Recruiting
Sponsor ID
20220159

A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis

Sponsor ID
20220159
Clinicaltrials.gov ID
NCT06072482
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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).

Additional Study Details

Phase
Phase 4
Product
AMG 569
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
300
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to Month 60

Percentage of Participants Experiencing Adverse Events of Special Interest

Timeframe: Up to Month 60

Percentage of Participants Experiencing Serious Adverse Events

Timeframe: Up to Month 60

Percentage of Participants Experiencing Adverse Events Leading to Withdrawal

Timeframe: Up to Month 60

Percentage of Participants Experiencing Adverse Events Leading to Death

Timeframe: Up to Month 60

Number of Participants Experiencing Clinical Significant Changes from Baseline in Vital Signs Measurements

Timeframe: Up to Month 60

Number of Participants Experiencing Clinical Significant Changes from Baseline in Hematology Assessments

Timeframe: Up to Month 60

Number of Participants Experiencing Clinical Significant Changes from Baseline in Serum Chemistry Assessments

Timeframe: Up to Month 60

Number of Participants Experiencing Clinical Significant Changes from Baseline in Urinalysis Assessments

Timeframe: Up to Month 60

Secondary Outcome Measures

Group A and B Participants who Achieved Remission at Month 12: Time to Relapse in AAV Between Month 12 and Month 60

Timeframe: Month 12 to Month 60

Group A and B Participants who Achieved Remission at Month 12: Percentage of Participants who Relapse After Achieving Remission at Month 12

Timeframe: Month 12 to Month 60

Groups A and C: Percentage of Participants who Achieved Sustained Remission at Month 60

Timeframe: 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)

Timeframe: 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

Timeframe: 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)

Timeframe: Baseline and Month 60

Percentage of Participants who Achieved Remission at Month 6

Timeframe: Month 6

Groups A and C: Change from Baseline to Month 60 in Vasculitis Damage Index (VDI)

Timeframe: Baseline and Month 60

Groups A and C: Percentage of Participants with Composite Outcome of Initiation of Maintenance Dialysis, Kidney Transplantation, or Death

Timeframe: Up to Month 60

Percentage of Participants With Glucocorticoid Use

Timeframe: Up to Month 60

Percentage of Participants With Immunosuppressant Use

Timeframe: Up to Month 60

Locations

Location
Status
Contact Us
Location
Brookview Hills Research Associates Llc
Winston-Salem, NC, United States, 27103
Status
Recruiting
Location
East Carolina University Brody Outpatient Center
Greenville, NC, United States, 27834
Status
Recruiting
Location
Mayo Clinic
Rochester, MN, United States, 55905
Status
Recruiting
Location
Virginia Mason Medical Center
Seattle, WA, United States, 98101
Status
Terminated
Location
Stat Research
Miamisburg, OH, United States, 45342
Status
Recruiting
Location
Southwest Kidney Institute
Surprise, AZ, United States, 85374
Status
Recruiting
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