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 | 
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.
			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
	
								Sacramento, California 95816			
	
			
					Principal Investigator: Emanual Maverakis
			
						
										Phone: 916-734-8254
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									1720 2nd Ave S
Birmingham, Alabama 35233
	
			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...  
  
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									800 Washington St
Boston, Massachusetts 02111
	
			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...  
  
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									75 Francis street
Boston, Massachusetts 02115
	
			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...  
  
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									4202 E Fowler Ave
Tampa, Florida 33620
	
			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...  
  
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								Bay City, Michigan 48706			
	
			
					Principal Investigator: Brent Boyce
			
						
										Phone: 989-895-9100
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									6565 West Loop South Freeway
Bellaire, Texas 77401
	
			
					Bellaire, Texas 77401
Principal Investigator: Craig Teller
			
						
										Phone: 832-553-2318
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								Beverly Hills, California 90211			
	
			
					Principal Investigator: Paul Wallace
			
						
										Phone: 310-652-8460
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								Bexley, Ohio 43209			
	
			
					Principal Investigator: Matthew Zirwas
			
						
										Phone: 614-947-1716
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									6051 North Eagle Road
Boise, Idaho 83713
	
			
					Boise, Idaho 83713
Principal Investigator: Ryan Harris
			
						
										Phone: 208-467-3006
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								Charleston, South Carolina 29414			
	
			
					Principal Investigator: Todd Schlesinger
			
						
										Phone: 843-556-8886
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									171 Ashley Avenue
Charleston, South Carolina 29425
	
			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...  
  
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									303 East Superior Street
Chicago, Illinois 60611
	
			
					Chicago, Illinois 60611
Principal Investigator: Jonathan Silverberg
			
						
										Phone: 312-695-8106
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								Cleveland, Ohio 44012			
	
			
					Principal Investigator: Neil J Korman
			
						
										Phone: 216-844-3178
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								Dallas, Texas 75231			
	
			
					Principal Investigator: Jennifer A Cather
			
						
										Phone: 214-361-2008
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								Danbury, Connecticut 06810			
	
			
					Principal Investigator: William A Notaro
			
						
										Phone: 203-730-0074
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								Darien, Illinois 60561			
	
			
					Principal Investigator: Vassilios A Dimitropoulos
			
						
										Phone: 630-920-1900
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								Encinitas, California 92024			
	
			
					Principal Investigator: Stacy R. Smith
			
						
										Phone: 760-203-3839
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								Exton, Pennsylvania 19341			
	
			
					Principal Investigator: Scott L Gottlieb
			
						
										Phone: 610-594-6660
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									3640 Colonel Glenn Highway
Fairborn, Ohio 45324
	
			
					Fairborn, Ohio 45324
Principal Investigator: Jeffrey Travers
			
						
										Phone: 937-775-2463
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								Farmington, Connecticut 06030			
	
			
					Principal Investigator: Bruce E Strober
			
						
										Phone: 860-679-4600
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								Fort Gratiot, Michigan 48059			
	
			
					Principal Investigator: Fasahat Hamzavi
			
						
										Phone: 810-455-1612
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								Fort Smith, Arkansas 72916			
	
			
					Principal Investigator: Sandra Johnson
			
						
										Phone: 479-649-3376
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									17271 Brookhurst Street
Fountain Valley, California 92708
	
			
					Fountain Valley, California 92708
Principal Investigator: Vivian Laquer
			
						
										Phone: 714-531-2966
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								Fremont, California 94538			
	
			
					Principal Investigator: Sunil S Dhawan
			
						
										Phone: 510-797-4111
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								Indianapolis, Indiana 46256			
	
			
					Principal Investigator: Scott A Fretzin
			
						
										Phone: 317-621-7731
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								Jacksonville, Florida 			
	
			
					Principal Investigator: Pearl Kwong
			
						
										Phone: 904-619-8157
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								Johnston, Rhode Island 02919			
	
			
					Principal Investigator: Ellen H Frankel
			
						
										Phone: 401-454-3800
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									2919 West Swann Avenue
Largo, Florida 33770
	
			
					Largo, Florida 33770
Principal Investigator: Matthew Zook
			
						
										Phone: 813-849-5566
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								Los Angeles, California 90033			
	
			
					Principal Investigator: Stefani Takahashi
			
						
										Phone: 323-442-0084
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								Louisville, Kentucky 40202			
	
