Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7
NCT ID: NCT03761537
Last Updated: 2025-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
277 participants
INTERVENTIONAL
2018-12-13
2020-09-28
Brief Summary
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To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA).
Secondary objectives:
To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared to placebo in combination with TCS.
To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS.
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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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Tralokinumab + TCS
4 subcutaneous (SC) injections of tralokinumab 150 mg as a loading dose on Day 0, followed by 2 SC injections of tralokinumab 150 mg every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.
Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration.
Placebo + TCS
4 subcutaneous (SC) injections of placebo as a loading dose on Day 0, followed by 2 SC injections of placebo every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.
Placebo
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Interventions
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Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration.
Placebo
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD
* History of AD for 1 year or more
* Subjects with a history within 1 year prior to screening of inadequate response to treatment with topical medications or subjects for whom topical treatments are otherwise medically inadvisable
* AD involvement of 10% (or more) body surface area at screening and baseline (visit 3) according to component A of SCORAD
* Documented history of either no previous CSA exposure and not currently a candidate for CSA treatment OR previous exposure to CSA in which case CSA treatment should not be continued or restarted
* Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation
Exclusion Criteria
* Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 6 weeks prior to randomisation
* Treatment with immunomodulatory medications or bleach baths within 4 weeks prior to randomisation
* Treatment with topical phosphodiesterase-4 (PDE-4) inhibitor within 2 weeks prior to randomisation
* Receipt of any marketed or investigational biologic agent (e.g. cell-depleting agents or dupilumab) within 6 months prior to randomisation or until cell counts return to normal, whichever is longer
* History of any active skin infection within 1 week prior to randomisation
* History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomisation
* A helminth parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
* Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care
* History of any known primary immunodeficiency disorder including a positive HIV test at screening, or the subject taking antiretroviral medications
18 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Expert
Role: STUDY_DIRECTOR
LEO Pharma
Locations
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Leo Pharma Investigationel Site
Brussels, , Belgium
Leo Pharma Investigationel Site
Brussels, , Belgium
Leo Pharma Investigationel Site
Edegem, , Belgium
Leo Pharma Investigationel Site
Ghent, , Belgium
Leo Pharma Investigationel Site
Ghent, , Belgium
Leo Pharma Investigationel Site
Herstal, , Belgium
Leo Pharma Investigationel Site
Kortrijk, , Belgium
Leo Pharma Investigationel Site
Leuven, , Belgium
Leo Pharma Investigationel Site
Liège, , Belgium
Leo Pharma Investigationel Site
Loverval, , Belgium
Leo Pharma Investigationel Site
Maldegem, , Belgium
Leo Pharma Investigationel Site
Karlovy Vary, , Czechia
Leo Pharma Investigationel Site
Kutná Hora, , Czechia
Leo Pharma Investigationel Site
Ostrava, , Czechia
Leo Pharma Investigationel Site
Pardubice, , Czechia
Leo Pharma Investigationel Site
Prague, , Czechia
Leo Pharma Investigationel Site
Prague, , Czechia
Leo Pharma Investigationel Site
Prague, , Czechia
Leo Pharma Investigationel Site
Prague, , Czechia
Leo Pharma Investigationel Site
Prague, , Czechia
Leo Pharma Investigationel Site
Grenoble, , France
Leo Pharma Investigationel Site
Nice, , France
Leo Pharma Investigationel Site
Paris, , France
Leo Pharma Investigationel Site
Pierre-Bénite, , France
Leo Pharma Investigationel Site
Valence, , France
Leo Pharma Investigationel Site
Aachen, , Germany
Leo Pharma Investigationel Site
Augsburg, , Germany
Leo Pharma Investigationel Site
Bad Bentheim, , Germany
Leo Pharma Investigationel Site
Berlin, , Germany
Leo Pharma Investigationel Site
Dresden, , Germany
Leo Pharma Investigationel Site
Dülmen, , Germany
Leo Pharma Investigationel Site
Frankfurt, , Germany
Leo Pharma Investigationel Site
Halle, , Germany
Leo Pharma Investigationel Site
Hanover, , Germany
Leo Pharma Investigationel Site
Jena, , Germany
Leo Pharma Investigationel Site
Kiel, , Germany
Leo Pharma Investigationel Site
Mainz, , Germany
Leo Pharma Investigationel Site
München, , Germany
Leo Pharma Investigationel Site
Osnabrück, , Germany
Leo Pharma Investigationel Site
Selters, , Germany
Leo Pharma Investigationel Site
Bialystok, , Poland
Leo Pharma Investigationel Site
Bochnia, , Poland
Leo Pharma Investigationel Site
Bydgoszcz, , Poland
Leo Pharma Investigationel Site
Gdansk, , Poland
Leo Pharma Investigationel Site
Krakow, , Poland
Leo Pharma Investigationel Site
Krakow, , Poland
Leo Pharma Investigationel Site
Krakow, , Poland
Leo Pharma Investigationel Site
Lodz, , Poland
Leo Pharma Investigationel Site
Lodz, , Poland
Leo Pharma Investigationel Site
Lublin, , Poland
Leo Pharma Investigationel Site
Poznan, , Poland
Leo Pharma Investigationel Site
Rzeszów, , Poland
Leo Pharma Investigationel Site
Warsaw, , Poland
Leo Pharma Investigationel Site
Warsaw, , Poland
Leo Pharma Investigationel Site
Warsaw, , Poland
Leo Pharma Investigationel Site
Wroclaw, , Poland
Leo Pharma Investigationel Site
Granada, Andalusia, Spain
Leo Pharma Investigationel Site
Alicante, , Spain
Leo Pharma Investigationel Site
Barcelona, , Spain
Leo Pharma Investigationel Site
Barcelona, , Spain
Leo Pharma Investigationel Site
Barcelona, , Spain
Leo Pharma Investigationel Site
Bilbao, , Spain
Leo Pharma Investigationel Site
Córdoba, , Spain
Leo Pharma Investigationel Site
Madrid, , Spain
Leo Pharma Investigationel Site
Madrid, , Spain
Leo Pharma Investigationel Site
Madrid, , Spain
Leo Pharma Investigationel Site
Pamplona, , Spain
Leo Pharma Investigationel Site
Seville, , Spain
Leo Pharma Investigationel Site
Bradford, , United Kingdom
Leo Pharma Investigationel Site
Cottingham, , United Kingdom
Leo Pharma Investigationel Site
Kirkcaldy, , United Kingdom
Leo Pharma Investigationel Site
London, , United Kingdom
Leo Pharma Investigationel Site
Southampton, , United Kingdom
Leo Pharma Investigationel Site
Wakefield, , United Kingdom
Countries
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References
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Reich K, Langley RG, Salvador JFS, Staumont-Salle D, Costanzo A, Pink AE, Paller AS, Katoh N, Wollenberg A, Warren RB, Blauvelt A, Oland CB, Tindberg AM, Gjerum L, Simpson EL. Safety of tralokinumab in patients with moderate-to-severe atopic dermatitis followed for up to 4.5 years: an integrated analysis of 8 clinical trials. Br J Dermatol. 2025 Aug 29:ljaf309. doi: 10.1093/bjd/ljaf309. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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LP0162-1346
Identifier Type: -
Identifier Source: org_study_id
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