A Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Atopic Dermatitis

Last updated: January 17, 2020
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

2

Condition

Atopic Dermatitis

Allergy

Eczema (Atopic Dermatitis)

Treatment

N/A

Clinical Study ID

NCT02465606
GS29735
  • Ages 18-75
  • All Genders

Study Summary

The primary objective for this study is to evaluate the safety of lebrikizumab compared with Topical Corticosteroids (TCS) alone in patients with persistent moderate to severe Atopic Dermatitis (AD) that is inadequately controlled with TCS.

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

Total Participants: 55
Study Start date:
July 30, 2015
Estimated Completion Date:
May 30, 2016

Connect with a study center

  • Dr. Lorne E. Albrecht Inc.

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Skin Care Centre

    Vancouver, British Columbia V5Z 4E8
    Canada

    Site Not Available

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • Guenther Research Inc.

    London, Ontario N6A 3H7
    Canada

    Site Not Available

  • The Centre for Clinical Trials Inc.

    Oakville, Ontario L6J 7W5
    Canada

    Site Not Available

  • York Dermatology Center

    Richmond Hill, Ontario L4C 9M7
    Canada

    Site Not Available

  • K. Papp Clinical Research Inc.

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • T. Joseph Raoof Md, Inc.

    Encino, California 91436
    United States

    Site Not Available

  • Allergy and Asthma Relief Experts

    Granada Hills, California 91344
    United States

    Site Not Available

  • Allergy and Asthma Associates of Southern California - CRN

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Forward Clinical Trials

    Tampa, Florida 33624
    United States

    Site Not Available

  • Dermatology Specialists Research, LLC

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Respiratory Medicine Research; Institue of Michigan P.L.C.

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Sadick Research Group

    New York, New York 10075
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland, Oregon 97223
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)

    Warwick, Rhode Island 02865
    United States

    Site Not Available

  • Center for Clinical Studies

    Cypress, Texas 77433
    United States

    Site Not Available

  • empty

    Webster, Texas 77598
    United States

    Site Not Available

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