medicinal product code

Other name

LY3009104

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

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

Arm description

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.

Arm type

Placebo

Investigational medicinal product name

Baricitinib

Investigational medicinal product code

Other name

LY3009104

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants 10 to < 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.

Investigational medicinal product name

Baricitinib

Investigational medicinal product code

Other name

LY3009104

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

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)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Baricitinib

Investigational medicinal product code

LY3009104

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants 10 to < 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.

Investigational medicinal product name

Baricitinib

Investigational medicinal product code

Other name

LY3009104

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Participants 2 to < 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.

Number of subjects in period 1	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose	Baricitinib Open Label High Dose (PK Lead-in)
Started	122	121	120	120	33
Received at Least One Dose of Study Drug	122	120	120	120	33
Completed	115	116	117	119	33
Not completed	7	5	3	1	0
Consent withdrawn by subject	1	2	2	-	-
Adverse event, non-fatal	2	1	-	1	-
Inadvertently randomized	-	1	-	-	-
Lack of efficacy	4	1	1	-	-

Baseline characteristics

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Reporting group title

Placebo Double-blind

Reporting group description

Participants 10 to < 18 years received placebo tablets. Participants 2 to < 10 years received placebo as oral suspension.

Reporting group title

Baricitinib Double-blind Low Dose

Reporting group description

Reporting group title

Baricitinib Double-blind Medium Dose

Reporting group description

Reporting group title

Baricitinib Double-blind High Dose

Reporting group description

Reporting group title

Baricitinib Open Label High Dose (PK Lead-in)

Reporting group description

Reporting group values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose	Baricitinib Open Label High Dose (PK Lead-in)	Total
Number of subjects	122	121	120	120	33	516
Age categorical
Units: Subjects
In utero						0
Preterm newborn infants (gestational age < 37 wks)						0
Newborns (0-27 days)						0
Infants and toddlers (28 days-23 months)						0
Children (2-11 years)						0
Adolescents (12-17 years)						0
Adults (18-64 years)						0
From 65-84 years						0
85 years and over						0
Age continuous
Units: years
arithmetic mean (standard deviation)	11.75 ± 4.012	12.35 ± 4.052	11.81 ± 3.661	11.93 ± 3.829	11.28 ± 4.296	-
Gender categorical
Units: Subjects
Female	64	62	63	53	20	262
Male	58	59	57	67	13	254
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	1	3	1	3	1	9
Asian	16	18	18	21	19	92
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0
Black or African American	3	2	5	4	0	14
White	94	94	93	88	13	382
More than one race	0	0	1	0	0	1
Unknown or Not Reported	8	4	2	4	0	18
Region of Enrollment
Units: Subjects
Argentina	16	18	18	18	0	70
Hungary	4	5	2	2	0	13
Czechia	6	7	4	5	0	22
Japan	9	10	10	9	0	38
United Kingdom	2	1	3	0	3	9
India	1	1	2	1	0	5
Russia	12	13	11	9	0	45
Spain	7	6	6	7	10	36
Austria	1	3	1	2	0	7
Taiwan	5	4	3	11	18	41
Brazil	7	9	7	11	0	34
Poland	19	19	25	26	0	89
Mexico	13	7	7	7	0	34
Israel	8	11	10	8	2	39
Australia	3	1	6	0	0	10
France	8	4	2	4	0	18
Germany	1	2	3	0	0	6

End points

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Reporting group title

Placebo Double-blind

Reporting group description

Participants 10 to < 18 years received placebo tablets. Participants 2 to < 10 years received placebo as oral suspension.

Reporting group title

Baricitinib Double-blind Low Dose

Reporting group description

Reporting group title

Baricitinib Double-blind Medium Dose

Reporting group description

Reporting group title

Baricitinib Double-blind High Dose

Reporting group description

Reporting group title

Baricitinib Open Label High Dose (PK Lead-in)

Reporting group description

Subject analysis set title

Baricitinib Open Label High Dose (PK Lead-in)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Subject analysis set title

Placebo Double-blind

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 10 to < 18 years randomised to placebo tablets. Participants 2 to < 10 years randomised to placebo as oral suspension.

Subject analysis set title

Baricitinib Double-blind Low Dose

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 10 to < 18 years randomised to Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to < 10 years randomised to Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.

Subject analysis set title

Baricitinib Double-blind Medium Dose

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 10 to < 18 years randomised to Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to < 10 years randomised to Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.

Subject analysis set title

Baricitinib Double-blind High Dose

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 10 to < 18 years randomised to Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to < 10 years randomised to Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.

Subject analysis set title

Baricitinib Open Label High Dose 2 to <6

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 2 to < 6 years received Baricitinib high dose (2 mg equivalent) administered oral suspension every day (QD).

Subject analysis set title

Baricitinib Open Label High Dose 6 to <10

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 6 to < 10 years received Baricitinib high dose (2 mg equivalent) administered oral suspension every day (QD).

Subject analysis set title

Baricitinib Open Label High Dose 10 to <18

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 10 to < 18 years received Baricitinib high dose (4 mg equivalent) administered orally every day (QD).

Subject analysis set title

Baricitinib (0.5mg): Low Dose (2 to<6 Years)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 2 to < 6 years of age randomised to Baricitinib low dose (0.5 mg) administered as oral suspension QD.

Subject analysis set title

Baricitinib (1 mg): Medium Dose (2 to<6 Years)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 2 to < 6 years randomised to Baricitinib medium dose (1 mg) administered as oral suspension QD.

Subject analysis set title

Baricitinib (2 mg): High Dose (2 to<6 Years)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 2 to < 6 years recieved Baricitinib high dose (2 mg) administered as oral suspension QD.

Subject analysis set title

Baricitinib (0.5mg): Low Dose (6 to <10 Years)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 6 to < 10 years randomised to Baricitinib low dose (0.5 mg) administered as oral suspension QD.

Subject analysis set title

Baricitinib (1 mg): Medium Dose (6 to <10 Years)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 6 to < 10 years randomised to Baricitinib medium dose (1 mg) administered as oral suspension QD.

Subject analysis set title

Baricitinib (2 mg): High Dose (6 to <10 Years)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 6 to < 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.

Subject analysis set title

Baricitinib (1 mg): Low Dose (10 to <18 Years)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 10 to < 18 years randomised to Baricitinib low dose (1 mg) administered orally in tablet form QD.

Subject analysis set title

Baricitinib (2 mg): Medium Dose (10 to <18 Years)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 10 to < 18 years randomised to Baricitinib medium dose (2 mg) administered orally in tablet form QD.

Subject analysis set title

Baricitinib (4 mg): High Dose (10 to <18 Years)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants 10 to < 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.

Primary: Percentage of Participants Achieving Investigator’s Global Assessment (IGA) of 0 or 1 with a ≥2 Point Improvement

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End point title

Percentage of Participants Achieving Investigator’s Global Assessment (IGA) of 0 or 1 with a ≥2 Point Improvement

End point description

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 AD, 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. Analysis population description (APD): All randomized participants in the double-blind treatment period.

