ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02576938
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : March 14, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: Baricitinib
Drug: Placebo
Drug: Triamcinolone (Optional)
Enrollment 124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo 2 mg Baricitinib 4 mg Baricitinib
Hide 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
Reason Not Completed
Adverse Event             5             3             6
Protocol Violation             1             1             1
Withdrawal by Subject             3             2             4
Lack of Efficacy             9             4             0
Lost to Follow-up             2             0             1
Physician Decision             0             1             0
Met Exclusion Criteria             0             1             0
Arm/Group Title Placebo 2 mg Baricitinib 4mg Baricitinib Total
Hide 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 Number of Baseline Participants 49 37 38 124
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 37 participants 38 participants 124 participants
37.3  (13.49) 40.0  (14.38) 36.4  (14.47) 37.8  (14.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 37 participants 38 participants 124 participants
Female 25 15 16 56
Male 24 22 22 68
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 37 participants 38 participants 124 participants
Hispanic or Latino 4 4 6 14
Not Hispanic or Latino 45 33 32 110
Unknown or Not Reported 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 37 participants 38 participants 124 participants
American Indian or Alaska Native 0 0 0 0
Asian 16 8 9 33
Native Hawaiian or Other Pacific Islander 1 0 2 3
Black or African American 7 9 9 25
White 23 20 18 61
More than one race 2 0 0 2
Unknown or Not Reported 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 37 participants 38 participants 124 participants
United States 42 31 32 105
Japan 8 6 6 20
Median EASI Total Score   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 49 participants 37 participants 38 participants 124 participants
22.1
(12.0 to 70.3)
22.1
(12.2 to 72.0)
19.5
(12.2 to 71.4)
21.2
(12.0 to 72.0)
[1]
Measure 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.
1.Primary Outcome
Title Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 49 37 38
Measure Type: Number
Unit of Measure: percentage of participants
37 57 61
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 2 mg Baricitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.065
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 4mg Baricitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.027
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the EASI at Week 16
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title Placebo 2 mg Baricitinib 4mg Baricitinib
Hide 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.
Overall Number of Participants Analyzed 49 37 38
Least Squares Mean (Standard Error)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title Placebo 2 mg Baricitinib 4mg Baricitinib
Hide 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.
Overall Number of Participants Analyzed 49 37 38
Least Squares Mean (Standard Error)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title Placebo 2 mg Baricitinib 4mg Baricitinib
Hide 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.
Overall Number of Participants Analyzed 49 37 38
Least Squares Mean (Standard Error)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 29 27 29
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who have received at least one dose of study drug.
Arm/Group Title Placebo 2 mg Baricitinib 4mg Baricitinib
Hide 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.
Overall Number of Participants Analyzed 49 37 38
Least Squares Mean (Standard Error)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title Placebo 2 mg Baricitinib 4mg Baricitinib
Hide 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.
Overall Number of Participants Analyzed 49 37 38
Least Squares Mean (Standard Error)
Unit of Measure: 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
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 37 38
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
18.5
(70.0%)
37.7
(38.9%)
Time Frame Baseline to end of study (up to 5 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 2 mg Baricitinib 4mg Baricitinib
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)      0/37 (0.00%)      0/38 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo 2 mg Baricitinib 4mg Baricitinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/49 (0.00%)      2/37 (5.41%)      1/38 (2.63%)    
Gastrointestinal disorders       
Large intestine polyp  1  0/49 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1
Infections and infestations       
Bronchitis  1  0/49 (0.00%)  0 1/37 (2.70%)  1 0/38 (0.00%)  0
Cellulitis  1  0/49 (0.00%)  0 1/37 (2.70%)  1 0/38 (0.00%)  0
Staphylococcal infection  1  0/49 (0.00%)  0 1/37 (2.70%)  1 0/38 (0.00%)  0
Skin and subcutaneous tissue disorders       
Eczema  1  0/49 (0.00%)  0 1/37 (2.70%)  1 0/38 (0.00%)  0
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo 2 mg Baricitinib 4mg Baricitinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/49 (28.57%)      13/37 (35.14%)      19/38 (50.00%)    
Blood and lymphatic system disorders       
Lymphopenia  1  3/49 (6.12%)  3 0/37 (0.00%)  0 1/38 (2.63%)  1
Gastrointestinal disorders       
Gastrooesophageal reflux disease  1  0/49 (0.00%)  0 2/37 (5.41%)  2 0/38 (0.00%)  0
Nausea  1  0/49 (0.00%)  0 2/37 (5.41%)  2 0/38 (0.00%)  0
Infections and infestations       
Cellulitis  1  3/49 (6.12%)  4 1/37 (2.70%)  3 0/38 (0.00%)  0
Nasopharyngitis  1  2/49 (4.08%)  2 1/37 (2.70%)  1 4/38 (10.53%)  4
Staphylococcal infection  1  0/49 (0.00%)  0 2/37 (5.41%)  3 0/38 (0.00%)  0
Subcutaneous abscess  1  1/49 (2.04%)  1 0/37 (0.00%)  0 2/38 (5.26%)  2
Upper respiratory tract infection  1  1/49 (2.04%)  1 1/37 (2.70%)  1 2/38 (5.26%)  2
Injury, poisoning and procedural complications       
Procedural pain  1  1/49 (2.04%)  2 0/37 (0.00%)  0 2/38 (5.26%)  3
Investigations       
Blood creatine phosphokinase increased  1  1/49 (2.04%)  1 1/37 (2.70%)  1 5/38 (13.16%)  5
White blood cell count decreased  1  0/49 (0.00%)  0 0/37 (0.00%)  0 2/38 (5.26%)  3
Nervous system disorders       
Headache  1  0/49 (0.00%)  0 2/37 (5.41%)  3 5/38 (13.16%)  5
Skin and subcutaneous tissue disorders       
Dermatitis atopic  1  5/49 (10.20%)  5 3/37 (8.11%)  3 2/38 (5.26%)  2
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02576938     History of Changes
Other Study ID Numbers: 16284
I4V-MC-JAHG ( Other Identifier: Eli Lilly and Company )
First Submitted: October 14, 2015
First Posted: October 15, 2015
Results First Submitted: February 16, 2018
Results First Posted: March 14, 2018
Last Update Posted: March 14, 2018