A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02576938
• Collaborator: (none)
• Enrollment: 124
• Locations: 13
• Arms: 2
• Duration (Months): 12.9
• Patients Per Site: 9.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of Baricitinib in eczema.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Baricitinib; Drug: Placebo; Drug: Triamcinolone (Optional)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Baricitinib in Patients With Moderate-to-Severe Atopic Dermatitis
• Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Baricitinib Administered once daily in multiple oral dose cohorts for 16 weeks (Triamcinolone 0.1% topical also permitted)	Drug: Baricitinib; Administered orally; Other Names: LY3009104 INCB028050 ; Drug: Triamcinolone (Optional); Administered topically
Placebo Comparator: Placebo Administered orally once daily, for 16 weeks (Triamcinolone 0.1% topical also permitted)	Drug: Placebo; Administered orally; Drug: Triamcinolone (Optional); Administered topically

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50) [Week 16]

   The EASI 50, defined as ≥ 50% reduction from baseline in EASI score, assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe.

Secondary Outcome Measures

1. Change From Baseline in the EASI at Week 16 [Baseline, Week 16]

   The Eczema Area and Severity Index (EASI) assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe. Change from baseline were analyzed with a Mixed-effect Model Repeated Measure (MMRM) with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.

2. Percentage Change From Baseline in the EASI at Week 16 [Baseline, Week 16]

   The Eczema Area and Severity Index (EASI) assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe. Changes from baseline were analyzed with an MMRM with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.

3. Change From Baseline in the Scoring Atopic Dermatitis (SCORAD) at Week 16 [Baseline, Week 16]

   The SCORAD index uses the rule of nines to assess disease extent and evaluates five clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation and (5) lichenification. SCORAD also assesses subjective symptoms of pruritus and sleep loss with Visual Analogue Scales (VAS) where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These three aspects: extent of disease (A: 0-102), disease severity (B: 0-18) and 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. Changes from baseline were analyzed with an MMRM with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.

4. Change From Baseline in the Investigator's Global Assessment (IGA) at Week 16 [Baseline, Week 16]

   The IGA consists of a 6-point severity scale to measure characteristics of erythema, infiltration, papulation, oozing and crusting as guidelines for the overall severity assessment. The scale ranges from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease).

5. Change From Baseline in the Dermatologic Life Quality Index (DLQI) at Week 16 [Baseline, Week 16]

   The DLQI is a simple, participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). Changes from baseline in DLQI score were analyzed with an MMRM with fixed effects for treatment, time, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit were included as covariates.

6. Change From Baseline in the Itch Numerical Rating Scale (NRS) at Week 16 [Baseline, Week 16]

   The Itch 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 participant's itching is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Changes from baseline were analyzed with an MMRM with fixed effects for treatment, time, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit were included as covariates.

7. Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Baricitinib [Week (Wk) 0: Predose, 15-30 minutes (min) postdose; Wk 4: 1.5 - 4 hour (hr) postdose; Wk 8: 4 - 8 hr postdose; Wk 12: Predose; Wk 16: 30 - 90 min postdose.]

   Pharmacokinetics (PK): Maximum serum concentration (Cmax) of Baricitinib

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have moderate-to-severe Atopic Dermatitis (AD), as determined by all of the following:

1. EASI of 12 or more

2. Greater than or equal to 10% of body surface area involvement

3. Diagnosed with AD at least 2 years prior

• Have a history of inadequate clinical response to other eczema treatments

Exclusion Criteria:

• Females who are pregnant or nursing

• Participants who do not agree to use adequate contraception

• Are currently experiencing or have a history of:

• Skin conditions such as psoriasis or lupus erythematosus

• Skin disease that requires frequent hospitalizations or intravenous treatment

• Compromised immunity

• Serious illness that could interfere with study participation, or a clinically important deviation in physical examination, vital sign measurements, electrocardiograms, or abnormalities on laboratory tests

