Phase
Condition
Atopic Dermatitis
Dermatitis, Atopic
Hives (Urticaria)
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 topicaltreatments during a washout period).
- Agree to use emollients daily.
Exclusion
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 intravenoustreatment for skin infections.
- A history of eczema herpeticum within 12 months, and/or a history of 2 or more episodeof 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 systemiccorticosteroids or otherwise interfere with study participation or require activefrequent 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 4weeks before randomization
- received any parenteral corticosteroid administered by intramuscular orintravenous injection within 6 weeks of planned randomization or are anticipatedto require parenteral injection of corticosteroids during the study
- have had an intra-articular corticosteroid injection within 6 weeks of plannedrandomization
- probenecid at the time of randomization that cannot be discontinued for theduration of the study
- Have high blood pressure characterized by a repeated systolic blood pressure >160millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
- Have had major surgery within the past eight weeks or are planning major surgeryduring the study.
- Have experienced any of the following within 12 weeks of screening: myocardialinfarction (MI), unstable ischemic heart disease, stroke, or New York HeartAssociation Stage III/IV heart failure.
- Have a history of venous thromboembolic event (VTE), or are considered at high riskfor VTE.
- Have a history or presence of cardiovascular, respiratory, hepatic, chronic liverdisease gastrointestinal, endocrine, hematological, neurological, lymphoproliferativedisease or neuropsychiatric disorders or any other serious and/or unstable illness.
- Have a current or recent clinically serious viral, bacterial, fungal, or parasiticinfection including herpes zoster, tuberculosis.
- Have specific laboratory abnormalities.
- Have received certain treatments that are contraindicated.
- Pregnant or breastfeeding.
Study Design
Connect with a study center
Institute for Skin Advancement
Calgary, Alberta T3A 2N1
CanadaSite Not Available
Kirk Barber Research
Calgary, Alberta T2G 1B1
CanadaSite Not Available
Stratica Medical
Edmonton, Alberta T5K 1X3
CanadaSite Not Available
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia V3R 6A7
CanadaSite Not Available
Enverus Medical Research
Surrey, British Columbia V3V 0C6
CanadaSite Not Available
Simcoderm Medical & Surgical Dermatology Centre
Barrie, Ontario L4M 7G1
CanadaSite Not Available
Kingsway Clinical Research
Etobicoke, Ontario M8X 1Y9
CanadaSite Not Available
Lynderm Research Inc
Markham, Ontario L3P1X2
CanadaSite Not Available
Allergy Research Canada Inc.
Niagara Falls, Ontario L2H 1H5
CanadaSite Not Available
SKiN Centre for Dermatology
Peterborough, Ontario K9J 5K2
CanadaSite Not Available
The Centre for Dermatology
Richmond Hill, Ontario L4B 1A5
CanadaSite Not Available
Medicor Research Inc
Sudbury, Ontario P3C 1X8
CanadaSite Not Available
K. Papp Clinical Research Inc
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
XLR8 Medical Research
Windsor, Ontario N8W 1E6
CanadaSite Not Available
Innovaderm Research Inc
Montreal, Quebec H2K4L5
CanadaSite Not Available
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Montréal, H2K4L5
CanadaSite Not Available
Centre de Recherche Dermatologique de Quebec Metropolitain
Quebec, G1V 4X7
CanadaSite Not Available
York Dermatology Center
Richmond Hill, L4C 9M7
CanadaSite Not Available
Office of Dr. Samuel Sanchez PSC
Caguas, 00727
Puerto RicoSite Not Available
Office of Dr. Alma M. Cruz
Carolina, 00985
Puerto RicoSite Not Available
Ponce School of Medicine CAIMED Center
Ponce, 00716
Puerto RicoSite Not Available
GCM Medical Group PSC
San Juan, 00917
Puerto RicoSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
Johnson Dermatology
Fort Smith, Arkansas 72916
United StatesSite Not Available
Wallace Medical Group, Inc.
Beverly Hills, California 90211
United StatesSite Not Available
California Dermatology and Clinical Research Institute
Encinitas, California 92024
United StatesSite Not Available
Tien Q. Nguyen, MD inc. DBA First OC Dermatology
Fountain Valley, California 92708
United StatesSite Not Available
Center for Dermatology Clinical Research, Inc.
Fremont, California 94538
United StatesSite Not Available
Keck School of Medicine University of Southern California
Los Angeles, California 90033
United StatesSite Not Available
University of California Davis-Dermatology
Sacramento, California 95816
United StatesSite Not Available
Medical Center for Clinical Research
San Diego, California 92108
United StatesSite Not Available
University Clinical Trials, Inc.