End point type

Primary

End point timeframe

Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	122	121	120	120
Units: Percentage of participants
number (not applicable)	16.4	18.2	25.8	41.7

Statistical Analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

243

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7261

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.13

Confidence interval

level

95%

sides

2-sided

lower limit

0.58

upper limit

2.21

Statistical Analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0718

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.95

upper limit

3.41

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

3.73

Confidence interval

level

95%

sides

2-sided

lower limit

2.02

upper limit

6.89

Primary: Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104

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End point title

Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104 ^[1]

End point description

Open label Pop PK: Cmax,ss was derived by a population pharmacokinetics approach. APD: All participants who received at least one dose of study drug in the PK Lead-in (PK LI) period and had evaluable PK data.

End point type

Primary

End point timeframe

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

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No inferential statistics were planned for this endpoint.

End point values	Baricitinib Open Label High Dose 2 to <6	Baricitinib Open Label High Dose 6 to <10	Baricitinib Open Label High Dose 10 to <18
Number of subjects analysed	6	7	20
Units: nanogram per milliliter (ng/mL)
geometric mean (geometric coefficient of variation)	63.2 ± 30	40.1 ± 32	50.6 ± 29

No statistical analyses for this end point

Primary: Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval of LY3009104 at Steady State (AUCtau,ss) of LY3009104

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End point title

Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval of LY3009104 at Steady State (AUCtau,ss) of LY3009104 ^[2]

End point description

Open label Pop PK: AUCtau,ss was reported for participants who received multiple doses of LY3009104 was derived by a population pharmacokinetics approach. APD: All participants who received at least one dose of study drug in the PK Lead-in (PK LI) period and had evaluable PK data.

End point type

Primary

End point timeframe

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

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No inferential statistics were planned for this endpoint.

End point values	Baricitinib Open Label High Dose 2 to <6	Baricitinib Open Label High Dose 6 to <10	Baricitinib Open Label High Dose 10 to <18
Number of subjects analysed	6	7	20
Units: hournanogram per milliliter (hng/mL)
geometric mean (geometric coefficient of variation)	251 ± 18	178 ± 18	290 ± 44

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)

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End point title

Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)

End point description

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.

End point type

Secondary

End point timeframe

Week 16 APD: All randomized participants in the double-blind treatment period.

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	122	121	120	120
Units: Percentage of participants
number (not applicable)	32	32.2	40	52.5

Statistical Analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

243

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9615

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.01

Confidence interval

level

95%

sides

2-sided

lower limit

0.59

upper limit

1.74

Statistical Analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.201

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.42

Confidence interval

level

95%

sides

2-sided

lower limit

0.83

upper limit

2.41

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0017

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.33

Confidence interval

level

95%

sides

2-sided

lower limit

1.38

upper limit

3.95

Secondary: Percentage of Participants Achieving EASI90

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End point title

Percentage of Participants Achieving EASI90

End point description

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.

End point type

Secondary

End point timeframe

Week 16 APD: All randomized participants in the double-blind treatment period.

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	122	121	120	120
Units: Percentage of participants
number (not applicable)	12.3	11.6	21.7	30.0

Statistical Analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

243

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8544

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.43

upper limit

2.01

Statistical Analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0561

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.96

Confidence interval

level

95%

sides

2-sided

lower limit

0.98

upper limit

3.91

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0012

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.99

Confidence interval

level

95%

sides

2-sided

lower limit

1.54

upper limit

5.82

Secondary: Change from Baseline in EASI Score

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End point title

Change from Baseline in EASI Score

End point description

The EASI assesses objective physician estimates of 2 dimensions of AD - 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.

End point type

Secondary

End point timeframe

Baseline, Week 16 APD: All randomized participants in the double-blind treatment period and had evaluable EASI data.

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	105	109	113	115
Units: Percentage of participants
least squares mean (standard error)	-14.16 ± 1.001	-15.67 ± 0.990	-15.83 ± 0.978	-16.88 ± 0.984

Statistical Analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

214

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2627

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-1.51

Confidence interval

level

95%

sides

2-sided

lower limit

-4.16

upper limit

1.14

Variability estimate

Standard error of the mean

Dispersion value

1.349

Statistical Analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

218

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2135

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-1.67

Confidence interval

level

95%

sides

2-sided

lower limit

-4.31

upper limit

0.97

Variability estimate

Standard error of the mean

Dispersion value

1.342

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

220

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0443

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-2.72

Confidence interval

level

95%

sides

2-sided

lower limit

-5.36

upper limit

-0.07

Variability estimate

Standard error of the mean

Dispersion value

1.347

Secondary: Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)

Top of page

End point title

Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)

End point description

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

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	122	121	120	120
Units: Percentage of participants
number (not applicable)	9.8	7.4	15.8	20.0

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

243

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4943

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.73

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

1.78

Statistical analysis 2

Comparison groups

Baricitinib Double-blind Medium Dose v Placebo Double-blind

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1677

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.72

Confidence interval

level

95%

sides

2-sided

lower limit

0.8

upper limit

3.7

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0336

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.24

Confidence interval

level

95%

sides

2-sided

lower limit

1.06

upper limit

4.7

Secondary: Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants 10 to <18 Years Old at Study Entry

Top of page

End point title

Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants 10 to <18 Years Old at Study Entry

End point description

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

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	55	63	62	62
Units: Percentage of participants
number (not applicable)	16.4	17.5	25.8	35.5

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8866

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.07

Confidence interval

level

95%

sides

2-sided

lower limit

0.42

upper limit

2.77

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

117

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2316

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.73

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

4.26

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

117

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0328

Method

Regression, Logistic

Parameter type

LS Mean difference (Final Values)

Point estimate

2.59

Confidence interval

level

95%

sides

2-sided

lower limit

1.08

upper limit

6.22

Secondary: Percentage of Participants Achieving EASI50

Top of page

End point title

Percentage of Participants Achieving EASI50

End point description

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

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	122	121	120	120
Units: Percentage of participants
number (not applicable)	55.7	59.5	60.8	71.7

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

243

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5361

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.18

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

1.98

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4417

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.23

Confidence interval

level

95%

sides

2-sided

lower limit

0.73

upper limit

2.06

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0121

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

1.16

upper limit

3.43

Secondary: Percentage of Participants Achieving IGA of 0

Top of page

End point title

Percentage of Participants Achieving IGA of 0

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, 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. APD: All randomized participants in the double-blind treatment period.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	122	121	120	120
Units: Percentage of participants
number (not applicable)	4.1	5.0	5.0	12.5

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

243

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7706

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.19

Confidence interval

level

95%

sides

2-sided

lower limit

0.37

upper limit

3.78

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7409

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.22

Confidence interval

level

95%

sides

2-sided

lower limit

0.38

upper limit

3.86

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0253

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

3.15

Confidence interval

level

95%

sides

2-sided

lower limit

1.15

upper limit

8.63

Secondary: Change from Baseline in SCORAD

Top of page

End point title

Change from Baseline in SCORAD

End point description

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.

End point type

Secondary

End point timeframe

Baseline, Week 16 APD: All randomized participants in the double-blind treatment period and had evaluable SCORAD data.

