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1月11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
•2.Require mechanical ventilation because of alveolar hemorrhage at
•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
•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 prednisoneequivalent
•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.
另有 10 项未显示

研究者

发起方

InflaRx GmbH

相似试验

进行中（未招募）

1 期

Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)MedDRA version: 21.1Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 21.1Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disorders

EUCTR2018-000768-27-DEInflaRx GmbH55

进行中（未招募）

1 期

EUCTR2018-000768-27-SEInflaRx GmbH55

进行中（未招募）

1 期

Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.

EUCTR2018-000768-27-GBInflaRx GmbH81

进行中（未招募）

1 期

EUCTR2018-000768-27-NLInflaRx GmbH55

进行中（未招募）

1 期

EUCTR2018-000768-27-IEInflaRx GmbH57