Phase
Condition
Atopic Dermatitis
Allergies & Asthma
Skin Infections/disorders
Treatment
Lebrikizumab
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must be ≥12 years of age inclusive, at the time of signing the informed consent/assent.
Participants who are self-reported race other than White, including but not limitedto persons who self-identify as Black or African American, American Indian or AlaskaNative, Asian, Native Hawaiian, or Other Pacific Islander.
Participants who are Fitzpatrick phototype IV-VI
Participants who have chronic AD that has been present for ≥1 year before screening.
Have EASI ≥16 at baseline
Have IGA score ≥3 (Scale of 0 to 4) at baseline
Have ≥10% body surface area (BSA) of AD involvement at baseline
Have a history of inadequate response to treatment with topical medications; ordetermination that topical treatments are otherwise medically inadvisable.
Adolescents body weight must be ≥40 kg at baseline.
Are willing and able to comply with all clinic visits and study-related proceduresand questionnaires.
Contraceptive use - Male and/or female
Male participants are not required to use any contraception except incompliance with specific local government study requirements.
Female participants of child-bearing potential: must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptivemethod during the treatment period and for at least 18 weeks after the lastdose of study drug. Women of non-child-bearing potential (non-WOCBP) mayparticipate without any contraception requirements.
Exclusion
Exclusion Criteria:
History of human immunodeficiency virus (HIV) infection or positive HIV serology atscreening.
Have a current infection or chronic infection with hepatitis B virus (HBV) atscreening, that is, positive for hepatitis B surface antigen (HBsAg) and/orpolymerase chain reaction positive for HBV DNA
Have a current infection with hepatitis C virus (HCV) at screening, that is,positive for HCV RNA
Have an uncontrolled chronic disease that might require multiple intermittent usesof oral corticosteroids at screening (as defined by the investigator).
Have uncontrolled asthma that
might require bursts of oral or systemic corticosteroids, or
required the following due to ≥1 exacerbations within 12 months before baseline
systemic (oral and/or parenteral) corticosteroid treatment, or
hospitalization for >24 hours.
Have known liver cirrhosis and/or chronic hepatitis of any etiology.
Had prior treatment with dupilumab
Had prior treatment with tralokinumab
Treatment with topical agents (corticosteroids, calcineurin inhibitors, JAKinhibitors, or phosphodiesterase-4 inhibitors) within 2 weeks prior to baseline.
Treatment with any of the following agents within 4 weeks prior to the baseline:
systemic immunosuppressive/immunomodulating drugs (for example, systemiccorticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine,methotrexate, and other immunosuppressants);
small molecules (for example, Janus Kinase (JAK) inhibitors);
phototherapy and photochemotherapy for AD.
History of malignancy, including mycosis fungoides or cutaneous T-cell lymphoma,within 5 years before the screening, except completely treated in situ carcinoma ofthe cervix of completely treated and resolved non-metastatic squamous or basal cellcarcinoma of the skin with no evidence of recurrence in the past 12 weeks.
Study Design
Connect with a study center
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama 35205
United StatesSite Not Available
River Region Dermatology and Laser
Montgomery, Alabama 36117
United StatesSite Not Available
First OC Dermatology
Fountain Valley, California 92708
United StatesSite Not Available
Center For Dermatology Clinical Research, Inc.
Fremont, California 94538
United StatesSite Not Available
Axon Clinical Research
Inglewood, California 90301
United StatesSite Not Available
Avance Clinical Trials Inc
Laguna Niguel, California 92677
United StatesSite Not Available
Avance Trials
Laguna Niguel, California 92677
United StatesActive - Recruiting
Dermatology Research Associates
Los Angeles, California 90045
United StatesSite Not Available
Wallace Medical Group, Inc.
Los Angeles, California 90056
United StatesSite Not Available
Cura Clinical Research
Palmdale, California 93551
United StatesSite Not Available
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California 95816
United StatesSite Not Available
University of California Davis-Dermatology
Sacramento, California 95816
United StatesActive - Recruiting
San Francisco Research Institute
San Francisco, California 94127
United StatesSite Not Available
Synergy Dermatology
San Francisco, California 94132
United StatesSite Not Available
Southern California Dermatology, Inc.
