A Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease - MITIGATE

Viela Bio, Inc.0 个研究点目标入组 200 人开始时间: 2020年11月19日最近更新: 2021年10月26日

研究概览

暂无简介。

•1.Male or female adults who have reached the age of consent in the applicable region (eg, =18 years in the US, = 20 years in Japan).
•2.Clinical diagnosis of IgG4-RD.
•3.Fulfillment of the 2019 ACR/EULAR classification criteria.
•4.Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of glucocorticoid (GC) treatment at the time of informed consent.
•5.IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD. One organ must meet the requirements for the ACR/EULAR classification criteria; the second organ is as defined by the investigator.
•6.Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide (where spermicide is available) from Day 1 through to the end of the study and must agree to continue using such precautions for at least 6 months after the final dose of IP. Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception
•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 160
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•1.History of solid organ or cell-based transplantation or known immunodeficiency disorder .
•2.Active malignancy or history of malignancy that was active within the last 10 years (some specific situations for cervical, skin or prostate cancer are acceptable).
•3.Receipt of any biologic B cell-depleting therapy or non-depleting B cell-directed therapy in prior 6 months
•4.Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within prior 4 weeks
•5.Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection
•6.Live vaccine or therapeutic agent in prior 2 weeks
•7.Glomerular filtration rate < 30 mL/min/1.73 m2

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