• Currently experiencing or have a history of:

• Active or latent Tuberculosis or specific immunity disorders and infections

• Malignancy or lymphoproliferative diseases in the last 5 years (or cervical, basal or squamous skin cancer re-occurrence in the last 3 years)

• Human Immunodeficiency Virus (HIV)

• Hepatitis B, Hepatitis C, or chronic liver disease

• Have received certain types of vaccinations

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology Research Associates	Los Angeles	California	United States	90045
2	Forward Clinical Trials, Inc	Tampa	Florida	United States	33624
3	Medical Dermatology Specialists	Atlanta	Georgia	United States	30342
4	Northwestern University	Chicago	Illinois	United States	60611
5	Icahn School of Medicine	New York	New York	United States	10029
6	Oregon Health and Science University	Portland	Oregon	United States	97239
7	Menter Dermatology Research Institute	Dallas	Texas	United States	75246
8	Center for Clinical Studies	Houston	Texas	United States	77004
9	Center for Clinical Studies	Houston	Texas	United States	77065
10	Center for Clinical Studies	Webster	Texas	United States	77598
11	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Fukuoka-shi		Japan	815-0082
12	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Sapporo		Japan	060-0063
13	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician	Takaoka-shi		Japan	933-0871

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

• Statistical Analysis Plan - Jan 11, 2017
• Study Protocol: Protocol - Sep 30, 2015
• Study Protocol: Protocol Amendment (a) - Oct 23, 2015
• Study Protocol: Protocol Amendment (b) - Mar 7, 2016
• Study Protocol: Protocol Amendment (c) - May 25, 2016
• Study Protocol: Protocol Amendment (d) - Jun 24, 2016

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02576938
• Other Study ID Numbers: 16284; I4V-MC-JAHG
• First Posted: Oct 15, 2015
• Last Update Posted: Jun 17, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Eli Lilly and Company: Atopic Eczema
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Triamcinolone

Study Results

Participant Flow

Arm/Group Title	Placebo	2 mg Baricitinib	4 mg Baricitinib
Arm/Group Description	Placebo administered orally (PO) once daily (QD), for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.	2 milligram (mg) Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.	4 mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
Period Title: Overall Study
STARTED	49	37	38
Received at Least One Dose of Study Drug	49	37	38
COMPLETED	29	25	26
NOT COMPLETED	20	12	12

Baseline Characteristics

Arm/Group Title	Placebo	2 mg Baricitinib	4mg Baricitinib	Total
Arm/Group Description	Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.	2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.	4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.	Total of all reporting groups
Overall Participants	49	37	38	124
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.3 (13.49)	40.0 (14.38)	36.4 (14.47)	37.8 (14.03)
Sex: Female, Male (Count of Participants)
Female	25 51%	15 40.5%	16 42.1%	56 45.2%
Male	24 49%	22 59.5%	22 57.9%	68 54.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 8.2%	4 10.8%	6 15.8%	14 11.3%
Not Hispanic or Latino	45 91.8%	33 89.2%	32 84.2%	110 88.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	16 32.7%	8 21.6%	9 23.7%	33 26.6%
Native Hawaiian or Other Pacific Islander	1 2%	0 0%	2 5.3%	3 2.4%
Black or African American	7 14.3%	9 24.3%	9 23.7%	25 20.2%
White	23 46.9%	20 54.1%	18 47.4%	61 49.2%
More than one race	2 4.1%	0 0%	0 0%	2 1.6%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	42 85.7%	31 83.8%	32 84.2%	105 84.7%
Japan	8 16.3%	6 16.2%	6 15.8%	20 16.1%
Median EASI Total Score (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	22.1	22.1	19.5	21.2

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)
Description	The EASI 50, defined as ≥ 50% reduction from baseline in EASI score, assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had EASI 50 data at Week 16.

