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Monoclonal Antibodies
Avacopan for Vasculitis
Phase 4
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newly diagnosed or relapse of granulomatosis with polyangiitis or microscopic polyangiitis, consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013), where treatment with cyclophosphamide or rituximab is needed
Positive test for anti-positive antiproteinase 3 or antimyeloperoxidase (current or historic) antibodies
Must not have
Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study
Any other known multisystem autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg-Strauss), systemic lupus erythematosus, immunoglobulin A vasculitis (Henoch-Schönlein), rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
"This trial aims to assess the safety of avacopan over a long period in individuals with a certain type of vasculitis called ANCA-associated vasculitis."
Who is the study for?
This trial is for adults over 18 with a new or returning diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis, needing cyclophosphamide or rituximab treatment. They must have tested positive for ANCA antibodies and show significant symptoms of vasculitis. Participants need at least minimal kidney function to join.
What is being tested?
The study aims to assess the long-term safety of avacopan in treating ANCA-associated vasculitis. It involves comparing avacopan against a placebo, alongside standard treatments like cyclophosphamide or rituximab, which are already used for this condition.
What are the potential side effects?
While specific side effects aren't listed here, generally such medications can cause immune system suppression leading to increased infection risk, potential kidney issues, nausea, vomiting, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a new or returning diagnosis of GPA or MPA and need specific treatment.
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I have tested positive for specific antibodies related to my condition.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need a machine to help me breathe due to bleeding in my lungs.
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I have a diagnosed autoimmune disease.
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I am not on long-term immunosuppressive drugs that could affect the study.
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I have had a kidney transplant.
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I do not have active hepatitis B, hepatitis C, or HIV.
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I have a serious liver condition, such as cirrhosis.
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I have not had any infections needing antibiotics in the last 4 weeks.
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I haven't taken cyclophosphamide in the last 12 weeks and can stop taking azathioprine, mycophenolate, or methotrexate if needed.
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I have been on more than 10 mg of a steroid medication daily for over 6 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group B: Avacopan/Placebo + SoCExperimental Treatment3 Interventions
Avacopan 30 mg twice daily for 1 year, followed by placebo twice daily for 4 years + SoC background immunosuppressive therapy.
Group II: Group A: Avacopan + Standard of Care (SoC)Experimental Treatment2 Interventions
Avacopan 30 mg twice daily for 5 years + SoC background immunosuppressive therapy.
Group III: Group C: Placebo + SoCPlacebo Group2 Interventions
Placebo twice daily for 5 years + SoC background immunosuppressive therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Avacopan
2018
Completed Phase 3
~950
Standard of Care
2017
Completed Phase 4
~4420
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,466 Previous Clinical Trials
1,401,139 Total Patients Enrolled
6 Trials studying Vasculitis
202 Patients Enrolled for Vasculitis
MDStudy DirectorAmgen
1,003 Previous Clinical Trials
944,940 Total Patients Enrolled
7 Trials studying Vasculitis
533 Patients Enrolled for Vasculitis