A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis



Status:Completed
Conditions:Psoriasis, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:10/4/2017
Start Date:May 2015
End Date:April 2016

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A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lebrikizumab in Patients With Persistent Moderate to Severe Atopic Dermatitis That is Inadequately Controlled by Topical Corticosteroids

This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy
of lebrikizumab administered subcutaneously (SC) in adult participants with persistent
moderate to severe atopic dermatitis (AD) who are inadequately controlled by topical
corticosteroids (TCS). The study includes a screening visit, a 2-week run-in period, a
12-week blinded treatment period, and an 8-week safety follow-up period. Following screening
visit, eligible participants will enter in run-in period (Days − 14 to − 1) during which a
protocol-specified topical therapy regimen will be initiated. At the end of the run-in
period, participants who have: 1) demonstrated compliance with the protocol-specified TCS
regimen, and 2) who continue to fulfill the eligibility criteria will be randomized.


Inclusion Criteria:

- AD diagnosed by the Hanifin/Rajka criteria and that has been present for at least 1
year 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 the
screening visit) treatment regimen of at least daily TCS and regular emollient for
treatment of AD

- EASI score >/= 14 at screening and end of the run-in period

- IGA score >/= 3 (5-point scale) at screening and end of the run-in period

- AD involvement of >/= 10% BSA at screening

- Pruritus VAS score >/= 3 at screening

Exclusion Criteria:

- Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy,
including lebrikizumab

- Use of an investigational agent within 4 weeks prior to screening or within 5
half-lives of the investigational agent, whichever is longer

- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or
known hypersensitivity to any component of the lebrikizumab injection

- Use of any complementary, alternative, or homeopathic medicines including, but not
limited to, phytotherapies, traditional or non-traditional herbal medications,
essential fatty acids, or acupuncture within 7 days prior to the run-in period or need
for such medications during the study

- Evidence of other skin conditions; including, but not limited to, T-cell lymphoma or
allergic contact dermatitis

- Evidence of, or ongoing treatment (including topical antibiotics) for active skin
infection 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 human immunodeficiency virus (HIV) infection

- Use of a topical calcineurin inhibitor (TCI) at the time of screening, unless the
participant 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 electrocardiogram (ECG) or laboratory
tests that, in the opinion of the investigator, may pose an additional risk in
administering study drug or TCS to the participant

- Known current malignancy or current evaluation for a potential malignancy, including
basal or squamous cell carcinoma of the skin or carcinoma in situ

- History of malignancy within 5 years prior to screening, except for appropriately
treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine
cancer
We found this trial at
17
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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911 Park Avenue
New York, New York 10075
212-710-9855
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New York, NY
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725 West Granada Blvd
Ormond Beach, Florida 32174
386-898-0547
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Ormond Beach, FL
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
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San Antonio, TX
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Aurora, CO
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Chicago, IL
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Houston, TX
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200 Hawkins Drive
Iowa City, Iowa 52242
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Iowa City, IA
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Kogarah, New South Wales 2217
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Kogarah,
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8930 South Sepulveda Boulevard
Los Angeles, California 90045
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Los Angeles, CA
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Norfolk, Virginia 23507
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Norfolk, VA
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Portland, OR
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4921 Parkview Place
Saint Louis, Missouri 63110
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Saint Louis, MO
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San Diego, California 92122
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San Diego, CA
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505 Parnassus Avenue
San Francisco, California 94143
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San Francisco, CA
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Tampa, Florida 33609
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Tampa, FL
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Troy, Michigan 48084
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Troy, MI
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