San Diego, California 92123
United StatesSite Not Available
Southern California Dermatology
Santa Ana, California 92701
United StatesSite Not Available
Clinical Science Institute
Santa Monica, California 90404
United StatesSite Not Available
Care Access Research-Walnut Creek
Walnut Creek, California 94598
United StatesSite Not Available
Clinical Research Center of CT/NY
Danbury, Connecticut 06810
United StatesSite Not Available
Univ of Connecticut
Farmington, Connecticut 06032
United StatesSite Not Available
GWU/Medical Faculty Associates
Washington, District of Columbia 20037
United StatesSite Not Available
Solutions Through Advanced Research, Inc.
Jacksonville, Florida 32256
United StatesSite Not Available
Olympian Clinical Research
Largo, Florida 33770
United StatesSite Not Available
Miami Dermatology & Laser Research
Miami, Florida 33173
United StatesSite Not Available
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines, Florida 33028
United StatesSite Not Available
ForCare Clinical Research
Tampa, Florida 33613
United StatesSite Not Available
University of South Florida
Tampa, Florida 33612
United StatesSite Not Available
Dermatologic Surgery Specialists, PC
Macon, Georgia 31217
United StatesSite Not Available
Advanced Medical Research
Sandy Springs, Georgia 30328
United StatesSite Not Available
Meridian Clinical Research
Savannah, Georgia 31406
United StatesSite Not Available
Treasure Valley Dermatology
Boise, Idaho 83713
United StatesSite Not Available
Dermatology Center of Canyon County
Nampa, Idaho 83651
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
University Dermatology
Darien, Illinois 60561
United StatesSite Not Available
Arlington Dermatology
Rolling Meadows, Illinois 60008
United StatesSite Not Available
Dawes Fretzin Clinical Research
Indianapolis, Indiana 46250
United StatesSite Not Available
The Indiana Clinical Trials Center, PC
Plainfield, Indiana 46168
United StatesSite Not Available
The South Bend Clinic
South Bend, Indiana 46617
United StatesSite Not Available
Dermatology Specialist
Louisville, Kentucky 40241
United StatesSite Not Available
Dermatology and Skin Cancer Specialists
Rockville, Maryland 20850
United StatesSite Not Available
Brigham and Womens Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 02111
United StatesSite Not Available
Great Lakes Research Group, Inc.
Bay City, Michigan 48706
United StatesSite Not Available
Hamzavi Dermatology
Fort Gratiot, Michigan 48059
United StatesSite Not Available
Central Dermatology PC
Saint Louis, Missouri 63117
United StatesSite Not Available
Skin Specialists, P.C
Omaha, Nebraska 68144
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10003
United StatesSite Not Available
DermResearchCenter of New York, Inc
Stony Brook, New York 11790
United StatesSite Not Available
Wake Forest Baptist Health
Winston-Salem, North Carolina 27104
United StatesSite Not Available
Bexley Dermatology Research
Bexley, Ohio 43209
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Wright State Univ School of Medicine
Fairborn, Ohio 45324
United StatesSite Not Available
Dermatologists of Southwest Ohio, Inc.
Mason, Ohio 45040
United StatesSite Not Available
OHSU Center for Health and Healing
Portland, Oregon 97239
United StatesSite Not Available
Oregon Dermatology and Research Center
Portland, Oregon 97210
United StatesSite Not Available
Dermatology and Skin Surgery Center
Exton, Pennsylvania 19341
United StatesSite Not Available
Clinical Partners LLC
Johnston, Rhode Island 02919
United StatesSite Not Available
Dermatology & Laser Center of Charleston
Charleston, South Carolina 29407
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Bellaire Dermatology
Bellaire, Texas 77401
United StatesSite Not Available
Modern Research Associates PLLC
Dallas, Texas 75231
United StatesSite Not Available
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas 78660
United StatesSite Not Available
Texas Dermatology and Laser Specialists
San Antonio, Texas 78218
United StatesSite Not Available
Acclaim Dermatology, PLLC
Sugar Land, Texas 77497
United StatesSite Not Available
University of Utah MidValley Dematology
Murray, Utah 84107
United StatesSite Not Available
Jordan Valley Dermatology Center
West Jordan, Utah 84088
United StatesSite Not Available
Virginia Clinical Research
Norfolk, Virginia 23502
United StatesSite Not Available
Multicare Health System
Tacoma, Washington 98405
United StatesSite Not Available
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