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	103	107	112	112
Units: units on a scale
least squares mean (standard error)	-20.93 ± 1.894	-24.82 ± 1.880	-26.08 ± 1.857	-28.55 ± 1.867

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

210

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1317

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-3.89

Confidence interval

level

95%

sides

2-sided

lower limit

-8.95

upper limit

1.17

Variability estimate

Standard error of the mean

Dispersion value

2.576

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

215

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0451

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-5.15

Confidence interval

level

95%

sides

2-sided

lower limit

-10.19

upper limit

-0.11

Variability estimate

Standard error of the mean

Dispersion value

2.564

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

215

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0031

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-7.62

Confidence interval

level

95%

sides

2-sided

lower limit

-12.66

upper limit

-2.58

Variability estimate

Standard error of the mean

Dispersion value

2.566

Secondary: Percentage of Participants Achieving SCORAD90

Top of page

End point title

Percentage of Participants Achieving SCORAD90

End point description

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.

End point type

Secondary

End point timeframe

Week 16 APD: All randomized participants in the double-blind treatment period.

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	122	121	120	120
Units: Percentage of participants
number (not applicable)	3.3	1.7	5.0	12.5

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

243

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4238

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.53

Confidence interval

level

95%

sides

2-sided

lower limit

0.11

upper limit

2.49

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5118

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.44

upper limit

5.08

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0129

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

3.92

Confidence interval

level

95%

sides

2-sided

lower limit

1.34

upper limit

11.52

Secondary: Change from Baseline in Body Surface Area (BSA) Affected

Top of page

End point title

Change from Baseline in Body Surface Area (BSA) Affected

End point description

Body surface area affected by AD 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). 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. APD: All randomized participants in the double-blind treatment period and had evaluable BSA data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	105	109	113	115
Units: units on a scale
least squares mean (standard error)	-20.31 ± 1.622	-21.83 ± 1.608	-22.06 ± 1.581	-25.66 ± 1.593

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

214

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4852

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-1.51

Confidence interval

level

95%

sides

2-sided

lower limit

-5.77

upper limit

2.75

Variability estimate

Standard error of the mean

Dispersion value

2.168

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

218

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4205

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-1.74

Confidence interval

level

95%

sides

2-sided

lower limit

-5.98

upper limit

2.5

Variability estimate

Standard error of the mean

Dispersion value

2.16

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

220

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0138

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-5.34

Confidence interval

level

95%

sides

2-sided

lower limit

-9.59

upper limit

-1.1

Variability estimate

Standard error of the mean

Dispersion value

2.161

Secondary: Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment

Top of page

End point title

Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment

End point description

Percentage of participants developing skin infections requiring antibiotic treatment. APD: All randomized participants in the double-blind treatment period.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	122	121	120	120
Units: Percentage of participants
number (not applicable)	5.7	5.0	3.3	2.5

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

243

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 1

Method

Fisher exact

Confidence interval

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.54

Method

Fisher exact

Confidence interval

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.302

Method

Fisher exact

Confidence interval

Secondary: Mean Number of Days without Use of Background Topical Corticosteroid (TCS)

Top of page

End point title

Mean Number of Days without Use of Background Topical Corticosteroid (TCS)

End point description

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

End point type

Secondary

End point timeframe

Baseline through 16 Weeks

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	122	121	120	120
Units: days
least squares mean (standard error)	27.74 ± 4.06	32.22 ± 4.07	30.86 ± 4.06	39.91 ± 4.10

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

243

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.375

Method

ANOVA

Parameter type

LS Mean difference (Final Values)

Point estimate

4.47

Confidence interval

level

95%

sides

2-sided

lower limit

-5.41

upper limit

14.35

Variability estimate

Standard error of the mean

Dispersion value

5.03

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.536

Method

ANOVA

Parameter type

LS Mean difference (Final Values)

Point estimate

3.12

Confidence interval

level

95%

sides

2-sided

lower limit

-6.76

upper limit

Variability estimate

Standard error of the mean

Dispersion value

5.03

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.016

Method

ANOVA

Parameter type

LS Mean difference (Final Values)

Point estimate

12.17

Confidence interval

level

95%

sides

2-sided

lower limit

2.29

upper limit

22.05

Variability estimate

Standard error of the mean

Dispersion value

5.03

Secondary: Mean Gram Quantity of TCS Use (Tube Weights)

Top of page

End point title

Mean Gram Quantity of TCS Use (Tube Weights)

End point description

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

End point type

Secondary

End point timeframe

Baseline through 16 Weeks

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	122	121	120	120
Units: grams
least squares mean (standard error)	265.79 ± 22.04	216.60 ± 22.09	228.41 ± 22.05	185.42 ± 22.26

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

243

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.073

Method

ANOVA

Parameter type

LS Mean difference (Final Values)

Point estimate

-49.19

Confidence interval

level

95%

sides

2-sided

lower limit

-102.81

upper limit

4.42

Variability estimate

Standard error of the mean

Dispersion value

27.28

Statistical analysis 2

Comparison groups

Baricitinib Double-blind Medium Dose v Placebo Double-blind

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.172

Method

ANOVA

Parameter type

LS Mean difference (Final Values)

Point estimate

-37.38

Confidence interval

level

95%

sides

2-sided

lower limit

-91

upper limit

16.23

Variability estimate

Standard error of the mean

Dispersion value

27.29

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

242

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004

Method

ANOVA

Parameter type

LS Mean difference (Final Values)

Point estimate

-80.37

Confidence interval

level

95%

sides

2-sided

lower limit

-133.98

upper limit

-26.75

Variability estimate

Standard error of the mean

Dispersion value

27.28

Secondary: Change From Baseline in Itch NRS for Participants 10 to <18 Years at Study Entry

Top of page

End point title

Change From Baseline in Itch NRS for Participants 10 to <18 Years at Study Entry

End point description

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

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	65	69	78	79
Units: units on a scale
least squares mean (standard deviation)	-1.15 ± 0.276	-1.80 ± 0.266	-1.65 ± 0.261	-2.25 ± 0.258

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

134

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0829

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.65

Confidence interval

level

95%

sides

2-sided

lower limit

-1.38

upper limit

0.08

Variability estimate

Standard error of the mean

Dispersion value

0.372

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1752

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-1.22

upper limit

0.22

Variability estimate

Standard error of the mean

Dispersion value

0.368

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0029

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.82

upper limit

-0.38

Variability estimate

Standard error of the mean

Dispersion value

0.366

Secondary: Change From Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants 2 to <10 Years at Study Entry

Top of page

End point title

Change From Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants 2 to <10 Years at Study Entry

End point description

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

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	31	29	27	21
Units: units on a scale
least squares mean (standard error)	-0.02 ± 0.139	-0.24 ± 0.146	-0.49 ± 0.145	-0.37 ± 0.158

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2688

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.21

Confidence interval

level

95%

sides

2-sided

lower limit

-0.6

upper limit

0.17

Variability estimate

Standard error of the mean

Dispersion value

0.193

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0166

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.47

Confidence interval

level

95%

sides

2-sided

lower limit

-0.85

upper limit

-0.09

Variability estimate

Standard error of the mean

Dispersion value

0.193

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0908

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.34

Confidence interval

level

95%

sides

2-sided

lower limit

-0.75

upper limit

0.06

Variability estimate

Standard error of the mean

Dispersion value

0.202

Secondary: Change from Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score

Top of page

End point title

Change from Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score

End point description

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

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	104	107	112	112
Units: units on a scale
least squares mean (standard error)	-3.02 ± 0.708	-3.93 ± 0.704	-4.58 ± 0.696	-4.58 ± 0.702

