Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis
NCT ID: NCT02347176
Last Updated: 2018-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
204 participants
INTERVENTIONAL
2015-01-23
2016-02-05
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
QUADRUPLE
Study Groups
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Placebo
Placebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Placebo
Subcutaneous injection with placebo
Tralokinumab Dose 1
Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 1
Subcutaneous injection with tralokinumab
Tralokinumab Dose 2
Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 2
Subcutaneous injection with tralokinumab
Tralokinumab Dose 3
Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 3
Subcutaneous injection with tralokinumab
Interventions
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Placebo
Subcutaneous injection with placebo
Tralokinumab Dose 1
Subcutaneous injection with tralokinumab
Tralokinumab Dose 2
Subcutaneous injection with tralokinumab
Tralokinumab Dose 3
Subcutaneous injection with tralokinumab
Eligibility Criteria
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Inclusion Criteria
* Atopic dermatitis involvement of greater than or equal to (\>=) 10 percent (%) body surface area
* EASI score of \>= 12
* SCORAD of \>= 25
* IGA score of \>= 3
* Effective birth control in line with protocol details
Exclusion Criteria
* Hepatitis B, C or human immunodeficiency virus
* Pregnant or breastfeeding
* History of cancer
* Previous receipt of tralokinumab
18 Years
75 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Locations
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Research Site
Phoenix, Arizona, United States
Research Site
Rogers, Arkansas, United States
Research Site
Fremont, California, United States
Research Site
Fullerton, California, United States
Research Site
Los Angeles, California, United States
Research Site
Oceanside, California, United States
Research Site
Rancho Santa Margarita, California, United States
Research Site
Santa Monica, California, United States
Research Site
Clearwater, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Worcester, Massachusetts, United States
Research Site
Warren, Michigan, United States
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Berlin, New Jersey, United States
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Verona, New Jersey, United States
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New York, New York, United States
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Rochester, New York, United States
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Portland, Oregon, United States
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Charleston, South Carolina, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Pflugerville, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
Research Site
Norfolk, Virginia, United States
Research Site
East Melbourne, , Australia
Research Site
Kogarah, , Australia
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Liverpool, , Australia
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Sydney, , Australia
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Woolloongabba, , Australia
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Surrey, British Columbia, Canada
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Courtice, Ontario, Canada
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Markham, Ontario, Canada
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Peterborough, Ontario, Canada
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Waterloo, Ontario, Canada
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Windsor, Ontario, Canada
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Berlin, , Germany
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Bochum, , Germany
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Dresden, , Germany
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Dülmen, , Germany
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Frankfurt am Main, , Germany
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Hanover, , Germany
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München, , Germany
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Münster, , Germany
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Stuttgart-Weilimdorf, , Germany
Research Site
Wuppertal, , Germany
Research Site
Nakano, , Japan
Research Site
Shibuya-ku, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Shinjuku-ku, , Japan
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Yokohama, , Japan
Research Site
Katowice, , Poland
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Lodz, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
Research Site
Wroclaw, , Poland
Countries
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References
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Silverberg JI, Guttman-Yassky E, Gooderham M, Worm M, Rippon S, O'Quinn S, van der Merwe R, Kragh N, Kurbasic A, Wollenberg A. Health-related quality of life with tralokinumab in moderate-to-severe atopic dermatitis: A phase 2b randomized study. Ann Allergy Asthma Immunol. 2021 May;126(5):576-583.e4. doi: 10.1016/j.anai.2020.12.004. Epub 2020 Dec 15.
Wollenberg A, Howell MD, Guttman-Yassky E, Silverberg JI, Kell C, Ranade K, Moate R, van der Merwe R. Treatment of atopic dermatitis with tralokinumab, an anti-IL-13 mAb. J Allergy Clin Immunol. 2019 Jan;143(1):135-141. doi: 10.1016/j.jaci.2018.05.029. Epub 2018 Jun 12.
Other Identifiers
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D2213C00001
Identifier Type: -
Identifier Source: org_study_id
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