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New treatment option for Antineutrophil Cytoplasmic Antibody-associated Vasculitis
Official title A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
ClinicalTrials.gov ID: NCT06072482
What this study is testing
What is Avacopan?
Avacopan is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for antineutrophil cytoplasmic antibody-associated vasculitis.
Also referred to as CCX168.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Participants has provided informed consent before initiation of any study-specific activities/procedures.
- Newly diagnosed or relapse of granulomatosis with polyangiitis or microscopic polyangiitis, consistent with Chapel-Hill Consensus Conference...
- Age \>/= 18 years (or \>/= legal age within the country if it is older than 18 years).
- Positive test for anti-positive antiproteinase 3 or antimyeloperoxidase (current or historic) antibodies.
- At least 1 Birmingham Vasculitis Activity Score (BVAS) major item, or at least 3 BVAS nonmajor items, or at least the 2 renal items of proteinuria...
You likely can't join if
- Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study.
- Any other known multisystem autoimmune disease that may confound study assessments and study conclusions including but not limited to eosinophilic...
- Any other medical condition requiring or expected to require continued use of immunosuppressive therapies, including corticosteroids that may cause...
- Received dialysis or plasma exchange within 16 weeks before Day 1 randomization.
- Have had a kidney transplant.
- Malignancy (except curatively treated nonmelanoma skin cancers, curatively treated cervical carcinoma in situ, or breast ductal carcinoma in situ)...
See the full eligibility criteria
- Participants has provided informed consent before initiation of any study-specific activities/procedures.
- Newly diagnosed or relapse of granulomatosis with polyangiitis or microscopic polyangiitis, consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013), where induction treatment with...
- Age \>/= 18 years (or \>/= legal age within the country if it is older than 18 years).
- Positive test for anti-positive antiproteinase 3 or antimyeloperoxidase (current or historic) antibodies.
- At least 1 Birmingham Vasculitis Activity Score (BVAS) major item, or at least 3 BVAS nonmajor items, or at least the 2 renal items of proteinuria and hematuria.
- eGFR \>/= 15 mL/min/1.73 m\^2 (using Chronic Kidney Disease Epidemiology Collaboration equations).
- Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study.
- Any other known multisystem autoimmune disease that may confound study assessments and study conclusions including but not limited to eosinophilic granulomatosis with polyangiitis (GPA [Churg-Strauss]), systemic lupus...
- Any other medical condition requiring or expected to require continued use of immunosuppressive therapies, including corticosteroids that may cause confoundment with study assessments and study conclusions.
- Received dialysis or plasma exchange within 16 weeks before Day 1 randomization.
- Have had a kidney transplant.
- Malignancy (except curatively treated nonmelanoma skin cancers, curatively treated cervical carcinoma in situ, or breast ductal carcinoma in situ) within the last 5 years before Day 1 randomization.
- Acute or chronic, active hepatitis B virus or hepatitis C virus, or human immunodeficiency virus infection during screening.
- Any known exposure to a case of active tuberculosis (TB) within the last 12 weeks before Day 1 randomization.
- Positive test for active or latent TB during screening.
- White blood cell count \< 3500/µL, neutrophil count \< 1500/µL, or lymphocyte count \< 500/µl. Note: Complete Blood Count can be repeated once in the screening period at the investigator discretion. In such instances...
- Evidence of clinically significant hepatic disease including prior diagnosis of cirrhosis.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) \>2.0 times the upper limit of normal (ULN).
- Total bilirubin \> 1.5 times the ULN. Note: A participant with documented Gilbert's syndrome with total bilirubin \< 2 x ULN may be eligible.
- Any of the following within 6 weeks prior to Day 1 randomization: serious infection, infection requiring treatment with intravenous (IV) anti-infective agents, any other infection (including active infection, chronic...
- Any of the following within 12 weeks prior to Day 1 randomization: myocardial infarction, stroke, unstable angina, symptomatic congestive heart failure requiring prescription medication, any other clinically significant...
- Received cyclophosphamide (CYC) within 12 weeks before signing the informed consent; if on azathioprine (AZA), mycophenolate, or methotrexate (MTX) at the time of screening, these drugs must be withdrawn before...
- Have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone equivalent for more than 6 weeks continuously before signing of the informed consent.
- Received RTX or other B-cell depleting therapies within 26 weeks before signing of the informed consent; if on AZA, mycophenolate, or MTX at the time of screening, these drugs must be withdrawn before receiving...
- Received any of the following within 16 weeks before Day 1 randomization:
- antitumor necrosis factor treatment
- abatacept
- alemtuzumab
- IV Ig
- belimumab
- anti interleukin-6 agent (eg, tocilizumab, sarilumab).
- Taking a strong or moderate inducer of the cytochrome P450 3A4 (CYP3A4) enzyme unless the strong or moderate CYP3A4 inducer can be changed to an alternative medicine at least 1 week before Day 1 randomization.
- Received an investigational drug within 30 days or within 5 half-lives (whichever is longer) before Day 1 randomization.
- Previously received avacopan without clinical benefit per the Investigator's opinion or received avacopan within 60 days before Day 1 randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Scottsdale, Arizona, United States
- Surprise, Arizona, United States
- Searcy, Arkansas, United States
- Covina, California, United States
- Fremont, California, United States
- Fresno, California, United States
- Fullerton, California, United States
- Menifee, California, United States
- San Francisco, California, United States
- Torrance, California, United States
- Aurora, Colorado, United States
- Boca Raton, Florida, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- New Albany, Indiana, United States
- Iowa City, Iowa, United States
+ 54 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Scottsdale, Arizona, United States; Surprise, Arizona, United States; Searcy, Arkansas, United States; Covina, California, United States; Fremont, California, United States and 68 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.