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

Phase 3

Terminated

Conditions: Atopic Dermatitis

Interventions: Drug: Baricitinib

Registration Number: NCT03559270

Lead Sponsor: Eli Lilly and Company

Brief Summary: This open-label study will evaluate the long-term efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis (AD).

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 374

Inclusion Criteria

Have a diagnosis of atopic dermatitis (AD) at least 12 months before screening.
Have moderate to severe AD, including all of the following:
- EASI score ≥16
- IGA score of ≥3
- 10%- 50% BSA involvement
Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.
Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments)
Agree to use emollients daily.

Exclusion Criteria

Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
A history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past.
Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
Have been treated with the following therapies:
- monoclonal antibody for less than 5 half-lives before randomization
- received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks before randomization
- received any parenteral corticosteroid administered by intramuscular or intravenous injection within 6 weeks of planned randomization or are anticipated to require parenteral injection of corticosteroids during the study
- have had an intra-articular corticosteroid injection within 6 weeks of planned randomization
- probenecid at the time of randomization that cannot be discontinued for the duration of the study
Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
Have had major surgery within the past eight weeks or are planning major surgery during the study.
Have experienced any of the following within 12 weeks of screening: myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
Have a history of venous thromboembolic event (VTE), or are considered at high risk for VTE.
Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
Have specific laboratory abnormalities.
Have received certain treatments that are contraindicated.
Pregnant or breastfeeding.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Baricitinib 2-mg Open-Label Addendum	Baricitinib	Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.
Baricitinib 1-mg/Baricitinib 2-mg	Baricitinib	Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
Placebo/Baricitinib 2-milligram (mg)	Baricitinib	Open-label 2 mg baricitinib administered orally once daily (QD) to participants who randomized to placebo in the originating study (JAIW).
Baricitinib 2-mg/Baricitinib 2-mg	Baricitinib	Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)	Week 16	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI75.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1	Week 16	The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Percentage of Participants Achieving a Body Surface Area (BSA) of ≤3%	Week 16	The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.
Percentage of Participants Achieving a ≥4-Point Improvement in Itch Numeric Rating Scale (NRS)	Week 16	The 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 selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.

