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



Status:Recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:February 20, 2018
End Date:May 25, 2021
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:Clinicaltrials.gov@lilly.com
Phone:1-317-615-4559

Use our guide to learn which trials are right for you!

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult
participants with moderate to severe atopic dermatitis.


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% of 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 during a washout period).

- 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 episode
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, chronic liver
disease 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.
We found this trial at
63
sites
Farmington, Connecticut 06030
Principal Investigator: Bruce E Strober
Phone: 860-679-4600
2491
mi
from 91732
Farmington, CT
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Boni Elizabeth Elewski
Phone: 2055029960
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
1777
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: David Rosmarin
Phone: 617-636-7462
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Joseph F. Merola
Phone: 617-264-5943
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Nishit Patel
Phone: 813-974-4270
University of South Florida The University of South Florida is a high-impact, global research university...
2135
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
Bay City, Michigan 48706
Principal Investigator: Brent Boyce
Phone: 989-895-9100
1933
mi
from 91732
Bay City, MI
Click here to add this to my saved trials
6565 West Loop South Freeway
Bellaire, Texas 77401
Principal Investigator: Craig Teller
Phone: 832-553-2318
1353
mi
from 91732
Bellaire, TX
Click here to add this to my saved trials
Beverly Hills, California 90211
Principal Investigator: Paul Wallace
Phone: 310-652-8460
21
mi
from 91732
Beverly Hills, CA
Click here to add this to my saved trials
Bexley, Ohio 43209
Principal Investigator: Matthew Zirwas
Phone: 614-947-1716
1964
mi
from 91732
Bexley, OH
Click here to add this to my saved trials
6051 North Eagle Road
Boise, Idaho 83713
Principal Investigator: Ryan Harris
Phone: 208-467-3006
668
mi
from 91732
Boise, ID
Click here to add this to my saved trials
Calgary, Alberta
Principal Investigator: Kirk Allen Barber
Phone: 4032995821
1189
mi
from 91732
Calgary,
Click here to add this to my saved trials
Charleston, South Carolina 29414
Principal Investigator: Todd Schlesinger
Phone: 843-556-8886
2184
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Lara Wine Lee
Phone: 843-792-5858
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
2184
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Jonathan Silverberg
Phone: 312-695-8106
1730
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
Cleveland, Ohio 44012
Principal Investigator: Neil J Korman
Phone: 216-844-3178
2032
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
Dallas, Texas 75231
Principal Investigator: Jennifer A Cather
Phone: 214-361-2008
1226
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Danbury, Connecticut 06810
Principal Investigator: William A Notaro
Phone: 203-730-0074
2458
mi
from 91732
Danbury, CT
Click here to add this to my saved trials
Darien, Illinois 60561
Principal Investigator: Vassilios A Dimitropoulos
Phone: 630-920-1900
1710
mi
from 91732
Darien, IL
Click here to add this to my saved trials
Encinitas, California 92024
Principal Investigator: Stacy R. Smith
Phone: 760-203-3839
82
mi
from 91732
Encinitas, CA
Click here to add this to my saved trials
Exton, Pennsylvania 19341
Principal Investigator: Scott L Gottlieb
Phone: 610-594-6660
2350
mi
from 91732
Exton, PA
Click here to add this to my saved trials
3640 Colonel Glenn Highway
Fairborn, Ohio 45324
Principal Investigator: Jeffrey Travers
Phone: 937-775-2463
1904
mi
from 91732
Fairborn, OH
Click here to add this to my saved trials
Fort Gratiot, Michigan 48059
Principal Investigator: Fasahat Hamzavi
Phone: 810-455-1612
2000
mi
from 91732
Fort Gratiot, MI
Click here to add this to my saved trials
Fort Smith, Arkansas 72916
Principal Investigator: Sandra Johnson
Phone: 479-649-3376
1339
mi
from 91732
Fort Smith, AR
Click here to add this to my saved trials
17271 Brookhurst Street
Fountain Valley, California 92708
Principal Investigator: Vivian Laquer
Phone: 714-531-2966
25
mi
from 91732
Fountain Valley, CA
Click here to add this to my saved trials
Fremont, California 94538
Principal Investigator: Sunil S Dhawan
Phone: 510-797-4111
325
mi
from 91732
Fremont, CA
Click here to add this to my saved trials
Indianapolis, Indiana 46256
Principal Investigator: Scott A Fretzin
Phone: 317-621-7731
1800
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida
Principal Investigator: Pearl Kwong
Phone: 904-619-8157
2130
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
Johnston, Rhode Island 02919
Principal Investigator: Ellen H Frankel
Phone: 401-454-3800
2558
mi
from 91732
Johnston, RI
Click here to add this to my saved trials
2919 West Swann Avenue
Largo, Florida 33770
Principal Investigator: Matthew Zook
Phone: 813-849-5566
2134
mi
from 91732
Largo, FL
Click here to add this to my saved trials
Los Angeles, California 90033
Principal Investigator: Stefani Takahashi
Phone: 323-442-0084
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
