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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 Sex: 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 induction 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, 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).

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 that may confound study assessments and study conclusions including but not limited to eosinophilic granulomatosis with polyangiitis (GPA [Churg-Strauss]), systemic lupus erythematosus, immunoglobulin (Ig) A vasculitis (Henoch-Schönlein), rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis. - 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, eligibility will be determined based on the repeat complete blood count. - 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 infection, opportunistic infection, or history of recurrent infection) that in the opinion of the investigator would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. Oral or vaginal candidiasis and cutaneous or nail fungal infections do not constitute an exclusion. - 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 cardiovascular disease that in the opinion of the investigator would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. - 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 receiving CYC. Note: If induction therapy with CYC was started within 1 week before signing the informed consent for the current episode of newly diagnosed or relapse of GPA or microscopic polyangiitis (MPA), the participant may be eligible, provided no CYC was received within 12 weeks before the start of the current induction therapy and if on AZA, mycophenolate, or MTX, these were withdrawn prior to receiving the current induction therapy with CYC. - 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 rituximab (RTX). Note: If induction therapy with RTX was started within 1 week before signing the informed consent for the current episode of newly diagnosed or relapse of GPA or MPA, the participant may be eligible, provided no RTX was received within 26 weeks before the start of the current induction therapy and if on AZA, mycophenolate, or MTX, these were withdrawn prior to receiving the current induction therapy with RTX. - 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.

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

Scottsdale Healthcare at Shea - HonorHealth
Scottsdale 5313457, Arizona 5551752 85258

Southwest Kidney Institute
Surprise 5316428, Arizona 5551752 85374

Medvin Clinical Research
Covina 5340175, California 5332921 91722

Palo Alto Medical Foundation Fremont
Fremont 5350734, California 5332921 94538

The Nephrology Group
Fresno 5350937, California 5332921 93720

Providence Medical Foundation
Fullerton 5351247, California 5332921 92835

Medvin Clinical Research
Menifee 5372205, California 5332921 92586

University of California San Francisco- Zuckerburg San Francisco General
San Francisco 5391959, California 5332921 94110

Harbor University of California at Los Angeles Medical Center
Torrance 5403022, California 5332921 90502

University of Colorado
Aurora 5412347, Colorado 5417618 80045

Florida Kidney Physicians
Boca Raton 4148411, Florida 4155751 33431

Malcom Randall Veterans Affairs Medical Center
Gainesville 4156404, Florida 4155751 32608

Mayo Clinic
Jacksonville 4160021, Florida 4155751 32224

ClinTrial Research Oakwater, Llc
Orlando 4167147, Florida 4155751 32806

University of South Florida
Tampa 4174757, Florida 4155751 33606

Emory University
Atlanta 4180439, Georgia 4197000 30322

Lake Cumberland Rheumatology
New Albany 4262045, Indiana 4921868 47150

University of Iowa Hospitals and Clinics
Iowa City 4862034, Iowa 4862182 52242

Dunes Clinical Research LLC
Sioux City 4876523, Iowa 4862182 51104

University of Kentucky
Lexington 4297983, Kentucky 6254925 40536

Johns Hopkins Bayview Medical Center
Baltimore 4347778, Maryland 4361885 21224

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

Brigham and Womens Hospital
Boston 4930956, Massachusetts 6254926 02115

Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202

Kidney Michigan Institute
Saginaw 5007989, Michigan 5001836 49804

University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55414

Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905

Renown Rheumatology
Reno 5511077, Nevada 5509151 89502

Dartmouth Hitchcock Medical Center
Lebanon 5088597, New Hampshire 5090174 03766

New York Nephrology Vasculitis and Glomerular Center
Albany 5106834, New York 5128638 12209

Northwell Health
Great Neck 5119218, New York 5128638 11021

Hospital For Special Surgery
New York 5128581, New York 5128638 10021

East Carolina University Brody Outpatient Center
Greenville 4469160, North Carolina 4482348 27834

Brookview Hills Research Associates Llc
Winston-Salem 4499612, North Carolina 4482348 27103

University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106

The Ohio State University
Columbus 4509177, Ohio 5165418 43201

Stat Research
Miamisburg 4518188, Ohio 5165418 45342

Hightower Clinical
Oklahoma City 4544349, Oklahoma 4544379 73114

Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239

University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104

Allegheny Health Network Cancer Institute at Mellon Pavilion
Pittsburgh 5206379, Pennsylvania 6254927 15224

University of Pittsburgh Medical Center
Pittsburgh 5206379, Pennsylvania 6254927 15261

Nephrology Associates Inc
East Providence 5221931, Rhode Island 5224323 02914

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425

West Tennessee Research Institute
Jackson 4632595, Tennessee 4662168 38305

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232

Renal Disease Research Institute - Landry Office
Dallas 4684888, Texas 4736286 75204

Scott and White Memorial Hospital
Temple 4735966, Texas 4736286 76502

Nephrology Associates of Northern Virginia Inc
Fairfax 4758023, Virginia 6254928 22033

Virginia Mason Medical Center
Seattle 5809844, Washington 5815135 98101

Rheumatology and Pulmonary Clinic
Beckley 4798308, West Virginia 4826850 25801

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226

More Details

NCT ID: NCT06072482
Status: Recruiting
Sponsor: Amgen

Study Contact

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