Santa Ana, California 92701
United StatesSite Not Available
Clinical Science Institute
Santa Monica, California 90404
United StatesSite Not Available
Cura Clinical Research
Sherman Oaks, California 91403
United StatesSite Not Available
Progressive Clinical Research
Vista, California 92083
United StatesSite Not Available
UConn Health
Farmington, Connecticut 06030-2840
United StatesSite Not Available
Yale University School of Medicine
New Haven, Connecticut 06510
United StatesSite Not Available
Skin Care Research, Inc
Boca Raton, Florida 33486
United StatesSite Not Available
Encore Medical Research of Boynton Beach
Boynton Beach, Florida 33436
United StatesSite Not Available
Total Vein and Skin LLC
Boynton Beach, Florida 33437
United StatesActive - Recruiting
Total Vein and Skin, LLC
Boynton Beach, Florida 33437
United StatesSite Not Available
Accel Research Sites
DeLand, Florida 32720
United StatesSite Not Available
Accel Research Sites- Clinical Research Unit
DeLand, Florida 32720
United StatesActive - Recruiting
D&H Doral Research Center LLC
Doral, Florida 33122
United StatesSite Not Available
Encore Medical Research of Boynton Beach
Hollywood, Florida 33021
United StatesActive - Recruiting
Skin Care Research, Inc
Hollywood, Florida 33021
United StatesSite Not Available
Solutions Through Advanced Research
Jacksonville, Florida 32256
United StatesSite Not Available
Miami Dermatology and Laser Research
Miami, Florida 33173
United StatesSite Not Available
Skin and Cancer Associates, LLP
Miami, Florida 33137
United StatesActive - Recruiting
Savin Medical Group, LLC
Miami Lakes, Florida 33014
United StatesSite Not Available
PureSkin Dermatology
Orlando, Florida 32819
United StatesSite Not Available
University Clinical Research-Deland, LLC
Orlando, Florida 32819
United StatesActive - Recruiting
ForCare Clinical Research
Tampa, Florida 33613-1244
United StatesSite Not Available
Skin Care Physicians of Georgia
Macon, Georgia 31217
United StatesSite Not Available
Advanced Medical Research
Sandy Springs, Georgia 30328
United StatesSite Not Available
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
United StatesSite Not Available
Skin Sciences, PLLC
Louisville, Kentucky 40217
United StatesSite Not Available
Kindred Hair and Skin
Columbia, Maryland 21104
United StatesSite Not Available
Allcutis Research, Inc.
Beverly, Massachusetts 01915
United StatesSite Not Available
Oakland Hills Dermatology
Auburn Hills, Michigan 48326
United StatesSite Not Available
Revival Research Institute - Troy
Troy, Michigan 48084
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Skin Specialists, P.C
Omaha, Nebraska 68144
United StatesSite Not Available
ALLCUTIS Research
Portsmouth, New Hampshire 03801
United StatesSite Not Available
Sadick Research Group
New York, New York 10075
United StatesSite Not Available
Weil Cornell Medicine Dermatology Research
New York, New York 10075
United StatesSite Not Available
Wilmington Health Family Medicine
Wilmington, North Carolina 28411
United StatesSite Not Available
Temple University Hospital
Philadelphia, Pennsylvania 19140
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
Arlington Research Center, Inc
Arlington, Texas 76011
United StatesSite Not Available
Clinical Trial Network
Houston, Texas 77074
United StatesSite Not Available
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
Progressive Clinical Research
San Antonio, Texas 78213
United StatesSite Not Available
Texas Dermatology and Laser Specialists
San Antonio, Texas 78218
United StatesSite Not Available
Complete Dermatology
Sugar Land, Texas 77479
United StatesSite Not Available
Virginia Clinical Research, Inc.
Norfolk, Virginia 23502
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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