Arm/Group Title	Placebo	2 mg Baricitinib	4mg Baricitinib
Arm/Group Description	Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.	2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.	4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
Measure Participants	49	37	38
Number [percentage of participants]	37 75.5%	57 154.1%	61 160.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 2 mg Baricitinib
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.065
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 4mg Baricitinib
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.027
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Change From Baseline in the EASI at Week 16
Description	The Eczema Area and Severity Index (EASI) assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe. Change from baseline were analyzed with a Mixed-effect Model Repeated Measure (MMRM) with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug.

Arm/Group Title	Placebo	2 mg Baricitinib	4mg Baricitinib
Arm/Group Description	Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.	2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.	4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
Measure Participants	49	37	38
Least Squares Mean (Standard Error) [units on a scale]	-10.84 (1.62)	-16.44 (1.72)	-16.04 (1.72)

3. Secondary Outcome

Title	Percentage Change From Baseline in the EASI at Week 16
Description	The Eczema Area and Severity Index (EASI) assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe. Changes from baseline were analyzed with an MMRM with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug.

Arm/Group Title	Placebo	2 mg Baricitinib	4mg Baricitinib
Arm/Group Description	Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.	2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.	4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
Measure Participants	49	37	38
Least Squares Mean (Standard Error) [units on a scale]	-45.87 (5.85)	-64.19 (6.20)	-64.69 (6.21)

4. Secondary Outcome

Title	Change From Baseline in the Scoring Atopic Dermatitis (SCORAD) at Week 16
Description	The SCORAD index uses the rule of nines to assess disease extent and evaluates five clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation and (5) lichenification. SCORAD also assesses subjective symptoms of pruritus and sleep loss with Visual Analogue Scales (VAS) where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These three aspects: extent of disease (A: 0-102), disease severity (B: 0-18) and 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. Changes from baseline were analyzed with an MMRM with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug.

Arm/Group Title	Placebo	2 mg Baricitinib	4mg Baricitinib
Arm/Group Description	Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.	2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.	4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
Measure Participants	49	37	38
Least Squares Mean (Standard Error) [units on a scale]	-11.89 (2.88)	-23.87 (3.03)	-26.54 (2.97)

5. Secondary Outcome

Title	Change From Baseline in the Investigator's Global Assessment (IGA) at Week 16
Description	The IGA consists of a 6-point severity scale to measure characteristics of erythema, infiltration, papulation, oozing and crusting as guidelines for the overall severity assessment. The scale ranges from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease).
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had IGA data at Week 16 .

Arm/Group Title	Placebo	2 mg Baricitinib	4mg Baricitinib
Arm/Group Description	Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.	2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.	4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
Measure Participants	29	27	29
Mean (Standard Deviation) [units on a scale]	-0.9 (0.69)	-1.4 (1.31)	-1.3 (1.01)

6. Secondary Outcome

Title	Change From Baseline in the Dermatologic Life Quality Index (DLQI) at Week 16
Description	The DLQI is a simple, participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). Changes from baseline in DLQI score were analyzed with an MMRM with fixed effects for treatment, time, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit were included as covariates.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All participants who have received at least one dose of study drug.

Arm/Group Title	Placebo	2 mg Baricitinib	4mg Baricitinib
Arm/Group Description	Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.	2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.	4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
Measure Participants	49	37	38
Least Squares Mean (Standard Error) [units on a scale]	-6.27 (0.82)	-6.89 (0.89)	-7.96 (0.86)

7. Secondary Outcome

Title	Change From Baseline in the Itch Numerical Rating Scale (NRS) at Week 16
Description	The Itch 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 participant's itching is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Changes from baseline were analyzed with an MMRM with fixed effects for treatment, time, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit were included as covariates.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug.