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

211

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3409

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.91

Confidence interval

level

95%

sides

2-sided

lower limit

-2.79

upper limit

0.97

Variability estimate

Standard error of the mean

Dispersion value

0.956

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

216

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1022

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-1.56

Confidence interval

level

95%

sides

2-sided

lower limit

-3.43

upper limit

0.31

Variability estimate

Standard error of the mean

Dispersion value

0.952

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

216

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1024

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-1.56

Confidence interval

level

95%

sides

2-sided

lower limit

-3.43

upper limit

0.31

Variability estimate

Standard deviation

Dispersion value

0.953

Secondary: Change From Baseline in Patient Global Impression of Severity–Atopic Dermatitis (PGI-S-AD) Score for Participants 10 to <18 Years at Study Entry

Top of page

End point title

Change From Baseline in Patient Global Impression of Severity–Atopic Dermatitis (PGI-S-AD) Score for Participants 10 to <18 Years at Study Entry

End point description

The PGI-S-AD is a single-item question asked to the participants on how they would rate their overall AD 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. APD: All randomized participants (10 to <18 years old) in the double-blind treatment period and had evaluable PGI-S-AD data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	65	68	78	79
Units: units on a scale
least squares mean (standard error)	-0.33 ± 0.115	-0.56 ± 0.112	-0.64 ± 0.109	-0.83 ± 0.108

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1436

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.23

Confidence interval

level

95%

sides

2-sided

lower limit

-0.54

upper limit

0.08

Variability estimate

Standard error of the mean

Dispersion value

0.157

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0483

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.31

Confidence interval

level

95%

sides

2-sided

lower limit

-0.61

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.154

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0012

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

-0.2

Variability estimate

Standard error of the mean

Dispersion value

0.154

Secondary: Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Pediatric Depression for Participants 5 to <18 Years at Study Entry

Top of page

End point title

Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Pediatric Depression for Participants 5 to <18 Years at Study Entry

End point description

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, views on self, and social cognition, as well as decreased positive affect and engagement. The PROMIS Depression Short Form (8a v2.0 and 6a 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 depression "in the past seven days." Response options range from 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores are converted to T-Scores with higher scores representing greater depression. LS Means were calculated using MMRM model.

End point type

Secondary

End point timeframe

Baseline, Week 16 APD: All randomized participants (5 to <18 years old) in the double-blind treatment period and had evaluable (PROMIS) - Pediatric Depression data.

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	93 ^[3]	102 ^[4]	106 ^[5]	107 ^[6]
Units: T-score
least squares mean (standard error)
5 to <8 years old	-3.95 ± 2.629	-2.54 ± 2.138	-7.07 ± 2.644	-2.83 ± 2.033
8 to <18 years old	-3.60 ± 1.190	-3.42 ± 1.343	-4.68 ± 1.034	-5.30 ± 1.436

Notes
[3] - 5 to <8 years old -> n=11 8 to <18 years old -> n=82
[4] - 5 to <8 years old -> n=17 8 to <18 years old -> n=85
[5] - 5 to <8 years old -> n=10 8 to <18 years old -> n=96
[6] - 5 to <8 years old -> n=18 8 to <18 years old -> n=89

Statistical analysis 1

Statistical analysis description

8 to <18 years old (Subjects in this analysis: 167)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

195

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9183

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

0.18

Confidence interval

level

95%

sides

2-sided

lower limit

-3.27

upper limit

3.63

Variability estimate

Standard error of the mean

Dispersion value

1.755

Statistical analysis 2

Statistical analysis description

8 to <18 years old (Subjects in this analysis: 178)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

199

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4805

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-1.08

Confidence interval

level

95%

sides

2-sided

lower limit

-4.09

upper limit

1.93

Variability estimate

Standard error of the mean

Dispersion value

1.529

Statistical analysis 3

Statistical analysis description

8 to <18 years old (Subjects in this analysis: 171)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

200

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3488

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-5.26

upper limit

1.86

Variability estimate

Standard error of the mean

Dispersion value

1.812

Statistical analysis 4

Statistical analysis description

5 to <8 years old (Subjects in this analysis=28)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

195

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2388

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

-4.85

upper limit

7.66

Variability estimate

Standard error of the mean

Dispersion value

3.12

Statistical analysis 5

Statistical analysis description

5 to <8 years old (Subjects in this analysis=21)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

199

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0098

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-3.13

Confidence interval

level

95%

sides

2-sided

lower limit

-10.23

upper limit

3.98

Variability estimate

Standard error of the mean

Dispersion value

3.542

Statistical analysis 6

Statistical analysis description

5 to <8 years old (Subjects in this analysis=29)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

200

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1698

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

1.12

Confidence interval

level

95%

sides

2-sided

lower limit

-5.18

upper limit

7.42

Variability estimate

Standard error of the mean

Dispersion value

3.14

Secondary: Change From Baseline in the PROMIS-Pediatric Anxiety for Participants 5 to <18 Years at Study Entry

Top of page

End point title

Change From Baseline in the PROMIS-Pediatric Anxiety for Participants 5 to <18 Years at Study Entry

End point description

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, anxious misery, hyperarousal, and somatic symptoms related to arousal. 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 past seven days. Response options range from 1= Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores are converted to T-Scores with higher scores representing greater anxiety. LS Means were calculated using MMRM model.

End point type

Secondary

End point timeframe

Baseline, Week 16 APD: All randomized participants (5 to <18 years old) in the double-blind treatment period and had evaluable (PROMIS) - Pediatric Anxiety data.

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	93 ^[7]	102 ^[8]	106 ^[9]	107 ^[10]
Units: T-score
least squares mean (standard error)
5 to <8 years old	-4.65 ± 2.864	-3.03 ± 2.318	-5.09 ± 2.931	-3.15 ± 2.214
8 to <18 years old	-4.40 ± 1.223	-4.09 ± 1.394	-5.44 ± 1.064	-6.81 ± 1.486

Notes
[7] - 5 to <8 years old -> n=11 8 to <18 years old -> n=82
[8] - 5 to <8 years old -> n=17 8 to <18 years old -> n=85
[9] - 5 to <8 years old -> n=10 8 to <18 years old -> n=96
[10] - 5 to <8 years old -> n=18 8 to <18 years old -> n=89

Statistical analysis 1

Statistical analysis description

8 to <18 years old (Subjects in this analysis: 167)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

195

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8611

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

0.32

Confidence interval

level

95%

sides

2-sided

lower limit

-3.24

upper limit

3.88

Variability estimate

Standard error of the mean

Dispersion value

1.813

Statistical analysis 2

Statistical analysis description

8 to <18 years old (Subjects in this analysis: 178)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

199

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5098

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-1.04

Confidence interval

level

95%

sides

2-sided

lower limit

-4.12

upper limit

2.05

Variability estimate

Standard error of the mean

Dispersion value

1.571

Statistical Analysis 3

Statistical analysis description

8 to <18 years old (Subjects in this analysis: 171)

Comparison groups

Baricitinib Double-blind High Dose v Placebo Double-blind

Number of subjects included in analysis

200

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1997

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-2.4

Confidence interval

level

95%

sides

2-sided

lower limit

-6.08

upper limit

1.27

Variability estimate

Standard error of the mean

Dispersion value

1.87

Statistical analysis 4

Statistical analysis description

5 to <8 years old (Subjects in this analysis=28)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

