A Randomized, Double-Blind, Multicentric, Parallel Group Therapeutic Equivalence Study Comparing Efficacy, Safety and Immunogenicity of Subcutaneous DMB-3115 and EU Sourced Stelara® in Patients with Moderate to Severe Chronic Plaque Psoriasis.

Dong-A ST Co. Ltd.0 个研究点目标入组 590 人开始时间: 2021年3月24日最近更新: 2023年10月23日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Dong-A ST Co. Ltd.
入组人数: 590

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Male and female patients aged =18 and =75 years at time of screening.
•2. Patients with body weight =140 kg.
•3. Patients who have a diagnosis of plaque-type psoriasis for at least 6 months prior to IP initiation.
•4. Patients with moderate to severe psoriasis defined by PASI score of 12 or greater, Physician Global Assessment (PGA) score of 3 or greater and body surface area (BSA) affected by plaque-type psoriasis of 10% or greater at screening and baseline.
•5. Patients who are considered by the treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis.
•6. Patients who previously had an inadequate response, intolerance to, or contraindication to at least 1 conventional anti-psoriatic systemic therapy
•Other protocol-defined inclusion criteria could apply
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 510
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

排除标准

•1. Patients with hypersensitivity to ustekinumab or any of the product excipients (for either DMB-3115 or Stelara).
•2. Patients with non-plaque forms of psoriasis including guttate, erythrodermic, inverse or pustular types or drug induced psoriasis.
•3. Patients who have received:
•- any biological therapeutic agents targeted at inhibiting IL-12 or IL-23, inhibiting IL-17, or integrin.
•- any biological therapeutic agents for psoriasis within past 90 days or within 5 drug half-lives prior to screening, whichever is longer. NOTE: If a biological therapeutic agent corresponds to both Exclusion criteria #4 and #5, Exclusion criterion #4 should be applied. If a biological therapeutic agent corresponds to both Exclusion criteria #5 and #6, Exclusion criterion #6 should be applied.
•- any monoclonal antibodies within 9 months prior to screening. NOTE: If a biological therapeutic agent corresponds to both Exclusion criteria #4 and #6, Exclusion criterion #4 should be applied.
•- any other investigational drugs within 5 half-lives of the investigational treatment prior to IP initiation.
•- phototherapy, photochemotherapy, or non-biological systemic treatment for psoriasis within 4 weeks prior to IP initiation.
•- topical treatment that is likely to impact signs and symptoms of psoriasis within 2 weeks prior to IP initiation.
•- topical treatment for psoriasis under investigation within 4 weeks prior to IP initiation.
•4. Patients with previous use of 2 or more biologics for treatment of psoriasis.
•5. Patients who have allergic reaction or hypersensitivity to previous biological treatments.
•6. Patients who have an active ongoing inflammatory disease other than psoriasis that might confound the evaluation of treatment with ustekinumab.
•7. Patients who have an active infection or history of infections as follows:
•- any active infection for which systemic anti-infectives were used within 4 weeks prior to IP initiation
•- a serious infection, defined as requiring hospitalization or IV anti-infectives within 8 weeks prior to IP initiation
•- recurrent or chronic infections or other active infection
•8. Patients who have a laboratory-confirmed COVID-19 test or have been in close physical contact (6 feet or closer for at least 15 minutes) with a person who is known to have laboratory confirmed COVID-19 or with anyone who has any symptoms consistent with COVID-19 within the past 14 days.
•9. Patients with a known infection with human immunodeficiency virus, hepatitis B, or hepatitis C.
•10. Patients who have an uncontrolled, clinically significant systemic disease
•11. Patients with an active or prior malignancy within 5 years
•12. Patients who have neurologic symptoms suggestive of central nervous system demyelinating disease.
•13. Patients who have received a live or live-attenuated vaccination within 6 weeks prior to the first administration of the IP
•14. Patients who have had Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to the first administration of the IP. Patients must agree not to receive a BCG vaccination during the study and up to 1 year after the last dose of the IP.
•15. Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection.
•16. Patients with history or symptoms of active tuberculosis
•17. Patients with a history of alcohol or substance abuse within 6 months prior to screening
•18. Patients taking medications known to worsen psoriasis
•Other protocol-defined exclusion criteria could apply

研究者

发起方

Dong-A ST Co. Ltd.

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