			
					Principal Investigator: Cindy E Owen
			
						
										Phone: 502-585-9059
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								Macon, Georgia 31217			
	
			
					Principal Investigator: David J Cohen
			
						
										Phone: 478-742-2180
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								Mason, Ohio 45040			
	
			
					Principal Investigator: Rocco Serrao
			
						
										Phone: 513-701-5526
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								Miami, Florida 33173			
	
			
					Principal Investigator: Jill Waibel
			
						
										Phone: 305-279-6060
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									243 6100 South
Murray, Utah 84107
	
			
					Murray, Utah 84107
Principal Investigator: Kristina Callis-Duffin
			
						
										Phone: 801-581-6465
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									1428 Madison Ave
New York, New York 10029
	
			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...  
  
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								Norfolk, Virginia 23507			
	
			
					Principal Investigator: David M Pariser
			
						
										Phone: 757-622-6315
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								Omaha, Nebraska 68144			
	
			
					Principal Investigator: Joel Schlessinger
			
						
										Phone: 402-697-6599
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									603 North Flamingo Road
Pembroke Pines, Florida 33028
	
			
					Pembroke Pines, Florida 33028
Principal Investigator: Robert Snyder
			
						
										Phone: 954-435-5100
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								Pflugerville, Texas 78660			
	
			
					Principal Investigator: Edward Lain
			
						
										Phone: 512-279-2545
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								Plainfield, Indiana 46168			
	
			
					Principal Investigator: Scott T Guenthner
			
						
										Phone: 317-837-6082
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								Portland, Oregon 97210			
	
			
					Principal Investigator: Phoebe Rich
			
						
										Phone: 503-226-3376
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									3303 Southwest Bond Avenue
Portland, Oregon 97239
	
			
					Portland, Oregon 97239
Principal Investigator: Eric L Simpson
			
						
										Phone: 503-494-4770
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								Rockville, Maryland 20850			
	
			
					Principal Investigator: Benjamin N. Lockshin
			
						
										Phone: 301-355-3183
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									5301 Keystone Court
Rolling Meadows, Illinois 60008
	
			
					Rolling Meadows, Illinois 60008
Principal Investigator: Michael Bukhalo
			
						
										Phone: 847-392-5440
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								Saint Louis, Missouri 63117			
	
			
					Principal Investigator: Craig L Leonardi
			
						
										Phone: 314-721-5565
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								San Antonio, Texas 78218			
	
			
					Principal Investigator: John C. Browning
			
						
										Phone: 210-829-5180
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								San Diego, California 92108			
	
			
					Principal Investigator: Daniel Marnell
			
						
										Phone: 619-521-2830
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								San Diego, California 92123			
	
			
					Principal Investigator: Walter K Nahm
			
						
										Phone: 858-278-8470
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								Sandy Springs, Georgia 30328			
	
			
					Principal Investigator: Jamie Debra Weisman
			
						
										Phone: 4049399220
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								Santa Ana, California 92701			
	
			
					Principal Investigator: Jennifer Soung
			
						
										Phone: 714-547-5151
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								Santa Monica, California 90404			
	
			
					Principal Investigator: Paul S Yamauchi
			
						
										Phone: 310-828-8887
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								Savannah, Georgia 31406			
	
			
					Principal Investigator: Corinne Howington
			
						
										Phone: 912-443-4253
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									211 North Eddy St.
South Bend, Indiana 46617
	
			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...  
  
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								Stony Brook, New York 11790			
	
			
					Principal Investigator: Elyse S Rafal
			
						
										Phone: 631-689-1900
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									314 Martin Luther King Junior Way
Tacoma, Washington 98405
	
			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...  
  
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								Tampa, Florida 33624			
	
			
					Principal Investigator: Seth B Forman
			
						
										Phone: 813-264-2155
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								Walnut Creek, California 94589			
	
			
					Principal Investigator: M. Christine Lee
			
						
										Phone: 908-941-2273
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								Washington, District of Columbia 20037			
	
			
					Principal Investigator: Maria Sotomayor
			
						
										Phone: 202-741-2437
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								West Jordan, Utah 84088			
	
			
					Principal Investigator: Douglass W Forsha
			
						
										Phone: 801-316-0266
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								Winston-Salem, North Carolina 27157			
	
			
					Principal Investigator: Lindsay Strowd
			
						
										Phone: 336-716-2768
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