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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

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 Type : Interventional  (Clinical Trial)
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 : February 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




Primary Outcome Measures :
  1. Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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. ]
    Pharmacokinetics (PK): Maximum serum concentration (Cmax) of Baricitinib



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576938


Locations
United States, California
Dermatology Research Associates
Los Angeles, California, United States, 90045
United States, Florida
Forward Clinical Trials, Inc
Tampa, Florida, United States, 33624
United States, Georgia
Medical Dermatology Specialists
Atlanta, Georgia, United States, 30342
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, New York
Icahn School of Medicine
New York, New York, United States, 10029
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Texas
Menter Dermatology Research Institute
Dallas, Texas, United States, 75246
Center for Clinical Studies
Houston, Texas, United States, 77004
Center for Clinical Studies
Houston, Texas, United States, 77065
Center for Clinical Studies
Webster, Texas, United States, 77598
Japan
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
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
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)

Documents provided by Eli Lilly and Company:
Statistical Analysis Plan  [PDF] January 11, 2017
Study Protocol: Protocol  [PDF] September 30, 2015
Study Protocol: Protocol Amendment (a)  [PDF] October 23, 2015


Additional Information:
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 Posted: October 15, 2015    Key Record Dates
Results First Posted: March 14, 2018
Last Update Posted: March 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Keywords provided by Eli Lilly and Company:
Atopic Eczema

Additional relevant MeSH terms:
Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action