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

• Status: Completed
• Trial end date: 2021-06-08
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InflaRx GmbH
• Collaborator: IQVIA
• Treatments: Glucocorticoids; Prednisone; Vilobelimab

Criteria

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