跳至主要内容
临床试验/jRCT2031240450
jRCT2031240450进行中(未招募)不适用

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study of LY4100511 (DC-853) for the Treatment of Adult Participants With Moderate-to Severe Plaque Psoriasis (J5C-MC-FOAB)

Eli Lilly Japan K.K.0 个研究点目标入组 220 人开始时间: 2024年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
220

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Double Blind

入排标准

年龄范围
18age old over 至 70age old under(—)
性别
All

入选标准

  • •Clinical diagnosis of plaque psoriasis for 6 months before the baseline day 1 randomization
  • •Must have a body mass index (BMI) of 18 to 40 kilogram/square meter (kg/m2) (inclusive).
  • •Must be willing to discontinue topical and/or systemic therapies for psoriasis before the first dose of study intervention.
  • •Must agree to avoid prolonged exposure to the sun and to refrain from the use of tanning booths, sun lamps, and other sources of ultraviolet light during the study

排除标准

  • •Have had a clinically significant flare of psoriasis during the 12 weeks before the baseline, as assessed by the investigator.
  • •Have a history of erythrodermic psoriasis, generalized or localized pustular psoriasis, predominantly guttate psoriasis, or medication-induced or medication-exacerbated psoriasis.
  • •Have any known or suspected diagnosis of inflammatory conditions other than psoriasis and psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, IBD (Crohn's disease or ulcerative colitis), or systemic lupus erythematosus.
  • •Have a diagnosis of psoriatic arthritis requiring, or are currently receiving, systemic immunosuppressant medical treatment (including corticosteroids, immunosuppressants, and biologics).
  • •Have a current or recent acute, active infection. Participant must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment for at least 30 days before screening and up to randomization/baseline.

研究者

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