Table 2.
Clinical trials with biological agents in ANCA associated vasculitis.
| Drug(s) | Status | Allocation | n | Inclusion criteria | Primary endpoint | Trial no. | Last Update Posted | Public-ation results |
|---|---|---|---|---|---|---|---|---|
| Rituximab | Completed | RCT | 197 | GPA | Disease remission for 6 mos. | NCT00104299 | 4/21/2017 | 13 |
| Rituximab | Completed | RCT | 44 | AAV with renal involvement | Disease remission and rates of relapse at 24 mos. |
ISRCTN28528813 | 3/6/2015 | 65 |
| Abatacept | Terminated | RCT | 7 | AAV | Relapse rate over 24 mos. | NCT00482066 | 3/29/2015 | |
| Abatacept | Recruiting | RCT | 63 | GPA | Reduce the treatment failure rate for 12 mos. |
NCT02108860 | 3/3/2019 | |
| Abatacept | Completed | N/A | 20 | GPA | Adverse events up to 3 yrs + 4 mos. | NCT00468208 | 1/18/2016 | 86 |
| Belimumab | Completed | RCT | 106 | GPA and MPA | Time to first relapse up to 4 yrs | NCT01663623 | 4/17/2018 | 75 |
| Belimumab + Rituximab |
Recruiting | RCT | 30 | AAV with PR3 ANCA positivity | Time to PR3 ANCA negativity | NCT03967925 | 6/9/2020 | |
| Infliximab/ Rituximab |
Completed | N/A | 20 | AAV | Partial or complete remission of the vasculitis |
NCT00307593 | 11/19/2007 | |
| Infliximab | Completed | Non- RCT |
37 | GPA, MPA, and renal limited vasculitis | Disease remission for 52 wks | NCT00753103 | 9/16/2008 | |
| Alemtuzumab | Unknown | RCT | 24 | GPA | Response and a severe adverse event for 6 mos. |
NCT01405807 | 7/29/2011 | |
| Etanercept | Completed | RCT | 180 | GPA | Sustained remissions for 27mos. | NCT00005007 | 12/28/2007 | 79 |
| Avacopan | Completed | RCT | 300 | AAV | Disease remission for 26 wks | NCT02994927 | 6/22/2020 | 97 |
| Avacopan | Completed | RCT | 42 | AAV | Disease remission at 12 wks | NCT02222155 | 11/16/2016 | 95 |
| Avacopan | Completed | RCT | 67 | AAV | Achieving ≥50% reduction in disease activity at 12 wks |
NCT01363388 | 6/27/2020 | 96 |
| Eculizumab | Withdrawn | RCT | 0 | AAV | Change in disease activity as measured at 12 wks |
NCT01275287 | 2/23/2017 | |
| Mepolizumab | Active, not recruiting |
Case Only | 300 | EGPA | Adverse events up to 2 yrs | NCT03557060 | 9/10/2018 | |
| Mepolizumab | Completed | RCT | 136 | EGPA | Each category of accrued duration of remission for 52 wks | NCT02020889 | 1/31/2018 | 15 |
| Mepolizumab | Completed | N/A | 10 | EGPA | Attain remission rate for 52 wks | NCT00716651 | 6/15/2012 | |
| Mepolizumab | Completed | N/A | 10 | EGPA | Adverse events for approx. 44 wks | NCT00527566 | 3/22/2017 | |
| Benralizumab/ Mepolizumab |
Recruiting | RCT | 140 | EGPA | Remission rate at 36 and 48 wks | NCT04157348 | 10/8/2020 |
AAV, ANCA-associated vasculitis; EGPA, eosinophilic granulomatosis with polyangiitis; GPA, granulomatosis with polyangiitis; mos., months; MPA, microscopic polyangiitis; N/A, not available; PR3 ANCA, proteinase 3 antineutrophil cytoplasmic antibody; RCT, randomized controlled trial; wks, weeks; yrs, years.