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

NCT06072482 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 20220159EU CT Number
• Study Type: interventional
• Target: 300
• Locations: 6 countries
• Sites: 76

Brief Summary

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).

Conditions

Antineutrophil Cytoplasmic Antibody-associated Vasculitis

Keywords

Avacopan; ANCA-associated Vasculitis; AAV

Outcome Measures

Primary Outcomes (9)

• Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

  Up to Month 60

• Percentage of Participants Experiencing Adverse Events of Special Interest

  Up to Month 60

• Percentage of Participants Experiencing Serious Adverse Events

  Up to Month 60

• Percentage of Participants Experiencing Adverse Events Leading to Withdrawal

  Up to Month 60

• Percentage of Participants Experiencing Adverse Events Leading to Death

  Up to Month 60

• Number of Participants Experiencing Clinical Significant Changes from Baseline in Vital Signs Measurements

  Up to Month 60

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

  Up to Month 60

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

  Up to Month 60

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

  Up to Month 60

Secondary Outcomes (11)

• Group A and B Participants who Achieved Remission at Month 12: Time to Relapse in AAV Between Month 12 and Month 60

  Month 12 to Month 60

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

  Month 12 to Month 60

• Groups A and C: Percentage of Participants who Achieved Sustained Remission at Month 60

  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)

  Baseline and Month 60

• Groups A and C: Change from Baseline to Month 60 in Short Form 36 Health Survey Version 2 (SF-36 v2) General Health Perception Score

  Baseline and Month 60

Study Arms (3)

Group A: Avacopan + Standard of Care (SoC)

EXPERIMENTAL

Avacopan 30 mg twice daily for 5 years + SoC background immunosuppressive therapy.

Drug: Avacopan; Drug: Standard of Care

Group B: Avacopan/Placebo + SoC

EXPERIMENTAL

Avacopan 30 mg twice daily for 1 year, followed by placebo twice daily for 4 years + SoC background immunosuppressive therapy.

Drug: Avacopan; Drug: Placebo; Drug: Standard of Care

Group C: Placebo + SoC

PLACEBO COMPARATOR

Placebo twice daily for 5 years + SoC background immunosuppressive therapy.

Drug: Placebo; Drug: Standard of Care

Interventions

Standard of Care DRUG

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.

Group A: Avacopan + Standard of Care (SoC); Group B: Avacopan/Placebo + SoC; Group C: Placebo + SoC

Avacopan DRUG

Administered orally.

Also known as: CCX168

Group A: Avacopan + Standard of Care (SoC); Group B: Avacopan/Placebo + SoC

Placebo DRUG

Administered orally.

Group B: Avacopan/Placebo + SoC; Group C: Placebo + SoC

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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).

You may not qualify 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 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 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (76)

Orthopedic Physicians Alaska

Anchorage, Alaska, 99508, United States

TERMINATED

Scottsdale Healthcare at Shea - HonorHealth

Scottsdale, Arizona, 85258, United States

RECRUITING

Southwest Kidney Institute

Surprise, Arizona, 85374, United States

RECRUITING

Unity Health

Searcy, Arkansas, 72143, United States

RECRUITING

Medvin Clinical Research

Covina, California, 91722, United States

RECRUITING

Palo Alto Medical Foundation Fremont

Fremont, California, 94538, United States

RECRUITING

The Nephrology Group

Fresno, California, 93720, United States

RECRUITING

Providence Medical Foundation

Fullerton, California, 92835, United States

RECRUITING

Medvin Clinical Research

Menifee, California, 92586, United States

RECRUITING

University of California San Francisco- Zuckerburg San Francisco General

San Francisco, California, 94110, United States

RECRUITING

Harbor University of California at Los Angeles Medical Center

Torrance, California, 90502, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Florida Kidney Physicians

Boca Raton, Florida, 33431, United States

RECRUITING

Malcom Randall Veterans Affairs Medical Center

Gainesville, Florida, 32608, United States

RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

ClinTrial Research Oakwater, Llc

Orlando, Florida, 32806, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Lake Cumberland Rheumatology

New Albany, Indiana, 47150, United States

RECRUITING

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

Dunes Clinical Research LLC

Sioux City, Iowa, 51104, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Kidney Michigan Institute

Saginaw, Michigan, 49804, United States

RECRUITING

Clinical Research Institute of Michigan

Saint Clair Shores, Michigan, 48081, United States

RECRUITING

Revive Research Institute

Sterling Heights, Michigan, 48313, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Renown Rheumatology

Reno, Nevada, 89502, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

RECRUITING

Renal Medicine Associates

Albuquerque, New Mexico, 87109, United States

RECRUITING

New York Nephrology Vasculitis and Glomerular Center

Albany, New York, 12209, United States

RECRUITING

Northwell Health

Great Neck, New York, 11021, United States

RECRUITING

Hospital For Special Surgery

New York, New York, 10021, United States

RECRUITING

East Carolina University Brody Outpatient Center

Greenville, North Carolina, 27834, United States

RECRUITING

Brookview Hills Research Associates Llc

Winston-Salem, North Carolina, 27103, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43201, United States

RECRUITING

Stat Research

Miamisburg, Ohio, 45342, United States

RECRUITING

Hightower Clinical

Oklahoma City, Oklahoma, 73114, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Allegheny Health Network Cancer Institute at Mellon Pavilion

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Nephrology Associates Inc

East Providence, Rhode Island, 02914, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Vital Rheumatology

Austin, Texas, 78727, United States

RECRUITING

Renal Disease Research Institute - Landry Office

Dallas, Texas, 75204, United States

RECRUITING

Scott and White Memorial Hospital

Temple, Texas, 76502, United States

RECRUITING

Nephrology Associates of Northern Virginia Inc

Fairfax, Virginia, 22033, United States

RECRUITING

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

TERMINATED

Rheumatology and Pulmonary Clinic

Beckley, West Virginia, 25801, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

RECRUITING

Fakultni nemocnice Olomouc

Olomouc, 779 00, Czechia

RECRUITING

Fakultni nemocnice Ostrava

Ostrava - Poruba, 708 52, Czechia

RECRUITING

Fakultni nemocnice Plzen

Pilsen, 304 60, Czechia

RECRUITING

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

RECRUITING

Revmatologicky ustav

Prague, 128 00, Czechia

RECRUITING

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Odense Universitetshospital

Odense C, 5000, Denmark

RECRUITING

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

RECRUITING

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, 7632, Hungary

RECRUITING

SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

Lodz, 90-153, Poland

RECRUITING

Spzoz Centralny Szpital Kliniczny Umed w Lodzi

Lodz, 92-213, Poland

RECRUITING

Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

Warsaw, 02-637, Poland

RECRUITING

Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy Centralny Szpital Kliniczny Mon

Warsaw, 04-141, Poland

RECRUITING

Spitalul Clinic Sf Maria, Bucuresti

Bucharest, 011172, Romania

RECRUITING

Spitalul Clinic Dr Ion Cantacuzino

Bucharest, 020475, Romania

RECRUITING

Spitalul Clinic Judetean de Urgenta Cluj

Cluj-Napoca, 400006, Romania

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Interventions

avacopan; Standard of Care

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 10, 2023
• Study Start: February 7, 2024
• Primary Completion (Estimated): December 31, 2036
• Study Completion (Estimated): December 31, 2036
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

DK (2); RO (3); US (58); CZ (7); PL (4); HU (2)