Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA (NCT03712345) | Clinical Trial Compass
TerminatedPhase 2
Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA
Stopped: Due to COVID-19 pandemic outbreak and its impact on overall study activities. All efforts were made to ensure that participants that were enrolled and/or were still in the study will continue to receive treatment and follow-up until study completion.
United States20 participantsStarted 2018-10-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, ≥18 years of age.
✓. Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus Conference.
✓. 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.
✓. New or relapsed GPA or MPA that require treatment with CYC or RTX plus GCs.
Exclusion criteria
✕. Any other multisystem autoimmune disease
✕. Requires mechanical ventilation because of alveolar hemorrhage at Screening.
✕. 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.
✕. 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(MTX), mycophenolate mofetil (MMF), or mycophenolate sodium (MPS) at the time of Screening, these drugs must be withdrawn prior to receiving CYC or RTX.
✕. Received more than 3 g cumulative high dose intravenous GCs within 4 weeks before Screening.
✕. On an oral dose of a GC of more than 10 mg prednisone equivalent at Screening or for more than 6 weeks before Screening.
✕. 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.
What they're measuring
1
Number and Percentage of Participants With at Least One TEAE Per Treatment Group.