195

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1957

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

1.62

Confidence interval

level

95%

sides

2-sided

lower limit

-5.11

upper limit

8.35

Variability estimate

Standard error of the mean

Dispersion value

3.351

Statistical analysis 5

Statistical analysis description

5 to <8 years old (Subjects in this analysis=21)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

199

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0881

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.44

Confidence interval

level

95%

sides

2-sided

lower limit

-8.19

upper limit

7.32

Variability estimate

Standard error of the mean

Dispersion value

3.864

Statistical Analysis 6

Statistical analysis description

5 to <8 years old (Subjects in this analysis=29)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

200

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1604

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-3.15

Confidence interval

level

95%

sides

2-sided

lower limit

-5.27

upper limit

8.28

Variability estimate

Standard error of the mean

Dispersion value

3.379

Secondary: Change From Baseline in the Children’s Dermatology Life Quality Index (CDLQI) at Week 16 for Participants 4 to <18 Years at Study Entry

Top of page

End point title

Change From Baseline in the Children’s Dermatology Life Quality Index (CDLQI) at Week 16 for Participants 4 to <18 Years at Study Entry

End point description

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

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	97	105	111	111
Units: Score on a Scale
least squares mean (standard error)	-3.06 ± 0.480	-3.73 ± 0.465	-3.70 ± 0.451	-3.36 ± 0.459

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

202

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2987

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.67

Confidence interval

level

95%

sides

2-sided

lower limit

-1.93

upper limit

0.59

Variability estimate

Standard error of the mean

Dispersion value

0.647

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

208

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3096

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.64

Confidence interval

level

95%

sides

2-sided

lower limit

-1.88

upper limit

0.6

Variability estimate

Standard error of the mean

Dispersion value

0.632

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

208

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6341

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-1.55

upper limit

0.95

Variability estimate

Standard error of the mean

Dispersion value

0.635

Secondary: Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry

Top of page

End point title

Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry

End point description

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

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	5	2	1	1
Units: units on a scale
least squares mean (standard error)	-1.40 ± 1.743	3.87 ± 4.423	3.33 ± 3.752	-6.40 ± 3.601

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2871

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

5.27

Confidence interval

level

95%

sides

2-sided

lower limit

-6.54

upper limit

17.09

Variability estimate

Standard error of the mean

Dispersion value

4.323

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3093

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

4.73

Confidence interval

level

95%

sides

2-sided

lower limit

-7.83

upper limit

17.29

Variability estimate

Standard error of the mean

Dispersion value

3.835

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2912

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-5

Confidence interval

level

95%

sides

2-sided

lower limit

-18.22

upper limit

8.21

Variability estimate

Standard error of the mean

Dispersion value

3.788

Secondary: Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry

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End point title

Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry

End point description

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	96 ^[11]	104	106	109
Units: score on a scale
least squares mean (standard error)
Absenteeism	3.99 ± 2.367	2.39 ± 2.135	2.14 ± 2.107	-0.94 ± 2.387
Presenteeism	-4.69 ± 2.719	-5.62 ± 2.452	-9.99 ± 2.451	-11.44 ± 2.797
Overall Work Impairment	0.38 ± 3.473	-3.80 ± 3.119	-5.86 ± 3.086	-11.15 ± 3.515
Activity Impairment	-7.03 ± 2.372	-11.45 ± 2.318	-11.90 ± 2.293	-14.05 ± 2.311

Notes
[11] - n for absenteeism=49, Presenteeism=55, Overall Work Impairment=49

Statistical analysis 1

Statistical analysis description

Absenteeism (Subjects in this analysis: 115)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

200

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6079

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-1.6

Confidence interval

level

95%

sides

2-sided

lower limit

-7.74

upper limit

4.54

Variability estimate

Standard error of the mean

Dispersion value

3.119

Statistical analysis 2

Statistical analysis description

Absenteeism (Subjects in this analysis: 111)

Comparison groups

Baricitinib Double-blind Medium Dose v Placebo Double-blind

Number of subjects included in analysis

202

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5492

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-1.85

Confidence interval

level

95%

sides

2-sided

lower limit

-7.94

upper limit

4.24

Variability estimate

Standard error of the mean

Dispersion value

3.092

Statistical Analysis 3

Statistical analysis description

Absenteeism (Subjects in this analysis: 104)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

205

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1338

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-4.93

Confidence interval

level

95%

sides

2-sided

lower limit

-11.39

upper limit

1.53

Variability estimate

Standard error of the mean

Dispersion value

3.281

Statistical analysis 4

Statistical analysis description

Presenteeism (Subjects in this analysis: 126)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

200

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7928

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.94

Confidence interval

level

95%

sides

2-sided

lower limit

-7.96

upper limit

6.08

Variability estimate

Standard error of the mean

Dispersion value

3.566

Statistical analysis 5

Statistical analysis description

Presenteeism (Subjects in this analysis: 126)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

202

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1366

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-5.3

Confidence interval

level

95%

sides

2-sided

lower limit

-12.3

upper limit

1.69

Variability estimate

Standard error of the mean

Dispersion value

3.553

Statistical analysis 6

Statistical analysis description

Presenteeism (Subjects in this analysis: 114)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

205

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.076

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-6.75

Confidence interval

level

95%

sides

2-sided

lower limit

-14.21

upper limit

0.71

Variability estimate

Standard error of the mean

Dispersion value

3.792

Statistical analysis 7

Statistical analysis description

Overall Work Impairment (Subjects in this analysis: 115)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

200

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3602

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-4.18

Confidence interval

level

95%

sides

2-sided

lower limit

-13.16

upper limit

4.8

Variability estimate

Standard error of the mean

Dispersion value

4.561

Statistical analysis 8

Statistical analysis description

Overall Work Impairment (Subjects in this analysis: 111)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

202

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1678

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-6.25

Confidence interval

level

95%

sides

2-sided

lower limit

-15.14

upper limit

2.65

Variability estimate

Standard error of the mean

Dispersion value

4.516

Statistical analysis 9

Statistical analysis description

Overall Work Impairment (Subjects in this analysis: 104)

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

205

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.017

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-11.54

Confidence interval

level

95%

sides

2-sided

lower limit

-21

upper limit

-2.08

Variability estimate

Standard error of the mean

Dispersion value

4.808

Statistical analysis 10

Statistical analysis description

Activity Impairment

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

200

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1645

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-4.42

Confidence interval

level

95%

sides

2-sided

lower limit

-10.66

upper limit

1.82

Variability estimate

Standard error of the mean

Dispersion value

3.174

Statistical analysis 11

Statistical analysis description

Activity Impairment

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

202

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.124

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-4.87

Confidence interval

level

95%

sides

2-sided

lower limit

-11.07

upper limit

1.34

Variability estimate

Standard error of the mean

Dispersion value

3.158

Statistical analysis 12

Statistical analysis description

Activity Impairment

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

205

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.027

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-7.02

Confidence interval

level

95%

sides

2-sided

lower limit

-13.23

upper limit

-0.8

Variability estimate

Standard error of the mean

Dispersion value

3.163

Secondary: Change From Baseline on the European Quality of Life–5 Dimensions–Youth (EQ-5D-Y) for Participants 4 to <18 Years at Study Entry

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End point title

Change From Baseline on the European Quality of Life–5 Dimensions–Youth (EQ-5D-Y) for Participants 4 to <18 Years at Study Entry

End point description

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.

