Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.

NCT03895801 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IFX-1-P2.5
• Study Type: interventional
• Target: 57
• Locations: 11 countries
• Sites: 76

Brief Summary

The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in subjects with polyangiitis (GPA) or microscopic polyangiitis (MPA).

Conditions

Granulomatosis With Polyangiitis (GPA); Microscopic Polyangiitis (MPA)

Keywords

granulomatosis; polyangiitis; corticosteroid; replacement; glucocorticoid

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Achieving Clinical Response

  Efficacy Endpoint: Percentage of subjects achieving clinical response (reduction in Birmingham Vasculitis Activity Score version 3 \[BVASv3\] of ≥50% compared to baseline and no worsening in any body system). Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity.

  Baseline, Week 16

Secondary Outcomes (11)

• Percentage of Subjects With Clinical Remission

  Week 16

• Change From Baseline in BVASv3 Total Score

  Baseline, Week 16

• Vasculitis Damage Index (VDI)

  Week 16

• Physician Global Assessment (PGA)

  Week 16

• Estimated Glomerular Filtration Rate

  Week 16

Study Arms (3)

Group A Experimental + active comparator

EXPERIMENTAL

IFX-1 + reduced dose GC

Drug: IFX-1; Drug: Glucocorticoid (GC)

Group B Placebo + active comparator

ACTIVE COMPARATOR

Placebo-IFX-1 + standard dose GC

Drug: Placebo-IFX-1; Drug: Glucocorticoid (GC)

Group C Experimental + placebo comparator

PLACEBO COMPARATOR

IFX-1 + Placebo-GC

Drug: IFX-1; Drug: Placebo-Glucocorticoid (Placebo-GC)

Interventions

IFX-1 DRUG

intravenously administered

Also known as: CaCP29

Group A Experimental + active comparator; Group C Experimental + placebo comparator

Placebo-IFX-1 DRUG

intravenously administered

Also known as: Placebo

Group B Placebo + active comparator

Glucocorticoid (GC) DRUG

orally administered

Also known as: Prednisone

Group A Experimental + active comparator; Group B Placebo + active comparator

Placebo-Glucocorticoid (Placebo-GC) DRUG

orally administered

Also known as: Placebo

Group C Experimental + placebo comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
• 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.

You may not qualify if:

• Any other multi-system autoimmune disease.
• 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

Sponsors & Collaborators

• InflaRx GmbH: lead

Study Sites (76)

Clinical Site

Leuven, Belgium

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Liège, Belgium

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Hradec Králové, Czechia

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Prague, 128 08, Czechia

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Prague, 140 21, Czechia

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Prague, 150 06, Czechia

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Angers, France

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Brest, France

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Créteil, France

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Grenoble, France

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Lille, France

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Montpellier, France

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Paris, 75012, France

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Paris, 75651, France

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Paris, 75679, France

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Pessac, France

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Poitiers, France

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Jena, Thuringia, Germany

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Aachen, Germany

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Berlin, Germany

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Cologne, Germany

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Dresden, Germany

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Essen, Germany

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Freiburg im Breisgau, Germany

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Hanover, Germany

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Kirchheim unter Teck, Germany

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Leipzig, Germany

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Ludwigshafen, Germany

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Mannheim, Germany

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Münster, Germany

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Stuttgart, Germany

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Catania, Italy

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Lecco, Italy

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Messina, Italy

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Milan, 20132, Italy

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Milan, 20153, Italy

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Monza, Italy

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Pavia, Italy

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Pisa, Italy

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Verona, Italy

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Maastricht, Netherlands

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Rotterdam, Netherlands

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Kemerovo, Russia

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Moscow, 119991, Russia

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Moscow, 121374, Russia

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Moscow, 129110, Russia

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Orenburg, Russia

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Petrozavodsk, Russia

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Saratov, 410039, Russia

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Saratov, 410053, Russia

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Yaroslavl, Russia

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Alcorcón, Spain

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Badalona, Spain

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Barcelona, 08025, Spain

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Barcelona, 08036, Spain

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Barcelona, Spain

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Fuenlabrada, Spain

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L'Hospitalet de Llobregat, Spain

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Seville, 41010, Spain

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Seville, 41013, Spain

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Seville, 41014, Spain

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Gothenburg, Sweden

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Stockholm, Sweden

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Uppsala, Sweden

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Sankt Gallen, Switzerland

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Zurich, Switzerland

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Aberdeen, United Kingdom

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Cambridge, United Kingdom

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Cardiff, United Kingdom

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Leicester, United Kingdom

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London, NW3 2QG, United Kingdom

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London, SE1 9RT, United Kingdom

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Portsmouth, United Kingdom

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Preston, United Kingdom

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Reading, United Kingdom

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Sheffield, United Kingdom

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MeSH Terms

Conditions

Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Systemic Vasculitis

Interventions

vilobelimab; Glucocorticoids; Prednisone

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Prof. Niels C. Riedemann
• Organization: InflaRx GmbH

niels.Riedemann@inflarx.de

+49 3641-508-180

Study Officials

• Anja Pfaff, PhD

  InflaRx GmbH

  STUDY DIRECTOR

• Peter A. Merkel, MD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 29, 2019
• Study Start: April 3, 2019
• Primary Completion: April 14, 2021
• Study Completion: June 8, 2021
• Last Updated: August 25, 2022
• Results First Posted: August 25, 2022

Record last verified: 2022-08

Locations

CH (2); FR (11); GB (10); CZ (4); RU (9); DE (14); ES (10); NL (2); SE (3); BE (2); IT (9)