A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA)

InflaRx GmbH0 个研究点目标入组 55 人开始时间: 2018年12月19日最近更新: 2021年7月5日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: InflaRx GmbH
入组人数: 55

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 or female, = 18 years of age.
•2. Written informed consent obtained from subject.
•3. Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus Conference (CHCC).
•4.History of positive antigen-specific ANCA testing since the time of diagnosis or at screening, or documented evidence of either anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) (for newly diagnosed subjects a recent positive antigen-specific ANCA testing is mandatory for inclusion)
•5. Have = 1 major” item, or = 3 other items, or = 2 renal items on the Birmingham Vasculitis Activity Score Version 3 (BVASv3).
•6. Newly diagnosed or relapsed GPA or MPA that requires treatment with CYC or RTX plus GCs.
•7. Estimated glomerular filtration rate (eGFR) = 20 mL/min/1.73 m².
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

排除标准

•Subjects who fulfil any of the following criteria at screening are not eligible to participate in the study:
•1.Any other multi-system autoimmune disease as listed in Appendix 18.4.
•2.Require mechanical ventilation because of alveolar hemorrhage at screening.
•3.Known hypersensitivity to any investigational medicinal product (IMP) (i.e. GC, IFX-1) and/or any excipients.
•4.Subject with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
•5.Have required management of infections, as follows:
•a.Chronic infection requiring anti-infective therapy (such as latent tuberculosis, pneumocystis, aspergillosis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria) within 3 months before screening.
•b.Use of intravenous antibacterials, antivirals, anti-fungals, or anti parasitic agents within 30 days of screening.
•6.Current and/or history (within the previous 5 years) of drug and/or alcohol abuse and/or dependence.
•7.Evidence of Hep B, C and/ or HIV infection. Only subjects with documented negative historical results (within 4 weeks before screening) for Hep B, C Virus and HIV or a negative test by Screening can be included into the study.
•8.Any of the following abnormal laboratory findings at screening:
•a.White blood cells < 3,500/mm3
•b.Platelet count < 100,000/mm3
•c.Transaminase values (AST and/or ALT) = 2.5 times the upper limit of normal range (ULN)
•d.Total bilirubin = 1.5 times ULN
•e.Alkaline Phosphatase (ALP) > 3 times ULN
•9.Current or history of malignancy, lymphoproliferative, or myeloproliferative disorder except squamous cell or basal cell carcinomas of the skin and cervical carcinoma in situ with curative surgical treatment.
•10.Received CYC or RTX within 12 weeks before screening or within 12 weeks before CYC or RTX is started for remission induction within 2 weeks before screening.; If subject is on AZA, MMF or MPS or MTX, these drugs must be discontinued prior to receiving the first dose of CYC or RTX.
•11.Received > 3 g cumulative intravenous GCs within 4 weeks before screening (RTX intravenous GC premedication is separate and does not count to the 3 g).
•12.a.Received an oral daily dose of a GC of > 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening.
•b.Received an oral daily dose of a GC of > 80 mg prednisone equivalent within 2 weeks before screening.
•13.Received a CD20 inhibitor, anti-tumor necrosis factor treatment, abatacept, alemtuzumab, any other experimental or biological therapy, intravenous immunoglobulin or plasma exchange, antithymocyte globulin, or required renal dialysis within 12 weeks before screening.
•14.Received a live vaccination within 4 weeks before screening or planned between screening and Week 2774.
•15.Either active or latent tuberculosis treatment is ongoing.
•16.Pregnant or lactating.
•17.Clinically significant abnormal electrocardiogram (ECG) during screening.
•18.Female subjects of childbearing potential unwilling or unable to use a highly effective method of contraception (pearl index < 1) during treatment and for at least 3 months after last administration of IFX-1/Placebo-IFX-1 (or up to 12 months, the timeframes for Standard of Care agents have to be considered as described in the respective Prescribing Information/SPCstimeframes). Contraception methods regarded as highly effective methods and the duration of contraception are further described in Section 7.7.
•19.Evidence or suspicion that the s

研究者

发起方

InflaRx GmbH

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