The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Administered orally.
Administered orally.
All participants will receive SoC background immunosuppressive therapy for induction and maintenance, at the discretion of the Investigator and as supported by current guidelines, product labels and local practices and informed by the individual participant's clinical condition, preferences, and values.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Month 60
Percentage of Participants Experiencing Adverse Events of Special Interest
Time frame: Up to Month 60
Percentage of Participants Experiencing Serious Adverse Events
Time frame: Up to Month 60
Percentage of Participants Experiencing Adverse Events Leading to Withdrawal
Time frame: Up to Month 60
Percentage of Participants Experiencing Adverse Events Leading to Death
Time frame: Up to Month 60
Number of Participants Experiencing Clinical Significant Changes from Baseline in Vital Signs Measurements
Time frame: Up to Month 60
Number of Participants Experiencing Clinical Significant Changes from Baseline in Hematology Assessments
Time frame: Up to Month 60
Number of Participants Experiencing Clinical Significant Changes from Baseline in Serum Chemistry Assessments
Time frame: Up to Month 60
Number of Participants Experiencing Clinical Significant Changes from Baseline in Urinalysis Assessments
Time frame: Up to Month 60
Group A and B Participants who Achieved Remission at Month 12: Time to Relapse in AAV Between Month 12 and Month 60
Time frame: Month 12 to Month 60
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Orthopedic Physicians Alaska
Anchorage, Alaska, United States
TERMINATEDScottsdale Healthcare at Shea - HonorHealth
Scottsdale, Arizona, United States
RECRUITINGSouthwest Kidney Institute
Surprise, Arizona, United States
RECRUITINGMedvin Clinical Research
Covina, California, United States
RECRUITINGPalo Alto Medical Foundation Fremont
Fremont, California, United States
RECRUITINGThe Nephrology Group
Fresno, California, United States
RECRUITINGProvidence Medical Foundation
Fullerton, California, United States
RECRUITINGMedvin Clinical Research
Menifee, California, United States
RECRUITINGUniversity of California San Francisco- Zuckerburg San Francisco General
San Francisco, California, United States
RECRUITINGHarbor University of California at Los Angeles Medical Center
Torrance, California, United States
RECRUITING...and 58 more locations
Group A and B Participants who Achieved Remission at Month 12: Percentage of Participants who Relapse After Achieving Remission at Month 12
Time frame: Month 12 to Month 60
Groups A and C: Percentage of Participants who Achieved Sustained Remission at Month 60
Time frame: Month 60
Group A and C Participants with Overt Renal Disease at Baseline: Change from Baseline to Month 60 in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline and Month 60
Groups A and C: Change from Baseline to Month 60 in Short Form 36 Health Survey Version 2 (SF-36 v2) General Health Perception Score
Time frame: Baseline and Month 60
Groups A and C: Change from Baseline to Month 60 in EuroQoL-5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS)
Time frame: Baseline and Month 60
Percentage of Participants who Achieved Remission at Month 6
Time frame: Month 6
Groups A and C: Change from Baseline to Month 60 in Vasculitis Damage Index (VDI)
Time frame: Baseline and Month 60
Groups A and C: Percentage of Participants with Composite Outcome of Initiation of Maintenance Dialysis, Kidney Transplantation, or Death
Time frame: Up to Month 60
Percentage of Participants With Glucocorticoid Use
Time frame: Up to Month 60
Percentage of Participants With Immunosuppressant Use
Time frame: Up to Month 60