Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03895801 | Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis. | PHASE2 | COMPLETED | 57 | — | — | Apr 3, 2019 | Jun 8, 2021 | Aug 25, 2022 | 76 | Belgium, Czechia +9 |
Efficacy Endpoint: Percentage of subjects achieving clinical response (reduction in Birmingham Vasculitis Activity Score version 3 \[BVASv3\] of ≥50% compared to baseline and no worsening in any body system). Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity.
| Arm | Type | Description |
|---|---|---|
| Group A Experimental + active comparator | EXPERIMENTAL | IFX-1 + reduced dose GC |
| Group B Placebo + active comparator | ACTIVE_COMPARATOR | Placebo-IFX-1 + standard dose GC |
| Group C Experimental + placebo comparator | PLACEBO_COMPARATOR | IFX-1 + Placebo-GC |
| Name | Type | Description |
|---|---|---|
| IFX-1 | DRUG | intravenously administered |
| Placebo-IFX-1 | DRUG | intravenously administered |
| Glucocorticoid (GC) | DRUG | orally administered |
| Placebo-Glucocorticoid (Placebo-GC) | DRUG | orally administered |
Inclusion Criteria: * Diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (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 treatmen...