Overview

Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

Status:
Completed
Trial end date:
2021-05-03
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to investigate the safety and tolerability of two dose regimens of IFX-1 as add-on to standard of care (SOC) in subjects with GPA and MPA compared with placebo.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
InflaRx GmbH
Collaborators:
IQVIA
Iqvia Pty Ltd
Treatments:
Vilobelimab
Criteria
Inclusion Criteria:

1. Male or female, ≥18 years of age.

2. Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus
Conference.

3. Have at least one "major" item, or at least three other items, or at least two renal
items on the Birmingham Vasculitis Activity Score (BVAS) Version 3.0.

4. New or relapsed GPA or MPA that require treatment with CYC or RTX plus GCs.

Exclusion Criteria:

1. Any other multisystem autoimmune disease

2. Requires mechanical ventilation because of alveolar hemorrhage at Screening.

3. Human immunodeficiency virus, hepatitis B, or hepatitis C viral screening test showing
evidence of active or chronic viral infection at Screening or a documented history of
the human immunodeficiency virus, hepatitis B, or hepatitis C.

4. Received CYC or RTX 12 weeks before Screening; if on azathioprine (AZA), methotrexate
(MTX), mycophenolate mofetil (MMF), or mycophenolate sodium (MPS) at the time of
Screening, these drugs must be withdrawn prior to receiving CYC or RTX.

5. Received more than 3 g cumulative high dose intravenous GCs within 4 weeks before
Screening.

6. On an oral dose of a GC of more than 10 mg prednisone equivalent at Screening or for
more than 6 weeks before Screening.

7. Received a CD20 inhibitor, anti-tumor necrosis factor treatment, abatacept,
alemtuzumab, any other experimental or biological therapy, intravenous immunoglobulin
or plasma exchange, antithymocyte globulin, or required dialysis within 12 weeks
before Screening.

8. Received a live vaccination within 4 weeks before Screening or planned between
Screening and Week 24.

9. Female subjects of childbearing potential unwilling or unable to use a highly
effective method of contraception (pearl index <1%) such as complete sexual
abstinence, combined oral contraceptive, vaginal hormone ring, transdermal
contraceptive patch, contraceptive implant, or depot contraceptive injection in
combination with a second method of contraception such as condom, cervical cap, or
diaphragm with spermicide during the study and for at least 4 weeks after last
administration of IFX-1 (timeframes for SOC have to be considered as described in the
respective Prescribing Information).