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Monoclonal Antibodies

Group A: Avacopan + Standard of Care (SoC) 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12 to month 60

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12 to month 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12 to month 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 to month 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

+6 more

Secondary outcome measures

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

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

+8 more

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

Avacopan

2018

Completed Phase 3

~940

Placebo

1995

Completed Phase 3

~2670

Standard of Care

2017

Completed Phase 4

~4420

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,371 Previous Clinical Trials

1,377,918 Total Patients Enrolled

6 Trials studying Vasculitis

202 Patients Enrolled for Vasculitis

MDStudy DirectorAmgen

915 Previous Clinical Trials

924,430 Total Patients Enrolled

7 Trials studying Vasculitis

533 Patients Enrolled for Vasculitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current total number of participants being recruited for this clinical study?

"Affirmative. Details on clinicaltrials.gov specify that this trial is actively in search of potential participants. Originally shared on February 7, 2024, with the most recent update noted on February 23, 2024, the investigation aims to enroll a total of 300 individuals from 13 distinct locations."

Answered by AI

At how many sites is this particular research study currently being conducted?

"Recruitment for this clinical research trial is ongoing at various sites, including prestigious institutions like Mayo Clinic in Rochester, Stat Research in Miamisburg, and Virginia Mason Medical Center in Seattle. Additionally, 13 more locations are participating in patient recruitment efforts."

Answered by AI

Is the current investigation open for participant enrollment?

"According to the information available on clinicaltrials.gov, this research project is currently in the process of seeking eligible candidates. The initial posting date for this study was recorded as February 7th, 2024, with the most recent update noted on February 23rd, 2024."

Answered by AI

Are individuals older than 50 years being enrolled in this research study?

"Eligible participants for this research must be aged between 18 and 100 years. There are designated trials for individuals under 18 and over 65, with a total of 6 trials for the former and 34 for the latter age group."

Answered by AI

Has Group A, consisting of Avacopan and Standard of Care (SoC), been officially endorsed by the FDA?

"On a grading scale of 1 to 3, our experts at Power have rated the safety level of Group A: Avacopan + Standard of Care (SoC) as a perfect 3. This high rating is due to this trial being classified under Phase 4, indicating that the treatment has already obtained official approval for use."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06072482.