End point type

Secondary

End point timeframe

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

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	98	105	110	110
Units: score on a scale
least squares mean (standard error)	3.15 ± 2.090	5.12 ± 2.025	5.16 ± 1.969	7.67 ± 2.000

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

203

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4778

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

1.97

Confidence interval

level

95%

sides

2-sided

lower limit

-3.49

upper limit

7.43

Variability estimate

Standard error of the mean

Dispersion value

2.778

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

208

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4649

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

2.01

Confidence interval

level

95%

sides

2-sided

lower limit

-3.38

upper limit

7.39

Variability estimate

Standard error of the mean

Dispersion value

2.743

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

208

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1013

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

4.52

Confidence interval

level

95%

sides

2-sided

lower limit

-0.89

upper limit

9.94

Variability estimate

Standard error of the mean

Dispersion value

2.755

Secondary: 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

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End point title

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

End point description

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

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	65	68	78	79
Units: score on a scale
least squares mean (standard error)	-0.42 ± 0.130	-0.35 ± 0.126	-0.43 ± 0.123	-0.55 ± 0.122

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6574

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-0.27

upper limit

0.42

Variability estimate

Standard error of the mean

Dispersion value

0.174

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9488

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-0.35

upper limit

0.33

Variability estimate

Standard error of the mean

Dispersion value

0.172

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4546

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.13

Confidence interval

level

95%

sides

2-sided

lower limit

-0.47

upper limit

0.21

Variability estimate

Standard error of the mean

Dispersion value

0.172

Secondary: Change From Baseline in Skin Pain NRS for Participants 10 to <18 Years at Study Entry

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End point title

Change From Baseline in Skin Pain NRS for Participants 10 to <18 Years at Study Entry

End point description

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

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Medium Dose	Baricitinib Double-blind High Dose
Number of subjects analysed	65	68	78	79
Units: score on a scale
least squares mean (standard error)	-1.15 ± 0.267	-1.23 ± 0.259	-1.56 ± 0.254	-1.77 ± 0.251

Statistical analysis 1

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Low Dose

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8133

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.09

Confidence interval

level

95%

sides

2-sided

lower limit

-0.79

upper limit

0.62

Variability estimate

Standard error of the mean

Dispersion value

0.36

Statistical analysis 2

Comparison groups

Placebo Double-blind v Baricitinib Double-blind Medium Dose

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2517

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.41

Confidence interval

level

95%

sides

2-sided

lower limit

-1.11

upper limit

0.29

Variability estimate

Standard error of the mean

Dispersion value

0.355

Statistical Analysis 3

Comparison groups

Placebo Double-blind v Baricitinib Double-blind High Dose

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0803

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.62

Confidence interval

level

95%

sides

2-sided

lower limit

-1.32

upper limit

0.08

Variability estimate

Standard error of the mean

Dispersion value

0.354

Secondary: Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old

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End point title

Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old

End point description

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".

End point type

Secondary

End point timeframe

Week 2 APD: All Pk lead-in participants (<10 years old) with data for suspension acceptability and palatability assessment at given time point.

End point values	Baricitinib Open Label High Dose (PK Lead-in)
Number of subjects analysed	13
Units: Participant responses
number (not applicable)
Question 1- Liked Very Much:	8
Question 1- Liked	1
Question 1- Neither Liked nor Disliked	3
Question 1- Disliked	1
Question 1- Disliked Very Much	0
Question 2- Liked Very Much:	6
Question 2- Liked	1
Question 2- Neither Liked nor Disliked	6
Question 2- Disliked	0
Question 2- Disliked Very Much	0
Question 3- Very Easy	8
Question 3- Easy	5
Question 3- Neither Easy nor Hard	0
Question 3- Difficult (or Hard)	0
Question 3- Very Difficult (or Hard)	0
Question 4- Very Easy	9
Question 4- Easy	4
Question 4- Neither Easy nor Hard	0
Question 4- Difficult (or Hard)	0
Question 4- Very Difficult (or Hard)	0

No statistical analyses for this end point

Secondary: Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old

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End point title

Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old

End point description

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

End point type

Secondary

End point timeframe

Week 2

End point values	Baricitinib Open Label High Dose (PK Lead-in)
Number of subjects analysed	18
Units: Participant responses
number (not applicable)
Question 1- Very Easy	18
Question 1- Easy	0
Question 1- Neither Easy nor Hard	0
Question 1- Difficult (or Hard)	0
Question 1- Very Difficult (or Hard)	0

No statistical analyses for this end point

Secondary: Pop PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104

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End point title

Pop PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104

End point description

PK: Cmax of LY3009104 APD: 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.

End point type

Secondary

End point timeframe

Baseline through 16 Weeks

End point values	Baricitinib (0.5mg): Low Dose (2 to<6 Years)	Baricitinib (1 mg): Medium Dose (2 to<6 Years)	Baricitinib (2 mg): High Dose (2 to<6 Years)	Baricitinib (0.5mg): Low Dose (6 to <10 Years)	Baricitinib (1 mg): Medium Dose (6 to <10 Years)	Baricitinib (2 mg): High Dose (6 to <10 Years)	Baricitinib (1 mg): Low Dose (10 to <18 Years)	Baricitinib (2 mg): Medium Dose (10 to <18 Years)	Baricitinib (4 mg): High Dose (10 to <18 Years)
Number of subjects analysed	9	8	15	24	26	30	87	86	108
Units: nanograms per milliliter (ng/mL)
geometric mean (geometric coefficient of variation)	18.9 ± 29	35.1 ± 21	64.8 ± 22	11.6 ± 29	23.1 ± 23	44 ± 41	13.2 ± 34	27.8 ± 34	50.7 ± 28

No statistical analyses for this end point

Secondary: Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104

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End point title

Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104

End point description

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

End point type

Secondary

End point timeframe

Baseline through 16 Weeks

End point values	Baricitinib (0.5mg): Low Dose (2 to<6 Years)	Baricitinib (1 mg): Medium Dose (2 to<6 Years)	Baricitinib (2 mg): High Dose (2 to<6 Years)	Baricitinib (0.5mg): Low Dose (6 to <10 Years)	Baricitinib (1 mg): Medium Dose (6 to <10 Years)	Baricitinib (2 mg): High Dose (6 to <10 Years)	Baricitinib (1 mg): Low Dose (10 to <18 Years)	Baricitinib (2 mg): Medium Dose (10 to <18 Years)	Baricitinib (4 mg): High Dose (10 to <18 Years)
Number of subjects analysed	9	8	15	24	26	30	87	86	108
Units: hournanogram per milliliter (hng/ mL)
geometric mean (geometric coefficient of variation)	94.3 ± 108	200 ± 63	298 ± 51	74.8 ± 64	155 ± 65	276 ± 76	109 ± 63	222 ± 66	383 ± 61

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Baseline Up to 16 Weeks

Adverse event reporting additional description

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).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.0

Reporting group title

Placebo Double-blind

Reporting group description

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.

