Eli Lilly Launches Phase 3 Trial of IL-13 Inhibitor Lebrikizumab for Moderate-to-Severe Atopic Dermatitis Across 40 Hospitals in China

Apr 04, 2024 08:32 CST Updated 08:32

Eli Lilly

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China Drug Clinical Trial Registration and Information Disclosure Platform recently announced,Eli Lilly and Company has launched aLebrikizumab InjectionTreatmentModerate to Severe Atopic DermatitisInternational multicenter (including China) Phase 3 clinical study. This studyPlanned to be held in 40 hospitals in China, with an estimated enrollment of 390 participants.Lebrikizumab is jointly developed by Almirall and Eli Lilly and Company.IL-13 Specific Antibody Therapy, which was approved for marketing in the EU last November, is used for adolescent and adult patients with moderate to severe atopic dermatitis.

Screenshot source:China Drug Clinical Trial Registration and Information Disclosure Platform Official Website

Atopic Dermatitis (AD) is a common chronic, recurrent, inflammatory skin disease. Patients often experience severe itching, which significantly affects their quality of life. For moderate to severe AD, topical medications often fail to adequately control the condition, necessitating the initiation of systemic treatment. Traditional systemic treatments mainly include antihistamines, immunosuppressants, and systemic corticosteroids, which present issues such as insufficient efficacy and suboptimal safety, leading to poor patient compliance and a lower overall control rate. In recent years, the advent of innovative drugs like biologics and JAK inhibitors has opened new avenues for the treatment of moderate to severe AD.

IL-13 is a key cytokine in atopic dermatitis, driving type 2 inflammatory responses in the skin.This reaction leads to impaired skin barrier function, itching, skin thickening, and infection.Lebrikizumab is a monoclonal antibody that binds to IL-13 with high affinity, effectively preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signal transduction.. This inhibition significantly alleviated the biological effects of IL-13. The product has demonstrated both short-term and long-term efficacy and safety.And the maintenance dose is once a month., forProvides a new treatment option for patients with moderate to severe atopic dermatitis who are unresponsive to localized therapy.。

Public information shows,Almirall has the rights to develop and commercialize lebrikizumab in Europe for the treatment of dermatological conditions, including atopic dermatitis.Eli Lilly and Company has exclusive development and commercialization rights in all regions outside of Europe.November 2023,Almirall AnnouncesLebrikizumab Receives European Commission ApprovalApproved for Marketing, for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis.In addition,The product alsoGranted Fast Track Designation by the U.S. FDA for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis.

This Phase 3, multicenter, randomized, double-blind, placebo-controlled trial launched by Eli Lilly in China aims at individuals aged 12 years and above.Subjects with Moderate to Severe Atopic DermatitisEvaluation of LebrikizumabWith/Without Topical CorticosteroidsEfficacy and safety during treatment. The key investigator in China for this study is from Peking University People's Hospital.Professor Zhang Jianzhongand Shanghai Dermatology HospitalProfessor Shi Yuling。

For the indication of atopic dermatitis,Ebrikizumab has previously achieved positive results in multiple pivotal Phase 3 clinical studies. Among them, the ADvocate 1 and ADvocate 2 studies evaluated its efficacy as a monotherapy, while the ADhere study assessed its effects when used in combination with topical corticosteroids (TCS). The results showed,At Week 16,Lebrikizumab demonstrated early clinical efficacy as monotherapy, with over 50% of patients achieving at least a 75% reduction in disease extent and severity (EASI-75).。When used in combination with TCS, this effectiveness increased to nearly 70% of patients.

In addition, earlierLong-term Extension StudyDisplay,Achieved remission at Week 16 andPatients who continued to receive lebrikizumab treatment, either as monotherapy or in combination with TCS,Nearly 80% of patients can maintain clear skin, itch relief, and reduced disease severity for up to two years.

References:

[1]ChinaOfficial Website of the Drug Clinical Trial Registration and Information Disclosure Platform. Retrieved Apr 1， 2024, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] Almirall Receives European Commission Approval of EBGLYSS® (lebrikizumab) for Moderate-to-Severe Atopic Dermatitis. Retrieved November 17, 2023, from https://www.businesswire.com/news/home/20231116347732/en

[3] Napolitano et al., (2023). The hidden sentinel of the skin: An overview on the role of interleukin-13 in atopic dermatitis. Frontiers in Medicine, https://doi.org/10.3389/fmed.2023.1165098

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