Phase
Condition
Atopic Dermatitis
Allergy
Eczema (Atopic Dermatitis)
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 to 75 years, inclusive, at the start of the run-in period
AD diagnosed by the Hanifin/Rajka criteria and that has been present for at least 1year at screening
Moderate to severe AD as graded by the Rajka/Langeland criteria at screening
History of inadequate response to a >/= 1 month (within the 3 months prior to thescreening visit) treatment regimen of at least daily TCS and regular emollient fortreatment of AD
EASI score >/= 14 at screening
IGA score >/= 3
AD involvement of >/= 10% body surface area
Pruritus Visual Analog Scale score >/= 3
Exclusion
Exclusion Criteria:
Past and/or current use of any anti-IL-13 or anti-IL-4/IL-13 therapy, includinglebrikizumab
Use of an investigational agent within 4 weeks prior to screening or within 5half-lives of the investigational agent, whichever is longer
Evidence of other skin conditions, including, but not limited to, T-cell lymphoma orallergic contact dermatitis
History of a severe allergic reaction or anaphylactic reaction to a biologic agent orknown hypersensitivity to any component of the lebrikizumab injection
Use of any complementary, alternative, or homeopathic medicines including, but notlimited to, phytotherapies, traditional or non-traditional herbal medications,essential fatty acids, or acupuncture within 7 days prior to the run-in period or needfor such medications during the study
Evidence of other skin conditions; including, but not limited to, T-cell lymphoma orallergic contact dermatitis
Evidence of, or ongoing treatment (including topical antibiotics) for active skininfection at screening
Other recent infections meeting protocol criteria
Active tuberculosis requiring treatment within the 12 months prior to Visit 1
Evidence of acute or chronic hepatitis or known liver cirrhosis
Known immunodeficiency, including HIV infection
Use of a topical calcineurin inhibitor (TCI) at the time of screening, unless thepatient is willing to stop TCI use during the study (including the run-in period) and,in the investigator's opinion, it is safe to do so
Clinically significant abnormality on screening ECG or laboratory tests
Known current malignancy or current evaluation for a potential malignancy, includingbasal or squamous cell carcinoma of the skin or carcinoma in situ
History of malignancy within 5 years prior to screening, except for appropriatelytreated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterinecancer
Study Design
Connect with a study center
Dr. Lorne E. Albrecht Inc.
Surrey, British Columbia V3R 6A7
CanadaSite Not Available
Skin Care Centre
Vancouver, British Columbia V5Z 4E8
CanadaSite Not Available
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba R3M 3Z4
CanadaSite Not Available
Guenther Research Inc.
London, Ontario N6A 3H7
CanadaSite Not Available
The Centre for Clinical Trials Inc.
Oakville, Ontario L6J 7W5
CanadaSite Not Available
York Dermatology Center
Richmond Hill, Ontario L4C 9M7
CanadaSite Not Available
K. Papp Clinical Research Inc.
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
T. Joseph Raoof Md, Inc.
Encino, California 91436
United StatesSite Not Available
Allergy and Asthma Relief Experts
Granada Hills, California 91344
United StatesSite Not Available
Allergy and Asthma Associates of Southern California - CRN
Mission Viejo, California 92691
United StatesSite Not Available
Forward Clinical Trials
Tampa, Florida 33624
United StatesSite Not Available
Dermatology Specialists Research, LLC
Louisville, Kentucky 40241
United StatesSite Not Available
Respiratory Medicine Research; Institue of Michigan P.L.C.
Ypsilanti, Michigan 48197
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
Sadick Research Group
New York, New York 10075
United StatesSite Not Available
Oregon Medical Research Center
Portland, Oregon 97223
United StatesSite Not Available
Temple University Hospital
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
Warwick, Rhode Island 02865
United StatesSite Not Available
Center for Clinical Studies
Cypress, Texas 77433
United StatesSite Not Available
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Webster, Texas 77598
United StatesSite Not Available

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