IXchange

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  256539

• Contact name

  David Jayne

• Contact email

  dj106@cam.ac.uk

• Sponsor organisation

  Inflarx

• Eudract number

  2018-000768-27

• Duration of Study in the UK

  1 years, 10 months, 28 days

• Research summary

  Summary of Research
  The purpose of this clinical research study is to investigate the study drug IFX-1 in people with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), which includes granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).

  AAV is a group of diseases responsible for the destruction and inflammation of small blood vessels caused by the accumulation of one type of white blood cells (the neutrophils). These diseases cause fatigue, fever, weight loss, joint pain, nose inflammation, cough and difficulty of breathing, urinary abnormalities, defective function of the kidney, skin lesions, and neurologic dysfunction. AAV are very severe diseases that can progress quickly and affect important organs if they are not treated. The goal of treatment is to stop the inflammation and prevent further damage to the organs.

  The medications chosen to treat GPA and MPA depend on the severity of the disease, organ systems that are involved, and the clinical situation. For serious cases, the standard treatment used to induce remission is a combination of anti-inflammatory drugs and immunosuppressive therapies. However, the efficacy of these treatments is not optimal, and they also have side effects that may be serious.

  The purpose of this study is to determine whether the treatment with IFX-1 in serious cases is effective and safe.

  Summay of Results
  No separate summary fo results provided. Please refer for study results as published on Clinicaltrial.gov and EudraCT

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  19/EE/0014

• Date of REC Opinion

  17 Apr 2019

• REC opinion

  Further Information Favourable Opinion