EUCTR2020-000417-33-IT进行中（未招募）1 期
A Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease(short title: MITIGATE – InebilizuMab effIcacy and safeTy in IGg4 relATed disEase) - MITIGATE
VIELABIO Inc.0 个研究点目标入组 200 人开始时间: 2020年10月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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 or female adults, = 18 years of age at time of informed consent.
- •2.Written informed consent and any locally required authorization
- •3.Clinical diagnosis of IgG4-RD.
- •4.Fulfillment of the 2019 ACR/EULAR classification criteria as determined by the Eligibility Committee.
- •5.Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of GC treatment at the time of informed consent
- •6.IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD with documentation to confirm.
- •7.Willing and able to comply with the protocol, complete study assessments, and complete the study period.
- •8.Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide 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 must have a negative serum pregnancy test at screening. Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception from signing informed consent and must agree to continue using such precautions through the end of the follow-up of the study and at least 180 days after the last dose of IP; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. A recommendation will be made that the female partners (of childbearing potential) of male study participants should use a highly effective method of contraception other than a barrier method.
- •Females of childbearing potential are defined as those who are not surgically sterile (ie, surgical sterilization includes bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or those who are not postmenopausal (defined as 12 months with no menses without an alternative medical cause and a follicle-stimulating hormone within the postmenopausal range as established by the clinical laboratory).
- •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
排除标准
- •1.Severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric
- •2.History of solid organ or cell-based transplantation.
- •3.Known immunodeficiency disorder.
- •4.Active malignancy or history of malignancy that was active within the last 10 years, with exceptions (please see the protocol)
- •5.Receipt of any biologic B cell-depleting therapy in the 6 months prior to screening.
- •6.Receipt of non-depleting B-cell-directed therapy (eg, belimumab), abatacept, or other biologic immunomodulatory agent within 6 months prior screening.
- •7.Receipt of non-biologic DMARD or immunosuppressive agent other than GCs (eg, azathioprine, mycophenolate mofetil, methotrexate, others) within 4 weeks prior to screening.
- •8.Receipt of any investigational agent < 12 weeks or < 5 half-lives of the drug (whichever is longer) prior to screening.
- •9.Inability to be tapered off of GC therapy by 8 weeks post-randomization, in the opinion of the Investigator.
- •10.Receipt of live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening.
- •11.Pregnancy, lactation, or planning to become pregnant within 6 months of the last dose of IP.
- •12.Positive test for, or prior treatment for, hepatitis B or HIV infection.
- •13.History of untreated hepatitis C infection, or positive antibody test for hepatitis C virus (HCV)
- •14.Evidence of active tuberculosis (TB) or being at high risk for TB
- •15.History of > 1 episode of herpes zoster (any grade) and/or any other definite or probable opportunistic infection in the 12 months prior to screening
- •16.Known history of allergy or reaction to any component of inebilizumab formulation or history of anaphylaxis to any human gamma globulin therapy.
- •17.Allergy to or intolerance of protocol-required treatment, including medications for prophylaxis of infusion reactions
- •18.Estimated glomerular filtration rate < 30 mL/min/1.73 m2 by Modification of Diet in Renal Disease Study (MDRD) equation (NIDDK).
- •19.Blood tests at screening that meet any of the criteria reported in the protocol
- •20.Subjects with the abnormal liver function tests in the absence of hepatobiliary IgG4-RD activity:
- •Subjects with the abnormal liver function tests in the presence of hepatobiliary IgG4-RD activity:
- •21.Anti-neutrophil cytoplasmic antibodies (ANCA) targeted against proteinase 3 or myeloperoxidase at the central laboratory.
- •22.History of alcohol or drug abuse that, in the opinion of the Investigator, might affect patient safety or compliance with visits or interfere with safety or other study assessments.
- •23.Active, clinically significant infection at the time of randomization (IP administration may be delayed until recovery, if within screening window, otherwise subject may be rescreened).
- •24.Participation in any clinical trial that includes use of any pharmacologic intervention.
研究者
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