Principal Investigator: Cindy E Owen
Phone: 502-585-9059
1813
mi
from 91732
Louisville, KY
Click here to add this to my saved trials
Macon, Georgia 31217
Principal Investigator: David J Cohen
Phone: 478-742-2180
1974
mi
from 91732
Macon, GA
Click here to add this to my saved trials
Mason, Ohio 45040
Principal Investigator: Rocco Serrao
Phone: 513-701-5526
1890
mi
from 91732
Mason, OH
Click here to add this to my saved trials
Miami, Florida 33173
Principal Investigator: Jill Waibel
Phone: 305-279-6060
2322
mi
from 91732
Miami, FL
Click here to add this to my saved trials
243 6100 South
Murray, Utah 84107
Principal Investigator: Kristina Callis-Duffin
Phone: 801-581-6465
564
mi
from 91732
Murray, UT
Click here to add this to my saved trials
1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: George Han
Phone: 212-844-8800
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
?
mi
from 91732
New York, NY
Click here to add this to my saved trials
Norfolk, Virginia 23507
Principal Investigator: David M Pariser
Phone: 757-622-6315
2336
mi
from 91732
Norfolk, VA
Click here to add this to my saved trials
Omaha, Nebraska 68144
Principal Investigator: Joel Schlessinger
Phone: 402-697-6599
1291
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
603 North Flamingo Road
Pembroke Pines, Florida 33028
Principal Investigator: Robert Snyder
Phone: 954-435-5100
2308
mi
from 91732
Pembroke Pines, FL
Click here to add this to my saved trials
Pflugerville, Texas 78660
Principal Investigator: Edward Lain
Phone: 512-279-2545
1215
mi
from 91732
Pflugerville, TX
Click here to add this to my saved trials
Plainfield, Indiana 46168
Principal Investigator: Scott T Guenthner
Phone: 317-837-6082
1780
mi
from 91732
Plainfield, IN
Click here to add this to my saved trials
Portland, Oregon 97210
Principal Investigator: Phoebe Rich
Phone: 503-226-3376
829
mi
from 91732
Portland, OR
Click here to add this to my saved trials
3303 Southwest Bond Avenue
Portland, Oregon 97239
Principal Investigator: Eric L Simpson
Phone: 503-494-4770
826
mi
from 91732
Portland, OR
Click here to add this to my saved trials
Rockville, Maryland 20850
Principal Investigator: Benjamin N. Lockshin
Phone: 301-355-3183
2274
mi
from 91732
Rockville, MD
Click here to add this to my saved trials
5301 Keystone Court
Rolling Meadows, Illinois 60008
Principal Investigator: Michael Bukhalo
Phone: 847-392-5440
1712
mi
from 91732
Rolling Meadows, IL
Click here to add this to my saved trials
Sacramento, California 95816
Principal Investigator: Emanual Maverakis
Phone: 916-734-8254
366
mi
from 91732
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63117
Principal Investigator: Craig L Leonardi
Phone: 314-721-5565
1566
mi
from 91732
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78218
Principal Investigator: John C. Browning
Phone: 210-829-5180
1193
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92108
Principal Investigator: Daniel Marnell
Phone: 619-521-2830
103
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92123
Principal Investigator: Walter K Nahm
Phone: 858-278-8470
105
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
Sandy Springs, Georgia 30328
Principal Investigator: Jamie Debra Weisman
Phone: 4049399220
1917
mi
from 91732
Sandy Springs, GA
Click here to add this to my saved trials
Santa Ana, California 92701
Principal Investigator: Jennifer Soung
Phone: 714-547-5151
24
mi
from 91732
Santa Ana, CA
Click here to add this to my saved trials
Santa Monica, California 90404
Principal Investigator: Paul S Yamauchi
Phone: 310-828-8887
26
mi
from 91732
Santa Monica, CA
Click here to add this to my saved trials
Savannah, Georgia 31406
Principal Investigator: Corinne Howington
Phone: 912-443-4253
2132
mi
from 91732
Savannah, GA
Click here to add this to my saved trials
211 North Eddy St.
South Bend, Indiana 46617
574-234-8161
Principal Investigator: Holly Hake Harris
Phone: 574-204-6432
South Bend Clinic The South Bend Clinic employs a staff of 610 at its five...
1799
mi
from 91732
South Bend, IN
Click here to add this to my saved trials
Stony Brook, New York 11790
Principal Investigator: Elyse S Rafal
Phone: 631-689-1900
2477
mi
from 91732
Stony Brook, NY
Click here to add this to my saved trials
Sugar Land, Texas 77497
Principal Investigator: Syed Ali
Phone: 832-770-6388
1345
mi
from 91732
Sugar Land, TX
Click here to add this to my saved trials
314 Martin Luther King Junior Way
Tacoma, Washington 98405
(253) 403-5200
Principal Investigator: Andrew P Pace
Phone: 253-572-2842
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
922
mi
from 91732
Tacoma, WA
Click here to add this to my saved trials
Tampa, Florida 33624
Principal Investigator: Seth B Forman
Phone: 813-264-2155
2129
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
Walnut Creek, California 94589
Principal Investigator: M. Christine Lee
Phone: 908-941-2273
354
mi
from 91732
Walnut Creek, CA
Click here to add this to my saved trials
Washington, District of Columbia 20037
Principal Investigator: Maria Sotomayor
Phone: 202-741-2437
2280
mi
from 91732
Washington,
Click here to add this to my saved trials
West Jordan, Utah 84088
Principal Investigator: Douglass W Forsha
Phone: 801-316-0266
561
mi
from 91732
West Jordan, UT
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
Principal Investigator: Lindsay Strowd
Phone: 336-716-2768
2126
mi
from 91732
Winston-Salem, NC
Click here to add this to my saved trials