A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in participants With Antineutrophil Cytoplasmic Antibody (ANCA)-associated Vasculitis

Antineutrophil cytoplasmic antibody-associated vasculitis (AAV)

Evaluation of the overall safety of avacopan, based on reported treatment-emergent adverse events (AEs), AEs of special interest, SAEs, AEs leading to withdrawal, deaths, and changes from baseline vital signs, hematology, serum chemistry, and urinalysis., AEs of special interest include: • Hepatic events and drug-induced liver injury (DILI) • Serious hypersensitivity reactions • Serious infections, Other safety endpoints include: • Infections, based on reported AEs • Creatinine phosphokinase (CPK) increases, based on reported AEs and measured CPK levels • General safety topics including malignancy and major cardiovascular events

Time to relapse in AAV between month 12 and month 60 among participants who achieved remission at month 12, in group A compared with group B, • Proportion of participants who relapse after achieving remission at month 12 in group A compared with group B • Proportion of participants who achieved sustained remission at month 60 in group A compared with group C, • Change from baseline to month 60 in: - eGFR of participants with overt renal disease at baseline in group A compared with group C - SF-36 v2 General Health Perception score in group A compared with group C - EQ 5D-5L visual analogue scale in group A compared with group C - Vasculitis damage index (VDI) in group A compared with group C • Proportion of participants who achieved remission at month 6 in groups A + B compared with group C, • Proportion of participants with composite outcome of initiation of maintenance dialysis, kidney transplantation, or death in group A compared with group C from baseline to month 60 • Glucocorticoid use • Immunosuppressant use

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