A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT02576938
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of Baricitinib in eczema.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
-
Have moderate-to-severe Atopic Dermatitis (AD), as determined by all of the following:
- EASI of 12 or more
- Greater than or equal to 10% of body surface area involvement
- Diagnosed with AD at least 2 years prior
-
Have a history of inadequate clinical response to other eczema treatments
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Baricitinib Triamcinolone (Optional) Administered once daily in multiple oral dose cohorts for 16 weeks (Triamcinolone 0.1% topical also permitted) Placebo Placebo Administered orally once daily, for 16 weeks (Triamcinolone 0.1% topical also permitted) Placebo Triamcinolone (Optional) Administered orally once daily, for 16 weeks (Triamcinolone 0.1% topical also permitted) Baricitinib Baricitinib Administered once daily in multiple oral dose cohorts for 16 weeks (Triamcinolone 0.1% topical also permitted)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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.
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).
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.
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.
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
Trial Locations
- Locations (10)
Medical Dermatology Specialists
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Menter Dermatology Research Institute
🇺🇸Dallas, Texas, United States
Forward Clinical Trials, Inc
🇺🇸Tampa, Florida, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
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
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
Center for Clinical Studies
🇺🇸Webster, Texas, United States
Icahn School of Medicine
🇺🇸New York, New York, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States