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

Purpose

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).

Condition

Antineutrophil Cytoplasmic Antibody-associated Vasculitis

Eligibility

Eligible Ages: Between 18 Years and 100 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion 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 treatment with cyclophosphamide or rituximab is needed. - 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, 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).

Exclusion Criteria

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. - Any 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 12 weeks before signing of the informed consent. - Have had a kidney transplant. - Malignancy except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years before signing the informed consent. - Acute or chronic, active hepatitis B virus or hepatitis C virus, or human immunodeficiency virus infection during screening. - Positive test for active or latent tuberculosis during screening. - White blood cell count < 3500/µL, neutrophil count < 1500/µL, or lymphocyte count < 500/µl. - Evidence of clinically significant hepatic disease including prior diagnosis of cirrhosis. - aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase >2.0 times the upper limit of normal (ULN). - Total bilirubin > 1.5 times the ULN. A participant with documented Gilbert's syndrome with total bilirubin < 2 x ULN may be eligible. - Active infection and/or infection requiring oral or intravenous (IV) antimicrobials within 4 weeks before signing of the informed consent. - History of any clinically significant cardiovascular disease, such as symptomatic congestive heart failure, unstable angina, myocardial infarction or stroke, within 12 weeks before signing of the informed consent. - Received cyclophosphamide (CYC) within 12 weeks before signing the informed consent; if on azathioprine, mycophenolate, or methotrexate at the time of screening, these drugs must be withdrawn before receiving the CYC or rituximab (RTX). - 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 52 weeks before signing of the informed consent or within 26 weeks before signing of the informed consent provided CD19 count > 0.01x10^9/L, or received any of the following within 12 weeks before signing the informed consent: - antitumor necrosis factor treatment - abatacept - alemtuzumab - IV immunoglobulin - belimumab - tocilizumab. - 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. - Received an investigational drug within 30 days or within 5 half-lives (whichever is longer) before signing of the informed consent. - Previously received avacopan without clinical benefit per the Investigator's opinion or received avacopan within 60 days before signing of the informed consent.

Study Design

Phase: Phase 4
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Group A: Avacopan + Standard of Care (SoC)	Avacopan 30 mg twice daily for 5 years + SoC background immunosuppressive therapy.	Drug: Avacopan Administered orally. Other names: CCX168 Drug: Standard of Care 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.
Experimental Group B: Avacopan/Placebo + SoC	Avacopan 30 mg twice daily for 1 year, followed by placebo twice daily for 4 years + SoC background immunosuppressive therapy.	Drug: Avacopan Administered orally. Other names: CCX168 Drug: Placebo Administered orally. Drug: Standard of Care 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.
Placebo Comparator Group C: Placebo + SoC	Placebo twice daily for 5 years + SoC background immunosuppressive therapy.	Drug: Placebo Administered orally. Drug: Standard of Care 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.

Recruiting Locations

Orthopedic Physicians Alaska
Anchorage, Alaska 99508

Hospital For Special Surgery
New York, New York 10021

Virginia Mason Medical Center
Seattle, Washington 98101

Nephrology Associates of Northern Virginia Inc
Fairfax, Virginia 22033

Renal Disease Research Institute - Landry Office
Dallas, Texas 75204

West Tennessee Research Institute, llc
Jackson, Tennessee 38305

Medical University of South Carolina
Charleston, South Carolina 29425

Nephrology Associates Inc
East Providence, Rhode Island 02914

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15261

Allegheny Health Network Cancer Institute at Mellon Pavilion
Pittsburgh, Pennsylvania 15224

Hightower Clinical
Oklahoma City, Oklahoma 73114

Stat Research
Miamisburg, Ohio 45342

The Ohio State University
Columbus, Ohio 43201

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

Brookview Hills Research Associates Llc
Winston-Salem, North Carolina 27103

East Carolina University Brody Outpatient Center
Greenville, North Carolina 27834

Northwell Health
Great Neck, New York 11021

Southwest Kidney Institute
Surprise, Arizona 85374

New York Nephrology Vasculitis and Glomerular Center
Albany, New York 12209

Mayo Clinic
Rochester, Minnesota 55905

Brigham and Womens Hospital
Boston, Massachusetts 02115

Massachusetts General Hospital
Boston, Massachusetts 02114

University of Kentucky
Lexington, Kentucky 40536

University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242

Lake Cumberland Rheumatology
New Albany, Indiana 47150

Florida Kidney Physicians
Boca Raton, Florida 33431

Harbor University of California at Los Angeles Medical Center
Torrance, California 90502

Medvin Clinical Research
Menifee, California 92586

Providence Medical Foundation
Fullerton, California 92835

The Nephrology Group
Fresno, California 93720

Palo Alto Medical Foundation Fremont
Fremont, California 94538

Medvin Clinical Research
Covina, California 91722

Rheumatology and Pulmonary Clinic
Beckley, West Virginia 25801

More Details

NCT ID: NCT06072482
Status: Recruiting
Sponsor: Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.