Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.
NCT ID: NCT03895801
Last Updated: 2022-08-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2019-04-03
2021-06-08
Brief Summary
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Detailed Description
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In this Phase II study of 20 to 55 subjects with granulomatosis with GPA and MPA, IFX-1 will be administered in combination with reduced dose glucocorticoids or a placebo glucocorticoid compared with standard dose glucocorticoids.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A Experimental + active comparator
IFX-1 + reduced dose GC
IFX-1
intravenously administered
Glucocorticoid (GC)
orally administered
Group B Placebo + active comparator
Placebo-IFX-1 + standard dose GC
Placebo-IFX-1
intravenously administered
Glucocorticoid (GC)
orally administered
Group C Experimental + placebo comparator
IFX-1 + Placebo-GC
IFX-1
intravenously administered
Placebo-Glucocorticoid (Placebo-GC)
orally administered
Interventions
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IFX-1
intravenously administered
Placebo-IFX-1
intravenously administered
Glucocorticoid (GC)
orally administered
Placebo-Glucocorticoid (Placebo-GC)
orally administered
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have ≥ 1 "major" item, or ≥ 3 other items, or ≥ 2 renal items on the Birmingham Vasculitis Activity Score Version 3 (BVASv3).
* Newly diagnosed or relapsed GPA or MPA that requires treatment with Cyclophosphamide (CYC) or Rituximab (RTX) plus GCs.
* Glomerular filtration rate ≥ 20 mL/min/1.73 m².
Exclusion Criteria
* Require mechanical ventilation at screening.
* Known hypersensitivity to any investigational medicinal product and/or any excipient.
* Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
* Have required management of infections, as follows (a) Chronic infection requiring anti-infective therapy within 3 months before screening. (b) Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 30 days of screening
* Current and/or history (within the previous 5 years) of drug and/or alcohol abuse and/or dependence.
* 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.
* Abnormal laboratory findings at screening
* Current or history of malignancy, lymphoproliferative, or myeloproliferative disorder
* 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.
* Received \> 3 g cumulative intravenous GCs within 4 weeks before screening.
* Received an oral daily dose of a GC of \> 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening.
* Received an oral daily dose of a GC of \> 80 mg prednisone equivalent within 2 weeks before screening.
* Received a CD20 inhibitor, anti-tumor necrosis factor treatment, abatacept, alemtuzumab, any other experimental or biological therapy, intravenous immunoglobulin (Ig) or plasma exchange, antithymocyte globulin, or required renal dialysis within 12 weeks before screening.
* Received a live vaccination within 4 weeks before screening
* Either active or latent tuberculosis treatment is ongoing.
* Pregnant or lactating.
* Abnormal electrocardiogram.
* Female subjects of childbearing potential unwilling or unable to use a highly effective method of contraception
* Participation in an investigational clinical study during the 12 weeks before screening.
* Male subjects with female partners of childbearing potential unwilling to use contraception
18 Years
ALL
No
Sponsors
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InflaRx GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Anja Pfaff, PhD
Role: STUDY_DIRECTOR
InflaRx GmbH
Peter A. Merkel, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Clinical Site
Leuven, , Belgium
Clinical Site
Liège, , Belgium
Clinical Site
Hradec Králové, , Czechia
Clinical Site
Prague, , Czechia
Clinical Site
Prague, , Czechia
Clinical Site
Prague, , Czechia
Clinical Site
Angers, , France
Clinical Site
Brest, , France
Clinical Site
Créteil, , France
Clinical Site
Grenoble, , France
Clinical Site
Lille, , France
Clinical Site
Montpellier, , France
Clinical Site
Paris, , France
Clinical Site
Paris, , France
Clinical Site
Paris, , France
Clinical Site
Pessac, , France
Clinical Site
Poitiers, , France
Clinical Site
Jena, Thuringia, Germany
Clinical Site
Aachen, , Germany
Clinical Site
Berlin, , Germany
Clinical Site
Cologne, , Germany
Clinical Site
Dresden, , Germany
Clinical Site
Essen, , Germany
Clinical Site
Freiburg im Breisgau, , Germany
Clinical Site
Hanover, , Germany
Clinical Site
Kirchheim unter Teck, , Germany
Clinical Site
Leipzig, , Germany
Clinical Site
Ludwigshafen, , Germany
Clinical Site
Mannheim, , Germany
Clinical Site
Münster, , Germany
Clinical Site
Stuttgart, , Germany
Clinical Site
Catania, , Italy
Clinical Site
Lecco, , Italy
Clinical Site
Messina, , Italy
Clinical Site
Milan, , Italy
Clinical Site
Milan, , Italy
Clinical Site
Monza, , Italy
Clinical Site
Pavia, , Italy
Clinical Site
Pisa, , Italy
Clinical Site
Verona, , Italy
Clinical Site
Maastricht, , Netherlands
Clinical Site
Rotterdam, , Netherlands
Clinical Site
Kemerovo, , Russia
Clinical Site
Moscow, , Russia
Clinical site
Moscow, , Russia
Clinical site
Moscow, , Russia
Clinical Site
Orenburg, , Russia
Clinical Site
Petrozavodsk, , Russia
Clinical site
Saratov, , Russia
Clinical Site
Saratov, , Russia
Clinical Site
Yaroslavl, , Russia
Clinical Site
Alcorcón, , Spain
Clinical Site
Badalona, , Spain
Clinical Site
Barcelona, , Spain
Clinical site
Barcelona, , Spain
Clinical Site
Barcelona, , Spain
Clinical Site
Fuenlabrada, , Spain
Clinical Site
L'Hospitalet de Llobregat, , Spain
Clinical Site
Seville, , Spain
Clinical Site
Seville, , Spain
Clinical Site
Seville, , Spain
Clinical Site
Gothenburg, , Sweden
Clinical Site
Stockholm, , Sweden
Clinical Site
Uppsala, , Sweden
Clinical Site
Sankt Gallen, , Switzerland
Clinical Site
Zurich, , Switzerland
Clinical Site
Aberdeen, , United Kingdom
Clinical Site
Cambridge, , United Kingdom
Clinical Site
Cardiff, , United Kingdom
Clinical Site
Leicester, , United Kingdom
Clinical Site
London, , United Kingdom
Clinical Site
London, , United Kingdom
Clinical Site
Portsmouth, , United Kingdom
Clinical Site
Preston, , United Kingdom
Clinical Site
Reading, , United Kingdom
Clinical Site
Sheffield, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IFX-1-P2.5
Identifier Type: -
Identifier Source: org_study_id
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