Trial Locations

Locations (74): University of Utah MidValley Dematology
🇺🇸
Murray, Utah, United States
First OC Dermatology
🇺🇸
Fountain Valley, California, United States
Wallace Medical Group, Inc.
🇺🇸
Los Angeles, California, United States
The South Bend Clinic Center for Research
🇺🇸
South Bend, Indiana, United States
Alberta DermaSurgery Centre
🇨🇦
Edmonton, Alberta, Canada
Southern California Dermatology, Inc.
🇺🇸
Santa Ana, California, United States
Center For Dermatology Clinical Research, Inc.
🇺🇸
Fremont, California, United States
Care Access Research-Walnut Creek
🇺🇸
Walnut Creek, California, United States
University Dermatology
🇺🇸
Darien, Illinois, United States
Johnson Dermatology
🇺🇸
Fort Smith, Arkansas, United States
Clinical Science Institute
🇺🇸
Santa Monica, California, United States
California Dermatology & Clinical Research Institute
🇺🇸
Encinitas, California, United States
Solutions Through Advanced Research, Inc.
🇺🇸
Jacksonville, Florida, United States
Advanced Medical Research
🇺🇸
Sandy Springs, Georgia, United States
Great Lakes Research Group, Inc.
🇺🇸
Bay City, Michigan, United States
Wright State Univ School of Medicine
🇺🇸
Fairborn, Ohio, United States
Keck School of Medicine University of Southern California
🇺🇸
Los Angeles, California, United States
Riverchase Dermatology and Cosmetic Surgery
🇺🇸
Pembroke Pines, Florida, United States
Forefront Research
🇺🇸
Louisville, Kentucky, United States
GWU/Medical Faculty Associates
🇺🇸
Washington, District of Columbia, United States
Arlington Dermatology
🇺🇸
Rolling Meadows, Illinois, United States
The Pennsylvania Centre for Dermatology, LLC
🇺🇸
Exton, Pennsylvania, United States
Clinical Partners, LLC
🇺🇸
Johnston, Rhode Island, United States
Office of Dr. Alma M. Cruz
🇵🇷
Carolina, Puerto Rico
MultiCare Good Samaritan Hospital
🇺🇸
Tacoma, Washington, United States
Dr. Chih-ho Hong Medical Inc.
🇨🇦
Surrey, British Columbia, Canada
Medicor Research Inc
🇨🇦
Sudbury, Ontario, Canada
Modern Research Associates
🇺🇸
Dallas, Texas, United States
Clinical Research Center of the Carolinas
🇺🇸
Charleston, South Carolina, United States
Bellaire Dermatology
🇺🇸
Bellaire, Texas, United States
Beacon Dermatology
🇨🇦
Calgary, Alberta, Canada
XLR8 Medical Research
🇨🇦
Windsor, Ontario, Canada
Centre de Recherche Dermatologique de Quebec Metropolitain
🇨🇦
Quebec, Canada
Simcoderm Medical & Surgical Dermatology Centre
🇨🇦
Barrie, Ontario, Canada
The Centre for Dermatology
🇨🇦
Richmond Hill, Ontario, Canada
Northwestern University
🇺🇸
Chicago, Illinois, United States
University Hospitals Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
Dermatology and Skin Cancer Specialists
🇺🇸
Rockville, Maryland, United States
Dr. Samuel Sanchez PSC
🇵🇷
Caguas, Puerto Rico
Medical Center For Clinical Research
🇺🇸
San Diego, California, United States
University Clinical Trials, Inc.
🇺🇸
San Diego, California, United States
Miami Dermatology and Laser Research
🇺🇸
Miami, Florida, United States
Texas Dermatology and Laser Specialists
🇺🇸
San Antonio, Texas, United States
Austin Institute for Clinical Research
🇺🇸
Pflugerville, Texas, United States
Enverus Medical Research
🇨🇦
Surrey, British Columbia, Canada
York Dermatology Center
🇨🇦
Richmond Hill, Ontario, Canada
K. Papp Clinical Research
🇨🇦
Waterloo, Ontario, Canada
Innovaderm Research Inc
🇨🇦
Montreal, Quebec, Canada
Dawes Fretzin Clinical Research Group, LLC
🇺🇸
Indianapolis, Indiana, United States
The Indiana Clinical Trials Center
🇺🇸
Plainfield, Indiana, United States
Advanced Clinical Research LLC
🇺🇸
Meridian, Idaho, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Olympian Clinical Research
🇺🇸
Largo, Florida, United States
Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
DermResearchCenter of New York, Inc
🇺🇸
Stony Brook, New York, United States
Bexley Dermatology Research
🇺🇸
Bexley, Ohio, United States
SKiN Centre for Dermatology
🇨🇦
Peterborough, Ontario, Canada
Dermatologic Surgery Specialists, PC
🇺🇸
Macon, Georgia, United States
Central Dermatology PC
🇺🇸
Saint Louis, Missouri, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Icahn Sch of Med at Mt. Sinai
🇺🇸
New York, New York, United States
Kirk Barber Research
🇨🇦
Calgary, Alberta, Canada
Lynderm Research Inc.
🇨🇦
Markham, Ontario, Canada
Kingsway Clinical Research
🇨🇦
Etobicoke, Ontario, Canada
Allergy Research Canada Inc.
🇨🇦
Niagara Falls, Ontario, Canada
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
ForCare Clinical Research
🇺🇸
Tampa, Florida, United States
University of California Davis-Dermatology
🇺🇸
Sacramento, California, United States
OHSU Center for Health and Healing
🇺🇸
Portland, Oregon, United States
University of South Florida
🇺🇸
Tampa, Florida, United States
Skin Specialists, P.C
🇺🇸
Omaha, Nebraska, United States
Oregon Dermatology and Research Center
🇺🇸
Portland, Oregon, United States
Ponce School of Medicine CAIMED Center
🇵🇷
Ponce, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
🇵🇷
San Juan, Puerto Rico