Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis
NCT ID: NCT04587453
Last Updated: 2025-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
106 participants
INTERVENTIONAL
2020-10-27
2021-07-15
Brief Summary
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To evaluate the efficacy of tralokinumab in combination with topical corticosteroids (TCS) compared with placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD).
Secondary objectives:
To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, health-related quality of life, and health care resource utilisation compared with placebo in combination with TCS.
To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 16 weeks.
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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
Week 0 to Week 16: Tralokinumab will be given as subcutaneous injections. Participants will receive tralokinumab loading dose on Day 0 followed by multiple tralokinumab injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed.
Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 subclass that specifically binds to human interleukin-13 (IL-13) and blocks the interaction with IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.
Topical corticosteroids (TCS)
TCS administered as needed.
Placebo+TCS
Week 0 to Week 16: Placebo will be given as subcutaneous injections. Participants will receive placebo loading dose on Day 0 followed by multiple placebo injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed.
Placebo
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Topical corticosteroids (TCS)
TCS administered as needed.
Interventions
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Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 subclass that specifically binds to human interleukin-13 (IL-13) and blocks the interaction with IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.
Placebo
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Topical corticosteroids (TCS)
TCS administered as needed.
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.
* A recent history (within 1 year before screening) of inadequate response to treatment with topical medication.
* AD involvement of 10% or more body surface area at screening and at baseline according to component A of SCORAD.
* Applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.
Exclusion Criteria
* Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
* Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
* Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 4 weeks prior to randomisation.
* Treatment with TCS, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to randomisation.
* Receipt of any marketed biological therapy (i.e. immunoglobulin, anti-immunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to randomisation.
* Active skin infections within 1 week prior to randomisation.
* Clinically significant infection within 4 weeks prior to randomisation.
* A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
* Tuberculosis requiring treatment within the 12 months prior to screening.
* Known primary immunodeficiency disorder.
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 Investigational Site
Nagoya, Aichi-ken, Japan
LEO Investigational Site
Ichikawa, Chiba, Japan
LEO Investigational Site
Ichikawa-shi, Chiba, Japan
LEO Investigational Site
Chikushino-shi, Fukuoka, Japan
LEO Investigational Site
Asahikawa, Hokkaido, Japan
LEO Investigational Site
Chuo-Ku-Sapporo, Hokkaido, Japan
LEO Investigational Site
Obihiro-shi, Hokkaido, Japan
LEO Investigational Site
Sapporo, Hokkaido, Japan
LEO Investigational Site
Sapporo, Hokkaido, Japan
LEO Investigational Site
Nishinomiya, Hyōgo, Japan
LEO Investigational Site
Nonoichi, Ishikawa-ken, Japan
LEO Investigational Site
Kagoshima, Kagoshima-ken, Japan
LEO Investigational Site
Kawasaki-shi, Kanagawa, Japan
LEO Investigational Site
Yokohama, Kanagawa, Japan
LEO Investigational Site
Yokohama, Kanagawa, Japan
LEO Investigational Site
Kamigyō-ku, Kyoto, Japan
LEO Investigational Site
Tokyo, Minato, Japan
LEO Investigational Site
Osaka, Osaka, Japan
LEO Investigational Site
Sakai-shi, Osaka, Japan
LEO Investigational Site
Toyonaka-shi, Osaka, Japan
LEO Investigational Site
Koto-ku, Tokyo, Japan
LEO Investigational Site
Setagaya City, Tokyo, Japan
LEO Investigational Site
Shinjuku-ku, Tokyo, Japan
LEO Investigational Site
Shinjuku-ku, Tokyo, Japan
LEO Investigational Site
Fukuoka, , Japan
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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LP0162-1343
Identifier Type: -
Identifier Source: org_study_id
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