Arm/Group Title	Placebo	2 mg Baricitinib	4mg Baricitinib
Arm/Group Description	Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.	2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.	4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
Measure Participants	49	37	38
Least Squares Mean (Standard Error) [units on a scale]	-1.72 (0.44)	-2.61 (0.47)	-2.22 (0.46)

8. Secondary Outcome

Title	Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Baricitinib
Description	Pharmacokinetics (PK): Maximum serum concentration (Cmax) of Baricitinib
Time Frame	Week (Wk) 0: Predose, 15-30 minutes (min) postdose; Wk 4: 1.5 - 4 hour (hr) postdose; Wk 8: 4 - 8 hr postdose; Wk 12: Predose; Wk 16: 30 - 90 min postdose.

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of study drug and provided at least 1 post-dose PK sample. PK sample was not collected for the placebo group.

Arm/Group Title	2 mg Baricitinib	4mg Baricitinib
Arm/Group Description	2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.	4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
Measure Participants	37	38
Geometric Mean (Geometric Coefficient of Variation) [nanogram per milliliter (ng/mL)]	18.5 (70.0)	37.7 (38.9)

Adverse Events

Time Frame	Baseline to end of study (up to 5 months)
Arm/Group Title	Placebo		2 mg Baricitinib		4mg Baricitinib
Arm/Group Description	Placebo administered orally (PO) once daily (QD), for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.		2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.		4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
All Cause Mortality
	Placebo		2 mg Baricitinib		4mg Baricitinib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/37 (0%)		0/38 (0%)
Serious Adverse Events
	Placebo		2 mg Baricitinib		4mg Baricitinib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		2/37 (5.4%)		1/38 (2.6%)
Gastrointestinal disorders
Large intestine polyp	0/49 (0%)	0	0/37 (0%)	0	1/38 (2.6%)	1
Infections and infestations
Bronchitis	0/49 (0%)	0	1/37 (2.7%)	1	0/38 (0%)	0
Cellulitis	0/49 (0%)	0	1/37 (2.7%)	1	0/38 (0%)	0
Staphylococcal infection	0/49 (0%)	0	1/37 (2.7%)	1	0/38 (0%)	0
Skin and subcutaneous tissue disorders
Eczema	0/49 (0%)	0	1/37 (2.7%)	1	0/38 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		2 mg Baricitinib		4mg Baricitinib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/49 (28.6%)		13/37 (35.1%)		19/38 (50%)
Blood and lymphatic system disorders
Lymphopenia	3/49 (6.1%)	3	0/37 (0%)	0	1/38 (2.6%)	1
Gastrointestinal disorders
Gastrooesophageal reflux disease	0/49 (0%)	0	2/37 (5.4%)	2	0/38 (0%)	0
Nausea	0/49 (0%)	0	2/37 (5.4%)	2	0/38 (0%)	0
Infections and infestations
Cellulitis	3/49 (6.1%)	4	1/37 (2.7%)	3	0/38 (0%)	0
Nasopharyngitis	2/49 (4.1%)	2	1/37 (2.7%)	1	4/38 (10.5%)	4
Staphylococcal infection	0/49 (0%)	0	2/37 (5.4%)	3	0/38 (0%)	0
Subcutaneous abscess	1/49 (2%)	1	0/37 (0%)	0	2/38 (5.3%)	2
Upper respiratory tract infection	1/49 (2%)	1	1/37 (2.7%)	1	2/38 (5.3%)	2
Injury, poisoning and procedural complications
Procedural pain	1/49 (2%)	2	0/37 (0%)	0	2/38 (5.3%)	3
Investigations
Blood creatine phosphokinase increased	1/49 (2%)	1	1/37 (2.7%)	1	5/38 (13.2%)	5
White blood cell count decreased	0/49 (0%)	0	0/37 (0%)	0	2/38 (5.3%)	3
Nervous system disorders
Headache	0/49 (0%)	0	2/37 (5.4%)	3	5/38 (13.2%)	5
Skin and subcutaneous tissue disorders
Dermatitis atopic	5/49 (10.2%)	5	3/37 (8.1%)	3	2/38 (5.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.