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Trial record 40 of 838 for:    eczema

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

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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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo administered orally (PO) once daily (QD), for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
2 mg Baricitinib 2 milligram (mg) Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
4 mg Baricitinib 4 mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.

Participant Flow:   Overall Study
    Placebo   2 mg Baricitinib   4 mg Baricitinib
STARTED   49   37   38 
Received at Least One Dose of Study Drug   49   37   38 
COMPLETED   29   25   26 
NOT COMPLETED   20   12   12 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least one dose of study drug.

Reporting Groups
  Description
Placebo Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.
2 mg Baricitinib 2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
4mg Baricitinib 4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
Total Total of all reporting groups

Baseline Measures
   Placebo   2 mg Baricitinib   4mg Baricitinib   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   37   38   124 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.3  (13.49)   40.0  (14.38)   36.4  (14.47)   37.8  (14.03) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female   25   15   16   56 
Male   24   22   22   68 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
       
United States   42   31   32   105 
Japan   8   6   6   20 
Median EASI Total Score [1] 
[Units: Units on a scale]
Median (Full Range)
 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] 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.


  Outcome Measures

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

2.  Secondary:   Change From Baseline in the EASI at Week 16   [ Time Frame: Baseline, Week 16 ]

3.  Secondary:   Percentage Change From Baseline in the EASI at Week 16   [ Time Frame: Baseline, Week 16 ]

4.  Secondary:   Change From Baseline in the Scoring Atopic Dermatitis (SCORAD) at Week 16   [ Time Frame: Baseline, Week 16 ]

5.  Secondary:   Change From Baseline in the Investigator's Global Assessment (IGA) at Week 16   [ Time Frame: Baseline, Week 16 ]

6.  Secondary:   Change From Baseline in the Dermatologic Life Quality Index (DLQI) at Week 16   [ Time Frame: Baseline, Week 16 ]

7.  Secondary:   Change From Baseline in the Itch Numerical Rating Scale (NRS) at Week 16   [ Time Frame: Baseline, Week 16 ]

8.  Secondary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: ClinicalTrials.gov@lilly.com



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