A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis
NCT ID: NCT02340234
Last Updated: 2017-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
212 participants
INTERVENTIONAL
2015-05-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lebrikizumab 250 mg Single Dose + TCS Cream
Participants will receive lebrikizumab 250 milligrams (mg) SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
Lebrikizumab
Lebrikizumab will be administered SC as per the schedule specified in the respective arms.
Placebo
Placebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms.
TCS Cream
TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily
Lebrikizumab 125 mg Single Dose + TCS Cream
Participants will receive lebrikizumab 125 mg SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
Lebrikizumab
Lebrikizumab will be administered SC as per the schedule specified in the respective arms.
Placebo
Placebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms.
TCS Cream
TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily
Lebrikizumab 125 mg Q4W + TCS Cream
Participants will receive lebrikizumab 125 mg SC every 4 weeks (Q4W) for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
Lebrikizumab
Lebrikizumab will be administered SC as per the schedule specified in the respective arms.
TCS Cream
TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily
Placebo Q4W + TCS Cream
Participants will receive placebo Q4W for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
Placebo
Placebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms.
TCS Cream
TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily
Interventions
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Lebrikizumab
Lebrikizumab will be administered SC as per the schedule specified in the respective arms.
Placebo
Placebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms.
TCS Cream
TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Dermatology Research Associate
Los Angeles, California, United States
UCSD Division of Dermatology
San Diego, California, United States
Univ of Calif-San Francisco
San Francisco, California, United States
University of Colorado; Anschutz Cancer Pavilion
Aurora, Colorado, United States
Ameriderm Research
Ormond Beach, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States
University of Iowa Healthcare; Dermatology
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Somerset Skin Centre
Troy, Michigan, United States
Washington University; Dermatology
St Louis, Missouri, United States
Sadick Research Group
New York, New York, United States
Oregon Health & Science University; Department of Dermatology
Portland, Oregon, United States
University of Texas Medical School-Houston
Houston, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Virginia Clinical Research Inc.
Norfolk, Virginia, United States
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, Australia
Skin & Cancer Foundation
Carlton, Victoria, Australia
Royal Melbourne Hospital; Dermatology Department
Parkville, Victoria, Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia
Institute for Skin Advancement
Calgary, Alberta, Canada
Guildford Dermatology Specialists
Surrey, British Columbia, Canada
Dr. Melinda Gooderham Medicine Professional Corporation
Peterborough, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
K. Papp Clinical Research Inc.
Waterloo, Ontario, Canada
XLR8 Medical Research Inc.
Windsor, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Faculty Hospital; Department of Dermatology
Pilsen, , Czechia
Charles University School of Medicine; Deptartment of Dermatology
Prague, , Czechia
Masarykova nemocnice o.z; kozni oddeleni
Ústí nad Labem, , Czechia
Helsinki University Central Hospital; Skin & Allergy Hospital
Helsinki, , Finland
Tampere University Hospital; Dermatology and allergology
Tampere, , Finland
Turku Central University Hospital; Dermatology and allergology
Turku, , Finland
Hopital Saint Andre CHU De Bordeaux; Dermatologie
Bordeaux, , France
Hopital du Bocage; Dermatologie
Dijon, , France
Hopital Hotel Dieu Et Hme; Clinique Dermatologique
Nantes, , France
Hopital l Archet 2; Ginestriere, Service de; Dermatologie
Nice, , France
Centre Hospitalier Lyon Sud; Dermatologie
Pierre-Bénite, , France
Charite Mitte; Klinik fur Dermatologie
Berlin, , Germany
Universitätsklinik Bonn
Bonn, , Germany
Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
Frankfurt, , Germany
SRH Wald-Klinikum Gera GmbH; Hautkrankheiten und Allergologie
Gera, , Germany
UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie
Kiel, , Germany
Universitätsklinikum Mainz
Mainz, , Germany
Academisch Medisch Centrum Universiteit Amsterdam; Dermatology and VU University Medical Center
Amsterdam, , Netherlands
University Medical Center Groningen; Department of Dermatology
Groningen, , Netherlands
UMC Utrecht; Dermatology
Utrecht, , Netherlands
Uniwersyteckie Centeum Kliniczne GUMed; Klinika Dermatologii, Wenerologii i Alergologii
Gdansk, , Poland
DERMED Centrum Medyczne; Sp zoo
Lodz, , Poland
Laser Clinic
Szczecin, , Poland
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
Tarnów, , Poland
dermMedica sp.z o.o.
Wroclaw, , Poland
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
ChungAng University Hospital
Seoul, , South Korea
Clinica Universitaria de Navarra; Servicio de Dermatologia
Pamplona, Navarre, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia
Barcelona, , Spain
Hospital Universitario La Princesa, Servicio dermatologia
Madrid, , Spain
HUGregorio Marañón, Servicio de dermatología
Madrid, , Spain
Hospital Ramon y Cajal; servicio dermatologia
Madrid, , Spain
Hospital Universitario La Paz; Servicio de dermatologia
Madrid, , Spain
Hospital General Universitario de Valencia; servicio de dermatología
Valencia, , Spain
Inselspital Bern; Dermatologie
Bern, , Switzerland
CHUV; Dermatologie
Lausanne, , Switzerland
Universitätsspital Zürich; Dermatologische Klinik
Zurich, , Switzerland
Chang Gung Medical Foundation;Kaohsiung Branch; Department of Dermatology
Kaohsiung City, , Taiwan
National Cheng-Kung University Hospital; Department of Dermatology
Tainan City, , Taiwan
National Taiwan University Hospital; Department of Dermatology
Taipei, , Taiwan
Russells Hall Hospital
Dudley, , United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital; Skin Therapy Research Unit
London, , United Kingdom
Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Poole Hospital
Poole, , United Kingdom
Salford Royal NHS Foundation Trust
Salford, , United Kingdom
Countries
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Other Identifiers
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2014-000049-56
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS29250
Identifier Type: -
Identifier Source: org_study_id