Wirksamkeits- und Sicherheitsstudie zu einem monoklonalen Antikörper als Ersatztherapie für eine Steroidbehandlung bei Patienten mit Granulomatose mit Polyangiitis (GPA) und mikroskopischer Polyangiitis (MPA)

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

Inclusion Criteria:

- Diagnosis of GPA or 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 CYC or RTX plus
GCs.

- Glomerular filtration rate = 20 mL/min/1.73 m².

Exclusion Criteria:

- 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

- 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