Reporting group title

Baricitinib Double-blind Low Dose

Reporting group description

Reporting group title

Baricitinib Double-blind Mid Dose

Reporting group description

Reporting group title

Baricitinib Double-blind High Dose

Reporting group description

Reporting group title

Baricitinib Open-label High Dose PK Lead-in

Reporting group description

Serious adverse events	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Mid Dose	Baricitinib Double-blind High Dose	Baricitinib Open-label High Dose PK Lead-in
Total subjects affected by serious adverse events
subjects affected / exposed	5 / 122 (4.10%)	2 / 120 (1.67%)	1 / 120 (0.83%)	1 / 120 (0.83%)	0 / 33 (0.00%)
number of deaths (all causes)	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0
Nervous system disorders
vertigo cns origin
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 122 (0.00%)	0 / 120 (0.00%)	1 / 120 (0.83%)	0 / 120 (0.00%)	0 / 33 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
bronchospasm
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 122 (0.00%)	1 / 120 (0.83%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 33 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
dermatitis atopic
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	3 / 122 (2.46%)	1 / 120 (0.83%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 33 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
suicide attempt
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 122 (0.82%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 33 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
covid-19
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 122 (0.82%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 33 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
corneal abscess
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 122 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	1 / 120 (0.83%)	0 / 33 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
impetigo
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 122 (0.82%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 33 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ophthalmic herpes simplex
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 122 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	1 / 120 (0.83%)	0 / 33 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	Placebo Double-blind	Baricitinib Double-blind Low Dose	Baricitinib Double-blind Mid Dose	Baricitinib Double-blind High Dose	Baricitinib Open-label High Dose PK Lead-in
Total subjects affected by non serious adverse events
subjects affected / exposed	42 / 122 (34.43%)	39 / 120 (32.50%)	44 / 120 (36.67%)	41 / 120 (34.17%)	11 / 33 (33.33%)
Nervous system disorders
dizziness
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	2 / 122 (1.64%)	3 / 120 (2.50%)	0 / 120 (0.00%)	0 / 120 (0.00%)	2 / 33 (6.06%)
occurrences all number	2	3	0	0	2
headache
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	10 / 122 (8.20%)	7 / 120 (5.83%)	11 / 120 (9.17%)	6 / 120 (5.00%)	1 / 33 (3.03%)
occurrences all number	10	9	20	6	1
Blood and lymphatic system disorders
lymphadenopathy
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 122 (0.00%)	3 / 120 (2.50%)	1 / 120 (0.83%)	0 / 120 (0.00%)	0 / 33 (0.00%)
occurrences all number	0	4	1	0	0
General disorders and administration site conditions
pyrexia
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 122 (0.82%)	3 / 120 (2.50%)	1 / 120 (0.83%)	2 / 120 (1.67%)	1 / 33 (3.03%)
occurrences all number	1	3	2	2	1
Gastrointestinal disorders
abdominal pain upper
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 122 (0.82%)	2 / 120 (1.67%)	2 / 120 (1.67%)	4 / 120 (3.33%)	1 / 33 (3.03%)
occurrences all number	1	2	4	5	1
abdominal pain
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	3 / 122 (2.46%)	3 / 120 (2.50%)	5 / 120 (4.17%)	6 / 120 (5.00%)	0 / 33 (0.00%)
occurrences all number	4	3	6	6	0
diarrhoea
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	2 / 122 (1.64%)	1 / 120 (0.83%)	2 / 120 (1.67%)	5 / 120 (4.17%)	1 / 33 (3.03%)
occurrences all number	2	1	2	7	1
vomiting
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	3 / 122 (2.46%)	2 / 120 (1.67%)	2 / 120 (1.67%)	1 / 120 (0.83%)	0 / 33 (0.00%)
occurrences all number	3	2	2	1	0
Chapped lips
subjects affected / exposed	0 / 122 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	1 / 33 (3.03%)
occurrences all number	0	0	0	0	1
Nausea
subjects affected / exposed	0 / 122 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	1 / 33 (3.03%)
occurrences all number	0	0	0	0	1
Reproductive system and breast disorders
dysmenorrhoea
alternative dictionary used: MedDRA 25.0
subjects affected / exposed ^[1]	2 / 64 (3.13%)	0 / 62 (0.00%)	2 / 63 (3.17%)	0 / 53 (0.00%)	0 / 33 (0.00%)
occurrences all number	3	0	5	0	0
Respiratory, thoracic and mediastinal disorders
asthma
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	4 / 122 (3.28%)	1 / 120 (0.83%)	3 / 120 (2.50%)	1 / 120 (0.83%)	0 / 33 (0.00%)
occurrences all number	7	1	5	1	0
cough
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	3 / 122 (2.46%)	1 / 120 (0.83%)	2 / 120 (1.67%)	2 / 120 (1.67%)	0 / 33 (0.00%)
occurrences all number	3	1	2	3	0
Skin and subcutaneous tissue disorders
acne
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	5 / 122 (4.10%)	3 / 120 (2.50%)	4 / 120 (3.33%)	6 / 120 (5.00%)	0 / 33 (0.00%)
occurrences all number	5	3	4	6	0
dermatitis atopic
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	3 / 122 (2.46%)	1 / 120 (0.83%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 33 (0.00%)
occurrences all number	3	1	0	0	0
Hair growth abnormal
subjects affected / exposed	0 / 122 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	1 / 33 (3.03%)
occurrences all number	0	0	0	0	1
Pruritus
subjects affected / exposed	0 / 122 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	1 / 33 (3.03%)
occurrences all number	0	0	0	0	1
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 122 (0.00%)	4 / 120 (3.33%)	2 / 120 (1.67%)	0 / 120 (0.00%)	0 / 33 (0.00%)
occurrences all number	0	4	2	0	0
Infections and infestations
covid-19
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	3 / 122 (2.46%)	5 / 120 (4.17%)	5 / 120 (4.17%)	3 / 120 (2.50%)	0 / 33 (0.00%)
occurrences all number	3	5	5	3	0
bronchitis
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 122 (0.82%)	6 / 120 (5.00%)	1 / 120 (0.83%)	3 / 120 (2.50%)	0 / 33 (0.00%)
occurrences all number	1	6	1	3	0
gastroenteritis
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 122 (0.00%)	0 / 120 (0.00%)	2 / 120 (1.67%)	3 / 120 (2.50%)	1 / 33 (3.03%)
occurrences all number	0	0	2	3	1
impetigo
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	3 / 122 (2.46%)	1 / 120 (0.83%)	2 / 120 (1.67%)	0 / 120 (0.00%)	0 / 33 (0.00%)
occurrences all number	3	1	2	0	0
molluscum contagiosum
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	3 / 122 (2.46%)	0 / 120 (0.00%)	0 / 120 (0.00%)	2 / 120 (1.67%)	0 / 33 (0.00%)
occurrences all number	3	0	0	3	0
influenza
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	3 / 122 (2.46%)	0 / 120 (0.00%)	1 / 120 (0.83%)	1 / 120 (0.83%)	0 / 33 (0.00%)
occurrences all number	3	0	1	1	0
pharyngitis
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 122 (0.82%)	3 / 120 (2.50%)	3 / 120 (2.50%)	1 / 120 (0.83%)	0 / 33 (0.00%)
occurrences all number	1	3	3	1	0
nasopharyngitis
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	6 / 122 (4.92%)	4 / 120 (3.33%)	5 / 120 (4.17%)	5 / 120 (4.17%)	2 / 33 (6.06%)
occurrences all number	6	4	5	6	2
rhinitis
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	2 / 122 (1.64%)	3 / 120 (2.50%)	0 / 120 (0.00%)	2 / 120 (1.67%)	0 / 33 (0.00%)
occurrences all number	2	3	0	3	0
urinary tract infection
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	6 / 122 (4.92%)	2 / 120 (1.67%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 33 (0.00%)
occurrences all number	7	2	0	0	0
upper respiratory tract infection
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 122 (0.82%)	3 / 120 (2.50%)	4 / 120 (3.33%)	5 / 120 (4.17%)	0 / 33 (0.00%)
occurrences all number	1	4	4	6	0
Folliculitis
subjects affected / exposed	0 / 122 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	1 / 33 (3.03%)
occurrences all number	0	0	0	0	1
Oral herpes
subjects affected / exposed	0 / 122 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	1 / 33 (3.03%)
occurrences all number	0	0	0	0	1
Metabolism and nutrition disorders
decreased appetite
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 122 (0.00%)	0 / 120 (0.00%)	0 / 120 (0.00%)	3 / 120 (2.50%)	0 / 33 (0.00%)
occurrences all number	0	0	0	3	0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

