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Clinical Trials/NL-OMON55826
NL-OMON55826CompletedPhase 2

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) - IFX-1-P2.5 IXchange

InflaRx GmbH0 sites20 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
20
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •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 antiproteinase
  • •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.

Exclusion Criteria

  • •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
  • •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 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.
  • •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
  • +3 more not shown

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