At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 57 enrolled
Drug / intervention
IFX-1 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating IFX-1, Placebo-IFX-1, and 2 other interventions for Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA). Completed, enrolled 57 participants across 76 sites in 11 countries.
Detailed Summary
The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in subjects with polyangiitis (GPA) or microscopic polyangiitis (MPA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Czechia, France, Germany, Italy, Netherlands, Russia, Spain, Sweden, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 2019
Enrollment StartApr 2019
Primary CompletionApr 2021
Study CompletionJun 2021
TodayJul 2026
First PostedMar 29, 2019
Enrollment StartApr 3, 2019
Primary CompletionApr 14, 2021
Study CompletionJun 8, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.3 years ago
Interventions
IFX-1drug
intravenously administered
Placebo-IFX-1drug
intravenously administered
Glucocorticoid (GC)drug
orally administered
Placebo-Glucocorticoid (Placebo-GC)drug
orally administered