A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis
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
2 other identifiers
interventional
124
2 countries
13
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of Baricitinib in eczema.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2016
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedResults Posted
Study results publicly available
March 14, 2018
CompletedJune 17, 2020
June 1, 2020
1 year
October 14, 2015
February 16, 2018
June 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)
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.
Week 16
Secondary Outcomes (7)
Change From Baseline in the EASI at Week 16
Baseline, Week 16
Percentage Change From Baseline in the EASI at Week 16
Baseline, Week 16
Change From Baseline in the Scoring Atopic Dermatitis (SCORAD) at Week 16
Baseline, Week 16
Change From Baseline in the Investigator's Global Assessment (IGA) at Week 16
Baseline, Week 16
Change From Baseline in the Dermatologic Life Quality Index (DLQI) at Week 16
Baseline, Week 16
- +2 more secondary outcomes
Study Arms (2)
Baricitinib
EXPERIMENTALAdministered once daily in multiple oral dose cohorts for 16 weeks (Triamcinolone 0.1% topical also permitted)
Placebo
PLACEBO COMPARATORAdministered orally once daily, for 16 weeks (Triamcinolone 0.1% topical also permitted)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Dermatology Research Associates
Los Angeles, California, 90045, United States
Forward Clinical Trials, Inc
Tampa, Florida, 33624, United States
Medical Dermatology Specialists
Atlanta, Georgia, 30342, United States
Northwestern University
Chicago, Illinois, 60611, United States
Icahn School of Medicine
New York, New York, 10029, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Menter Dermatology Research Institute
Dallas, Texas, 75246, United States
Center for Clinical Studies
Houston, Texas, 77004, United States
Center for Clinical Studies
Houston, Texas, 77065, United States
Center for Clinical Studies
Webster, Texas, 77598, 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.
Fukuoka, 815-0082, 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.
Sapporo, 060-0063, 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, 933-0871, Japan
Related Publications (2)
Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.
PMID: 36255569DERIVEDKing B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.
PMID: 33826132DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2015
First Posted
October 15, 2015
Study Start
February 1, 2016
Primary Completion
February 1, 2017
Study Completion
March 1, 2017
Last Updated
June 17, 2020
Results First Posted
March 14, 2018
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.