12 Jun 2019

Protocol (a): Updated Study Period 3 and Study Period 4 to a combination study design with topical corticosteroids (TCS) based on feedback from regulatory agencies; - Only participants who have moderate (IGA 3) or severe (IGA 4) atopic dermatitis was transitioned to open-label treatment after Study Period 3; - participants in Study Period 3 should tolerate TCS; - Eosinophilia (>5%) was removed from permanent discontinuation of investigational product (IP) criteria; Additional text was included to allow for required analyses to support regulatory submissions after participants have completed the primary endpoint.

06 Aug 2020

Protocol (b): Increased the treatment period from 2 to 4 years, additional exploratory objectives were included for timepoints in the extended treatment period, and relevant updates were included to describe possible termination of the study in a specific geography after commercial availability or negative regulatory opinion; - Added provisional language for participation in the study during exceptional circumstances such as the coronavirus disease 2019 (COVID-19) pandemic; - Included provision for home visits to collect laboratory tests.

14 Feb 2023

Protocol (c): Included Regulatory Agency Identifier Number(s); - Extended Study Period 4 by up to an additional 1 year for patients for whom a systemic selective Janus kinase (JAK) inhibitor or biologic treatment is not available; - Defined that sponsor will provide low- and moderate-potency topical corticosteroids through study specific to study visits; Defined that the collection of imaging (x-ray, MRI) is not required after the participant reaches 18 years of age; - Revised additional visits; - Added “Proportion of participants achieving SCORAD75 at 2, 3, 4, and 5 years during long-term extension.” as exploratory objective ; - Addition of new appendix to describe additional procedures for countries participating in the PK Lead-in Period (Study Period 2), SoA content specific to EU-specific Requirements

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 3, Multicenter, Randomized, Double blind, Placebo controlled, Parallel group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients with Moderate to Severe Atopic Dermatitis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Achieving Investigator’s Global Assessment (IGA) of 0 or 1 with a ≥2 Point Improvement

Primary: Percentage of Participants Achieving Investigator’s Global Assessment (IGA) of 0 or 1 with a ≥2 Point Improvement

Primary: Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104

Primary: Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104

Primary: Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval of LY3009104 at Steady State (AUCtau,ss) of LY3009104

Primary: Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval of LY3009104 at Steady State (AUCtau,ss) of LY3009104

Secondary: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)

Secondary: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)

Secondary: Percentage of Participants Achieving EASI90

Secondary: Percentage of Participants Achieving EASI90

Secondary: Change from Baseline in EASI Score

Secondary: Change from Baseline in EASI Score

Secondary: Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)

Secondary: Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)

Secondary: Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants 10 to <18 Years Old at Study Entry

Secondary: Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants 10 to <18 Years Old at Study Entry

Secondary: Percentage of Participants Achieving EASI50

Secondary: Percentage of Participants Achieving EASI50

Secondary: Percentage of Participants Achieving IGA of 0

Secondary: Percentage of Participants Achieving IGA of 0

Secondary: Change from Baseline in SCORAD

Secondary: Change from Baseline in SCORAD

Secondary: Percentage of Participants Achieving SCORAD90

Secondary: Percentage of Participants Achieving SCORAD90

Secondary: Change from Baseline in Body Surface Area (BSA) Affected

Secondary: Change from Baseline in Body Surface Area (BSA) Affected

Secondary: Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment

Secondary: Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment

Secondary: Mean Number of Days without Use of Background Topical Corticosteroid (TCS)

Secondary: Mean Number of Days without Use of Background Topical Corticosteroid (TCS)

Secondary: Mean Gram Quantity of TCS Use (Tube Weights)

Secondary: Mean Gram Quantity of TCS Use (Tube Weights)

Secondary: Change From Baseline in Itch NRS for Participants 10 to <18 Years at Study Entry

Secondary: Change From Baseline in Itch NRS for Participants 10 to <18 Years at Study Entry

Secondary: Change From Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants 2 to <10 Years at Study Entry

Secondary: Change From Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants 2 to <10 Years at Study Entry

Secondary: Change from Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score

Secondary: Change from Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score

Secondary: Change From Baseline in Patient Global Impression of Severity–Atopic Dermatitis (PGI-S-AD) Score for Participants 10 to <18 Years at Study Entry

Secondary: Change From Baseline in Patient Global Impression of Severity–Atopic Dermatitis (PGI-S-AD) Score for Participants 10 to <18 Years at Study Entry

Secondary: Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Pediatric Depression for Participants 5 to <18 Years at Study Entry

Secondary: Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Pediatric Depression for Participants 5 to <18 Years at Study Entry

Secondary: Change From Baseline in the PROMIS-Pediatric Anxiety for Participants 5 to <18 Years at Study Entry

Secondary: Change From Baseline in the PROMIS-Pediatric Anxiety for Participants 5 to <18 Years at Study Entry

Secondary: Change From Baseline in the Children’s Dermatology Life Quality Index (CDLQI) at Week 16 for Participants 4 to <18 Years at Study Entry

Secondary: Change From Baseline in the Children’s Dermatology Life Quality Index (CDLQI) at Week 16 for Participants 4 to <18 Years at Study Entry

Secondary: Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry

Secondary: Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry

Secondary: Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry

Secondary: Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry

Secondary: Change From Baseline on the European Quality of Life–5 Dimensions–Youth (EQ-5D-Y) for Participants 4 to <18 Years at Study Entry

Secondary: Change From Baseline on the European Quality of Life–5 Dimensions–Youth (EQ-5D-Y) for Participants 4 to <18 Years at Study Entry

Secondary: 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

Secondary: 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

Secondary: Change From Baseline in Skin Pain NRS for Participants 10 to <18 Years at Study Entry

Secondary: Change From Baseline in Skin Pain NRS for Participants 10 to <18 Years at Study Entry

Secondary: Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old

Secondary: Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old

Secondary: Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old

Secondary: Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old

Secondary: Pop PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104

Secondary: Pop PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104

Secondary: Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104

Secondary: Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Clinical Trial Results:
A Phase 3, Multicenter, Randomized, Double blind, Placebo controlled, Parallel group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients with Moderate to Severe Atopic Dermatitis